Posts – Page 93 – PEAH – Policies for Equitable Access to Health

Impact of the Amended Indian Patent Act (1970) on Access to Medicines in India

In the recent past, there have been several significant developments in India in the area of using TRIPS flexibilities for promoting access to health products. Several of these involve the Indian Patent Act (2005) especially Section 3(d) that defines the scope of patentability, limiting data protection, providing for government use and compulsory licenses to non-patentees etc. A major concern of several patent offices all over the world in respect of providing access is the growing prevalence of what are known as 'secondary' patents i.e., patents covering various ancillary features of existing medicines. In addition, there are also attempts toward filing numerous patent applications for the same medicine (to create what are called as 'patent clusters' or 'patent thickets', especially by global multinational companies (MNCs). The strategy called evergreening, that refers to patenting strategies to secure sequential and overlapping patents on a single object (qua invention) through trivial changes such as change in size, colour, dosage, delivery mechanism and composition of a patented drug. Broadly, there are two strategies to limit the scope of patentability: i) increase the threshold limit of patentability criteria by providing a definition of patentability criteria, viz. novelty, inventive step and industrial applications; and ii) exclude certain types of inventions, which do not satisfy any one of the patentability criteria, or those inventions which are in conflict with public morality, national security or affecting the health of humans, animals and plants. Section 3 of the Indian Patents Act (1970) lists 15 broad categories of knowledge as not inventions within the meaning of this Act. These include i) new uses of known substances [section 3(d)]; ii) new forms of known substances, without significant enhancement in efficacy [section 3(d)] providing for government use and compulsory licenses to non-patentees. This provision while excluding new forms of known substance, discovery of new property of known substance and new use of known substance, treats salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance as the same substance that do not confer significant enhancement in efficacy [section 3(d)]. The section 3(e) covers what are known as 'mere admixtures'. Other safeguards include the pre-grant opposition where any person may file opposition by way of representation to the Controller against the grant of Patent, at the appropriate office, at any time after publication of patent application u/s 11A, but before the grant of Patent on any of the grounds mentioned in Section 25(1). The potential impact of effective implementation of these initiatives for promoting  access to health care with specific reference to India are discussed

Impact of the Amended Indian Patent Act (1970) on Access to Medicines in India

By Sadhana Srivastava*

and Kanikaram Satyanarayana**

Indian Council od Medical Research, Department of Health Research
(Ministry of Health & Family Welfare), New Delhi

Introduction

It is widely believed that pharmaceutical patents promote monopoly and thus significantly delay the entry of generics. Due to the lack of competition, the prices of medicines rise. The current system of product patent protection due to the harmonized global intellectual property rights laws are widely considered to be a major barrier for the access to medicines, especially in the developing countries.1 [1] Until such a time the poor and middle income countries became signatories to the World Trade Organization’s 1995 Trade Related Intellectual Property Rights (TRIPS) agreement, they had the freedom and flexibility to design patent laws that prohibited product patents.

With the enforcement of the TRIPS agreement in 2005, developing countries have been compelled to modify and introduce TRIPS-compliant national patent laws. The TRIPS Agreement harmonized the life of patent to a minimum of 20 years besides mandating the granting of patents in all fields of technology including food and drugs. The potential adverse impact of the new patent legislation on global public health has been widely studied and reported although some observers feel that the full impact is being felt only in recent years.1 [1] Like, over the past decade, the global focus in this area is largely on India for at least two reasons. Firstly, India is considered to be global pharmacy for providing cheap drugs for diseases like the HIV/AIDS that brought a dramatic reduction of price from over US$ 10000 to about US$ 150. 2 [2] Also, close to 80 percent of drugs for HIV-AIDS to low income countries in Africa are sourced from India 3 [3] Secondly, a new battle is being currently fought in the Indian courts on issue of access to cancer medicines.

Given the legal complexities of the enforcement of the TRIPS agreement, especially in middle income countries, and the critical role countries as India and Brazil play in the manufacture and supply of cheap medicines for their own people and also the needy in other poor countries, legal interpretation of many clauses has been frustratingly slow. Public health and legal scholars have suggested that developing countries might ameliorate the potential negative effects of TRIPS on access to medicines by exploiting TRIPS “flexibilities”3 [3] which provide some room for manoeuvre while designing national patent laws. This is because the TRIPS Agreement provides for considerable discretion on how the obligations are interpreted and implemented by sovereign governments. Yet, several developing countries have faced obstacles when seeking to implement measures to promote access to affordable medicines in view of lack of clarity and/or willingness of developed countries and perhaps the lack of adequate expertise in the interpretation of international law. Thus, developing countries have been constantly seeking clarity about the provisions in the TRIPS Agreement that provide sufficient flexibility and discretion to ensure access to medicines. And in the light of public health beginning with the Doha Declaration which affirmed that the TRIPS agreement “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”. 4 [4] TRIPS flexibilities include, for example, the ability to delay entry into TRIPS (developing countries had until 2005, and least developed countries have until 2016) and to grant compulsory licenses, among other provisions. Another flexibility is the scope to define patentability standards. While countries cannot, under article 27.1 of TRIPS, exclude entire fields from patenting, they do have the right to determine standards of patentability.5 [5] This is considered essential due to the continued attempts by multinational companies (MNCs) to seek IP protection and monopoly to prevent the entry of generics. One of the major concerns relates to filing of frivolous patents in developing countries on so-called incremental modifications to drugs. 5 6 [5][6] Such patenting is sometimes characterized as “evergreening,” since such patents are often filed late in the product life cycle and are used to temporally extend market exclusivity. 6 7 [6] [7]

Significantly, in the pre-TRIPS era due to absence of product patent protection, virtually all the HIV/AIDS programmes in countries like Brazil and Thailand were successfully run as several key pharmaceuticals could be produced locally at much lower costs. 8 [8] These include the so called ‘1st line’ drugs, that are used when patients first begin AIDS treatment. The production of anti HIV drugs (antiretrovirals-ARVs) in Brazil also created a large market for ARV active pharmaceutical ingredients (API), making it possible for the Indian pharma companies to produce ARVs in large volumes. 9 [9] The resulting scale of manufacture dramatically brought down the prices. In fact most of the currently affordable ARVs come from India. Like by 2008, an estimated 3 million people in low and middle income countries received ARV therapy for HIV/AIDS of which as much as 60% originated from India. 10 [10] What is more, 70% of the medicines for AIDS purchased by the United Nations Children’s Fund (UNICEF), International Dispensary Association (IDA), the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and the Clinton Foundation supplied to over 80 developing countries came from Indian suppliers. Similar is the case with purchases by the MSF and the US President’s Emergency Plan for AIDS Relief (PEPFAR).These efforts meant cost-savings of up to 90%. 11 [11] As many as 91% of all the generic ARVs manufactured in India were in US Food and Drug Administration (US FDA) approved facilities in India.12 [12] Significantly, as stated above these medicines could be brought in to the market in the pre-TRIPS era as they were not under product patent regime.

While the developing world is grappling with the issue of access to Types II and III diseases, there is a steady rise of non-communicable diseases (NCDs) like heart disease, stroke, diabetes and cancers in the middle income and poor countries. 13 [13] 14 [14] In the next two decades a dramatic change on health needs of poor and middle income countries is anticipated. At present, lifestyle and behaviour are linked to 20-25% of the global burden of disease. In the developing countries, where four-fifths of the planet’s people live, NCDs such as cancers, heart disease, diabetes and mental health problems will replace the traditional public health problems such as infectious diseases and malnutrition, as the leading causes of disability and premature death. Also, by 2020, NCDs are expected to account for seven out of every ten deaths in the developing regions, compared with less than half today. 14 [14] This is going to put the health care system of developing and least developed countries under more strain due to increased cost of medicines.

In the light of the dual disease burden, one of the most pragmatic solutions available for developing countries, including India, is to make prudent use of the flexibilities available in TRIPS. But it is also equally important that these TRIPS flexibilities are incorporated into domestic patent laws. This requires clear understanding of the TRIPS obligations and the techno-legal expertise to translate the flexibilities into the domestic patent law. For India it is important that the vibrant and dynamic domestic generic industry built over the last three decades is allowed to play its critical role for providing cheap medicines. 15 [15]

Important Sections of Amended Patent Act

India has modified its Patent Act (1970) through three amendments in the years 1999, 2002 and 2005. The main objectives of these amendments are to ensure that the changes made are TRIPS-complaint and at the same time as many safeguards as possible are built-in to protect the interest of public health. Some main components of modified Indian patent law that address the above include i) scope of patentability [Sections 3(d)] and 3[e], ii) limiting data protection, providing for government use; iii) and compulsory licenses (Section 84) to non-patentees.

Section 3(d)

Section 3(d) of India’s Amended Patents Act of 2005 aims at reducing the scope of taking patent protection on grounds of new use of known compounds without establishment of significant enhanced efficacy: “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” Section 3(d) specifically states that for the patenting purposes, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.16 [16]

Section 3 of the Indian Patents Act, 1970 lists 15 broad categories of knowledge as ‘not inventions’ within the meaning of this Act particularly relevant in the pharmaceutical context. The Section 3(d) also aims to address the issue of evergreening, a strategy through which companies aim at securing sequential and overlapping patents on a single invention through trivial changes or ‘improvements’. It may involve changes in size, colour, dosage, delivery mechanism and composition. A particular salt form of a drug may establish improvements along a number of important parameters, including bioavailability, stability, ease of manufacture, and other solid-state properties.17 [17] While these improvements may be useful, they may not necessarily be particularly inventive falling short of the criteria of patenting. Like there are a limited number of known acids employed by pharma companies to produce pharmaceutically acceptable salts through well known processes. These therefore cannot fulfil the criteria of patentability. Some other common practices include the discovery that a previously known compound in another stereoisomeric configuration (e.g., as enantiomers) may be more biologically active. Or it could even be a more pharmaceutically active metabolite of a known compound. There have been several cases where applications have been filed with claimed improvement in physiochemical and pharmacokinetical properties like better solubility and improved plasma stability etc. Sometimes a claimed ‘new drug’ may not be new at all like the active substance in the ARV drug zidovudine (AZT) that is known since the 1960s investigated as an anti-cancer drug. 18 [18] In fact over 75% of the patented drugs were reportedly modifications of known substances, with a study concluding that only 15% of drugs approved by the US Food and Drug Authority during 1989 and 2000 can be considered âhighly innovativeâ. 19 [19] The Glivec case is a more recent and appropriate example on the issue of legal interpretation of Section 3(d).

Glivec

An Indian application “Crystal modification of A N-phenyl-2 Pyrimidineamine derivative, processes for its manufactures and its use” was filed by Novartis on July 17, 1998. (1602/MAS/1998). Glivec (Imatinib mesylate) is a patented product by Novartis for Chronic Myeloid Leukemia in 35 countries. Various generic pharmaceutical companies including Ranbaxy, Cipla, Natco Pharma and one patients group - the Cancer Patient Aid Association (CPAA) filed a pre-grant opposition to this Indian application under the provisions of section 25 (1) (e) & (g) of the Indian Patents (Amendment) Act 2005. The Chennai patent Office rejected the Glivec patent application in January 2006, on the grounds that the application claimed ‘only a new form of a known substance’. This Indian patent application is directed to the beta-crystal form of methanesulphonic acid salt, commercially called Imatinib Mesylate. Two polymorphs of imatinib mesylate are claimed: alpha and beta (Original molecule imatinib is disclosed in US 5521184 titled “Pyrimidine derivatives and processes for the preparation thereof” in 1993). The patent office rejected patent application because the invention claimed only a new form of a known substance without making any significant improvements in efficacy, and hence constituted non-patentable subject matter.

Novartis appealed against the decision of the Chennai Patent Office before the Madras High Court. In addition to appealing against the rejection of the patent, Novartis also challenged the very validity of section 3(d), claiming that the provisions of the section are not consistent with India’s obligations under the TRIPS Agreement and therefore unconstitutional. The Madras High Court dismissed the appeal of Novartis challenge on all counts. The Court clearly distinguished between ‘efficacy’ as ‘therapeutic efficacy,’ and between drug’s ‘potency,’ indicating that a very high threshold would have to met before the ‘efficacy’ requirement is fulfilled under section 3(d). However, the Madras High Court decided only on the matter of section 3(d)’s validity and not the Chennai Patent Office’s rejection of its patent application. Subsequently, during the pendency of the appeal, the Indian Patent Appellate Board (IPAB) which has exclusive jurisdiction to hear appeals against decisions of all Indian patent office decisions was notified and created. The IPAB endorsed the Madras High Court’s interpretation of the meaning of ‘efficacy,’ and made a clear distinction between “advantageous properties” and “therapeutic efficacy”. The IPAB specifically excluded improved bio-availability; better stability; improved flow properties; and lower hygroscopicity from the “advantageous properties”. In 2009, Novartis appealed to the Supreme Court. On 1^st April, 2013, the Supreme Court rejected the Glivec patent. 20 [20]

From the above it becomes clear that i) the legislative intent of Parliament in enacting section 3(d) was to protect public health and prevent ever-greening was recognized; ii) Indian patent offices must recognize that “pharmaceutical product [patents] in India should be granted with utmost care and should be granted only to very genuine cases;” iii) while interpreting the meaning of ‘efficacy,’ extremely high standard have to be applied; iv) an ‘advantageous property’ is not the same as efficacy in that ‘new forms’ that result in advantageous properties with respect to bioavailability, stability, etc., are not patentable; and v) ‘mere admixtures,’ compositions, dosage forms, formulations, and combinations are not patentable unless there is a demonstrable synergistic effect between the components. 21 [21]

Section 25(1)- Pre-Grant Opposition

Pre-grant opposition is another unique safeguard to promote accessibility and affordability through preventing of granting patents to inventions that do not fulfil the criteria of patenting by way of representation to the Controller at any time after publication of patent application but before the grant of patent. There are 11 grounds under Section 25(1) under which an application can be challenged. There are at least 10 instances where, using this provision, patents filed have been challenged in India.

Some of these include: 22 [22]

Darunavir (Tibotec v Cipla) Polymorph 3598/DELNP/2004 Section 3(d). In the matter of Application for patent no 3598/ DELNP/ 2004, Delhi Patent Office, 6 July 2009.

Adefovir dipivoxil (Gilead v Ranbaxy) Crystal Form 712/DEL/2002 on the basis of 3(d) In the matter of Patent application no. 712/del/2002 filed on 03/07/2002, Delhi Patent Office, 18 March 2009

Amlodipine-atorvastatin combination (Pfizer v Torrent) 2571/DEL/1998 Section (3d and 3e). In the matter of the application for Patent No. 2571/del/1998 filed on 28th Aug. 1998, Delhi Patent Office, 3 February 2009.

Rosiglitazone (Smithkline Beecham) Sulphonate Salt 295/DELNP/2003 on the basis of 3(d) Patent Application No.00295/DELNP/2003 - Hearing U/S 14 read with 15 of the Patents Act, 1970, Delhi Patent Office, 6 January 2009.

Erlotinib polymorph (OSI v Cipla) Crystal Form IN/PCT/2002/507/DEL. Section 3(d) In the matter the application for patent No. IN/PCT/2002/507/DEL filed on 14^th May,2002, Delhi Patent Office, 15 December 2008.

Crystalline Macrolides (Novarts v Ranbaxy) Crystal Form 1440/MAS/1998. Section (3d) In the matter of Application for Patent bearing the number as 1440/MAS/1998 filed on 29th June 1998 by Novertis AG of Schwarzwaldallee 215, 4058 Basel, Switzerland,, A Swiss Company, Chennai Patent Office, 13 July 2007.

Atorvastatin (Warner-Lamber v Torrent) Crystal Form 1577/DEL/1996 Section (3d) In the matter of the Application for patent No.1577 /DEL/1996 filed on 19th April, 1998, Delhi Patent Office, 12 June 2007.

All these cases of pre-grant opposition were successful as the applicants failed to fulfil the conditions required under section 3(d), 3(e) and section 2(1.j) of the Patent Act. The main objective of such opposition is to improve the quality of patents or to prevent frivolous and unworthy patents from being granted. The rejection of these patent applications is considered a big step in towards ensuring access to cheap life-saving drugs.

Section 84(1) and 92 A (1)- Compulsory Licensing

Compulsory Licensing (CL) is a procedure whereby a Government can allow any company, agency or designated person the right to make a patented product, or use a patented process under licence, without the consent of the original patent holder. CL is an important legal tool to promote competition to increase the affordability of drugs at once compensating the patent owner for the use of the invention. Section 84 of the Amended Indian Patents Act (2005) deals with compulsory licenses and allows any interested person to apply for a CL but only after the patentee rejects the request of applicant for issuance of a voluntary license. The Indian Patent Law provides sufficient powers to the Controller of Patents to issue compulsory licenses to deal situations that warrant intervention. Two sections directly address the requirement of essential drugs for domestic use and countries which do not have the manufacturing capacity for these drugs. Section 84 mandates prevent the abuse of patent as a monopoly and facilitate manufacturing of invention by any interested person. Sections 92 (1) and 92 (3) lay down circumstances of national emergency or extreme urgency while Section 92(a) is meant for exporting pharmaceutical products to other countries that need such products for public health purpose. The grounds broadly could be: i) reasonable requirements of the public with reference to patented invention are not met; ii) the patented invention was not available to public at an affordable price; and iii) patent is not worked in the territory of India to the fullest extent that is reasonably practicable. Generally, such a license can be applied after three years of the grant of a patent: “At any time after the expiration of three years from the date of the grant a patent, any person interested may make application to the Controller for grant of compulsory license.” In addition, a ‘reasonable time period’ of up to six months has been introduced, before the Controller considers request for grant of a compulsory license in cases where the applicant fails to obtain a licence from the patentee on reasonable terms and conditions. 23[23]

First Compulsory License by the Indian Patent Office was granted for Nexavar

‘Sorafenib Tosylate’ is a compound patented by Bayer Corporation, USA and marketed as Nexavar. The drug is life-extending drug used in the treatment of advanced stages of kidney cancer (Renal Cell Carcinoma) and liver cancer (Hepatocellular carcinoma). Sorafenib can extend the life of kidney cancer patients by 4-5 years and in liver cancer patients by 6-8 months. 24 [24] Bayer was granted a patent (No. 215758) as well as regulatory approval for importing and marketing the Drug in India in the year 2008. Bayer charges approximately US$66,812 per patient per year/ over US$5,500 per month in India for this drug.25 [25]

M/s Natco Pharma (Natco) tried for voluntary licence to manufacture and sell its generic version of drug in December 2010 for Nexavar from Bayer but the company rejected Natco’s proposal, saying it needed to reinvest its earnings from such patented products for future R&D. 26 [26] After the lapse of 3 years since the date of grant of patent to Bayer Corp. for Nexavar, Natco filed an application in July 2011 before the Controller of Patents for grant of Compulsory License under section 84 in respect of Sorafenib.25 [25]

The grounds on which the appeal was made were: i) reasonable requirements of the public with reference to the patented invention have not been met; ii) patented invention was not available to public at an affordable price; and iii) patent has not been worked in the territory of India to the fullest extent that is reasonably practicable. Also M/s Bayer charged for Rs. 2.85 lakhs for a one month’s course of the medicine while Natco proposed to sell its generic version, sorafenib tosylate, for about Rs. 8,800, which is a about 3 percent of the cost of the innovatorâs product. 27 [27]

In a landmark decision the Indian Patent office on 9th March 2012 granted the country’s first compulsory license. The CL allowed Natco Pharma Ltd, an Indian generic drug maker to make and sell generic version of liver/kidney cancer drug Nexavar patented by M/s Bayer Corporation. The order of patent controller is significant because this is the first time India had invoked the compulsory licensing provision to increase citizensâ access to expensive, life-saving drugs. Itâs also the first time that an Indian company has been granted compulsory license to market a generic version of a patented drug. 27 [27]

The CL is valid till the expiry of the patent i.e. up to 2021. The company has to fulfil certain conditions like maintaining account of sales, and payment of royalty at 6% of the net sales on a quarterly basis. The order also makes it mandatory for Natco to supply the drug free of cost to at least 600 needy and deserving patients per year. 28 [28] Bayer appealed against this order to the Intellectual Property Appellate Board (“IPAB”). The IPAB held that the failure to meet the demand of the public on reasonable terms has to include both “quantity” and “price” i.e. the patentee has to work the invention in India on a commercial scale and the invention has to be available at a reasonably affordable price. 25 [25]

Concluding Notes

In the recent past, the Indian Patent Act (2005), has been put to test with several sections challenged in the Indian Courts. The decisions of the courts have provided clarity on the interpretation in the decisions taken by the Patent Controller that comply with India’s obligations under the TRIPS agreements. This clarity should help India to make use of the safeguards available to limit the impact of the patent barriers towards promoting affordable health care. The uninterrupted supply of generic drugs from India has played a key role in lowering the price of essential drugs for poor both in India as well as many developing countries. It is also hoped that discussions as these will facilitate formulation of a cohesive policy. The significant participation of the civil society groups in the ongoing battle has been very important and such a pressure must be maintained. A robust legally enforceable mechanism is important as with time the effectiveness of CL is likely to be blunted and it is only competition among generic suppliers that would help India keep the supply channels of cheap medicines to poor countries open. 12 [12]

References

1.’t Hoen. Ellen F. M. TRIPS, Pharmaceutical Patents, and Access to Essential Medicines:Seattle, Doha, and Beyond. World Health Organization topic. 2003; 39-62. & ‘t Hoen. Ellen F. M. Drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and Public Health. The Global Politics of Pharmaceutical Monopoly Power 2009; 1-135

2. Running in Place: Too many patients still in urgent need of HIV/AIDS treatment. Briefing document on HIV/AIDS.XVII International AIDS Conference. Médecins Sans Frontières 2008

3. Correa, C, Matthews D. The Doha Declaration Ten Years On and Its Impact on Access to Medicines and the Right to Health. Discussion Paper, UNDP 2011. 1-31

4. Doha WTO Ministerial. Declaration on the TRIPS Agreement and Public Health. WTO, 2001

5. Correa, CM. Pharmaceutical Innovation, Incremental Patenting, and Compulsory Licensing. South Centre Research Paper no. 41. 2011; 1-22

6. Kapczynski, Amy and Park, Chan and Sampat, Bhaven N., Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of Secondary Pharmaceutical Patents. Yale Law School, Public Law Working Paper No. 271; Yale Law & Economics Research Paper No. 462. doi:10.1371/journal.pone.0049470. PLOS One 2012; 7:12

7. Hemphill, S, Bhaven Sampat B. When Do Generics Challenge Drug Patents? doi:10.1111/j.1740-1461.2011.01235.x. Journal of Empirical Legal Studies, 2011; 8: 4; 613-649

8. Satyanarayana K. TRIPS, patents and HIV/AIDS drugs. Indian J Med Res. 2005;121:211-214

9. Satyanarayana K, Srivastava S. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) - A Strategic Option for India. The Open AIDS Journal 2010; 4: 41-53

10. Report of the Inquiry of The All Party Parliamentary Group on AIDS into long-term access to HIV medicines in the developing world. The treatment Timebomb 2009

11. Satyanarayana K, Srivastava S. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) - A Strategic Option for India, The Open AIDS Journal 2010, 4, 41-53

12. Untangling the Web of Antiretroviral Price Reductions, 16^th Edition. Médecins Sans Frontières, 2013

13. WHO. Defining Disease Types I, II And III, Background document provided by the WHO Secretariat, 2012: 1-3

14. Millennium Development Goal 8, The Global Partnership for Development: The Challenge We Face. United Nations, MDG Gap Task Force Report 2013

15. Chaudhuri S, Park. C, Gopakumar K M. Five Years into the Product Patent Regime: India’s Response. A study by United Nations Development, Programme Poverty reduction and HIV/AIDS 2010:73-105

16. Gopakumar K M. Product Patents and Access to Medicines in India: A Critical Review of the Implementation of TRIPS Patent Regime. The Law and Development Review 2010;3:2:Article11

17. Berge, et al. Pharmaceutical Salts. Journal of Pharmaceutical Sciences, 1977; 66:1:1-19

18. Horwitz, J., et al. The monomesylates of 1-(2â-deoxy-B-D-lyxofuranosyl) thymine, Journal of Organic Chemistry 1964: 29:7: 2076-2078

19. Anand G. Analysing the Supreme Court Judgment. Economic & Political Weekly 2013. 48(32)

20. Kulkarni K, Mohanty S. (2013), Novartis loses landmark India patent case on Glivec. Reuters article 2013

21. Novartis case: background and update-Supreme Court of India to recommence hearing. Lawyers Collective HIV/AIDS Unit 2011

22. I-MAK. Initiative for Medicines, Access & Knowledge, Pharmaceutical Patent Case Law

23. Indian Patents Act, 1970, s. 84 & s. 92

24. Background Information on India’s First Compulsory Licence. Médecins Sans Frontières 2012

25. Jha and Gokhle (2013), IPAB upholds the first compulsory license granted to generic drug company. Nishith Desai Associates 2013

26. Natco Pharma bags licence to sell Bayer’s cancer drug Nexavar, ET Bureau The Economic Times 2012

27. Vijayakumar S, Rajagopal D. Natcoâs compulsory licence for selling generic copies of Bayer’s cancer drug Nexavar upheld by IPAB. ET Bureau The Economic Times 2013

28. NATCO granted compulsory licence for Nexavar. Natco Pharma Ltd. News 2012

Links

1. http://www.who.int/intellectualproperty/topics/ip/tHoen.pdf & http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/ACCESS_book_GlobalPolitics_tHoen_ENG_2009.pdf

2. http://issuu.com/msf_australia/docs/msf-mexico-iac-briefing-document?e=1047569/4458580

3. http://www.undp.org/content/dam/undp/library/hivaids/Discussion_Paper_Doha_Declaration_Public_Health.pdf

4. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

5. http://www.prachatai.com/sites/default/files/RP%2041%20Pharm%20CompLice%20CCorrea.pdf

6. http://www.ssrn.com/abstract=2191728

7. http://www.onlinelibrary.wiley.com/doi/10.1111/j.1740-1461.2011.01235.x/abstract

8. http://www.icmr.nic.in/ijmr/2005/april/editorial2.pdf

9. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2819698/

10. http://www.i-mak.org/storage/APPG%20Policy%20Report.pdf

11. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2819698/

12. http://d2pd3b5abq75bb.cloudfront.net/2013/09/11/10/25/44/896/MSF_Access_UTW_16th_Edition_2013.pdf

13. http://www.who.int/phi/3-background_cewg_agenda_item5_disease_types_final.pdf

14. http://www.un.org/en/development/desa/policy/mdg_gap/mdg_gap2013/mdg_report_2013_en.pdf

15. http://apps.who.int/medicinedocs/documents/s17761en/s17761en.pdf

16. http://www.infojustice.org/download/gcongress/global_architecture_and_the_development_agenda/gopakumar%20article.pdf

17. http://www.onlinelibrary.wiley.com/doi/10.1002/jps.2600660104/abstract

18. http://www.pubs.acs.org/doi/abs/10.1021/jo01030a546

19. http://www.epw.in/glivec-precedent/analysing-supreme-court-judgment.html

20. http://in.reuters.com/article/2013/04/01/india-drugs-patent-novartis-glivec-idINDEE93000920130401

21. http://www.lawyerscollective.org/news/archived-news-a-articles/126-novartis-case-background-and-update-supreme-court-of-india-to-recommence-hearing.html

22. http://www.i-mak.org/pharma-patent-decisions/

23. http://www.ipindia.nic.in/ipr/patent/eVersion_ActRules/sections-index.htm

24. http://www.msfaccess.org/content/background-information-indias-first-compulsory-licence

25. http://www.lexology.com/library/detail.aspx?g=19b855c5-9e51-4854-8b8c-cf4a859c9483

26. http://articles.economictimes.indiatimes.com/2012-03-13/news/31159811_1_patent-owner-compulsory-licensing-patent-law

27. http://articles.economictimes.indiatimes.com/2013-03-04/news/37437382_1_nexavar-compulsory-licence-leena-menghaney

28. http://www.natcopharma.co.in/index.php/news-for-dump/149-natco-granted-compulsory-licence-for-nexavar

—————————————————————————————————————–

*Dr Sadhana Srivastava, a qualified patent agent was an intern at the Cornell University and Office of Technology Transfer, NIH, Bethesda. She was a Government delegate in the Inter-Governmental Working Group on Intellectual Property & Public Health, WHO, Geneva. Dr Srivastava is a senior scientist with the Indian Council of Medical Research, New Delhi looking after the IPR activities of the Indian Council of Medical Research.

**Dr Kanikaram Satyanarayana has been instrumental in the formulation of the guidelines and policies for IPR and technology transfer of the Indian Council of Medical Research, Govt of India. He advises the Ministry of Health & Family Welfare, Government of India on IPR, health and trade issues and also served as a temporary adviser for the Inter-Governmental Working Group on Public Health and Innovation (IGWG) for the WHO, Geneva and also the SEAR (WHO) for Consultative Expert Working Group (CEWG) meetings. He was a member of the International Editorial Board for the Technology Transfer Manual on Agriculture and Health of the MIHR, UK and founder-Secretary of the Society for Technology Management (STEM), India. Dr Satyanarayana is currently Co-ordinator in the Department of Health Research, New Delhi.

News Link n. 84

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

News Link 84

Uganda donors cut aid after president passes anti-gay law

Europe reconsiders Uganda aid following anti-gay law

Uganda: The Politics of Uganda’s Anti-Homosexuality Legislation

African farmers cut use of âtoxicâ pesticides through EU-funded project

Land Grabs in Africa: Senegal Farmers and Herders Demand Shady Transnational Corporation to Get off their Land

How does crop biotechnology help food security

Big food companies improve policies in developing nations, Oxfam

EU scientistsâ biofuels warnings were ignored

Parliament kicks off debate on the legal right to water

EU, African science groups support biotech development

The Trans-Pacific Partnership Agreement: Implications for Access to Medicines and Public Health

Evidence-based medicine vital for health and medical progress in China

TRIPS Council: Discussion Of IP And Innovation Irritates India: Other Issues Unchanged

The State Of Health Reform: A Health Affairs Conversation With James Capretta, Genevieve Kenney, and Larry Levitt

Obamacare. Salute, lavoro, bugie

The G-20â²s Growing List of Unfinished Business

Top 5 Lame Excuses Not to Support Extreme-Poverty Alleviation Work

World Bank to help map Africa’s mineral resources

More Than a Phone: Mobile Empowering Women

Compulsory patent licensing and local drug manufacturing capacity in Africa

Quanto costano i migranti in Europa

News Link n. 83

News Link 83

ROBIN HOOD TAX MEDIA BRIEF FEBRUARY 2014

Future News? 3 enlightened reasons to help make the Robin Hood Tax a reality now

How microfinance disappointed the developing world

TTIP: No Lowering Of Standards, Officials Say; New Trade Consultation Body Scrutinised

Where policy fora collide: country-code Top-Level Domains and the Trans Pacific Partnership agreement

More Data Needed on USAID Global Health Supply Chain

Interview With Nazeem Mohamed, CEO Of Kampala Pharmaceutical Industries

Battles Over Patents: Is India Changing The Rules Of The Game?

Graphics on U.S. Pharmaceutical Exports to India, Patents, the Compulsory License, and Prices

Asia-Pacific’s fight against malaria gets a boost from Australia

South-South Cooperation Takes Off in Arab World

New food production models needed in Africa

Federica Mogherini agli Esteri, blindata la riforma della cooperazione

Africaâs Promising Energy Future

How important is clean water for education?

Revolutionary Vaccine Breaks Refrigeration Barrier in Africa

Let There Be Peace (and Power Africa) on Capitol Hill

Africa’s Mega Micro Hedgers: Why We Have a Lot to Learn From Smallholder Farmers

The Need for Asian Climate Leadership

New Initiative to Support Priority Setting for Universal Health Coverage

Chagas Disease in Non-Endemic Countries, Still a Neglected Public Health Issue

Chagas disease has recently emerged as an important, potentially chronic or lethal, illness in many non-endemic areas such as USA, Canada, Japan, Australia and several European countries. Unfortunately, only few governments in non-endemic countries have implemented adequate public health measures to avoid autochthonous transmission and provide appropriate care to subjects that are affected

Chagas Disease in Non-Endemic Countries, Still a Neglected Public Health Issue

by Alessandro Bartoloni*

and Lorenzo Zammarchi**

Infectious Diseases Unit, Department of Experimental & Clinical Medicine

University of Florence School of Medicine, Florence, Italy

Worldwide, an estimated 8 million persons, are thought to have Chagas disease, the majority of whom living in continental Latin America, where the disease is endemic 1. Chagas disease is caused by Trypanosoma cruzi, a protozoan parasite transmitted principally by blood sucking insects of the subfamily Triatominae 1 that typically live in cracks in the walls of mud and straw houses in rural Latin American communities. Transmission can also occur congenitally and by laboratory accidents, contamination of food with feces of triatomines, and transfusion or transplantation of infected blood or organs 1. Acute infection with T. cruzi is usually asymptomatic and is followed by a chronic asymptomatic phase that, in about one-third of cases, leads to severe organ involvement (cardiomyopathy and/or intestinal megasyndromes) after 10 to 30 years 1. The infection may reactivate and cause severe manifestations in immunosuppressed patients 1.

The disease has recently emerged in many non-endemic countries such as USA, Canada, Japan, Australia and several European countries, due to increasing population movements from Latin America in the last decade. Nowadays an estimated 300,000 of these persons live in the United States 1 and some thousands of them in Europe and other non-endemic countries 2. In particular, it was estimated that in 2009 there were between 68,000 and 122,000 cases in Europe, mostly concentrated in Spain, Italy, France and United Kingdom, but only 3-6% of these are estimated to be detected 3.

The high rate of under diagnosis can be explained mostly by the long period between the infection and the development of cardiac and digestive involvement during which the patient may be completely asymptomatic. However, even in case of symptomatic disease it can be misdiagnosed with other cosmopolite conditions since physicians in non-endemic countries are not familiar with Chagas disease and may not consider the disease in differential diagnosis. For example, Chagas disease associated cardiomyopathy is clinically similar to other causes of cardiomyopathy, and no sign or symptom is pathognomonic, then the etiologic diagnosis may not be considered, appropriate diagnostic testing might not be requested or performed, and, therefore, the diagnosis might be often missed 4. However confirming that Chagas disease is the cause of cardiomyopathy may have implications for patient treatment and prognosis and for possible testing and treatment of family members. A recent cross-sectional study showed that 13% of Latino immigrants with dilated cardiomyopathy who were living in New York City had Chagas disease 4.

The under-detection of Chagas disease may have not only clinical consequences but even public health implications since this disease can be transmitted in non-endemic countries even in absence of an effective vector. Transmission of T. cruzi through transfusion of blood and other hemocomponents, organ transplant 5,6, laboratory accident 7, travel to Latin America 8, and mother-to-child vertical transmission 9 has been already demonstrated in non-endemic countries.

So far few non-endemic countries have implemented adequate public health measures to avoid autochthonous transmission and provide appropriate care to subjects that are affected. Country such as Spain, United Kingdom and France have already implemented a routine serological systematic screening for Chagas disease in blood donors at risk 10. In the US, the “American Association of Blood Banks” has introduced serological screening for all blood donors since 2007 11.

To the best of our knowledge, no European countries have implemented at national level a screening for Latin American childbearing women and this activity is currently carried out only in circumscribed regions such as Catalonia, Comunitat Valenciana (Spain) or Tuscany (Italy) 12, 13,14. Screening for Chagas disease in pregnant women allows to perform diagnostic test in the neonates of the sero-positive mothers to early recognize a congenital infection, which may occur in about 5% of newborns, and to provide antiparasitic treatment to affected neonates, which is almost 100% effective in eradicate the disease in this stage 15,16. The cost-effectiveness of this intervention has been supported by an economical model in Spain 17.

There is still much work to do in the field of research. For example, the only two currently available drugs for antiparasitic treatment (benznidazole and nifurtimox) are not enough effective and safe especially in adults 18. In particular, the role of antiparasitic treatment in preventing or reducing the risk of development of organ chronic damage in chronically infected patients is still unclear.

To summarize, Chagas disease is of public health importance in non-endemic areas, not only because patients might develop, in case of progression, a severe and potentially lethal disease or a chronic disease representing a high cost in terms of disability-adjusted life years and quality adjusted life years, but also because there is a risk of autochthonous transmission.

As already agreed by several experts at the 6th European Congress of Tropical Medicine and International Health in Verona, Italy, September 2009, it is time to take a step forward and move from technical recommendations to public health decisions 19.

References

1.Rassi AJ, Rassi A, Marin-Neto J. Chagas disease. Lancet 2010;;375:1388-1402.

2.Gascon J, Bern C, Pinazo M. Chagas disease in Spain, the United States, and other non-endemic countries. Acta Trop 2010 115:22-27.

3.Basile L, Jansa JM, Carlier Y, et al. Chagas disease in European countries: the challenge of a surveillance system. Euro Surveill 2011;16.

4.Kapelusznik L, Varela D, Montgomery SP, et al. Chagas disease in Latin American immigrants with dilated cardiomyopathy in New York City. Clin Infect Dis 2013;57:e7.

5.Piron M, Verges M, Munoz J, et al. Seroprevalence of Trypanosoma cruzi infection in at-risk blood donors in Catalonia (Spain). Transfusion 2008;48:1862-1868.

6.Huprikar S, Bosserman E, Patel G, et al. Donor-derived Trypanosoma cruzi infection in solid organ recipients in the United States, 2001-2011. Am J Transplant 2013;13:2418-2425.

7.Alvar J. Un caso agudo de enfermedad de Chagas causado por una inoculacion accidental de laboratorio. Laboratorio 76:645-648.

8.Lescure FX, Canestri A, Melliez H, et al. Chagas disease, France. Emerg Infect Dis 2008;14:644-646.

9.Carrilero B, Quesada JJ, Alfayate S, et al. [Congenital Chagas disease in a newborn of a Bolivian mother]. Enferm Infecc Microbiol Clin 2009;27:486-487.

10.WHO. Control and prevention of Chagas disease in Europe. Report of a WHO Informal Consultation (jointly organized by WHO headquarters and the WHO Regional Office for Europe). Geneva: WHO 2009.

11.Blood donor screening for chagas disease–United States, 2006-2007. MMWR Morb Mortal Wkly Rep 2007;56:141-143.

12.Regione Toscana. Approvazione documento: “Prevenzione e controllo della malattia di Chagas congenita: indicazioni per l’assistenza in gravidanza”. Delibera regionale numero 489 del 04-06-2012.

13. Basile L, Oliveira I, Ciruela P, et al. The current screening programme for congenital transmission of Chagas disease in Catalonia, Spain. Euro Surveill 2011;16.

14.Generalitat Valenciana, Conselleria de Sanitat. Enfermedad de Chagas Importada. Protocolo de Actuacion en la Comunitat Valenciana. 2009.

15.Munoz J, Coll O, Juncosa T, et al. Prevalence and vertical transmission of Trypanosoma cruzi infection among pregnant Latin American women attending 2 maternity clinics in Barcelona, Spain. Clin Infect Dis 2009;48:1736-1740.

16.Barona-Vilar C, Gimenez-Martì M, Fraile T, et al. Prevalence of Trypanosoma cruzi infection in pregnant Latin American women and congenital transmission rate in a non-endemic area: the experience of the Valencian Health Programme (Spain). Epidemiol Infect 2012;140:1896-1903.

17.Sicuri E, Munoz J, Pinazo M, et al. Economic evaluation of Chagas disease screening of pregnant Latin American women and of their infants in a non endemic area. . Acta Trop 2011;118:110-117.

18.Pinazo M, Munoz J, Posada E, et al. Tolerance of Benznidazole in Treatment of Chagas’ Disease in Adults. Antimicrobial Agents and Chemotherapy 2010;54:4896-4899.

19.Angheben A, Bartoloni A, Anselmi M, et al. Infection a Trypanosoma cruzi/maladie de Chagas en Europe. Conclusions du sixieme congres europeen de medecine tropicale et sante internationale. [Trypanosoma cruzi/Chagas disease in Europe. Conclusions of the sixth European congress of tropical medicine and international health]. Bull Soc Pathol Exot 2010;103:359-363.

—————————————————————————————-

*Professor Alessandro Bartoloni is an Italian physician graduated at the University of Florence -Italy in 1983. He later obtained his specialization in Infectious Diseases at the University of Siena in 1987 and received his Diplome in Tropical Medicine at the Leopold Institute of Tropical Medicine in 1991.

Author of over 160 papers and multiple book chapters, Prof. Bartoloni is currently Associate Professor of the Infectious Diseases Unit, Department of Experimental & Clinical Medicine, University of Florence; Head of the Infectious and Tropical Diseases Unit, Careggi Hospital, Florence, and Director of the Tuscany Regional Reference Center for Tropical Medicine, in Florence. He has longstanding field experience as co-ordinator of the research activity that the Infectious Diseases Unit of the University of Florence is carrying out in Latin America since 1986. His main research interests include: epidemiology of antimicrobial resistant bacteria, tropical medicine, parasitology.

**Dr Lorenzo Zammarchi is an Italian physician graduated at the University of Florence -Italy in 2006. He then obtained his specialization in Infectious Diseases at the same University in 2011. Since 2011 he’s working as researcher fellow investigating cysticercosis and tuberculosis within the COHEMI-project financed by the European Commission. He is currently researcher at the Infectious Diseases Unit, Department of Experimental & Clinical Medicine, University of Florence, and works in the Tuscany Regional Reference Center for Tropical Medicine, in Florence.

Easier Said Than Done (in Global Health): A Glimpse at Nonfinancial Challenges in International Cooperation

More attention should be paid to the consequences that the increasingly intricate panorama of international cooperation in health (ICH) has on low- and middle-income countries (LMIC), and the complex set of connections of decision-making processes, power relations, and global/local articulations involved in planning, channelizing, and executing international aid. These notes aim to give a glimpse at some of the (nonfinancial) issues that the governments of LMIC confront in the process of incorporating technical and financial ICH in their national health agendas

Easier Said than Done (in Global Health): A Glimpse at Nonfinancial Challenges in International Cooperation

by Laura L. Nervi*

Adjunct Faculty at the Public Health Program of the University of New Mexico, USA

In the past decade, health has received a growing deal of attention in the international political agendas, and the funds disbursed for international cooperation in health (ICH) have nearly tripled.¹ Accompanying this trend, the corpus of analysis in several issues, such us financial flows, milestones declarations on aid effectiveness, and setting and monitoring of global health goals, has increased substantially. However, less attention has been paid to the consequences that the increasingly intricate panorama of ICH has on low- and middle-income countries (LMIC), and the complex set of connections of decision-making processes, power relations, and global/local articulations involved in planning, channelizing, and executing international aid. These notes aim to give a glimpse at some of the (nonfinancial) issues that the governments of LMIC confront in the process of incorporating technical and financial ICH in their national health agendas. Since the notes will underline general common challenges observed in ICH, crucial differences among countries will be overlooked and challengeable concepts will be used (for example, developed/developing), without referencing a specific donor, organization, country or region.

1.- Introducing International Cooperation in Health

Ideally, international cooperation in health (ICH) is the association among countries and/or their public and private institutions to mobilize technical (sharing know-how, best practices, and experiences), material and financial resources to reach common goals in the quest for social justice and health for all. ICH is also called global health aid, international health aid and development assistance for health. Though in these notes ICH will be used as a synonym for the other denominations, they have different underlying ideological assumptions. The concept of ICH emphasizes “…a joint effort integrating the partners in a process in which know-how and strategic orientations are shared, thus aiming at the joint planning and execution of programs or projects, with the autonomy of the partners and the sustainability of the process as a whole.”² The concepts of development assistance for health, global health aid, and international health aid evoke a vision based on a unidirectional, technology-transfer approach to aid, which was hegemonic among bilateral and multilateral agencies from the forties to the late seventies.³

ICH is a large piece of overall development aid. In the year 2012 alone, it accounted for an estimated 28.1 billion dollars in loans and non-reimbursable funds for health.⁴ ICH plays an important role in many LMIC. In some low-income countries, ICH is a crucial complement, although always subsidiary to government health expenditures. In 2010, for example, for all of Sub-Saharan Africa (the region where ICH has the greatest significance), total government health expenditures reached 29.4 billion dollars, 3.6 times more than the ICH disbursed that same year in the area. Although ICH is not a significant financial component of health spending in most middle-income countries, it often plays an important role, particularly in the area of technical cooperation. Moreover, a number of middle-income countries have become pivotal to triangular and South-South cooperation even while they still receive international aid. Altogether, LMIC government health expenditures are more than 18 times the funds disbursed in ICH (in 2010, 521 billion dollars for the former and 28.2 billion for the latter).⁵

ICH (and all development cooperation) is an important part of the foreign policy (“national interests”) of donor countries.⁶ Sometimes, ICH policies change in the donor countries at the rhythm of the administrations and sometimes they stay the same. Some donor countries are greatly influenced by particular interests and lobbyists that pressure for specific ICH policies. South-South cooperation and trilateral cooperation are not exempt (at least by definition) to the potential influence of these forces.

2.- A Changing Panorama and Challenges in ICH Governance

Assistance vs. Cooperation Models

Before neoliberal policies began to take hold about thirty years ago, ICH was mostly channelized through multilateral health organizations and bilateral agencies, which were (and still are) funded mostly with public resources. Multilateral agencies were mostly funded by the annual dues of their member countries and bilateral agencies were (and still are) funded by their countries ‘taxpayers’ money. Bilateral agencies and philanthropic and private funding always contributed to the multilateral system, which (at the time) would use the funds for multilaterally set priorities (although the private sector has always, in many ways, influenced the international health agenda). The one-country-member/one-vote system of governance in the multilateral system gave the developing countries at least a formal participation in the decision-making process.

Concerns with the efficacy of those agencies were raised by the donor countries and the academic world. They were sometimes blamed for their lack of expertise in expanding public health skills to attend the health needs of LMIC. Also, they were criticized for having the “ideological imprint of the West,” developing a (paternalistic, preconceived, unidirectional, vertical) technology-transfer vision, showing a limited corporate memory, adopting untested policies that become unchallengeable doctrines, looking to satisfy their bureaucratic needs instead of the recipient countriesâ needs, basing their cooperation activities mostly in meetings (the âworkshop syndromeâ) instead of more vigorous actions, and others.⁷

The technology-transfer vision (called technical assistance) was challenged in the seventies by Halfdan Mahler and the movement he led for the democratization of WHO.⁸ They saw the asymmetrical power relations between donor and recipient countries and called for a shift from technical assistance to technical cooperation, something that other United Nations agencies were also discussing.^{9 10} Paulo Freire also influenced visions on cooperation, fighting the idea of prefabricated solutions as proper development instruments. He emphasized the importance of symmetrical relations between all the actors involved, one of his most famous statements being the following: “We knew we had something to contribute to respond to that challenge. If not, there would be no reason to accept the invitation. But fundamentally, we knew that the help that was asked of us would only be true to the extent that, in the process, we would never pretend we were the exclusive subjects, reducing the role of the nationals who requested aid to pure objects. Authentic help -this can never be said enough- is that in which all who are involved help each other, growing together in the common effort of understanding the reality they seek to transform. Only such a practice, in which those who give help and those who are helped simultaneously help each other, is the only kind in which the act of helping is not distorted into the dominance of those who help over those who are helped.”¹¹

Cuba’s notion of ICH was influential in Latin America and Africa. It was the first country to develop what we today call South-South cooperation. Based on the principle of solidarity among peoples and the lessons learned through the building of its own public and universal national health system (despite the massive emigration of its doctors when the revolutionary government took office), Cuba started short and long-term cooperation in the early sixties. It developed one of the biggest ICH programs that included (and still includes) everything from humanitarian aid to the development of human resources, public health interventions, health services development, managerial capacities development, direct provision of health services and many other aspects of health. Cuba has proven that cooperation in health exceeds the form of direct financial support, garnering recognition and admiration for over 50 years of sustained work in most of the developing world. Today, ICH is one of its most important forms of diplomacy.¹²

However, none of the models (assistance vs. cooperation) in ICH truly stood out or eliminated the other. Rather, they coexisted in bilateral and multilateral agencies and in NGOs and philanthropy-funded projects. As for the long-ago identified problems in the operations of bilateral agencies and multilateral health organizations, they were either overcome or partially addressed by some agencies, or maintained or even deepened by others. Some of those problems were used as (for us, unacceptable) excuses to weaken the multilateral system instead of improving it, just as the national statesâ weaknesses were used in most LMIC to impose structural adjustments in the eighties and other neoliberal policies in the nineties, and as the global financial crisis was recently used as an excuse to attack the universal social protection systems in Europe.

The Big Comeback of the Vertical Vision

Global governance and international cooperation started changing at a remarkable speed in the late nineties in what has been called the “emergence of private authority in global governance”.¹³ Increasing proliferation of actors, fragmentation, “verticalization”, and private authority have profoundly affected international development aid. It is important to note that this has transformed the way that conflicts of interest and public interest are seen. UN agencies, governments, the private for-profit sector (including the pharmaceutical industry), the corporate philanthropic sector, business associations, and global non-governmental development organizations from developed countries, are all seen as equal “partners” to share global health governance.¹⁴

These changes also affected international health agencies in many ways and significantly weakened them. They are now severely underfunded and becoming host agencies, thus decreasing their ability to set up a countries-led agenda. Multilateral health agencies have been displaced (and their dependence on extra-budgetary and ear-market funds has climbed) and multilateral financial institutions have taken a leadership role in global health funding and policy-making, while bilateral agencies have raised their profile in developing countries.¹⁵ The philanthropic private sector has dramatically increased in its involvement with developing countries, either directly or through multilateral agencies, universities, or global NGOs. Since funding is voluntary, usually unpredictable and has high transaction costs, ICH has become more unstable.

The new ICH structure is characterized by a growing importance of health in the international political agendas combined with a rapid increase in funding for health¹⁶, but also by a proliferation of transnational actors at a global scale. Private players from developed countries have started directly influencing public policies in developing countries. New modes of association have become the new doctrine to fund and channelize aid, resulting in new global health initiatives, particularly public-private partnerships (PPP’s). PPP’s need quick results.¹⁷ They are unable and unwilling to pay enough attention to national capacity building and the strengthening of health systems. They do not integrate with ongoing horizontal processes, but rather tend to build up vertical structures. PPP’s and most global health initiatives focus on a disease, a group of diseases, or a special topic. In a 2007 study on 112 global health initiatives (that number must have grown by now), it was found that almost all initiatives invoked their intended contribution to the health-related MDGs. Looking at the initiatives’ primary purpose, an overwhelming number focused on infectious diseases, concentrating on either research and development of material health products (particularly drugs and vaccines) or on facilitating product access (especially to drugs and vaccines). On the other end, there were only two initiatives whose primary purpose was to contribute to the strengthening of health systems.¹⁸

Developing countries are underrepresented in the board of directors of the new mechanisms of aid (PPP’s and other initiatives). Headquarters are set mostly in developed countries, and they are the ones who set the priorities and allocation of resources.¹⁹

Beyond all, the common perception that private donors are sustaining ICH is mistaken. Private donors have an increasing importance in funding ICH, but taxpayers of developed countries are by far the main funders of the aid system. The visibility and influence of private actors in global health governance largely outweighs their monetary contribution.

The unwanted negative results of some global health partnerships are only a part of the problem. The bulk of the issue is the progressive weakening (by reduced funding and leadership) of the multilateral system as an arena of international-policy setting and global coordination.

Advances in the Discourse of the Difficult-to-fix World of Development Aid

Trying to deal with this setback in global governance and its potential negative influence on the fulfilling of the MDG’s, donors and aid recipients have taken firm steps to address development aid effectiveness. OECD states that, despite its large achievements, international development cooperation confronts serious challenges, such us lack of coordination, overly ambitious targets, unrealistic time and budget constraints, and political self-interest.²⁰ The massive recognition of these problems resulted in a new set of principles to improve aid effectiveness. Since they were formulated, these principles have been adhered to by more than 100 countries. Four high-level forums have taken place in order to advance the aid-effectiveness agenda: the High Level Forum on Aid Effectiveness in Rome (2003)²¹, Paris (2005)²², Accra (2008)²³, and Busan (2011).²⁴ In 2011, a survey about the Paris Declaration, in which 78 countries participated, showed that some progress had been made, but overall, donors and LMIC fell short of the targets.²⁵ In the area of ICH, the forums significantly impacted the discourse, and in a minor way, the actions of donors and the expectations of some LMIC. In addition, some initiatives and declarations emerged in the global health arena.²⁶

Despite the general consensus and the resources and energy invested in setting a different scenario for aid effectiveness, countries, in general, did not see their ICH problems solved. Furthermore, it is common that authorities and technical teams in the ministries of health of LMIC are not aware of the forums or how to benefit from the global commitments in place.

What is clear is that there is a growing body of evidence that identifies major and unsolved problems in aid effectiveness. In 2004, Birdsall called them the “seven deadly sins on donor failings”: 1) impatience with institution building, 2) pride (failure to exit), 3) ignorance (failure to evaluate), 4) sloth (pretending “participation” is sufficient for “ownership”), 5) envy (collusion and coordination failure), 6) greed (stingy, and worse, unreliable transfers), 7) foolishness (underfunding of regional public goods). Ten years later, despite global declarations, the landscape shows that (with some exceptions) the problems have deepened thanks to the big comeback of the vertical mindset.²⁷ As Severino and Ray acknowledged in 2010, the Paris Declaration has various limitations. They raised four issues to characterize the problems that reduced aid effectiveness: a) marginal player syndrome (a product of the explosion in stakeholders of international cooperation that makes donors feel less and less responsible for the success or failure of their projects); b) diverging accountability syndrome (there are at least three coexistent systems of accountability in international cooperation policies: donors are accountable to recipient country’s governments, to the beneficiary population of the recipient country, and to the taxpayers of their own country and their representatives); c) evaluation gap syndrome (some actors are more effective than others but there is no way of establishing who is better than whom at doing what); d) the capacity-building paradox (the weaker the state capacities, the more donors tend to be massively present and design coordination mechanisms that require high administrative capacities from the receiving state).²⁸ Problems identified by Birdsall and Severino and Ray apply to the ICH field, particularly but not exclusively, in North-South cooperation. ICH, however, has specific determinants that make it one of the most difficult fields to approach.

The Specifics of Health in International Cooperation

Health may be very well, for many reasons, the most complicated component of the development cooperation arena. All cultures develop knowledges, practices and representations on the health-ill-care process and most produce authorized individuals to explain, care or decide on health-ill-related needs. So, there will always be one or more medical models to meet locally. With the expansion of capitalism, the western hegemonic medical model articulated with the local models and subsumed them, creating a complex stage that may be unique in every country/region.

Global expenditures in health are enormous; the health industry is one of the most profiting investment sectors and healthcare one of the most important employers. The medical-industrial complex interests (products, services and insurances) are at the root of today’s health systems in many developed and developing countries. Large portions of the population that only a few years ago were considered healthy are now being labeled with new “diseases”. Pharmaceutical products are directly targeting the population, and enhancement drugs and procedures proliferate. It isnât exactly the idea of a collective health/social medicine approach to spread this model in either the developed or the developing world.

In a world with appalling inequities (and health inequities are among the most evident), there are billions who do not have access to healthcare, medicines or basic public-health interventions. The discourse of ICH intends to address this situation, but there are at least three tensions that makes this difficult: the “imprint of the West” force that imposes aid priorities, mechanisms and tools to recipient countries (with few exceptions, ICH is still a donor-driven field), the universal and public health system model vs. segmented/fragmented and inequitable health systems models, and the technoscience-driven ICH vs. the right to health and a social justice based ICH approach.

Therefore, the debate on what ICH is really contributing begins long before an actual ICH policy is discussed. It starts by questioning what health system and social protection system is attainable by a country, and how to address the social determinants of health. It starts with understanding which actors (inside and outside governments) have already defined a horizon for building a public and universal national health system with the guarantee of extensive solidarity, integrality and quality.

In health, there are also values dilemmas. One example in public health and particularly in women’s rights is the penalization of therapeutic abortion (induced abortion when the mother’s life is threatened). When a recipient country has changed its constitution to explicitly forbid all kinds of abortion, is it OK to overlook this? To what extent should ICH address it? In every country that penalizes therapeutic abortion, there is a women’s movement that fights and opposes the current legislation. How should cooperation organizations respond to the dilemma of supporting national policies while local womenâs organizations are sometimes being persecuted because of this opposition? Where are the limits? What strategies should be developed with civil society, and which actors of civil society should participate? How is this related to the progressive call to untie aid?

3.- Developing Countries Own (Health) Governance Capacity Challenges

The governance capacity of the ministries of health (or the accumulation of institutional and personal competencies, abilities, vision, willingness, and commitment to build viability for the national health policy) is essential for an agenda of change.²⁹ It is clear, however, that health ministries possess restricted power to single-handedly decide on the structure, healthcare models, or distribution of power within the health system they are supposed to lead.

Putting aside the lack of necessary financial resources, many LMIC have to confront serious governance issues. The stewardship of the ministries of health to lead the national health system may be weak, particularly in countries where the private sector is increasingly significant in the delivery of health services and products and/or in the selling of private health insurance. In highly segmented health systems, there are also challenges in regulating and monitoring the social security subsector (which could be composed of many independent entities) and the nonprofit sector (which may account for a large part of health coverage). Governance challenges may also be evident within the administration. Even in progressive administrations that recognize the importance of advancing public and universal health systems, it is not unusual for health ministers to have to make the case for health with the economic cabinet and, many times, with the presidential office. An equitable universal health system is not a concept that many would challenge today, but advancing an agenda based on the right to health implies many decisions that affect particular interests, and various decisions within the presidential cabinet (to reallocate resources) that in many cases have not been foreshadowed during the previous political campaign. Proclaiming the right to health and being in a position to offer a comprehensive health system that honors that right are two different things. Somehow, ministers pay the price of this gap, even when they usually donât participate in deciding how big an administration’s commitment will be to build a strong public-based health sector for all. In most cases, all they get is the power of deciding -with dramatically insufficient resources- upon how to improve health services for the poor. But as Richard Titmuss famously put it, “services for the poor will always be poor services.”

Ministers of health have limited decision-making power in ICH, too. In most cases, the amount of loans granted by the multilateral banks isn’t determined in the ambit of the ministry, under the (correct) principles that the national development model must be set at the presidential level and the economic cabinet has the mandate to consider both credit repayment possibilities and the implications of indebtedness. Often, however, the problem is that ministers of health are expected to fulfill the presidential agenda for building universal health systems with grossly insufficient resources and limited power to make the changes. Sometimes, they even see their ICH funds being diverted from their original purposes due to extra-sectoral pressures. Also, there are too many actors involved in the governance of ICH at the national level. Usually, several governmental entities participate in the negotiation and monitoring of ICH, such as foreign relations ministries, ministries of economy, planning secretaries and even the presidential office. It is not uncommon for some of them to become competing actors for international resources against the health sector while simultaneously supervising the canalization of aid to it.

ICH funds are unpredictable. Under more regular circumstances, they are short-lived and with long periods of negotiation (multiannual projects are exceptions and not the norm). Thus, fear of losing resources is always central and increases dependency. In the midst of this, there is a generally accepted never-say-no attitude when it comes to accepting ICH. And if the national health authority rejects an offer for ICH, it is not unusual for some donors to knock on the door of other government officials in order to override the decision made in the health sector.

4.- Dealing with ICH at the National Level

In dealing with ICH, many national teams find out that they are subjected to persistent stereotypes and oversimplifications by donors’ agencies. Among them are two easily identifiable ones. First are the “one size fits all” approaches that make the developing world a homogenous target of interventions. However, although they share common pressing issues, LMIC are not homogenous in their needs for ICH. Low-income countries share the burden of poverty and thus a common need for resources to confront their health problems and institutional capacity challenges, but they are not equal to even their own selves when different historical periods are considered, nor are middle-income countries, and neither are donors homogenous in their political and economic interests or priorities.

Second, there is a problem with language (and its implicit assumptions) in international cooperation: the concept of “technical assistance” has been reenergized. While the Paris Declaration and other forums advanced concepts like “partner countries”, there are others ideas that contradict the advances. One example is the “graduated country” concept. Although the notion of graduation was conceived to measure economic development for the least developed countries, it is now utilized by donor countries and aid institutions to evaluate how well a country has advanced in some health indicators and to justify the withdrawing of aid. Developing countries see this graduation topic as a penalization of their achievements and health gains, while most donors see this as a decent mechanism of accountability for the developed countriesâ taxpayers who want to be reassured that their money is used where it is most needed. In any case, this concept shows that those who set the tests for graduation, the evaluators, and the decision-makers on aid allocation are from developed countries and so ICH is still based on their views, requirements and standards.

Management (or the processes of dealing with ICH in the cycle of identification of resources and needs, through planning, channelizing, executing, monitoring/evaluating ICH related endeavors) is an important component of ICH for both the recipient countries and the donors. It accounts for a big part of lost resources because of the high opportunity costs on both donors’ and recipient countries’ sides, and for (most of) the delays in the execution of ongoing projects, which are one of the main problems identified by donor agencies in the area of health.

Ministries of health in the recipient countries have to deal with a plethora of poorly coordinated initiatives and actors with several (sometimes contradictory) agendas that pressure to fulfill deadlines: bilateral agencies, multilateral organizations for technical cooperation (several from UN, each with their owns goals and projects with the ministry of health)³⁰, multilateral banks, universities, research institutions, medical missions and brigades of all kinds, diplomatic missions, global funds and global health initiatives, international NGOs, decentralized cooperation from donor countries (municipalities, regions and communities), corporate philanthropy, pharmaceutical and technology companies that make donations, among others. In many cases though, ICH projects and funds aren’t even in the radar of the health national authority, and it is common for a big piece of ICH be unaccounted for (ministries may not be informed about projects developed at the local level or about projects with municipalities, NGOs or churches).

There are also regulatory aspects. One of them is the often seen regulatory limbo for material donations (medicines, supplies and medical equipment) and medical missions. Sometimes regulations exist, but they are not enforced. Some actors (including government officials) may want to channelize (and be recognized for) donations that do not pass the test for obsolescence or need. Sometimes, ministers of health have to accept all kinds of unapproved (and difficult to discard) donations of medical equipment, sometimes expired or out-of-the-list pharmaceuticals, and medical services for the sole reason that they have been given at no cost.

Another issue is the clientelism that international agencies sometimes establish with their national focal points in a long partnership that is immune to changes in the health policy goals. Some donors see this as a guarantee for the continuation of projects at a ministerial level, but -besides the ethical component of favoritism and informal privileges that arise with it- clientelism obstructs cooperation with new goals that ministries may set.

Agencies need to execute their budget for ICH. Level of execution is one of the components of staff evaluation. So, when the end of the budgetary year nears, training activities, technical meetings, and other activities suddenly skyrocket. Opportunity costs aren’t estimated, and ministries and agencies very rarely measure the negative or positive impact of these activities on the performance of public health services (how many consults, surgeries, public health interventions were postponed or cancelled? how many health units or services were closed instead of open because of those activities?) and on the competencies of the health workforce.

Other problems are more closely related to procedural aspects of management. Among them is the contradiction between creating project implementation units and using national capacity. After the nineties, when multilateral banks created project implementation units, which often became virtually parallel ministries of health, many national and international actors called for a change. Although many donors (and also recipient countries) are still pushing to create or maintain project implementation units separate from the ministry, the Paris Declaration (reinforced by many donors) states that donors must respect national procedures and mechanisms that already exist in recipient countries. Therefore, using national procedures is a way to both recognize countries’ capacities and to strengthen management offices at the national level. The problem is that by doing so, donors sometimes idealize the capacities of national institutions to process (within very short time frames) acquisitions and services, which multiplies the workload of the national procurement offices. Only some of the agencies plan to provide resources to strengthen the procurement national capacity while executing the projects, and even fewer define time frames accordingly.

Other obstacles can be found in regard to aid instruments. Each agency has developed its own planning, monitoring and evaluation frameworks needed for accountability and project evaluation. The problem at the national level is that national teams have to manage dozens (if not hundreds) of different aid instruments that are not useful in monitoring the country’s own health policy, and on top of this, most of these instruments in ICH prioritize financial aspects, underplaying goal achievement. Proper instruments oriented to assess outcomes are scarce and the indicators are challengeable (many trying to measure outcomes in a unicausal, simplistic way). This is even more evident in the area of technical cooperation. Sometimes it seems as if some don’t want to truly know what is happening out of fear of potentially disappointing results. If evaluations and monitoring were oriented toward improving ICH quality (and not discrediting underperformance), their role would be useful to identify and correct problems. And even though new planning instruments are labeled “strategic planning,” “situational planning” and so forth, it should be noted that many of them are just as rigid and normative as the traditional instruments.

Finally, the tension between lengthy negotiations and recipient countries’ urgency to accomplish the goals of their health policies is a significant issue. Negotiating some projects can take two or more years. When resources come, competitive bidding and delivery times and services may add more. It is common for an administration to spend more time negotiating ICH than using the resources. This, added to the problems of discontinuation of political and technical teams, high rotation rate of leaders, and changes in the health policy, puts the potential results of ICH at risk.

5.- Building an ICH Country-led Policy at a National Level

In a context of financially strained national health systems, health ministers that try to make the necessary changes toward universal coverage and health equity struggle to guarantee countless aspects of funds and governance, and to gain political support to make their case for health. Ministers have to strengthen governance capacities at leadership and institutional levels to develop stewardship within health systems that, in most countries, are fragmented and segmented (an uncoordinated combination of public, social security, private for-profit and nonprofit entities). They are also responsible for public health interventions and, usually, their mandate includes the direct provision of health services. Ministers are aware that health workers are the basis of the health system and that the shortage of health workers is one of the key limitations of success, and that a motivated workforce with the appropriate expertise in specific knowledges is crucial to run the system.³¹ And many ministers know that they (might) increase their chances to make a bigger difference by designing an ICH policy capable of mobilizing the maximum possible amount of technical and financial resources as well as partners, in support of the countries’ health priorities.

An ICH policy at the national level in a recipient country must be part of the national health policy and the strategic plan of the ministry of health, which must be aligned, at the same time, with the national development plan for a given governmental period. Also, an ICH policy is only part of a country’s international interests in health, which include a wide range of matters that are vital to gain health sovereignty, such as: health diplomacy as a component of foreign policy, health sector participation in negotiations of trade and investment agreements (those which have the potential to affect national health regulations), development of a body of research on consequences of international neoliberal policies on the health of the national population, proposing policies and actions through the multilateral system, and monitoring execution of international mandates agreed upon by the country.

An ICH policy should contemplate governance aspects, such as: a) agreed upon mechanisms to hold donors and beneficiaries (including the ministry of health) accountable; b) all players involved in policy-making, mobilization and management of international resources should have a coherent vision and understanding of the priorities and goals of the health policy, as well as the strategies, priorities, and political agendas of international agencies and other donors; c) health ministries should have the chance to exercise national stewardship in ICH, actively coordinating the negotiation and management components of ICH with the other governmental players involved, such us foreign ministries, planning secretaries, economic cabinet, and others; d) specific negotiations and agreements should be undertaken to avoid competition for international resources among different sectors of a same government, or different levels (local, regional, central) of the same sector; e) a body of evidence that documents how high the opportunity costs of ICH are at the national level (including the processes of negotiation, execution, monitoring and evaluation of aid) and considers the possibility of rejecting some supply-led offers if the potential opportunity costs are higher than the aid itself, and if aid is tied to questionable goals or if national health sovereignty has been threatened; f) LMIC also have things to offer, and have developed competencies in a range of fields; an ICH policy should identify potential areas for technical cooperation with other countries through South- South cooperation, trilateral cooperation, regional cooperation, and even South-North cooperation (why not!).

An ICH policy should also identify specific strategies for resource mobilization and management. Among them: a) definition of a strategy to mobilize international resources aligned with the national health policy, its priorities and the strategic plan; b) mapping international financial and technical opportunities in detail and analyzing the antecedents of ICH with the country; c) assessment of gaps between the targets set by the ministryâs strategic plan and the available resources at national level, in order to orient ICH in filling those gaps; d) a resource mobilization strategy that includes civil society organizations and intersectoral ventures; e) definition of a set of flexible mechanisms for monitoring and evaluating ICH aligned with the indicators defined by the health policy and, when possible, for utilizing national information systems (ICH to improve health information systems will always be welcome in most countries).

In addition, there are specific regulatory aspects at an ICH national-led policy level, such us the regulation of donations (medicines, medical supplies and medical equipment) and medical missions (that provide direct health services to the population or in association with governmental or non-governmental entities, or the ministry of health’s health services), among many others.

Definition and implementation of ICH policies based on social and international justice will always require strong political incidence initiatives aimed at generating public support in developed and developing countries in the hope to achieve less asymmetrical, more democratic, and equalitarian North-South relations âin order to make all actors accountable (including private actors), and to call for a shift from policies based on national interests or particular interests to cooperation policies based on the principle of solidarity among peoples.³²

ACKNOWLEDGEMENTS

I am very grateful to Anne-Emanuelle Birn and Celia Iriart for their timely suggestions on the contents and conceptualization of this paper.

—————————————————————————————————————————————

¹ IHME: Financing Global Health 2012: The End of the Gold Age?, University of Washington, Seattle, 2013.

² Buss PM, Ferreira JR: Critical essay on international cooperation in health. RECIIS -Eletr Rev of Com Inf Innov Health 2010, 4(1): p 87.

³ Ferreira, JR: Estrategias internacionales en educacion medica: asistencia tecnica y cooperacion tecnica. Educacion Medica y Salud 1976; 10 (4): 335-344.

⁴ This number accounts for the estimated development assistance for health for the year 2012 funded by national treasuries, debt repayments to international financial institutions, private philanthropists and corporate donations, and channelized through bilateral development assistance agencies, European Commission, UN agencies ( UNFPA, UNAIDS, WHO, UNICEF, PAHO) , World Bank and other regional development banks, The Global Fund to Fight AIDS, Tuberculosis and Malaria, GAVI Alliance, Foundations, and International NGOs. IHME: Financing Global Health 2012: The End of the Gold Age?, Seattle, Washington, 2013.

⁵ Ib.

⁶ Birn A-E, Pillay Y and Holtz T.: Texbook of International Health: Global Health in a Dynamic World. Oxford University Press, 2009, p 17-53.

⁷ Foster, G.: Bureaucratic Aspects of International Health Agencies. Soc. Sci. Med.1987; 25 (9):1039-1048.

⁸ Dr. Halfdan Mahler served three terms as director-general of WHO (1973-1988), and under his leadership the ”Health for All by 2000″ goal and the Primary Health Care strategy were launched.

⁹ Mahler, H.: Shift for Technical Cooperation, WHO Journal, June 1976.

¹⁰ UNITAR: The Search for New Methods of Technical Cooperation, Conference. Report No. 4, New York, 1974.

¹¹ Freire, P.: Cartas a Guiné-Bissau. Registros de uma Experiencia em Processo. Ed Paz e Terra, Rio de Janeiro, 1978, p. 8.

¹² Feinsilver, J.: “Fifty Years of Cuban Medical Diplomacy: from Idealism to Pragmatism”, in Krull et al (editors). Cuban Studies 41, University of Pittsburgh Press, 2010, pp. 85-104.

¹³ Hall, R. and Biersteker, T.:The Emergence of Private Authority in Global Governance. Cambridge Studies in International Relations. London: Cambridge University Press, 2002.

¹⁴ See STAKES inputs in this matter: Ollila, E.: Restructuring global health policy making: The role of global public-private partnerships. In Koivusalo, M. & Mackintosh, M. (Eds.),Commercialisation of health care: global and local dynamics and policy responses. Basingstoke: Palgrave, 2004.

Olilla, Eeva: Health-Related Public-Private Partnerships and the United Nations. In Global Social Governance. Themes and Prospects. Edited by: Bob Deacon, Eeva Ollila, Meri Koivusalo and Paul Stubbs Ministry of Foreign Affairs of Finland, 2004.

Olilla, Eeva: Global health Prioritites: Priorities of the Wealthy?. GASPP, National Research and Development Centre for Welfare and Health, Helsinski, Finland. 2005.

Also: Martens, J.: Multistakeholder Partnerships-Future Models of Multilateralism?. Dialogue on Globalization, Occasional Papers N29. Friedrich Ebert Stifung, Berlin, 2007.

¹⁵ Global Health Watch: An Alternative World Health Report. Zed Books, London, 2011. P229-249.

¹⁶ Development health aid had a moderate growth from 1990 to 2001 (it went from 5.7 billion dollars in 1990 to 10.8 billion dollars in 2001. In 2001 aid expanded quickly exceeding 11.2% on an annualized basis between 2001 and 2010 and almost tripled from 2001 (climbing to $28.2 billion in 2010). Due to the global financial crisis, aid stagnated: 28.1 billion dollars were disbursed in 2012, a 53 million dollars drop from 2010. IHME, Ib.

¹⁷ Bull and McNeill analyze the emergence of GHPs and their concentration in product development and product access as associated with a series of factors. Among them are 1) the technological changes produced by the biotechnological revolution (that, on the one hand, affected negatively the development of impeded and developing market vaccines and drugs and, on the other hand, made vaccines and drugs more costly than before), 2) the restructure of the pharmaceutical industry in a few number of highly concentrated and also inter-cooperative companies (merges between research-based pharmaceutical industry and the takeover of the biotechnology companies by the pharmaceutical companies). For example, four companies account actually for over 75% of the world’s supply of vaccines , and 3) the changes in global health governance that include changes in leadership of the WHO and UN (with increasingly strained financial resources and an ideological change in the vision of who the partners are in the pursuit of Health For All), and a growing importance of private foundations in funding and advocating for specific health issues and technologies. Those factors resulted in the development of new mechanisms that were seen as convenient by all of the players involved. Bull, B. and McNeill, D. Development Issues in Global Governance. Public-Private Partnerships and Market Multilateralism. Routledge, London, 2007.

¹⁸ Nervi, Laura: “Mapping a Sample of GHI”, PAHO/WHO, WDC, 2008. Report.

¹⁹ Ib.

²⁰ OECD: The High Level Forum on Aid Effectiveness: A History,http://www.oecd.org/document/63/0,3746,en_2649_3236398_46310975_1_1_1_1,00.html

²¹ Rome marked the moment in which for the first time principles of aid effectiveness were proclaimed in a declaration. Priority actions were identified: development assistance should be delivered based on the priorities and timing of the recipient countries, donor efforts should concentrate on delegating cooperation and increasing the flexibility of staff on country programs and projects, and good practices should be encouraged and monitored.

²² Paris marked the first time that donors and recipients committed to work together and hold each other accountable. The Paris Declaration defines five principles on effective aid and lays out a roadmap to improve the quality of aid. The principles are: ownership (developing countries set their own strategies for poverty reduction, improve their institutions and tackle corruption), alignment (donor countries align behind these objectives and use local systems), harmonization (donor countries coordinate, simplify procedures and share information to avoid duplication), results (developing countries and donors shift focus to development results and results get measured), and mutual accountability (donors and partners are accountable for development results).

²³ In Accra representatives of civil society added their voices. The Forum was oriented to try to strengthen and deepen the implementation of the Paris Declaration. The Accra Agenda for Action (AAA) gives a roadmap to achieve Paris targets and gives an important role to capacity development.

²⁴ In Busan non-traditional donors participated, recognized as the South-South cooperation providers (China, India and Brazil participated as providers in establishing commons principles alongside traditional donors). Busan calls for changes in the governance of the aid system. Paris principles are recovered and taken further: country-ownership (developing countries have to lead the process of setting development priorities); development results (keeping focused on the lasting impact of investments and efforts in reducing poverty, inequality and sustainable development, as well as capacity building); inclusive partnerships (establishing partnerships which have openness, trust and mutual respect, and acknowledging the complementary role of all actors in the partnership); and transparency and accountability (ensuring that this applies not only within the partnership but also in relation to the intended beneficiaries of development processes, such as the citizens, constituents and other stakeholders from donor and recipient countries). Busan also established a number of complementary actions on untying aid, predictability of development cooperation and use of country systems.

²⁵ OECD: Aid Effectiveness 2005-10: Progress in Implementing the Paris Declaration, 2011.

²⁶ These initiatives address the challenges in ICH directly or indirectly. Among the initiatives is the launch of the Global Health Workforce Alliance, created in 2006 as a common platform for action to address the crisis in human resources for health. The Oslo Ministerial Declaration of 2007 issued an statement on global health as a pressing foreign policy issue (Ministers of Foreign Affairs of Brazil, France, Indonesia, Norway, Senegal, South Africa, and Thailand)..In 2010, the European Commission calls to gear up on health actions and, among other accounts, calls for establishing a more democratic and coordinated global governance. The International Health Partnership (IHP and later IHP+) created in 2007 explicitly approaches the topic of aid and aid effectiveness. IHP+ include international organizations, bilateral agencies and country governments that signed the IHP+ Global Compact to work to put internationally agreed principles for effective aid and development cooperation into practice in the health sector. Major results at recipient countries level are still to be seen.

²⁷ Birdsall, N.: Seven Deadly Sins: Reflections on Donor Failings. Working Paper 50. Center for Global Development, Washington DC, 2004.

²⁸ Severino J-M and Ray O: “The End of ODA II: The Birth of Hypercollective Action”, Working Paper Number 218, Center for Global Development, WDC, 2010.

²⁹ Testa M. Decidir en Salud, Quién?, Como? y Por qué? Salud Colectiva. 2007;3(3):247-257.

³⁰ Each UN agency deals independently with their national counterparts the execution of projects and resources. Although they try to harmonize goals and actions through the United Nations Development Assistance Framework (UNDAF), their annual plans, negotiations and executions of resources are kept independent.

³¹ Crisp, N.: Global health partnerships: the UK contribution to health in developing countries. DFID, London, 2007.

³² Political incidence is a set of “activities aimed to increase access to/generate influence on the actors who have decision-making power in matters of importance for a group or for the society at large”. Gibradze, N.: Evaluation of the RegionalProject on Political Analysis and Prospective Scenarios. Report. UNDP, 2012.

—————————————————————–

*Laura L. Nervi, born in La Plata, Argentina, holds a PhD in anthropology, a master’s degree in social sciences, another in public health, a bachelor’s degree in anthropology, and was also a resident of PAHO/WHO’s International Health Training Program. She has more than thirty years of experience in teaching, researching, mobilizing resources, and working with multi-disciplinary teams in managing technical/financial cooperation. Laura has worked in most countries of the Americas with governments, bilateral and multilateral agencies, universities, social movements, and NGOs, advocating for public and universal health systems and international cooperation policies based on the right to health. Currently, she leaves in Albuquerque and is an adjunct faculty at the Public Health Program (PHP) of the University of New Mexico, USA.

News Link n. 82

News Link 82

The political origins of health inequity: prospects for change

Manica Balasegaram: Drugs for the poor, drugs for the richâwhy the current research and development model doesnât deliver

U.S. International Trade Commission (USITC) Hearing on India

UNAIDS and Lancet Commission to put forward recommendations on AIDS and global health for the post-2015 debate

The global AIDS response can help in fighting hepatitis C

Africa could manufacture its own ARVs drugs

South Africa Promotion And Protection Of Investment Bill 2013 â A Review

Genetic Resources: ACCESS AND BENEFIT-SHARING CLEARING-HOUSE (ABS-CH) website

Interviews With The Candidates For WIPO Director General

Time for a Reality Check for Neglected Diseases

The Concept of Reproductive Health Care and Abortion: A Small Survey in Turkey and Comparative Ethical Debate

The future of aid: UNICEF Executive Board addresses funding and partnerships

Polio immunization programme needs to be more robust: UNICEF

USTR: âNotoriousâ Markets For Counterfeiting, Piracy In 2013

Obama energy policy hurts African poor

Nigel Lawson: David Cameronâs aid policy is doing more harm than good

Jim Kim’s ambitious World Bank reforms

Can the World Bank’s ‘global practices’ meet country needs?

World Bank probes Tata tea project over worker abuse in India

Doctors Without State Borders: Practicing Across State Lines

Managing Intellectual Property Rights to Ensure Access to HIV Medicines

The levels of enforcement of intellectual property rights (patents) may have critical impact in fostering or hindering access to medicines. The UNAIDS vision of “zero new infections, zero AIDS-related deaths, and zero stigma and discrimination” is based on the recognition that medicines are public goods and, therefore, the proprietary/private right must not prevail over the public interest

Managing Intellectual Property Rights to Ensure Access to HIV Medicines

by Carlos Passarelli*

Senior Expert Treatment, UNAIDS

The impact of intellectual property rights on access to health

Since the establishment of World Trade Organization in 1994, being the Trade Related Intellectual Property Rights (TRIPS) agreement one of its founding documents, WTO members must grant patent protection to commodities, including pharmaceutical products and processes, for a minimum period of 20 years, once they fulfil patentability criteria, such as novelty, inventive step and industrial application. Assuming that countries present different levels of development, the TRIPS agreement also foresaw some flexibilities in order to ensure an appropriate balance between the (private) right of the inventor and the social welfare, a public good. This paper will discuss the importance of using those flexibilities by developing countries to implement and/or sustain public policies in the realm of public health and to achieve international agreed targets on access to essential medicines to treat HIV infection.

The first AIDS cases were reported in 1981, and since then the epidemic rapidly became a public health concern for both developed and developing nations. From a period of fear and lack of alternatives for those affected by the HIV infection to the appearance of several preventive and therapeutic approaches, the international community has been suffering losses, but also sharing hopes. In 1996, almost 13 years after the isolation of the virus which causes AIDS - the HIV, new scientific evidences have proven that the HIV infection could be controlled, and that AIDS was not the same of a death sentence. Nevertheless, in the year 2001, when UNAIDS estimated that almost 30 million people were living with HIV worldwide, less than 200 thousand people were accessing antiretroviral (ARV) treatment. In 2013, 9.7 million people were enrolled on ARV programs, against 28 million people who would be eligible, according to the most recent (2013) WHO guidelines for HIV treatment. Thus, even if there is a huge gap to be filled, much have been achieved and it is important to identify the pathways that may assist countries in further reducing the AIDS-related deaths by scaling-up access to ARV treatment. This paper will focus on those public health opportunities that could be enhanced (or challenged) by trade issues.

The year 2001 constitutes a landmark towards more determined efforts to curb the AIDS epidemic. In September of that year, during the United Nations General Assembly Special Session on HIV AIDS (UNGASS 2001), member states agreed on concrete actions to face the global crisis posed by the epidemic, by issuing the UN Declaration of Commitment on HIV/AIDS. It created a favourable political environment to the establishment, in the same year, of the Global Fund to Fight AIDS, Tuberculosis and Malaria, mobilizing financial resources to address the major threats to the public health of developing countries.

Still in 2001, in November, the WTO conference in Doha discussed the impact of the intellectual property rights on access to essential medicines, being the HIV epidemic one of the major topics that served as a background for WTO members to sign the inter-ministerial declaration on TRIPS and Public Health, known as the Doha Declaration.

“(§1) We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. (§4) We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose” (Doha Declaration)

The great majority of flexibilities provided within the TRIPS agreement, highlighted by the Doha Declaration, are in direct relation to the ability of governments to protect public health and ensuring the right to access to medicines¹, such as: exhaustion of rights (parallel importation; article 6), patentable subject matter (article 27); research and experimental use and bolar exceptions (article 30); compulsory license and government use (article 31), data protection (article 39.3), competition law (article 40), transition periods (articles 65.2, 65.4, and 66.1)^2;3.

Despite the great importance of the Doha Declaration in supporting developing countries to further utilize the flexibilities within TRIPS, they are also challenged to not make use of them, by the threat of trade barriers posed by industrialized countries or by the so-called TRIPS-plus measures contained in Free Trade Agreements (FTAs)⁴. In the realm of public health, those agreements may imply concrete barriers in ensuring access to health products and services⁵, since they reduce the possibility of developing countries to benefit from the application of the above mentioned flexibilities. For instance, some TRIPS-plus provisions might eliminate and/or reduce the transitional periods for developing countries provided in TRIPS, preventing them to lessen the negative effects that intellectual property enforcement might originate for local development. Furthermore, those provisions may also extend the lifespan of a given license beyond the 20 years established by TRIPS, by pushing health authorities to comply with more restrictive data exclusivity protection and therefore making difficult the marketing approval of generic products. There are also TRIPS-plus provisions that will address directly the extension of patent protection term. Additionally, TRIPS-plus measures will seek for reducing, and even excluding the possibility of developing countries to undertake parallel importations, to issue compulsory licenses, to explore use exceptions and also to enlarge patentability criteria.

New paradigms for managing intellectual property rights within the public health arena

Generic competition has proven to be an effective tool for pushing prices down and therefore scaling-up treatment. From 2000 to 2010, prices for first line anti-retroviral drugs (ARV) of originators decreased from U$ 10,000 to U$ 300 per patient per year (pppy), while generic prices varied from U$ 2,700 to U$ 70 pppy. In this regard, since the Doha Declaration, international health negotiations have been undertaken aiming at supporting developing countries to preserve the political space to use TRIPS flexibilities and, in doing so, to enhance affordable prices for assured-quality products.

Following on a 2003 World Health Assembly resolution, WHO has established the Commission on Intellectual Property Rights, Innovation and Public Health⁶ in 2004, to “collect data and proposals from the different actors involved and produce an analysis of intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries” (WHA56.27). In its report, the Commission concludes that the current intellectual property system is not properly addressing the health needs of developing countries, since it doesn’t foster research and development (R&D) of health products that don’t represent an attractive market for the pharmaceutical industry. The report puts a set of recommendations forward to enhance innovation within the health sector taking into consideration the health gaps in the R&D landscape.

Based on the recommendations of the Commission, WHO established the Intergovernmental Working Group (IGWG). This body was mandated to elaborate a global strategy and plan of action to support countries to address innovation and management of intellectual property rights in relation to their health needs. The document was endorsed by the World Health Assembly in 2008⁷ and it paved the way for the formation of the Consultative Expert Working Group on Research and Development (R&D): Financing and Coordination (CEWG). The main recommendations in their final report⁸, launched in 2012, were based on the assumption that new financing models for R&D are needed to ensure that innovation should be funded by other mechanisms than granting patents (delinking).

Specifically in the realm of the HIV epidemic, an independent body of eminent persons expressed their concerns regarding the potential failure of the current patent system to address the health needs of people living with HIV in the developing world, especially the access to ARV treatment: “while intellectual property protection is supposed to provide an incentive for innovation, experience has shown that the current laws are failing to promote innovation that serves the health needs of the poor”⁹. In its report, the Global Commission on HIV and the Law included a chapter on the impact of intellectual property rights on access to HIV medicines, recommending that the management of the intellectual property system should be undertaken through the lens of human rights protection and principles.

Some concrete mechanisms were developed to explore alternative and public health-oriented models to manage intellectual property rights. In 2010, the UNITAID executive board, a WHO-hosted initiative to purchase drugs for HIV, Malaria and Tuberculosis, channelled resources for the creation of the Medicines Patent Pool, an independent foundation that negotiates voluntary license agreements with patent holders to foster generic production of second-line and paediatric ARVs and drugs to treat opportunistic infections in people living with HIV. Through the patent pool, “patent holders voluntarily offer, under certain conditions, the intellectual property related to their inventions to the patent pool. Any company that wishes to use the intellectual property to develop medicines can seek a license from the pool against the payment of royalties and may then produce the medicines for use in developing countries”¹⁰.

Platforms for action

In 2010, UNAIDS and WHO have launched the Treatment 2.0¹¹platform, a framework designed to support countries in achieving and sustaining universal access and, at the same time, maximizing the preventive benefits of antiretroviral therapy. The main components of this programmatic approach are: treatment optimization, simplification of treatment monitoring tools, cost reduction, adaptation of service delivery, and community mobilization. Against this background, it was possible to further mobilize and coordinate technical and financial resources, at global and local levels, helping countries to identify the bottlenecks and opportunities towards scaling-up access to ARV treatment. On the price reduction pillar, much discussion is still being undertaken, especially around availability and affordability of optimized drugs (fixed dose combinations) and entry into market (with affordable prices) of newer/innovative (second- and third-line) ARVs.

The levels of enforcement of intellectual property rights (patents) may have critical impact in fostering or hindering access to those products. As stated before, the Medicines Patent Pool plays an important role in facilitating licensing agreements with a public health-oriented (access) perspective. But other mechanisms must be put in place by individual countries, intergovernmental bodies, and even pharmaceutical companies (both originators and generics) to explore political options for scaling-up access to medicines. Some mechanisms are directly related to the use of the above mentioned TRIPS flexibilities, and the Doha Declaration offers directions¹²that could be taken by concerned stakeholders to protect public health. Moreover, other measures, which are not necessarily in close relation with intellectual property matters, such as, strengthening regulatory (quality assurance) capacity of local and regional agencies in developing countries, ensuring drug security, coordinating procurement supply management procedures and adapting services to more efficient care provision and drug delivery, should also be under the focus of policy makers and health providers, within the public, private and community sectors.

Current initiatives are on the lookout for synergizing these different driving aspects of access to HIV-related medicines. For instance, the African Union roadmap on Shared Responsibility and Global Solidarity for AIDS, Tuberculosis and Malaria, through its second pillar - “ensure accelerated access to affordable and quality assured medicines and health-related commodities as enshrined in the Pharmaceutical Manufacture Plan for Africa (PMPA)” - convene several stakeholders, including UNAIDS, around common objectives, such as: to promote investing in medicines manufacturers; to strengthen regional regulatory capacities and lay foundations for a continental regulatory agency; to develop essential skills on drug production and foster technological transfer, mainly through South to South cooperation; and create a legislative environment that incorporates the TRIPS flexibilities and avoid TRIPS-plus measures. With African Union Commission, NEPAD agency, UNIDO, UNDP, WHO, and other, UNAIDS is advocating for sustained political leadership to ensure the full implementation of the PMPA and the sovereignty of African countries to address their access to health needs.

More recently, UNAIDS, WHO, The Global Fund, and PEPFAR joined efforts to assist countries in achieving the 2011 United Nations Political Declaration on HIV/AIDS treatment targets, i.e., enrolling 15 million people under treatment until 2015. Recognizing the progresses made by countries in expanding ART coverage, but, at the same time, focusing on the existing bottlenecks in relation to key geographic settings and populations where rates of HIV transmission and unmet access needs are still high, the “Treatment 2015″¹³ initiative intends providing countries with a comprehensive framework to greatly scale-up ARV treatment.

The HIV epidemic has been the ground on which the global community is continuously advocating access to life-saving drugs, and, broader, access to health, as a fundamental human right. Every single person in this world, regardless his/her place of birth, must be offered the existing assured-quality treatment options, and governments, agencies, companies have to provide people with the conditions to make drugs available and affordable. All these initiatives converge to this same ultimate goal: no one will be left behind. The UNAIDS vision of “zero new infections, zero AIDS-related deaths, and zero stigma and discrimination” is led by the principle that the AIDS response cannot be dissociated from the Human Rights agenda, and, in this regard, it is based on the recognition that medicines are public goods and, therefore, the proprietary/private right must not prevail over the public interest.

References

¹ UNAIDS. DOHA+10 - TRIPS flexibilities and access to antiretroviral therapy: lessons from the past, opportunities for the future. Geneva, 2011 (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2260_DOHA+10TRIPS_en.pdf)

² UNAIDS. Implementation of TRIPS and access to HIV medicines after January 2016: strategies and options for Least Developed Countries. Geneva, 2011 (http ://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2011/JC2258_techbrief_TRIPS-access-medicines-LDC_en.pdf)

³UNAIDS, UNDP. TRIPS transition period extensions for least-developed countries. Geneva,2013 (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2013/JC2474_TRIPS-transition-period-extensions_en.pdf)

⁴ UNAIDS, UNDP. Issue brief: The potential impact of Free Trade Agreements on public health. Geneva, 2012. (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2012/JC2349_Issue_Brief_Free-Trade-Agreements_en.pdf)

⁵ Mohamed K. El Said. Public health related TRIPS-plus provisions in bilateral trade agreements: a policy guide for negotiators and implementers in the Eastern Mediterranean Region. WHO and International Centre for Trade and Sustainable Development, Cairo, 2010

⁶ WHO; Commission on Intellectual Property Rights, Innovation and Public Health. Public health, innovation and intellectual property rights: report of the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva, 2006

⁷ WHO. Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. Geneva, 2011

⁸ WHO. Research and Development to meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination. Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination. Geneva, April 2012

⁹ UNDP. Risks, Rights and Health. Report of the Global Commission on HIV and the Law. New York, July 2012

¹⁰ ‘t Hoen, E. Passarelli, C. The role of intellectual property rights in treatment access: challenges and solutions. Current Opinion on HIV/AIDS. 2013, 8:70â74

¹¹ WHO, UNAIDS. The treatment 2.0 framework for action: catalysing the next phase of treatment, care, and support. Geneva. WHO, 2011. (http://whqlibdoc.who.int/publications/2011/9789241501934_eng.pdf)

¹² Doha Declaration, Paragraph 6 and 7: (§) We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002. (§) We reaffirm the commitment of developed-country members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country members pursuant to Article 66.2. We also agree that the least-developed country members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.

¹³Treatment 2015. Geneva, UNAIDS, 2013 (http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2013/JC2484_treatment-2015_en.pdf)

—————————————————————————————————

*Carlos Passarelli is Senior Expert Treatment at UNAIDS in Geneva. Prior to this, he was the Chief of the International Relations Advisory at the Oswaldo Cruz Foundation (FIOCRUZ) office in Brasilia. Dr Passarelli has a long career in HIV/AIDS programming, research and policy. He served as Chief of the International Cooperation Advisory of the National STD/AIDS/VH Department within the Brazilian Ministry of Health (MoH); Executive Director of the International Centre for Technical Cooperation on HIV/AIDS (ICTC); Deputy Executive Director of the National SDT/AIDS Programme within the MoH; and Project Officer at the Brazilian Interdisciplinary AIDS Association (ABIA).

He received a BA from the Institute of Psychology at the University of Sao Paulo, a Masters in Social Psychology from Catholic University of Sao Paulo, and a PhD in Clinical Psychology form Catholic University in Rio de Janeiro. He has published several articles on HIV/AIDS policy and access to ARVs in Brazil.

News Link n. 81

News Link 81

MSF Director: ‘We are losing the battle’ for cheap drugs in developing world

MSF urges South Africa to stand strong in defiance of aggressive pharma moves to delay change

Wanted: a new model to encourage pharmaceutical innovation

UN shifts approach to help Sahelâs 20 million hungry

Europe-wide opposition to the Syngenta patent on pepper plants

Africa: New Era Possible in EU Development Aid

EU seals free trade deal with West Africa

Move On Data Protection Or Fail On TTIP, EU Parliament Chair Says

Quando i cinesi muoiono di lavoro. A Prato

Chinese development financing to Africa: An update

For an upside of Sino-Japanese rivalry, look to developing Africa

International development aid: a ‘hand out’ or a ‘leg up’?

Does US aid have a double standard for procurement?

SOTU 2014: The Developmentista Edition

Riforma della Cooperazione, Il Manifesto

Bill Gates is wrong, the rich-poor divide is only getting wider

No universal health coverage without strong local health systems

Protecting policy space for public health nutrition in an era of international investment agreements

Why 2014 is a key year for women’s rights and gender equality

African Union Executive Council: African Candidatures within the International System

WIPO Director General Election: How It Works

WIPO CASE – Centralized Access to Search and Examination

Biopiracy Watch

Indigenous Panel At WIPO Asks For International Instrument Compliant With Their Recognised Rights

Why donât humanitarian NGOs want free science advice?

Health Affairs Connected Health Briefing: Reminder And Webcast Information

Successes And Missing Links In Connected Health

Payors In Care Delivery: When Does Vertical Integration Make Sense?

News Link n. 80

News Link 80

MSF responds to news of pull out of neglected disease R&D by AstraZeneca

HIV testing in 2014: An update on access, ethics, human rights and

New study captures the value of new medicines in middle-income countries

New Study Makes Case for Innovative Medicines

Campaign to Prevent Damage to Innovation from the Proposed Draft National IP Policy in South Africa

Concerns Erupt Over Leaked Pharma Lobbying Plan Against IP Policy In South Africa

Why the European Parliament elections matter for international development

European development loans: At what cost?

Obama highlights US aid priorities in SOTU

In State Of The Union, Obama Highlights Need For Patent Reform

Obamacare. Tra Via crucis e Manna dal cielo

Obamacare

ACA Coverage Goes Live: A Health Affairs Conversation With Karen Davis, Dan Mendelson, And Tom Scully

Accountable Care Growth In 2014: A Look Ahead

At WIPO, Global Experts Share Experiences On Open Collaboration

The 0.000001%: Committed to “Improving the State of the World”?

MEPs call for ‘inclusion’ of disabled in EU development policies

3 MYTHS THAT BLOCK PROGRESS FOR THE POOR

2014 African Year of Agriculture and Food Security

(RED), U2 and Bank of America Partner to Fight AIDS

Per eliminare le mutilazioni genitali femminili

5 Lessons on Integrating Family Planning and Maternal Health

Reflections on Davos: It’s Not Just Women Who Are Working Towards Gender Equality

Synergizing Roles: Experiences of Civil Society Working Towards Promoting Local Generic Pharmaceutical Manufacturing in the EAC Region

Due to a number of bottlenecks, the generic pharmaceutical manufacturers in the East African Community region produce at a cost disadvantage compared to their large-scale Asian counterparts. This article highlights some of the key areas where civil society has engaged and can still engage with local pharmaceutical industries to address these challenges

SYNERGIZING ROLES: EXPERIENCES OF CIVIL SOCIETY WORKING TOWARDS PROMOTING LOCAL GENERIC PHARMACEUTICAL MANUFACTURING IN THE EAC REGION

By Moses Mulumba

Executive Director, Center for Health, Human Rights and Development*(CEHURD), Kampala Uganda

Background & Introduction

Although civil society activists and local pharmaceutical manufacturers serve different objectives, the two groups have had to work together in the area of access to affordable quality medicines, which are much needed in the East African region. Indeed this is one of the unique working relationships where health-related civil society has had to move away from the traditional shelving away from private “profit oriented” pharmaceutical companies to combine efforts towards scaling up access to generic medicines in a region that is heavily burdened by diseases such as HIV, malaria tuberculosis and several other health challenges. I must quickly point out that the central reason that has led to this relationship is the realization that in order to deal with gaps of access to adequate basic medicines in the region, promoting local manufacturing is key. As UNAIDS, WHO and UNDP have advised, countries like those in the East African Community (EAC) need to invest in regional and national production capacities in the pharmaceutical sector and in the development of local expertise.

The pharmaceutical manufacturing sector in the EAC is largely dominated by generic manufacturing. In Uganda all existing local pharmaceutical companies are generic manufacturers. Generic medicines are pharmaceutical products usually intended to be interchangeable with an innovator product and manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights. It is significant to note that due to a number of issues including infrastructural challenges, tax policies, investment policies and others, the generic pharmaceutical producers in the EAC region produce at a cost disadvantage compared to their large-scale Asian counterparts. As such, even when local generic manufacturing offers such a huge opportunity for bridging the access to essential medicines gap, without addressing some of these tailbacks, the EAC region will be yet to realize the full benefits of local manufacturing.

As such, there are clear opportunities for health civil society to combine efforts with the local generic pharmaceutical manufacturers to address the bottlenecks to fully benefit from generic local manufacturing. The paragraphs below highlight some of the key areas where civil society has engaged and can still engage with local pharmaceutical industries to address these challenges.

Key Issues for Local Generic Manufacturers and Civil Society

Addressing the Legal and Policy Environment in the Region

The legal and policy environment for the production of local generic medicines still has a number of gaps that need to be addressed. There are a number of laws and policies that still need to be reviewed and others put in place both at the individual country level and at the EAC regional level. The legal environment touches a number of aspects including investment laws, tax laws and several commercial laws which cannot all be highlighted within the space for this paper. As an example, I will throw more light on the intellectual property regime, which is key for local generic pharmaceutical manufacturing. Except Kenya, all the other EAC countries are still listed as Least Development Countries and are therefore still exempted from Intellectual Property rights enforcement with respect to pharmaceuticals under the TRIPS agreement. This provides ample opportunities for these countries to maximize the benefits provided by the TRIPS flexibilities. The current legal reforms in the EAC countries indicate that countries are not fully utilizing these flexibilities. For instance, the TRIPS flexibilities have been only sparsely incorporated in Uganda’s process of enacting the Industrial Properties Bill. Similarly, Rwanda remains the only country in the region that has implemented the TRIPS Council’s August 30th decision which allows member states to grant compulsory licenses to import or manufacture urgently needed patented medicines.

Another disturbing development is the fact that countries in the EAC are at various stages of enacting laws to address counterfeiting and these laws have been defining counterfeiting so widely as to include generic medicines. This could hinder locally manufactured legitimate generic medicines from entering the channels of commerce, thereby undermining public health objectives in the region by obstructing access to essential generic medicines. These legal challenges exist regardless of continuous drug stock-outs occurring across the region. The current inability of governments in the region to wield the power conferred by the TRIPS flexibilities means that continuous health civil society engagement with the relevant stakeholders is required to protect the critical legal and policy space used by local generic pharmaceutical manufacturers.

Poor Infrastructure and Capacity Issues of Local Pharmaceutical Manufacturers

Another concern is that the technical and financial capacity of East African pharmaceutical manufacturers is compromised by a lacking technical labour force as well as low investment into the sector in the region. The private foreign investors who dominate the regional manufacturing sector inject limited financial resources into East Africa. Because of this, the regional governments still have a very vital role to play in facilitating the sustainability of pharmaceutical manufacturers. Quality Chemicals, which was initially a joint venture between the Government of Uganda and private actors, experienced a strong start following various forms of support provided by the Government of Uganda.

Low financial and technical capacity means that local manufacturers are unable to produce sufficient generic medicines to supply the high demand at affordable prices. This is further aggravated by challenges such as inadequate electricity supply and weak transport and communications infrastructures, increasing the cost of production of generics in the region. While regional governments should be commended for creating some tax incentives for investors and at times providing financial support, such support is usually not sufficient to enable companies to perform to capacity. This also affects other critical processes such as WHO prequalification, a prerequisite for successful local generic manufacturing.

Low Investments in R&D and Poor Signs of Technology Transfer

Directly related to the lack of capacity of local generic medicines manufacturers is the low level of technology transfer and investment in research and development. One of the cornerstones of the TRIPS Agreement as embodied in its principles and objectives is the adoption of measures (Article 7-9) that promote technological innovation, transfer and dissemination in the development of intellectual property laws. One way in which national technology innovation, transfer and dissemination can be achieved is by encouraging pharmaceutical companies, which are driven by foreign private investment, to train a local labour force and transfer advanced technology into the country. The continued importation of semi-processed raw materials made from raw materials already existent in the region and the perpetual importation of skilled labour creates a resource and labour dependence syndrome which significantly inhibits the development of the regional capacity to manufacture generic medicines. This is a critical area where civil society can engage with governments to promote local generic pharmaceutical manufacturing.

Civil Society Engagements In initiatives Promoting Local Generic Pharmaceutical Manufacturing

The EAC Partner State governments have relegated themselves to a mainly regulatory role in the pharmaceutical manufacturing sector. East African civil society organizations have often bridged the gap between governments and manufacturers, adding the voice of public interest into the sector. The following paragraphs highlight some of the instances in which civil society has engaged in initiatives that either directly or indirectly boost local pharmaceutical production in the EAC region.

– Intellectual Property Legal, Policy and Institutional Reforms: As the EAC Partner States worked on their legal reforms, health-related civil society has provided a critical eye to all the provisions suggested in the national legislation in the area of intellectual property to ensure that TRIPS flexibilities are fully utilized. Some of these flexibilities, such as compulsory licenses and the adoption of the August 30th Decision, are central to encouraging local generic pharmaceutical manufacturing. In addition to the legal reforms, health civil society organizations are undertaking a campaign to encourage national intellectual property offices to undertake the necessary reforms to do patent searches and registration at the country level as opposed to doing this at the regional level through ARIPO (African Regional Intellectual Property Organization), where patent pre- and post-grant opposition procedures are almost impossible. This will enable the opposition of possible patent grants for the benefit of local manufacturing of generic medicines.

– Influencing Policy Decisions: Health civil society organizations continue to play a critical role in defining the policy decisions both at the country and regional level. A clear example has been making a decision on the policy of legislating for the counterfeiting problem in the region. While the Government of Kenya had already embraced a law that broadly defines counterfeiting to include generic medicines, the civil society movement undertook several counteractive measures including a human rights court challenge on the possible implications of this approach on access to medicines in Kenya. With a successful court challenge, the law has been put on hold pending its revision to reflect the importance of access to generic medicines in Kenya.

– Promoting Public Trust in Locally Manufactured Medicines: There has been a lot of misconception about the quality of locally manufactured medicines within communities in the region. This has been partly due to current talk about counterfeits and substandard medicines. To clear this doubt in Uganda for instance, a group of civil society actors working towards access to medicines has fostered dialogues between the manufacturers and the public. Within these dialogues, the public has expressed some of the concerns and the manufacturers have addressed misconceptions. Civil society continues to play the role of bridging the gap between local pharmaceutical manufacturers and the public through sensitization and awareness campaigns to encourage the use of safe and efficacious generic medicines.

– Towards a Better Environment for Local Generic Pharmaceutical Manufacturers: Many of the challenges of pharmaceutical manufacturing in the region are related to the local infrastructural environment. For instance, commercial and taxing policies heavily affect the success of local generic pharmaceutical manufacturing. Health civil society organizations have engaged with the governments in the region to encourage them to address many of these challenges. For instance, Ugandan civil society organizations have campaigned for governments to waive taxes on health commodities including raw materials for local pharmaceutical manufacture.

– Delinking the Medicines Patent Status for Drug Registration: A further major challenge for locally manufactured medicines is registration with the national regulatory authorities to enable the medicines to enter the market. In the past there have been requirements by some EAC national regulatory authorities that in order for drugs to be registered they should not be on patents in other regions. This clearly bars the approval for marketing any locally manufactured generic medicines that may be on patent elsewhere even when the East African countries in question have no obligation to protect such patents. Health civil society has encouraged these governments through the drug regulatory agencies to delink drug registration from patent status in order to protect local generic pharmaceutical production.

– Regional and International Initiatives: Civil society organizations are currently involved in campaigns to mitigate possible consequences of regional and international trade negotiations that could affect local manufacturing of generic medicines. A key example is the Economic Partnership Agreement between the European Union and the EAC which introduced several provisions including intellectual property provisions that could deter local manufacturing of legitimate generic medicines. Health and trade civil society organizations in the region are working hard to get such provisions expunged from these initiatives.

Conclusions and Moving Forward

There is no doubt that successful local pharmaceutical manufacturing of generic medicines calls for some joint collaboration between local pharmaceutical manufactures and civil society organizations. While their general objectives seem different, the interests of the two sectors converge when it comes to bridging the gap in access to medicines in the region. The paragraphs above have indicated some challenges of local generic pharmaceutical production and how civil society efforts have tried to address some of these. The key message from this is the fact that while the local manufacturing sector can play an important role in increasing access to and promoting the affordability of medicines in the region, a lot of support is needed for them to not only increase their production capacity but also to make a greater contribution to healthcare in the EAC region. Health civil society now needs to get into wider campaigns for the development of regulatory guidelines stating requirements for manufacturers of generic medicines to develop local capacity and undertake increased technology transfer into the region while at the same time lobbying EAC partner states to create subsidies and concessions which can boost the local pharmaceutical manufacturers’ capacity to adequately provide the much needed legitimate, affordable and quality medicines. This should be in addition to scaling up wider campaigns necessary to sensitize the public on the safety of generic medicines and combat the current assumption that generic medicines are counterfeits.

—————————————————————————

*The Center for Health, Human Rights and Development (CEHURD) is an indigenous, non-profit, research and advocacy organization which is pioneering the enforcement of human rights and the justiciability of the right to health in Eastern Africa. CEHURD was founded in 2007 and was registered under the laws of Uganda as a company limited by guarantee Certificate No. 114712. It was formed to contribute towards ensuring that laws and policies are used as principal tools for the promotion and protection of health and human rights of populations in Uganda and in the East African region. CEHURD realizes this through a set of programs: (1) Human Rights Advocacy; (2) Community Empowerment; and (3) Research and Documentation. CEHURD focuses its efforts on critical issues of human rights and health systems in East Africa such as sexual and reproductive health rights, trade and health, and medical ethics which affect the vulnerable and less-advantaged populations such as women, children, orphans, sexual minorities, people living with HIV/AIDS, persons with disabilities, internally-displaced persons, refugee populations and victims of violence, torture, disasters and conflict.