News Link n. 75

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 75

International development in 2014

Development cooperation in 2013: A year in review

Pascal Lamy: How trade can work better for development

Synergies between trade, biodiversity, and climate change in the Post-2015 Development Agenda 

High Hopes for the Green Climate Fund: 5 Messages on Private Sector Engagement 

Do it like Britain — Paul Collier on how EU can help the bottom billion

The joy of facts and figures

New law a setback for Uganda’s HIV response

MSF responds to G-FINDER survey on R&D funding for neglected diseases 

An Emerging Leader: Germany’s Role in Neglected and Poverty-related Disease R&D

Developing Countries Lack Capacity To Take Advantage Of Marrakesh Treaty  

A Results-Based Financing Duo: The World Bank and Global Fund

Global health icon says aid must build local systems  

Berne Declaration: Clinical trials (special edition)

The Implementation of Exhaustion Policies: Lessons from National Experiences 

Five Reasons Why ‘Food’ Is A Massive Global Health Issue

FAO: Make a shift from business-as-usual in animal disease control

TTIP Leak Illustrates Depth Of “Enhanced Regulatory Cooperation” As NGOs Sound Off 

A major step backward for anti-AIDS in India

Millions in aid to China criticized

US Move on Livestock Antibiotics Includes Possibly Fatal Loophole

Financing Essential HIV Services: A New Economic Agenda

A Policy Dialogue On Connected Health

Are volunteer programs empowering — or exploitative?






News Link n. 73

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 73

Mandela’s Unfinished Business


WTO commits to development under historic agreement

Universal health: From private coverage to public care  

Responding to Health Challenges: the role of domestic resource mobilisation 

Cape Town Conference Highlights Innovation, IP And Public Interest

Intellectual Property, Competition and Regulatory Aspects of Medicines: International Determinants and Public Policy  

IFPMA and Global Fund Collaborate to Help Protect Patients from Fake Medicines 

OMS e diritto alla salute: quale futuro 

Experts At WHO Select Eight Projects To Boost Medical R&D For Developing Countries 

IP-Watch Works To Open TPP Text; USTR Misses Response Deadline

First as Tragedy, Then as Farce 

EU to consider policy change on tying aid to land rights

World AIDS Day 2013: Moving Closer to Zero

To Win the Fight Against AIDS, We Must First Defeat TB

Community-based intervention to enhance provision of integrated TB-HIV and PMTCT services in South Africa

Is Aid a Waste of Money? 

How to cut the multilateral aid budget 

Why Are Cancer Drugs Commonly The Target Of Schemes To Extend Patent Exclusivity? 

Trade: the real cost of red tape 

Is India breaking new ground by requiring corporates to spend 2% of company profits on CSR? 





Poor-quality Anti-tuberculosis Drugs Threaten the Global Disease Control Strategy

The importance of poor-quality anti-tuberculosis drugs cannot be underestimated, as they may disrupt all major complex interventions to ensure treatment efficacy. Not only treatment failure may ensue, but, more importantly, rapid emergence of acquired drug resistances can also be favoured

Poor-quality Anti-tuberculosis Drugs Threaten the Global Disease Control Strategy


by Giorgia Sulis*and Alberto Matteelli**

University Division of Infectious and Tropical Diseases, University of Brescia

Tuberculosis (TB) represents a major public health problem worldwide, with over 8.6 million estimated cases and 1.3 million deaths in 2012. TB remains a global threat in low- and middle-income countries where it represents the paradigm of poverty-related diseases [1]. Undoubtedly, important progresses have been achieved since the first global TB strategy was launched in 1994 and subsequently updated in 2006 in order to better address the needs [2-5], leading to declining trends in incidence and mortality during the recent decades [1]. However, several challenges continue to undermine the way towards control and eventually elimination of the disease.

Quality-assured drug supply is certainly among the most relevant issues under debate, with counterfeits and sub-standards appallingly on the rise [6, 7]. By definition, counterfeit drugs are deliberately and fraudulently mislabelled medicines with respect to identity and/or source [8]. For instance, quantitative and/or qualitative alterations of ingredients and fake packaging all belong to this category. Furthermore, substandard medicines include those lacking quality control requirements, and might probably be even more common than counterfeits [9].

WHO estimates that counterfeits account for about 10% of the global drug trade, reaching a peak of at least 25% in developing countries, where regulatory and enforcement systems for medicines are weak. However, the real burden of poor-quality medical products on the global market is not exactly known. The very few studies that have been conducted to assess the dimension of the problem of under qualified medicines are limited by the small sample size and are mainly related to a specific drug class in selected geographic areas [10]. Antimicrobials are by far the most frequently involved class of medicines and, coincidentally, they are also the most needed in resource-limited settings which are disproportionately affected by infectious diseases as compared to industrialized countries [11, 12]. Fake pharmaceuticals can be purchased at lower prices thus widening access possibilities especially for the poors. Since most drug stocks do not routinely undergo a proper quality control procedure before usage in several TB high burden countries, the product characteristics vary considerably depending on its final destination. Though usually found on illegal circuits, authorized companies may also be involved in their market [13].

The mainstay of TB control programs is early diagnosis and proper treatment of patients, principally the contagious ones. Standard short course chemotherapy has been at the centre of any TB control strategy. It is composed of a two-month induction phase with four drugs followed by a four-month continuation phase with two drugs [14]. Treatment adherence is essential for a successful outcome and TB programs devote huge efforts and resources to ensure patient support throughout the entire treatment period. Fixed dose combinations were developed and widely adopted, in order to reduce the number of pills and treatment complexity.

The importance of poor-quality drugs cannot be underestimated, as they may disrupt all major complex interventions to ensure treatment efficacy [15]. Not only treatment failure may ensue, but, more importantly, rapid emergence of acquired drug resistances can also be favoured [16].

Multidrug resistance tuberculosis (MDR-TB) is currently recognized as one of the most serious challenge to TB control and eventual elimination. Diagnosis is a real challenge for the weak health systems in resource constrained settings: it is estimated that only approximately 10% of the MDR-TB cases estimated to occur in 2012 were enrolled in care [1]. Moreover, in settings where MDR-TB diagnosis is actively promoted, rapidly increasing the number of identified MDR-TB cases, patients start queuing for treatment for the limited availability of second line TB drugs. While treating a TB patient with a short-course standard regimen has an average cost of 19 US dollars, the economic costs of treatment for one single MDR-TB case can reach 10.000 US dollars. 

Solutions for the challenge posed by counterfeit medicines are strongly needed, but they are not at reach. In 2001 a targeted strategy to fight this scourge (the Global Drug Facility, GDF) was developed, with the purpose of providing assistance and support to needing countries in terms of affordable supplying of medicines and their management [17]. This is among the most important initiatives within the global TB control program aimed to directly provide drugs to both governments and non-governmental organizations (NGOs) through a well-established and strictly controlled process assuring absolute adherence to quality criteria from the sourcing of raw materials to the final distribution and proper stocking of the packaged product. Today, uncertainty about the quality profile is particularly significant for products coming from outside the GDF channel, which miss the prequalification process and unfortunately still constitute a large proportion of the global drug stock. The consolidation of public funds- €”and the GDF source – €”for the purchase of TB drugs has a twofold rationale: it maximises leverage for reduced prices on quality-assured first-line drugs and second-line drugs, thus enabling wider access to them, while also minimising the use of public funds for procurement of drugs of uncertain, potentially substandard, quality.

A relevant proportion of underqualified medicines could be detected through relatively inexpensive and simple assays at destination countries, based on chromatographic techniques, like HPLC and TLC [18]. Such tests are able to identify the type and concentrations of the various components but their execution is not compulsory and then only rarely pursued. In a vicious mechanism, whenever local regulatory authorities fail implementing their controller role not requiring to operate in accordance with basic standards, fraudulent manufacturers are encouraged to enter the market.

The way to fight counterfeit medicines with global efforts is not straight forward and sometimes crosses with political problems. The Indian and Brazilian Governments and some non-governmental organisations, have opposed the work of IMPACT – the International Medical Products Anti-Counterfeiting Taskforce -€“ created by WHO in 2006 [19]. The principal reason is they believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas.

So, once again, the poorest are also the most vulnerable, widely lacking access to adequate healthcare facilities and medications that results in worsening conditions. Putting aside financial responsibilities, our major and definitely unacceptable defeat remains the loss of human lives.


*Giorgia Sulis (Resident in Infectious Diseases since August 2013), was born in Italy in 1986. After graduating from the University of Pavia as a medical doctor in July 2011, she earned a postgraduate research fellowship on HIV/AIDS infection among migrants at the University of Brescia. During the first semester of 2013 she attended a TropEd Course in Tropical Medicine and International Health held in Brescia.

**Alberto Matteelli was born in Italy in 1960. After graduating from the University of Pavia as a medical doctor he got his first job as WHO Junior Professional Officer in 1988 to work in Tanzania. He is employed by the Spedali Civili di Brescia since 1991. Currently he is the head of the Community Infections Unit, head of the Hospital STI centre, and co-Director of the WHO collaborating Center for TB/HIV co-infection.



[1]  World Health Organization (WHO). Global tuberculosis report 2013. Available  at: accessed 16 Nov 2013).

[2]  World Health Organization (WHO). Global Plan to Stop TB (2001-2005). A comprehensive plan to tackle TB, including opportunities, actions, and investments needed. October 2001. Available at: (last accessed 16 Nov 2013). 

[3] Raviglione MC. The Global Plan to Stop TB, 2006-2015. Int J Tuberc Lung Dis. 2006 Mar;10(3):238-9. 

[4] World Health Organization (WHO). The Global Plan to Stop TB, 2006-2015. January 2006. Available at: (last accessed 16 Nov 2013).7 

[5] World Health Organization (WHO). The Global Plan to Stop TB 2011-2015. October 2010. Available at: (last accessed 16 Nov 2013). 

[6] Seear M. The need for coordinated action against falsified and substandard medicines. Int J Tuberc Lung Dis. 2013 Mar;17(3):286. doi: 10.5588/ijtld.12.0988. 

[7] Gautam CS, Utreja A, Singal GL. Spurious and counterfeit drugs: a growing industry in the developing world. Postgrad Med J. 2009 May;85(1003):251-6. doi: 10.1136/pgmj.2008.073213. 

[8] World Health Organization (WHO). Counterfeit drugs. Guidelines for the development of measures to combat counterfeit drugs, 1999. Available at: (last accessed 16 Nov 2013). 

[9] Ravinetto RM, Boelaert M, Jacobs J, Pouget C, Luyckx C. Poor-quality medical products: time to address substandards, not only counterfeits. Trop Med Int Health. 2012 Aug 22. doi: 10.1111/j.1365-3156.2012.03076.x. 

[10] Kelesidis T, Kelesidis I, Rafailidis PI, Falagas ME. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother. 2007 Aug;60(2):214-36. 

[11] Murray CJ, Lopez AD. Measuring the global burden of disease. N Engl J Med. 2013 Aug 1;369(5):448-57. doi: 10.1056/NEJMra1201534. 

[12] Almuzaini T, Choonara I, Sammons H. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open. 2013 Aug 17;3(8):e002923. doi: 10.1136/bmjopen-2013-002923. 

[13] Bate R, Jin GZ, Mathur A. Does price reveal poor-quality drugs? Evidence from 17 countries. J Health Econ. 2011 Dec;30(6):1150-63. doi: 10.1016/j.jhealeco.2011.08.006. 

[14] World Health Organization (WHO). Treatment of Tuberculosis: guidelines for national programmes, 4th Edition. Available at: (last accessed 16 Nov 2013). 

[15] Bate R, Jensen P, Hess K, Mooney L, Milligan J. Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis. Int J Tuberc Lung Dis. 2013 Mar;17(3):308-11. doi: 10.5588/ijtld.12.0355. Epub 2013 Jan 14. 

[16] Barber SL, Smid M, Hennig C, Huang B, Arifaj D. Multidrug-resistant tuberculosis and quality-assured medicines. Lancet. 2009 Jul 25;374(9686):292. doi: 10.1016/S0140-6736(09)61366-0. 

[17] Arinaminpathy N, Cordier-Lassalle T, Vijay A, Dye CThe Global Drug Facility and its role in the market for tuberculosis drugs. Lancet. 2013 Oct 19;382(9901):1373-9. doi: 10.1016/S0140-6736(13)60896-X. 

[18] Laserson KF, Kenyon AS, Kenyon TA, Layloff T, Binkin NJ.Substandard tuberculosis drugs on the global market and their simple detection. Int J Tuberc Lung Dis. 2001 May;5(5):448-54. 

 [19] World Health Organization (WHO). IMPACT. The handbook, 2011. Available at: (last accessed 28 Nov 2013). 

Devil in the Detail: Health in Jeopardy at US-led Ministerial TPP Talks in Singapore

The ominous prospects on health bound up with TPP negotiations are alarming at a time when trade agreements and governments’€™ choices, largely by the US and the European Union, are turning IP agendas into policies which protect monopolistic interests at the expense of unbiased access to care and  lifesaving treatments in resource-limited settings

Devil in the Detail

Health in Jeopardy at US-led Ministerial TPP Talks in Singapore

By Daniele Dionisio
Member, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases




The Trans-Pacific Partnership, or TPP, talks began in March 2010, promoted by the United States (US) to deepening free trade in the Pacific realm. Shrouded in unprecedented level of secrecy,  the talks aim to address global trade issues including piracy and counterfeiting, while raising standards by taking into account the implications for the multilateral trade system and the different economic levels and needs of participating countries. These currently include Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, US and Vietnam. 


A plan for medicines, known as Trade Enhancing Access to Medicines, or TEAM, was

introduced by US negotiators at the eighth round of TPP talks in Chicago on September 9-15, 2011.

While the US administration did not disclose the plan contents, a US white paper

released September 12 outlined its aims to accelerate access to medicines, get rid of tariffs on medicines and medical devices, and step up legal certainty for manufacturers of generic medicines. The paper also urged TPP parties to reaffirm their commitment to the Doha Declaration on the TRIPS Agreement and Public Health.


The TEAM plan incurred, however, harsh opposition by many public interest groups and non-governmental organizations, also in the light of a leaked draft which led Médecins Sans Frontières to allege that the TPP chapter on intellectual property (IP) would encompass TRIPS-plus measures including:

– Making it easier to patent new forms of old medicines that offer no added therapeutic efficacy for patients (“evergreening”). 

– Restricting “€œpre-grant opposition,”€ which allows a patent to be challenged before it is

being granted.

– Enforcing intellectual property beyond what TRIPS requires, allowing customs officials to impound shipments of drugs on mere suspicion of IP infringement, including “€œin transit”€ products that are legal in origin and destination countries.

– Expanding data exclusivity beyond World Trade Organization (WTO)’€™s request for data protection against unfair commercial use only.

– Extending patent lengths beyond 20-year TRIPS requirements.

– Preventing drug regulatory authorities from approving new drugs if they may infringe existing patents.


And India raised concerns that the TEAM approach would delay access to affordable generic medicines.

Regrettably,  while on 12 November 2011 TPP negotiators agreed to reinforce and develop existing WTO’€™s TRIPS rights and obligations, no shared solutions to the issues above were achieved over  the subsequent years of strictly “€œclosed doors”€ negotiations, in the face of growing controversy in many TPP nations about demanded trade-offs relevant to  medicine prices and the overall health impact of  IP chapter terms.

Relevantly, US Congress members have been severely limited in their access to treaty-related documents, while as reported, “…Content industries and pharmaceutical industries sit on the IP advisory committee…smaller innovators, generics companies, and public interest groups do not…”€

As such, it is good news that the whole draft of IP chapter  from the 26-30 August 2013 round of TPP negotiations in Brunei  was leaked and made available by Wikileaks on 13 November 2013.

While showing  that at least the August draft was hugely prone to big industry interests, the leak has confirmed that all concerns above were definitely to the point. As such, enforcement, which makes up the widest  section of IP chapter, not only re-presents but even exacerbates, mainly per US requests (including much blamed penalties relevant to third party accountability), the provisions from the shelved ACTA treaty.

As an effect of  mounting resonance bound up with the leaked draft, some lip-service has been flaunted as a corrective to the “€œriding roughshod”€ bullying policy over TPP negotiators the US still pursued throughout the 19-24 November 2013  TPP round in Salt Lake City.


Relevantly, an 27 November 2013 statement by the US Trade Representative  gave little openings limited to data protection length of biologic medicines and patent pre-grant opposition procedures.

However, as reported, “…Required patents for new uses, required granting of patents on medicines even in the absence of improved therapeutic effects, data/regulatory monopolies on clinical trial data (data exclusivity), mandatory patents on virtually all medical, surgical, and diagnostic procedures, enhanced damages for patent infringement, mandatory injunctions, and stronger border measures will all be mandatory the minute the TPP is signed. Even more ominously, IP will remain in the investment chapter, meaning that drug companies will immediately be able to sue TPP members if the companies’€™ expectations of IP-based profits are thwarted by fully lawful legislative, regulatory, or judicial decisions…”

Inherently, the  impending threat of an investor state system enforcement as regards access to medicines cannot be underestimated. In this regard, many forms of government regulations, including price cuts of medicines, could be argued not to conflict with the TRIPS agreement, yet to make pointless or erode the expectations of the patent owners.

Relevant risk sectors also include tariffs on medicines, as would be the case should a country that has agreed to reduce tariffs on an imported product later subsidize home manufacturing of the same medicine. A complaint against this country under an investor state system would be allowed to re-establish the conditions of competition in the original transaction.

Additionally, the sectors relevant to packaging and labelling requirements, and to IP protection enforcement measures, may also result as risk target areas, since they might affect the patent holders’€™ access to the market of medicines.

Under these circumstances, should an investor-state system be enforced in TPP, it would make it easier for a claim to be lodged against a member for nullifying or eroding benefits by applying IP protection rules or packaging and labelling models that, despite full alignment with TRIPS requirements, are deemed to be insufficiently stringent or fraudulent.

These prospects appear ominously alarming at a time when trade agreements and governments’€™ choices, largely by the US and the European Union, are turning IP agendas into policies which protect monopolistic interests at the expense of unbiased access to care and  lifesaving treatments in resource-limited settings. So, it was not by chance that on 27 November 2013, after inclusion in the just-concluded Canada-EU Trade Agreement, the European Union Trade Commissioner  defended the inclusion of an investor-state dispute settlement provision also in the Transatlantic Trade and Investment Partnership (TTIP).

Not to mention fear that terms including an “€œinvestor-state mechanism“€ could be approved inside an EU-India deal on track to conclusion.  This would mean a threat to India as a provider of lifeline medicines to the poor’€™s world.

The concern is even greater now that a 12 June 2013 EU custom regulation has incurred criticism of allowing illicit seizing of in-transit goods (including legal generic medicines) “€œover a simple suspicion of IP infringement without checking beforehand whether these goods are headed to the European territory or just in transit” and without “€œclear and convincing evidence of a substantial risk of diversion”€. These terms would hamper TRIPS flexibility grants and run against EU commitments regarding access to treatments without restrictions.

On these grounds, what expectations now that trade ministers are gathering from  7 to 10 December at  an TPP meeting in Singapore that the US eagerly wishes to be the “€œend game”€ of negotiations?  Claims that a “€œdeal”€ could finally be announced are hardly credible with the load of unresolved issues still on the table. And, unless there is an infusion of standing power by TPP participating countries against US  pressure,  the US will certainly force through its position to consolidate monopoly control by large companies, hence undermining access to  health and lifesaving medicines for millions of people in resource-constrained settings.


Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is an advisor for “€œMedicines for the Developing Countries”€ for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy).  

 He may be reached at