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Tree rings expand African climate records

Anti-Microbial Resistance (AMR) Control 2015

This book gathers more than 30 outstanding authors on a broad range of topics and concepts, from proposals for new Intellectual Property Rights approaches to R&D for antibiotics, to the latest data showing that the 44 billion dollars spent on antibiotic for animal husbandry may only be wasteful, to the need for urgent investments in water and waste management by banks and investors, or, last but not least, as it is top in the just adopted United Nations Global Plan of Action on AMR: infection prevention and control (IPC) as a must against AMR, Ebola and MERS

Garance Fanny Upham

by Garance Fannie Upham

Deputy General Secretary, AC2BMR/WAAAR World Alliance Against Antibiotic Resistance

Anti-Microbial Resistance (AMR) Control 2015

 

The book AMR Control 2015 gathers more than 30 outstanding authors on a broad range of topics and concepts, from proposals for new Intellectual Property Rights approaches to R&D for antibiotics, to the latest data showing that the 44 billion dollars spent on antibiotic for animal husbandry may only be wasteful, to the need for urgent investments in water and waste management by banks and investors, or, last but not least, as it is top in the just adopted United Nations Global Plan of Action on AMR: infection prevention and control (IPC) as a must against AMR, Ebola and MERS.

Let me tell you a secret: the book is intended for the lazy professional, the investment decision makers, because it gives a pocket overview of all the different facets of AMR, all into one single book!

The book was put together by the President and Deputy Secretary of the Paris based World Alliance Against Antibiotic Resistance (WAAAR). It can be consulted on line, articles downloaded individually. Printed copies can be ordered on line.

Global overview of Antimicrobial Resistance. A world leader in the drive to control AMR, Professor Dame Sally Davies, Chief Medical Officer of England, along with Professor John Watson, Deputy Chief Medical Officer and Dr Laura Shallcross, UCL Research Department of Infection and Population Health, present here a succinct overview of the need for action: “Individual nations have recognised the importance of antimicrobial resistance as a health issue, but countries have different needs and priorities. In many parts of the world, those with treatable infections lack access to antibiotics, particularly in rural areas. Here the challenge is to improve access without making the drugs so readily available that they can be used inappropriately, the so-called paradox of controlling drug resistance.”

Antibiotic Innovation– Some Lessons from the WHO Processes on Public Health, Innovation and Intellectual Property. This very comprehensive overview, from the Norwegian Institute of Public Health Professors Jens Plathe and John-Arne Røttingen provides us a well informed overview of business models, inspired by the experience of  WHO’s Consultative Expert Working Group on Research and Development (CEWG), which the second author had chaired: How to combine reduction of ‘excess use’, with ‘equitable access’? Experience from neglected diseases can be brought to bear. “How can IPR be mobilized and harnessed in ways that contribute to a feasible economic reward model for sustainable access to effective antibiotics, and in this respect what experiences can be drawn from the field of neglected diseases generally and from the recommendations proposed by the CEWG under the auspices of WHO?”

Creating an Intergovernmental Consortium for New Antibiotics. WHO Assistant Director-General Dr Marie-Paule Kieny has given a lot of thoughts to the kind of new development models which would carry the features necessary to satisfy the need to reward R&D. She proposes an “Intergovernmental Consortium for New Antibiotics” that would feature: 1) mostly public sector funded research and clinical trials, 2) grants to small and medium-size innovative companies or universities to develop new products, 3) milestone and end prizes to reward innovation, 4) patent pools to bring together Intellectual Property Rights generated by public sector funded research, 5) production and marketing agreements for a needs-based number of treatments per year”.

Surveillance and Monitoring of Antimicrobial Resistance. US Centers for Disease Control Director for AMR, Professor Steve Solomon, with Dr Kashef Ijaz, unlike many norm setting institutions or public health specialists, do not in the least “demand” yet another load of data to LMICs. On the contrary, they write from the standpoint of how low income countries can be partners in the needed global effort. For example, on the need for Improving laboratory capacity: «The ability of laboratories to accurately and consistently identify pathogens and their antibiotic susceptibility varies greatly. Trained personnel are the single most important asset in any laboratory» Further down he writes «Prioritize which bacteria are most important to track» which is so important in view of the ‘kitchen sink’ approach to bacterial resistance which is a tendency in some resource poor countries after years of not looking at all.

Antimicrobial Resistance Control in Asia. From South Korea, Professor Jae-Hoon Song, a member of STAG (the WHO initiated expert working group on AMR), takes us through the “six major action plans to control and prevent AMR in the Asian region can provide Asian countries: 1) Strengthen the surveillance of AMR and antibiotics use; 2) Improve awareness of AMR; 3) Promote appropriate uses of antimicrobial agents; 4) Strengthen hospital infection control, 5) Promote vaccination against bacterial infections; 6) Strengthen the national infrastructures and international efforts”.

The Actions of China in Antimicrobial-Resistance Containment. Since 2011 China has embarked on an ambitious program for “rational antibiotic use”, reports Professor Yonghong Xiao of the Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases. What is striking is that the same levels of antibiotic drug resistance are found in all regions and settings even though the regions are widely different in terms of socio-economic development, neglected – element in proper antibiotics usage.

A middle-income country model national AMR Plan: South Africa. A very comprehensive model program on AMR control has been put together by the Republic of South Africa, described by Professor Marc Mendelson and Ms Malebona Precious Matsoso in South Africa, the report highlights reinforcement of infection prevention and control within health care structures, and comprises just about all the recommended features, including flu vaccination to decrease superfluous use of antibiotics in the flu season. The South African Strategy Framework features: “Optimization of surveillance and early detection of AMR with a watch on: 1) Antimicrobial resistance patterns; 2) Antimicrobial consumption; , 3) Antimicrobial drug quality; 4) Medication errors.” Overall the RSA program is a model of the kind for a middle income country.

Actions to Face AMR/ABR-Prescription Control in Human Health. Professor Céline Pulcini, of France’s Nancy University Hospital, and WAAR’s General Secretary, a pioneer innovator in her field, discusses what is called antibiotic stewardship. The paper describes the main measures that could be implemented and discuss the potential limitations and barriers to implementation of those restrictive antibiotic stewardship strategies.

The Role of Sanitation in the Development and Spread of AMR. The article from Professor Timothy Walsh, UK Cardiff University and Professor Antoine Andremont, is set to challenge many perceived notions on AMR Control. One sentence for example says: The link between sanitation, or lack thereof, and antimicrobial resistance (AMR) is primarily to do with two factors: the level of antibiotic resistant bacteria in a person’s gut, and 2, the level of AMR in the environment”.

Diagnostic Solutions Critical to Limit Antimicrobial Resistance Development. Time has come for more investments and more expenditures in diagnostics, in every way, postulate Dr Catharina Boehme (Foundation for Innovative Diagnostics), Mark Kessel, and Professor Ilona Kickbush: Accurate, precise, diagnostic tools ought to be considered as crucial as medicines, the necessary companion. Too many doctors in well to do countries bypass precise diagnostic to put patients on antibiotics indiscriminately. Too many LMIC hospitals systematically give ‘a shot of antibiotics’ to a patient coming up with diarrhoea, for example, in regions where parasitic and viral pathogens causing diarrhea are widespread.

Infection Prevention and Control – Patient Safety a Key Objective for AMR Control. Is Patient Safety important for AMR Control says USAID team with Professor Rashad Massoud (with Danika Barry, Sonali Vaid, Samson M. Haumba, Nokuthula Mdluli Kuhlase). According to USAID ‘patient safety’, starting with the prevention and control of infection in health care settings, is a crucial component of any AMR control program, internationally and nationally. This article takes us through the USAID outstanding effort in this area and their partnering with low income countries, in this case Zambia.

Multidrug Resistant Tuberculosis monitoring in India.“Systematic surveillance for TB drug resistance is the best way to document its presence and has been very difficult to establish in most of the high burden countries, the major obstacle to the expansion of routine surveillance activities has been the lack of laboratory capacity needed to detect resistance.” writes Assistant Director General of the TB program for the Indian government Department of Health, Dr Kuldeep Singh Sachdeva, (with Dr S. Anand and Dr Ranjani Ramachandran of the WHO-India).

HIV Resistance to Antiretrovirals another key issue of AMR Management. ​From South Africa, Professor Gary Maartens, Head of Clinical Pharmacology, University of Cape Town, South Africa; Professor Lyn Morris, HIV Virology laboratories at the National Institute for Communicable Diseases, Dr Gillian Hunt, senior research scientist, Centre for HIV and STI and Professor François Venter, Wits Reproductive Health and HIV Institute (RHI) review the management of HIV resistance in a high burden country. With over 6 million persons living with HIV, South Africa has, on record, the highest number of patients to whom the country offers antiretroviral treatment. The RSA is truly a model country today considering that it is not a high resource country, and that it also has, historically, a high load of tuberculosis.

From civil society’s input, other than WAAAR, we have two contributions: CDDEP director Hellen Gelband, reports on the Center for Disease Dynamics, Economics & Policy partnership with LMIC : “The Partnership operates to bring a set of new voices to the antibiotic resistance issue and to establishing local capacity to develop and help to implement evidence-based policies in eight LMICs from Africa and Asia”, while our WAAAR collaborator, Dr Abdul Ghafur explains his Mumbai Declaration initiative, an India wide coalition which has been extremely effective, in that it convinced authorities to stop over the counter sales of medicines.

Just before  the European Médicines Agency  organized the first ever seminar on the Therapeutic use of bacteriophages (June 8th, 2015), which I attended,  I had sollicited two articles on the issue:

Phagoburn: an EU Research program. Professor Patrick Jault, French Military Health Services, and Jérôme Gabard, CEO of Pherecydes Pharma, gives us an account of a specific clinical research “Phagoburn”, funded by the European Union, on the use of viruses specific to bacteria (phages) to combat bacterial infection so dangerous on burn wounds, the type of research which might well open our arsenal to treat antibiotic resistant infections.

Phage therapy: Could viruses help resolve the worldwide antibiotic crisis?The article from Professor Daniel de Vos and Dr Jean-Paul Pirnay, both with the Belgian Military Hospital research, gives a background on ‘phages’ as therapy and stresses the epistemological hurdles in its acceptance for mainstream medicine. Phage therapies could be part of a ‘patient-centered’ highly individualised medicine of the future.

Costs and benefits of antimicrobial use in livestock. Could Animal Husbandry Do Without Antibiotics?  Aude Teillant, researcher at Princeton’s Environmental Institute, discusses the costs and benefits of antimicrobial use in livestock. She is co-author of the OECD just released first study on global consumption of antibiotics in food producing industries.

What are law makers waiting for? In 2006 the EU banned AGPs (Antibiotic Growth Promoters), the US FDA only ‘recommends it’.

 

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Public health round-up 

Tracking progress to 2030 

TTIP: a corporate lobbying paradise 

The Trans-Pacific Partnership – Is It Bad for Your Health? 

Mylan criticisms of the TPP provisions as regards generic medicines, warns USTR on “lazy drafting” 

Investor-State Cases Could Have Cost Cash-Strapped Argentina $80B, Paper Says 

“BRICS” bank launches in Shanghai, to work with AIIB 

The New BRICS Bank Should Be Green and Focus on Poverty 

The Guardian view on global development goals: heed the good news, but more needs to be done 

EU Commissioner Signals Support For LDC Request To Waive IP Rights Enforcement On Pharma 

Human Rights Reader 365 

Technology, innovation and health equity 

UN talks deliver development financing framework for post-2015 era 

The Medicine Patent Pool Statement on the Addis Ababa Action Agenda: Third International Conference on Financing for Development 

To Support Physician Decision-Making, Re-Evaluate Industry Funding Of Science 

A comparative analysis of national HIV policies in six African countries with generalized epidemics 

Roche expands HIV Global Access Program to include infants in resource limited settings 

Aid Agencies Hail Agreement On Access To Early Infant HIV Diagnostic Technologies 

MSF warns successful global HIV response will require bigger emphasis on adherence 

A UNAIDS–Lancet Commission on Defeating AIDS—Advancing Global Health 

Strengthening Incentives for a Sustainable Response to AIDS: A PEPFAR for the AIDS Transition 

SECONDO WORKSHOP DI ECONOMIA E FARMACI PER L’ HIV WEF HIV 2015 – Milano 8/9 settembre 2015 

Learning From Ebola 

Merck, UNESCO and Cambridge University join hands to build Research Capacity in Africa with the aim to fight against Ebola 

Ebola recovery is impossible unless resilient health systems are rebuilt in Guinea, Liberia, and Sierra Leone 

The need to accelerate access to new drugs for multidrug-resistant tuberculosis 

Antimicrobial resistance: a priority for global health action 

The FACT project: a successful approach to solving public health needs 

We need to grow 50% more food yet agriculture causes climate change. How do we get out of this bind? 

Health impacts of household energy use: indicators of exposure to air pollution and other risks 

3 Reasons Why Women are Key to the Future of Global Health and Development 

Management of Latent Infection to End the TB Epidemic

Persons with LTBI (latent tuberculosis infection) have no signs or symptoms and are not contagious; however, they are at risk of progression from latency to active disease. On average, this happens in 5-10% of those affected during their lifetime, but some (“at-risk”) populations have a substantially higher risk of progression than the average. Hence, diagnosis and treatment of LTBI may represent an attractive strategy for TB prevention 

by Giorgia Sulis, Lucia Urbinati, Alberto Matteelli        

 Division of Infectious and Tropical Diseases – WHO Collaborating Centre for “TB/HIV co-infection and for TB elimination”, University of Brescia, Brescia, Italy

Management of Latent Infection to End the TB Epidemic

 

Latent tuberculosis infection (LTBI) is a condition in which TB bacteria (M. tuberculosis) survive in the body in a dormant state. In 1999 it was calculated that one third of the world population has LTBI (1), providing an estimate of the huge magnitude of the human reservoir of M. tuberculosis.

Persons with LTBI have no signs or symptoms and are not contagious; however, they are at risk of progression from latency to active disease. On average, this happens in 5-10% of those affected during their lifetime, but some (“at-risk”) populations have a substantially higher risk of progression than the average (2). Hence, diagnosis and treatment of LTBI may represent an attractive strategy for TB prevention. Historically, diagnosis and treatment of LTBI did not attract interest for TB control, as diagnosis and treatment of active TB is a more direct intervention to reduce transmission and incidence of the disease. However, the benefits of treating LTBI for individuals with high risk of progression (e.g. those with HIV infection) are well known since decades; moreover, in low TB incidence countries (i.e. 10 cases per 100,000 population or lower) it is now recognized that further decrease of incidence, and eventually TB elimination, will not be possible without addressing LTBI.

From a programmatic perspective, and under a public health approach, the management of LTBI stands on three main components: i) identifying those who should be tested, ii) defining the testing algorithm, and iii) the relevant treatment options. In addition, several supportive interventions need to be put in place, from involving multiple services of the health system, to ensuring sustained procurement of diagnostics and drugs, to setting up a manageable recording and reporting system for effective monitoring and evaluation.

According to the World Health Organization (WHO) policies, all people living with HIV (PLHIV) and children under 5 years of age who are household or close contacts of a TB case should be systematically assessed and treated for LTBI, given their extremely high risk of disease progression. Testing is not required for PLHIV, but it is encouraged whenever possible, based on the use of TST (tuberculin skin test) and limiting treatment to those with a positive test (3). In children, however, testing is not recommended. In both groups, LTBI treatment should be offered as soon as active TB is safely excluded. A 6-month regimen of isoniazid (300 mg daily in PLHIV; 10 mg/kg per day, range 7-15 mg/kg, with a maximum dose of 300 mg/day in children) is the mainstay of treatment in resource constrained countries; lifelong (approximated to 36 months) isoniazid treatment is conditionally recommended for PLHIV in areas with a high TB/HIV-burden, to account for the large risk of reinfection (3, 4). Unfortunately, LTBI management in these populations is either a poorly implemented intervention (5) or a fully neglected area (6), due to low political commitment and the limited availability of financial and material resources hindering implementation on a large scale.

The new END-TB strategy aims at changing radically this picture. By including LTBI management among the essential components of its biomedical interventions, and by setting a global indicator on coverage of LTBI treatment initiation in the above-mentioned groups, the strategy claims for a key role for this intervention on a global scale (7).

In high and upper-middle income countries with TB incidence below 100 per 100,000 population a substantial proportion of new TB cases are due to progression from recent or remote LTBI (2). In this setting TB elimination is stated as a realistic target within 2050 (8), and a list of eight priority actions has been proposed, including systematic screening and treatment of LTBI. WHO issued a guidance document for a public health approach to LTBI management in this context in 2014 (9).

Several at-risk populations, in addition to PLHIV and child contacts were strongly recommended for systematic testing and treatment of LTBI in this setting. These include persons with silicosis and those requiring treatment with tumour necrosis factor-alfa inhibitors, solid organ or bone marrow transplantation, or haemodialysis. For other risk groups, like prisoners, homeless people, injection drug users, migrants originating from high-TB burden areas, and health care workers, the decision to embark in LTBI testing and treatment should be taken locally based on prevailing epidemiology and resource availability (9). Candidates to treatment should be identified through immunological tests such as tuberculin skin tests (i.e. Mantoux test) and IGRAs (Interferon-gamma Release Assays) and those who yield a positive result should be systematically offered treatment, after exclusion of active TB. In such a context, treatment options go beyond isoniazid, and include short-course rifamycin-based regimens which may favour good patient adherence: 3 months of weekly rifapentine plus isoniazid; 3 months of daily rifampicin plus isoniazid; 4 months of daily rifampicin alone (9).

The existence of two different policies for rich and resource-constrained countries might look embarrassing. However, it stands on solid scientific basis. LTBI testing and treatment, even when considered under a public health perspective, must provide more potential benefits than potential harms to each single individual who is candidate to treatment. Wherever TB transmission is intense (high TB-burden countries) the occurrence of reinfections hampers the durability of LTBI treatment and significantly reduces the benefits, while the harms remain the same. Wherever resources are limited, LTBI activities cannot compete, in terms of cost-effectiveness, with diagnosis and care of active TB, since treatment of LTBI has an indirect effect on incidence.

The END-TB strategy has set a target of 90% LTBI treatment coverage (among PLHIV and children under five) within 2025: this may look unrealistic (7). Indeed, national TB Programs or their equivalent at ministerial level must face an incredible challenge as they virtually start from scratch in terms of LTBI testing and treatment interventions. Nevertheless, this very ambitious target can have a pulling effect on activities implementation and bring us close to the final goal, provided that substantial investment will be made in human resources and infrastructures.

 

References

  1. Dye C, Scheele S, Dolin P, Pathania V, Raviglione MC. Consensus statement. Global burden of tuberculosis: estimated incidence, prevalence, and mortality by country. WHO Global Surveillance and Monitoring Project. JAMA. 1999;282(7):677-86.
  2. Getahun H, Matteelli A, Chaisson RE, Raviglione M. Latent Mycobacterium tuberculosis infection. N Engl J Med. 2015;372(22):2127-35.
  3. Intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. Geneva: World Health Organization 2011.
  4. Guidance for national tuberculosis programmes on the management of tuberculosis in children. Geneva: World Health Organization, 2014.
  5. Global Tuberculosis Report 2014. Geneva: World Health Organization, 2014.
  6. Acosta CD, Rusovich V, Harries AD, Ahmedov S, van den Boom M, Dara M. A new roadmap for childhood tuberculosis. Lancet Glob Health. 2014;2(1):e15-7.
  7. Uplekar M, Weil D, Lonnroth K, Jaramillo E, Lienhardt C, Dias HM, et al. WHO’s new end TB strategy. Lancet. 2015;385(9979):1799-801.
  8. Lonnroth K, Migliori GB, Abubakar I, D’Ambrosio L, de Vries G, Diel R, et al. Towards tuberculosis elimination: an action framework for low-incidence countries. Eur Respir J. 2015;45(4):928-52.
  9. Guidelines on the Management of Latent Tuberculosis Infection. Geneva: World Health Organization 2015.; 2015.

 

—————————————————-

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. She also holds a diploma in tropical medicine and international health with TropEd accreditation issued by the University of Brescia in 2013. In 2014 she performed an internship at the Global Tuberculosis Programme of the World Health Organization in Geneva, working with the TB/HIV team.

Lucia Urbinati was born in Italy in 1982. After graduating from the University of Bologna as a medical doctor, she attended a TropEd Course in Tropical Medicine and International Health held in Brescia. In June 2014 she completed her residency training in Tropical Medicine at University of Pavia. She is currently research fellow at the University of 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.

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Civil Society representatives: Call for expression of interest is open for the EMA Management Board

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UNAIDS 2015: ORAL PRE-EXPOSURE PROPHYLAXIS QUESTIONS AND ANSWERS 

No Ordinary Free Trade Agreements – Health and the New Generation Trade Agreements

...from health policy priorities perspective, the more systemic danger of TTIP is that it could hinder necessary change of corporate profiteering and an already failing model for innovation and R&D towards pharmaceutical policy in the public interest...

Meri Koivusalo

by Meri Koivusalo*

Senior Researcher on Health Policy
National Institute for Health and Welfare
Helsinki

No Ordinary Free Trade Agreements  – Health and the New Generation Trade Agreements

 

The new generation trade agreements, such as the TPP (Trans-Pacific Partnership) and TTIP (Transatlantic Trade and Investment Partnership), have changed the ground and context of trade negotiations through extension of negotiations further to national policies and regulation. These new generation trade agreements have gained criticism not only from activists, but also from international and US economists (Krugman 2015, Summers 2015, Stiglitz 2015).

What has been made clear is that these are no ordinary free trade agreements. In Europe and in particular in European Union focus remains, perhaps unsurprisingly, dominated by trade and export opportunities. This is reflected, for example, in the number of references to EU- South Korea FTA as an example of prospective benefits from a trade agreement (Malmström 2015a):

We know that trade agreements do bring benefits. Since the EU-South Korea free trade agreement entered into force in 2011 our exports are up by 35%. In some sectors, like cars, they are up by 90%.”

On the other hand TTIP remains promoted explicitly due to the assumed benefits for global standard-setting at a higher-level. The European Union trade policy materials make the point that:

Aligning EU and US standards and regulations would mean exporters in other countries would only have to comply with one set of rules instead of two.  This would make it easier for them to export and would help their economies.

Aligning EU and US standards and regulations could also provide the basis for high global standards, bringing benefits to consumers and business alike.” (European Commission 2015)

The current engagement with negotiations thus implies a road paved with opportunities and win-win options, yet it seems that many of the claims would require further elaboration.  Furthermore, they do not seem to really hold, when what is actually negotiated is put under scrutiny. In other words, while there may be many lofty aspirations of what is to be achieved, what is negotiated is what counts.

The problem of comparing EU- South Korea FTA with potential benefits from TTIP is of course that it does not compare like with like as trade negotiations with US exceed in breadth what has been agreed with EU-South Korea agreement.  Change is also dependent on situation before and after as well as how particular markets are shaped.  It is also clear that realization of some aspects of what was negotiated with EU- South Korea agreement, for example, in the pharmaceutical annex, will be more problematic in the context of negotiations of TTIP. The likelihood of EU-Korea and the US-Korea agreements to be used as basis for further negotiations has already drawn attention from the European Consumer Organisation (BEUC 2015).

While the rationality of achieving common regulatory practices for the benefits of trade are emphasized, it is not made clear how the scope and requirements for regulation are affected and how a stronger role of multinational industries can affect policy space for health both at European and national and local level role in domestic regulation.  Promises of not lowering current standards are not sufficient, when what matters is how and on what basis new standards can be set and new regulation can take place. Furthermore, through constraining the process of standard-setting and establishing new requirements for regulatory process, the negotiations do have implications for regulatory policy space, even if it would not directly restrict or explicitly deny a possibility for higher level of standards. The purpose and role of regulatory council envisaged as part of negotiations may also have different implications to the Parties. There already exists a relatively strong centrally based presence of regulatory affairs in United States (Office of Information and Regulatory Affairs, OIRA) making this more easily negotiable for USA.  The idea of oversight on regulatory initiative across Atlantic may be appealing to many industries, but may look different from the perspective of Member States.

In many areas industries are no longer local and interests promoted at EU level will be similar to those in USA.  Yet, it is clear that common regulatory process and requirement standards set under influence of multinational actors can be against public interest and the interests of citizens of European Union Member States and citizens of United States, while still making it easier and more beneficial for multinational industries to trade across countries. The win-win for global corporate interests can become a “lose-lose” for public health and public interest.

TTIP and global governance

We do need to question why we should negotiate all public policy and regulatory issues under trade agreements, where agenda is more easily dominated by interests of multinational corporations and coalitions of export industries, when there are other forums for international cooperation. Trade policy should not be the only show in town.

We have United Nations specialized agencies involved with health and food safety. It is perfectly possible to seek closer transatlantic cooperation through other means than trade agreements. If improving regulatory frameworks is the aim of the game, then why are we seeking this through the most difficult route, where corporate interests, in particular, dominate? Another explanation is that what is understood as improvement actually considers improvements for corporate beneficiaries or trade.

This would not need to be the case. Furthermore, the principles and objectives of the Unions’ external action have been defined in TEU (Treaty on European Union) 21 (1) as follows:

  1. The Union’s action on the international scene shall be guided by the principles which have inspired its own creation, development and enlargement, and which it seeks to advance in the wider world: democracy, the rule of law, the universality and indivisibility of human rights and fundamental freedoms, respect for human dignity, the principles of equality and solidarity, and respect for the principles of the United Nations Charter

The Union shall seek to develop relations and build partnerships with third countries, and international, regional or global organisations which share the principles referred to in the first subparagraph. It shall promote multilateral solutions to common problems, in particular in the framework of the United Nations and international law.

These should, in principle, guide also the European Union commercial policy. According to the TFEU (Treaty on the Functioning of the European Union) Article 207 (1) commercial policy is to be “conducted in the context of the principles and objectives of the Union’s external action”. This is partially reflected in Commissioner Malmströms’ speech, where she has emphasised values in foreign policy context of commercial policies (Malmström 2015b):

When partners sign EU trade agreements, they commit to the core standards of the International Labour Organisation– like the right to form unions and strike. They also agree to environmental treaties on issues like transport of hazardous waste and the protection of endangered species.”

…//…

“Furthermore, we also use strategic bilateral trade agreements like the Transatlantic Trade and Investment Partnership as a vehicle to support those EU values that we share with the US – like democracy, open markets, the rule of law, and respect for the individual.”

The challenge is that if TTIP negotiations really represent the democratic values we wish to uphold, it is clear there is a problem in terms of how these democratic values are currently understood, delivered and respected as part of the negotiation process.  United States has not ratified more than two of the eight ILO standards (ILO 2015).  According to ITUC (International Trade Union Confederation) report South Korea is known to have ratified only four of the ILO core labour standards, which do not include right to form Unions and strike (ITUC 2012).  The list of common values promoted by the TTIP seem to lack human rights, equity and solidarity – or perhaps it has been implicitly recognised, that TTIP is not a vehicle to support human rights, equity and solidarity.

If we focus on global governance and the role of European Union, it is possible to argue that current commercial policies are not fully in line with principles and objectives of the European Union external policies. The aim to feed rest of the world standards and regulatory cooperation practices agreed between European Union and United States does not fit well with external policy priorities on multilateral cooperation. It is also unclear how negotiations of TTIP and in particular on investment protection and trade secrets relate to promotion of democracy or consideration of TTIP as a vehicle for promotion of democracy globally.

The relationship between global industries and public policies

The estimates of economic benefits from TTIP have been under scrutiny, but what everybody seems to agree is that key implications from TTIP do not result from lowering tariffs, but from “beyond the border measures” , through changes in future requirements for regulatory measures.  These are much harder to estimate and can also imply unanticipated costs. The question on regulatory action is not just about trade barriers. For example, Joseph Stiglitz has emphasised that (2015):

Rules and regulations determine the kind of economy and society in which people live. They affect relative bargaining power, with important implications for inequality, a growing problem around the world. The question is whether we should allow rich corporations to use provisions hidden in so-called trade agreements to dictate how we will live in the twenty-first century. I hope citizens in the US, Europe, and the Pacific answer with a resounding no.”

What is negotiated in TTIP does relate to health and social policies as what is proposed will have implications to health promotion, protection as well as to financing and organization of health services and social security. While European Union has made promises to exclude publicly funded health services, these remain constrained by overarching commitments to investment protection and potential for overarching obligations for national treatment of investment, regulatory cooperation and in relation to state enterprises and government interventions can. At the core of the concerns is the lack of clear-cut and unequivocal exclusion of health services and social security from the negotiations with potential expansion of more general obligations. (see below)

Regulatory cooperation under TTIP can perhaps be best described as a process seeking to establish procedural framework on how governments can regulate. As these procedures make regulation more burdensome and allow stronger engagement of stakeholders and the other negotiation Party, it is likely to hamper the scope of regulatory measures that governments can take.

Lack of regulation has human and societal costs. What provides benefits for investors and corporations, does not automatically lead to benefits for all, but can imply substantial costs for society at large. The 119 billion € estimated economic benefits of TTIP after ten years on the basis of the Centre for Economic Policy Research (CEPR 2013) assessment are comparable to, although lower than,  estimated annual social costs of alcohol, which have been estimated as 156 billion € (Rehm and Shield 2012). Endocrine disruptive chemicals have been estimated to result in attributable costs of similar annual magnitude to the expected benefits of the TTIP in European Union (Trasande et al. 2015).  The costs of lack of regulation and regulatory action can thus be substantial both in terms of monetary and human costs. The additional requirements and bureaucracy also imply costs for public authorities if they wish to uphold capacity for regulatory action.

While negotiators keep on emphasizing that existing regulatory levels will be upheld, the more cumbersome and more requiring future regulation is made, the harder it will be to enact new regulatory measures.  It is also not clear how TTIP relates to revision of existing regulations and standards. This is particularly important to consider if European Unions’ REFIT (Regulatory Fitness) measures, which will open up and reassess regulatory measures in future as then revision of these new regulations, could be affected by new requirements set as part of TTIP negotiations.

As we are told the importance of growth and the TTIP a crucial means for new growth, it is also necessary to ensure that what is negotiated does not result in “cold growth” accumulating in tax havens with increasing social inequalities, declining public funds, strengthening of the position of multinational industries and corporate monopolies, worsening terms of employment, increasing vulnerability to financial crises, more complex public bureaucratic requirements, and regulatory and public policy impotence.

Enhancing innovation and pharmaceutical policy in the public interest?

A particular case of point needs to be made with respect to pharmaceuticals. It is necessary to ask what public benefits will an even greater influence of global pharmaceutical industry bring to the market approval and reimbursement process of new pharmaceuticals?  It has already been shown that corporate influence can play an influential role in reimbursement decisions in Europe (van Herk et al. 2013).

While the formal focus on pharmaceuticals and TTIP has been on policies with respect to generics and imports from third countries, the real cost pressures for national health systems come from new medicines. High prices of new medicines in both United States and European Union have led to legitimate concerns over the longer term sustainability, affordability and added clinical value of the new medicines, priced at the level that markets can bear.  Yet the TTIP negotiation seem to focus on making it harder for the public administrations to intervene or influence pricing of medicines, while empowering the pharmaceutical industry to maintain and strengthen the current regulatory context and position of major multinational players. Furthermore, from health policy priorities perspective, the more systemic danger of TTIP is that it could hinder necessary change of corporate profiteering and an already failing model for innovation and R&D towards pharmaceutical policy in the public interest.

It is reasonable to assume, that what has been negotiated under Trans-Pacific Partnership (TPP) will emerge to the agenda of the TTIP negotiations. We can thus form some understanding of issues at table from what has been negotiated on the basis of the leaked pharmaceuticals annex of the TPP (TPP 2015). While United States representatives have denied that the transparency annex could be subject to investment protection claims (Weisman 2015), this would be surprising as procedural fairness, which is the aim of the very chapter, provides a feasible route for claims. The relationship between requirements for procedural fairness and what is considered as fair and equitable treatment may also be closer than assumed. Indeed, European Commission explanatory note on investment protection uses these interchangeably:   “Protection against unfair and inequitable treatment – e.g. denying basic procedural fairness “(European Commission 2013, p. 4).

While it may be understandable that producers might seek to ensure the best treatment for their products in other countries, it is not sufficiently recognised that TTIP negotiations can have substantial implications to the ways in which medicines are approved to markets and reimbursed, in particular, within European Union.  Furthermore, while “transparency” seems to be sought in the reimbursement process, there are due concerns over implications of transparency directive to progress in access to data on clinical trials in Europe , which has been criticised by American research-based pharmaceutical industry in their 2014 submission to USTR 301 trade review (PhRMA/USTR 2014). Public health groups and researchers have already drawn concern over definition of trade secrets as part of the transparency directive and links to TTIP negotiations (HAI ym. 2015). Transparency should also not imply a shift towards legitimizing direct-to-consumer advertising in Europe as the TPP transparency chapter seems to seek legitimising more broad-based direct-to-consumer advertising through the internet (TPP 2015).

The danger of the TTIP is that it becomes a protective shield for corporate benefits against duly and timely efforts to change public policies in limiting markets, when commercialization of services becomes too costly, when public interests and opinion do not support profiteering in health services or favour non-profit organizations or public provision (e.g. in publicly funded services), or in the case of pharmaceuticals, using competition to lower prices.  Furthermore, while TTIP is likely to bring growth to the multinational pharmaceutical industry, it is less certain that this will result in taxable income, innovation or cost-effective clinical benefits to patients. On the other hand we can be relatively confident that if exclusivities for pharmaceuticals are expanded or lengthened as result of the negotiations, this is likely to take place at the cost of public purse and those ill, not only within Europe and United States, but as well globally.

We need to be clear that when “high standards” are discussed  this does not only apply to investment and intellectual property rights as it is also important to recognise that trade negotiations can lead to transatlantic sinking of new safety standards, while protecting and tightening those which serve particular interests.  What is good for European Union exporters and industry may not necessarily be safe or great for consumers.

Are health services as “safe” as is claimed ?

TTIP is a negotiated treaty and has its focus on where political priorities are set. It is clear, that while there have been statements on public services (European Commission 2015), this has not so far resulted in explicit exclusions of these services from negotiations.  Legitimate concerns over health, education and social services seem to have become dealt with by separate statements and promises, which are likely to be forgotten, when the final agreement has been signed. We know that it is entirely possible to establish clauses and articles excluding services and sectors or declining to negotiate on investment protection. It is thus a matter of political choice whither we accept health and social security exclusions to remain aspirational and vulnerable to interpretation or explicit “hard” priorities representing European values on what is to be traded and what is not.  It is also likely that other chapters under negotiation, such as government procurement, competition, subsidies or state owned enterprises will have relevance to how publicly financed services can operate and whither these can compete against commercial providers.

There is a danger that trade negotiators may implicitly consider government and public services role as a residual function, where there are no commercial interests. Trade agreements may also impede European problems as internal market rules and regulations may be considered as a starting point for negotiations with third countries.  This applies not only to health services, but as well how services of general economic interest and general interest are understood. The problems emerge if public funding and role for health care provision is pushed to a residual function and required not to affect markets, then excluding publicly funded health services just means excluding services for which there are no commercial interests or which are not tradable.

One concern in relation to the TTIP is the emphasis on general rules and priorities across all sectors. This is reflected in the regulatory chapter on general principles which seeks to build on previous OECD guidance (EU/TTIP 2015).  The shift towards a more general application of rules applies also to TISA (Trade in Services Agreement) negotiations on services on which the TTIP builds, where a push seems again to be from specific commitments to more horizontal obligations (TISA 2015). European Union and Singapore FTA investment chapter expands national treatment obligations for investment to all sectors, including health, social and educational services, with the exception of audiovisual services and procurement for governmental purposes (EU-SSFTA 2014). It may thus be expected that European Commission will seek to expand this horizontal inclusion of national treatment of existing investors in all services also to TTIP. This is not about trade, it is about regulation of national policies.

This has relevance with respect to the role and position of non-profit providers and can affect how services of general interest and general economic interest are treated in service provision as a government may wish to treat these differently from commercially driven multinational corporations, which can provide “like services”. The application of restrictions to performance requirements could limit means to ensure continuity of care, equity in access to services or to ensure efficient use of resources within the health system.

Health services or national exclusions on health services from trade agreements are not necessarily as “safe” as we have been told, if exclusions only apply to ability to restrict new establishments, while governance of national policies and investment has slipped further under trade agreements.

The paradox of evidence in the context of TTIP negotiations

The paradox of the TTIP negotiations is that an international legal framework limiting public policy options and policy space for health is negotiated with very limited evidence on broader societal benefits, while this very framework will not only require increasing and more narrowly defined evidence for future regulatory measures to take place, but can also make it more difficult to gain evidence for public policies and regulation for health.

It is clear that costs from TTIP have not been addressed fully in terms of investment protection, lack of regulatory action, regulatory burden for governments or increased costs for new medicines and technologies. Even broader financial sustainability issues may be at stake in the context of financial services chapter, including social security systems or vulnerability to new financial crises. The legal language introduces new terminology and obligations, which may not be fully understood in terms of implications as this type of requirements may not have been dealt with as part of health policy-making and governance.  While consultations have provided managed information and sharing of European Union stances to the wider public and academic research, which is an improvement, the consolidated negotiation texts are still available only to chosen few.

The focus on transparency may seem a move to the right direction, but measures promoted under transparency seem to go only to one direction. There is a danger of creating a transparency ratchet, where all that is on public sector remains open and accessible to early scrutiny by corporations, while at the same time access to information for regulatory purposes from the corporate sector becomes safeguarded by stronger protection of trade secrets.

A major challenge with respect to “evidence” relates to precautionary principle. It is also clear that impact assessments have shifted to serve more commercial needs with proposals of regulatory and trade impact assessments (EU/TTIP 2015). A reaffirmed commitment to OECD good regulatory practices is to be made as part of the agreement (OECD 2012), which raises also questions of purpose and role of the regulatory cooperation focus. If OECD already provides soft guidance on regulatory cooperation, the TTIP can’t be about “soft” guidance, but seems to be much more about locking in a framework for regulatory cooperation and enforcement through TTIP.  Furthermore, if the agreement is a “living agreement”, the initial negotiation round will need to be only a placement for further negotiations.

If TTIP is the answer, then what is the problem?

It is possible to argue that trade should preferably be negotiated under multilateral governance with a broad participation and actual transparency, rather than making a bilateral deals and then imposing them to all others, which does not sound as great foreign policy or respect for democratic accountability.

Governments can deregulate without a broader international framework and if TTIP partnership is only about “encouraging” regulatory cooperation, then perhaps this encouraging could be done in a less legally binding form under OECD. Most of health promotion legislation has not taken place as result of international agreements, but as result of governments following wise regulatory measures of other governments.  As world has not ended in spite of corporate predictions, other governments have dared to follow the lead. However, the TTIP fits perhaps too well with an aim to ensure that there is less scope for innovative regulatory measures for the benefit of public health policies through the imposition of a more restrictive overarching regulatory framework, enhancing investor and intellectual property rights protection, and enabling early corporate presence as part of the regulatory process.

Do trade policies then really suffer from lack of empowerment of multinational industries and insufficient consideration of corporate and transnational investor interests as part of public policy-making and regulatory decisions in European Union and United States?  Do we really need to have consultations across Atlantic or a regulatory council on potential regulatory interests in case these might affect trade interests? Why should framework for health-related standard-setting and regulation be decided under closed trade negotiations between United States and European Union?

The pass of the fast track vote in USA implies that more scrutiny and oversight is now required from the European Union side and, in particular, from the European Parliament. The process of the European Parliament vote was not promising. If a closer partnership is to be desired, then any advancement of regulatory cooperation with respect to pharmaceuticals, health promotion, health, environmental protection and safety should best take place elsewhere, than under trade or corporate friendly regulatory councils governed under trade and economic policy priorities. Innovative solutions could be sought on the basis of public health and health policy priorities and has been done. The point is not about international cooperation, it is about where, on what basis and for what purpose this cooperation takes place.

 

References

CETA (2014) Comprehensive Trade and Economic Agreement.  Avaible from: http://ec.europa.eu/trade/policy/in-focus/ceta/

European Commission (2015) Questions and answers.  Available from: http://ec.europa.eu/trade/policy/in-focus/ttip/about-ttip/questions-and-answers/index_en.htm

European Commission (2015) Joint Statement 20 March 2015.  Available from: http://europa.eu/rapid/press-release_STATEMENT-15-4646_en.htm

European Commission (2013) Fact Sheet. Investment Protection and Investor-to-State Dispute Settlement in EU agreements. November 2013. Available from: http://trade.ec.europa.eu/doclib/docs/2013/november/tradoc_151916.pdf

EU/TTIP (2015) Regulatory chapter proposal 4th of May 2015. Available: http://trade.ec.europa.eu/doclib/html/153403.htm

EU-SSFTA (2015) Draft EU-Singapore FTA. October 2014. Chapter 9. Investment. Available from: http://trade.ec.europa.eu/doclib/press/index.cfm?id=961

HAI et al. (2015) EU trade secrets directive threat to free speech, health, environment and worker mobility. 23 March 2015. Statement.  Available from:  http://haieurope.org/wp-content/uploads/2015/03/Statement-updated-on-trade-secrets-directive.pdf

ILO (2015) Ratifications for United States. Available from: http://www.ilo.org/dyn/normlex/en/f?p=1000:12001:0::NO:::

ITUC (2012) Internationally recognised core labour standards in Republic of Korea. Report for the WTO General Council review of the trade politics of Republic of Korea. Geneva, 19 and 21 September, 2012. Available from: www.ituc-csi.org/IMG/pdf/korea_tpr_final.pdf

Krugman P (2015) This is not a trade agreement. April 26, New York Times.  Available from: http://krugman.blogs.nytimes.com/2015/04/26/this-is-not-a-trade-agreement/?_r=0

Malmström C (2015a) Bringing EU trade policy up to date. 23 June. Speech. European Trade Policy Day. Keynote (website).Available from: http://trade.ec.europa.eu/doclib/press/index.cfm?id=1334

Malmström C (2015b) Integrated trade and  foreign policy. 11 of June. Speech Annual on European Council of Foreign Relations. Available from: http://trade.ec.europa.eu/doclib/press/index.cfm?id=1328

OECD (2012) Recommendation of the regulatory council on regulatory policy and governance. Available from: www.oecd.org/governance/regulatory-policy/49990817.pdf

PhRMA/USTR (2014) Pharmaceutical Research and Manufacturers of America (PhRMA)special 301 submission 2014. Available from: www.phrma.org/sites/default/files/pdf/2014-special-301-submission.pdf

Rehm and Shield (2012) Alcohol consumption, alcohol dependence and attributable burden of disease in Europe. Amphora project. Centre for Addition and Mental Health, 2012. Available from: http://amphoraproject.net/w2box/data/AMPHORA%20Reports/CAMH_Alcohol_Report_Europe_2012.pdf

TISA (2015) Domestic regulation. Available from: https://wikileaks.org/tisa/domestic/

TPP (2015) Transparency chapter. Available from: https://wikileaks.org/tpp/healthcare/

Trasande L, Zoeller RT, Hass U, Kortenkamp A, Grandjean P, Peterson  Myers J, DiGangi J, Bellanger M, Hauser R, Legler J, Skakkebaek NE, and Heindel JJ (2015) Estimating Burden and Disease Costs of Exposure to Endocrine-Disrupting Chemicals in the European Union. The Journal of Clinical Endocrinology & Metabolism 2015 100:4, 1245-1255. Available from: http://press.endocrine.org/doi/ref/10.1210/jc.2014-4324

Stiglitz J (2015) The secret corporate takeover. May 13 2015. Available from: http://www.project-syndicate.org/commentary/us-secret-corporate-takeover-by-joseph-e–stiglitz-2015-05

Summers L (2015) Rescuing free trade agreements. June 14, 2015. The Washington Post. Available from: http://www.washingtonpost.com/opinions/rescuing-the-free-trade-deals/2015/06/14/f10d82c2-1119-11e5-9726-49d6fa26a8c6_story.html

Van Herck P, Annemans L, Sermeus W, Ramaekers D (2013) Evidence-Based Health Care Policy in Reimbursement Decisions: Lessons from a Series of Six Equivocal Case-Studies. PLoS ONE 8(10): e78662. doi:10.1371/journal.pone.0078662

Weisman J(2015) U.S. Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals. New York Times June 10, 2015. Available from: http://www.nytimes.com/2015/06/11/business/international/us-shifts-stance-on-drug-pricing-in-pacific-trade-pact-talks-document-reveals.html?_r=2

 

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*Meri Koivusalo is a senior researcher in National Institute for Health and Welfare in Finland. She is a medical doctor with a PhD in public health and MSc in environmental health policy. She has written and published on international and European health policies, including on trade and health. She has followed trade policy developments for more than 15 years. She has served as an advisor for Finnish Ministry of Social Affairs and Health as well as for European Commission DGV, DG VIII and WHO. She was a member of the WHO Consultative expert group on research and development: financing and coordination (CEWG). 

We Have a Dream: Universal Early Access to Innovative, Life-Saving Medicines

In April 2015, The WHO Expert Committee, tasked with the review and update of the WHO Lists of Essential Medicines for adults (EML) and children (EMLc), recommended the addition of 36 new medicines to the EML, and of 16 to the EMLc. It is hoped that the indications of the WHO Expert Committee will be considered and followed by all the concerned stakeholders, including pharmaceutical companies and policy makers

raffaella ravinetto

by Raffaella Ravinetto*

Head of Clinical Trials Unit, Antwerp Institute of Tropical Medicine

WE HAVE A DREAM: UNIVERSAL EARLY ACCESS TO INNOVATIVE, LIFE-SAVING MEDICINES

 

The inclusion of antiretroviral medicines in the WHO Model List of Essential Medicines (EML) represented in 2002 an important step in the path toward getting universal access to medicines for HIV/AIDS. Even if the overarching goal is not reached yet, the inclusion of ARVs in the WHO EML gave a strong message that these medicines must be available to all those in needs, because of their safety and efficacy for treating an otherwise deadly disease, and irrespectively of their price. The inclusion of antiretrovirals in the WHO EML  slightly preceded the launch of other key-initiatives, such as  the WHO Pre-qualification project (1) and the Global Fund, aimed respectively at giving guidance on the choice of quality-assured generics, and at facilitating the universal access to life-saving medicines for HIV/AIDS, malaria and tuberculosis.

More than a decade after this milestone event, the 20th meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines made in April 2015 other “essential” choices. The Expert Committee, tasked with the review and update of the WHO EML for adults and of the Model List of Essential Medicines for children (EMLc), recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list), and of 16 to the EMLc (five to the core list and 11 to the complementary list)[1]. The new essential medicines cover a wide range of conditions, including multi-drug resistant tuberculosis, extensively drug resistant tuberculosis (XDR) and pre-XDR, HIV/AIDS, viral hepatitis, cancer, cardiovascular diseases,  and contraceptive products (2, 3). Some of the choices made by the Expert Committee, are in line with the principle that early access to innovative, life-saving medicines should be universal.

The case of viral hepatitis The new EML sub-section for hepatitis C includes six oral direct-acting antiviral (DAAs) medicines: daclatasvir, ledipasvir + sofosbuvir, ombitasvir + paritaprevir + ritonavir with or without dasabuvir, simeprevir, and sofosbuvir, chosen on the basis of “comparative efficacy, increased tolerability and the potential public health impact”.

The high prices of these medicines are making their access extremely challenging not only in middle- and low-income countries (LMICs) (4), but also in some high-income countries (5), and could have discouraged their inclusion in the EML. Conversely, according to the WHO, “the very high cost of hepatitis C medicines was considered and the Committee recommended that WHO take actions at global level to make these medicines more accessible and affordable”.  This decision strongly underlines the need to ensure access to DAAs for all those in need. It is now hoped that it may trigger other international initiatives to upscale the access to DAAs, just as it happened 13 years ago with antiretrovirals. Noteworthy, a few months before the new EML was issued, the WHO Pre-qualification had already expanded its scope to hepatitis C (6), as a first step to provide reliable guidance on quality-assured generic versions of these medicines.

The case of cancer medicines Hepatitis C is, like HIV/AIDS, malaria and tuberculosis, an infectious disease, and so far the focus of most “access” initiatives has been on transmissible diseases, whether present worldwide or mainly/ exclusively prevalent in LMICs. But LMICs are not exclusively of mainly hit by infectious diseases, and the morbidity and mortality of non-transmissible diseases such as cancer, cardiovascular diseases and diabetes, are steadily increasing. For instance, according to the WHO, more than 60% of world’s total new annual cases of cancer occur in Africa, Asia and Central and South America, and these regions account for 70% of the world’s cancer deaths. Ensuring universal access to anti-cancer medicines  thus represents a major ethical challenge for the international community (7).

The EML Committee has recommended the addition to the EML of 16 medicines for cancer, and it has endorsed the use of 30 medicines for the treatment of specific cancers. Among the recommended medicines there are some high-cost medicines (including imatinib, trastuzumab and rituximab), for which the possibility of universal access may also be put at stake by intellectual property issues and high prices. Their inclusion in the EML underlines that early access to innovative essential medicines should be seen as a human right irrespectively of whether they are costly or not, and irrespectively of whether the concerned diseases have or have not a potential for epidemics.

It is hoped that the indications of the WHO Expert Committee will be considered and followed by all the concerned stakeholders, including pharmaceutical companies and policy makers.

 

References

1) ‘t Hoen EFM, Hogerzeil HV, Quick JD, Sillo H. A quiet revolution in global public health: the World Health Organization’s Prequalification of Medicines Programme. Journal of Public Health Policy 2014; doi:10.1057/jphp.2013.53

2) 19th WHO Model List of Essential Medicines (April 2015) . Last accessed on 5th July 2015 at http://www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf

3) WHO Model List of Essential Medicines for Children (April 2015). Last accessed on 5th July 2015 at http://www.who.int/medicines/publications/essentialmedicines/EMLc2015_8-May-15.pdf

4) Kamal-Yanni M. Hepatitis C drug affordability. Lancet Global Health 2015; 3: e73-e74

5) Brunetto MR et al. Reducing the price of new hepatitis C drugs in the Tuscany region of Italy. BMJ. 2015 Jun 24;350:h3363

6) 12th Invitation to manufacturers and suppliers of medicinal products for HIV infection and related diseases, including treatment for hepatitis B and C, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team – Medicines Last accessed on 5th July 2015 at http://apps.who.int/prequal/info_applicants/eoi/EOI-HIV-v12.pdf

7)  ‘t Hoen E. Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication. A report prepared for Oxfam, 2014.

[1] The core lists present a list of “minimum medicine needs for a basic health‐care system, listing the most efficacious, safe and cost‐effective medicines for priority conditions”, while the complementary lists present essential medicines “for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed”.

 

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*Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine.   

After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011).   

Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health.