Access to medicines amendment of the WTO TRIPS Agreement– hype or hope?

By Ellen ‘t Hoen, Global Health Unit Department of Health Sciences, UMCG Groningen, e.f.m.t.hoen@umcg.nl

On 30 January the World Trade Organization (WTO) announced the first ever amendment to the TRIPS Agreement under the headline WTO members welcome entry into force of amendment to ease access to medicines.

WTO members were celebrating and some media reported the announcement as a major breakthrough. Here is some sobering background to the announcement.

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Voices in the Field: Professor Hans Hogerzeil

Hans Hogerzeil is a Professor at the University of Groningen’s Faculty of Medical Sciences who has a rich background in the field of health and human rights that has involved hands on practice as a doctor in Ghana and India, important contributions to pharmaceutical policy development via the WHO, and a large quantity of significant academic publications. While working at the WHO,he advised over 40 developing countries, was Secretary to their Expert Committee on the Selection and Use of Essential Medicines, and worked as Director of Essential Medicines and Pharmaceutical Policies. He is a Fellow of the Royal College of Physicians in Edinburgh and has an honorary Doctorate of Science from the Robert Gordon University in Aberdeen, Scotland.

As an expert in global health, access to essential medicines, pharmaceutical policy, and human rights, Prof. Hogerzeil has much to add to the health and human rights discussion as a contributor to Voices in the Field*

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‘Equitable access to controlled medicine: between drug control and human rights in post-market access in low- and middle income countries’ – Conference report

By Marie Elske Gispen, Utrecht University, m.e.c.gispen@uu.nl

On 8 and 9 October 2015 several GHLG members participated in a symposium on ‘Equitable access to controlled medicine: between drug control and human rights in post-market access in low- and middle income countries’ (co-organized by Marie Elske Gispen, Utrecht University). Marie Elske presented the preliminary conclusions of her Ph.D. research on access to controlled medicines at this meeting. GHLG fellows Brigit Toebes and Hans Hogerzeil commented on her work from a legal and global health perspective respectively. Brigit mainly touched upon the question whether or not the normative framework of the right to health is sufficiently equipped to further access to medicine provision. Hans particularly reflected on the progress, or lack thereof, made so far in the area of access to (controlled) medicines. GHLG fellow Katrina Perehudoff joined on the second day of the symposium as participant.

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Balancing innovation and access to medicines: Considerations for a public interest derogation to patent rights in the EU

By Lisa Noort

Affordable medicines are a decisive factor in access to treatment in the European Union (EU). Drug prices are highly influenced by a medicine’s patent protection, which is argued to stimulate medical innovation to bring patients the medicines they need. In Europe, patients enjoy the right to healthcare as part of the Charter of Fundamental Rights. Tension arises when the public interest demands affordable and accessible healthcare, and innovation at the same time, while the interest of the patent holder needs to be respected.

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Get research experience in access to medicines & human rights: GHLG is recruiting students for country case studies

Want to find out how human rights translate into access to medicines for patients in the global south? Interested in doing your own analysis of access to medicines situation in low and middle income countries? Gain this research experience with the Essential Laws for Medicines Access project at the Global Health Law Groningen Research Centre.  

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GHLG presents empirical evidence on access to medicines at international norms & domestic law-making @ University of Basel workshop

On September 4th, our pilot results from the Essential Laws for Medicines Access project were presented at the workshop‘International Law and Domestic Law Making Process’ at the University of Basel. This invited presentation contributed empirical evidence about the introduction of access to medicines in domestic law as part of the international norm, the right to health, to the broader discussion about which factors determine the relationship between international and domestic law and whether governments have sufficient leeway in deciding how to implement their international commitments.

Our preliminary findings show that only two countries in our sample take a rights-based approach to universal access in domestic law. Future research will elaborate on these results to understand what factors led governments to make these commitments and what has resulted from them. (See our open call for research assistance)

Dr. Ioana Cismas (Stirling Law School, Scotland) chaired our discussion about this and other evidence from the democratic legitimation of trade agreements in Switzerland, presented by Dr. Charlotte Sieber-Gasser (World Trade Institute & Graduate Institute), and the use of flexibility mechanisms in human rights treaties, presented by Gentiana Imeri (University of St. Gallen). The workshop was graciously organised by Dr. Evelyne Schmid and Dr. Tilmann Altwicker in collaboration with the AjV (Arbeitskreis junger Volkerrechtswissenschaftler*innen). The workshop programme is available here.

How to improve equitable access to medicines for non-communicable diseases (NCDs)? GHLG comments on WHO’s discussion paper

Equitable access to medicines to treat non-communicable diseases (NCDs), such as cancer and diabetes, is a major public health challenge in need of a global response. In August 2015, GHLG submitted comments to the WHO’s consultation on its discussion paper Essential medicines and basic health technologies for non-communicable diseases: towards a set of actions to improve equitable access in Member States. Our response presents key findings to date as strategies on legal approaches to promote access to essential medicines, including those for NCDs, such as:

The rational selection of medicines as a legal requirement: A national essential medicines list is a valuable tool to promote the rational use of medicines while also achieving the greatest public health impact for the least cost. Creating a legal obligation in domestic law to maintain an EML may be an effective way of giving effect to States’ core obligation to provide essential medicines defined by the WHO and to support access in the national context. GHLG provided model legal text identified in our pilot study of 14 countries in our Essential Laws for Medicines Access project.

 

Reliable health & supply systems for access to essential pain treatment: In many low- and middle-income countries, the availability and accessibility of opioid analgesics, often used to treat pain, conform human rights law could conflict with international drug control standards, whereas the quality and cultural appropriateness of medicines could conflict with international standardisation guidelines. There is a certain degree of urgency in low- and middle-income countries that increasingly suffer from the threat of NCDs, and where curative care is often unavailable, leaving palliative treatment, which heavily relies on the use of opioid analgesics, as the only viable therapeutic option. GHLG drew on its research of approaches taken at the national level.

 

Constitutional commitments to essential medicines to enhance advocacy efforts: A guarantee of access to essential medicines in national constitutions may create a supportive environment for advocacy efforts by creating a rights-based framework to guide the implementation of policy and programmes. In some countries, constitutional health rights are also enforceable before domestic courts. Results from GHLG’s global survey of constitutional language for access to medicines from our project Constitutional Health Commitments.

Next steps: Legal & policy responses to NCDs in 2016 GHLG Summer School

Besides our response to the WHO’s consultation, GHLG continues to follow the development of legal and policy responses to NCDs. We’ll tackle access to medicines for NCDs, and the link between NCDs and the regulation of tobacco and food in our July 2016 summer school NCDs & the law: A human rights response to the global health crisis.