Dolutegravir Patent Licences Can Provide Access To All

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

This year the World Health Organization (WHO) added dolutegravir, an antiretroviral medicine for the treatment of HIV infection, to its Model List of Essential Medicines in response to the recent evidence showing the medicine’s safety, efficacy, and high barrier to resistance. A recent study HIV drug resistance report 2017 launched by the WHO at the IAS2017 shows that in 6 of the 11 countries surveyed in Africa, Asia and Latin America, over 10% of people starting antiretroviral therapy had a strain of HIV that was resistant to some of the most widely used HIV medicines. This is a worrying trend and such levels of resistance demand a review of the treatment practices including switching to more robust ARV regimen.

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The Most Common Misunderstanding About Compulsory Licences

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

The belief that a country can only use compulsory licensing in cases of public health emergencies is a myth that has proven difficult to bust.

Recently Jay Taylor, a lobbyist for Phrma, stated: “In certain instances, such as public health emergencies, trade partners may legally issue a compulsory license.” Mr Taylor references his statement with a link to the World Trade Organization’s fact sheet on compulsory licensing, which says:

Does there have to be an emergency? Not necessarily. This is a common misunderstanding. The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, the Doha Declaration on TRIPS and Public Health confirms that countries are free to determine the grounds for granting compulsory licences.

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A New Access to Medicines Initiative: Medicines Law & Policy

By Jacquelyn Veraldi, University of Groningen, j.d.veraldi@rug.nl

This week during the WHO’s 70th World Health Assembly, GHLG member Ellen ‘t Hoen announced the launch of the new website, ‘Medicines Law & Policy’, established with colleagues Pascale Boulet and Kaitlin Mara, all experts in intellectual property and access to medicines.  ML&P provides expertise in the form of policy and legal analyses, best practice models, and other information to work toward the goal of ensuring the availability of effective, safe, and affordable medicines for all.
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Vision for sustainable access to innovative medicines: GHLG & UMCG’s Global Health Unit respond to the OECD

By: Katrina Perehudoff, Global Health Unit Department of Health Sciences, UMCG Groningen, katrina.perehudoff@gmail.com

Excessively high prices of innovative medicines threaten patient access and health system sustainability in developing and industrialised countries alike. The Organisation for Economic Co-operation and Development (OECD) has launched a new initiative to facilitate high-level dialogue between stakeholders on access to innovative medicines and the sustainability of prices. On April 30, 2017, members of the GHLG Research Centre and the Global Health Unit in the Dept. of Health Sciences at the University Medical Centre Groningen responded to OECD’s online consultation for sustainable access to innovative medicines. Below are excerpts from our response.

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The Italian Exception: A personalised approach to accessing high-priced patented medicines

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

At the end of March 2017, the Italian Minister of Health Beatrice Lorenzin authorised the importation of generic medicines. She did this with only a veiled reference to the high-priced hepatitis C (HCV) medicine sofosbuvir, marketed under the trade name Sovaldi. However, the authorisation is not restricted to the treatment of HCV and can be used to find alternatives for any medicine not available or affordable in Italy.

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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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