European Commission Publishes Expert Panel’s Recommendations on High Drug Prices

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

This month the European Commission published Innovative Payment Models for High-Cost Innovative Medicines, a report of the Expert Panel on effective ways of investing in Health (EXPH).

The report examines new ways of paying for new and costly medicines as a means to finding solutions for the ever-increasing prices of new pharmaceutical treatments. The panel does not shy away from exploring hot-button topics such as the need for greater transparency in medicines pricing, R&D and marketing cost, enlisting competition authorities to investigate drug pricing, ‘orphanisation’ of new medicines, revisiting the patent and market exclusivity as a cornerstone of innovation, developing alternative paths for innovation financing based on delinkage principles such as prize awards and the question how to ensure a ‘public return on public investment’. It further explores ways to bolster negotiating power of governments in price negotiations, including through the use of compulsory licensing of medicines patents.

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Growing consensus on importance of delinkage in pharmaceutical R&D

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

The movement to delink the cost of developing medicines from their market price received another boost this week, with the publication of a new report from the Netherlands Council for Public Health and Society, an official government advisory body.

This report is part of a recent phenomenon in which even the wealthiest of health systems have been unable to afford medicines developed under a monopoly-based pharmaceutical innovation model, and underlines a growing international consensus that better models to incentivise the creation of new medicines are needed. High priced medicines resulting from this model cause access problems and are a threat to the affordability of health care in almost all European countries. Medical professionals and patients are calling on their governments to take action.

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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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