Groningen Centre for Health Law

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 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 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.

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.

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.

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.

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.

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.

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.

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).