Protection of intellectual property on the one hand and the right to healthcare on the other: this is a balancing act which is the subject of the European Parliament’s health committee initiative report.

MS – 12/2016

In order to resolve this conflict and to ensure the supply of innovative medicines, the Committee on the Environment, Public Health and Food Safety (ENVI), under the leadership of Ms Soledad Cabezòn Ruiz (ES/S&D), has addressed the issue. The draft report was released in September 2016. The more than 600 amendments tabled by MEPs show how much interest there is and how divergent opinions are on the matter. 


In the debate held by the Health Committee in December 2016, MEPs mainly discussed new ways of thinking about the regulation of spending on medicinal products against the backdrop of exploding prices at EU level. This involves numerous aspects which play a role in ensuring not only the viability of health systems but also the survival of the pharmaceutical industry.  


There was criticism in the debate, for example, that a patent on a drug is currently not a guarantee that it is actually a new or good medicine. Other MEPs, however, demanded that manufacturers who invest in a good drug should also benefit from good patents. Copyrights must be respected and good investments must be rewarded with profits; however, high-price medicines must not be a threat to entire healthcare systems. 

Research and innovation are important and should be encouraged in the area of health. This also ensures the competitiveness of European pharmaceutical companies on the international scene. How can the competitiveness of the sector be strengthened but at the same time prices in the EU as a whole be reduced? According to the parliamentarians, medicinal products must ultimately be affordable, otherwise patients will not be able to take advantage of them.  


Health Technology Assessment (HTA) also requires discussion. MEPs are yet to agree as to whether a European approach can deliver a positive effect while at the same time avoiding duplication. It is also questionable whether a European HTA should focus exclusively on scientific criteria or also on ethical and social criteria.  

The GKV-Spitzenverband and the ESIP welcome the debate in Brussels. The ongoing discussions in EU institutions confirm concerns about current developments in the area of pharmaceuticals. Talks between key stakeholders over future supply of medicinal products must continue to be established. The statutory insurance providers definitely belong to this group – not only as guests, but as equal partners.  


The Parliament’s proposal contains a clear call for the Commission to get involved in this area and to take appropriate measures. However, given the division of competences, it is important to discuss what should be decided at EU level and what should be decided at national level. Setting prices and reimbursing the costs of medicinal products is the responsibility of the Member States and this should remain the case.  


Voting in the Health Committee is scheduled for 31 January 2017 and voting in the plenum will take place in February 2017. 


Draft report: