New game, new rules: Pathways for better and affordable medicines in Europe

July 13, 2017

If you are interested in the pharmaceutical industry, look at this very interesting article from PharmaFile! It focuses on the political and economic influences of the medicine market in Europe.




“Yannis Natsis, Policy Manager for Universal Access and Affordable Medicines at the European Public Health Alliance (EPHA), discusses the latest developments in market access across Europe, and the collaborative efforts its constituents are engaging in to improve it


Political correctness flew out the window in 2016 when it came to the access to medicines agenda in Europe, largely thanks to visionary leadership by the Netherlands. The problems of the current pharmaceutical business model – unjustifiably high prices, questionable innovative value of new drugs, the need to guarantee a fair return on public investment to name but a few – took centre stage during the Dutch Presidency of the EU in the first half of 2016, along with some recommendations for next steps.


Disruptive political developments


These are by far the most meaningful, strongly-worded and disruptive conclusions that EU Health Ministers have signed off in years. The then Dutch Minister for Health, Edith Schippers, spearheaded the negotiations during which she managed to demolish several long-standing taboos that stakeholders in Brussels and beyond had carefully fostered. She took many by surprise and surely made drug manufacturers very uncomfortable when she shone the spotlight onto the elephant in the room: the correlation between patent monopolies and the affordability and accessibility crises that many Europeans face today.


As a result of these Conclusions, the European Commission (EC) is currently conducting an evidence-based analysis on the impact of additional forms of patent protection – namely data and market exclusivities, as well as the supplementary protection certificate on the availability, affordability and accessibility of medicines and on the quality of medical innovation, notably on orphan drugs. It is a particularly bold and welcome step as there is an increasing political consensus that the incentives originally put in place to promote innovation in the field of rare diseases are being abused to maximise profit. Governments and the EMA need to send a clear signal to the market that rare cannot and should not mean orphaned, and the agency must change course and prevent the further orphanisation of the pharmaceutical regulation.


This incentives review will undoubtedly prove to be one of the most heavily lobbied items in the sphere of Brussels EU advocacy as it questions one of the sacred cows of the current profit-driven pharmaceutical model: the suitability of intellectual property rights. All eyes are on the EC, which needs to guarantee a transparent and impartial drafting process as well as a level-playing field for the balanced involvement of all stakeholders. It will be highly unfortunate if the study is contested due to its quality at the time of its delivery. That said, it is critical that national experts contribute data and solid evidence to the study so that it is not hijacked by narrow commercial and political interests.”


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