Summary of the Exchange of Views on the Draft Report on “EU Options for Improving Access to Medicines”, between EU Parliamentarians, members of the Healthcare Committee (Provided by EUCOPE) – 12 October 2016
Members of the EU Parliament (MEPs) working on healthcare dossiers discussed the Draft Report in the context of the current debate on access to innovative medicines at EU and national levels, and the related topic of increased drug prices.
The rapporteur, MEP Cabezon Ruiz, kicked off the Exchange of Views. Joined by fellow Socialist MEPs and other Left-wing MEPs she called for, inter alia:
- Sustainable health systems, which guarantee equal and universal access to medicines for EU citizens,
- A facilitated entry of generic drugs onto the market, through the review of Intellectual Property (IP) rights protection to limit them to protection of “genuine” innovation,
- Greater transparency in price-setting, in particular with the development of EU “harmonised economic, social and moral criteria”
- Strengthened cooperation of EU Member States, with regards to pricing, reimbursement and Health Technology Assessment (HTA)
Several MEPs of the European Peoples Party (EPP) and the Liberals and Democrats (ALDE) deplored a “gloomy”, somewhat “industry-bashing” picture of a situation, saying they did not deem the industry to be “driven by profit only”. Those MEPs defended a competitive industry, which has played a major role in medical progress, in particular when it comes to finding therapeutic solutions to rare diseases.
While all of the above parliamentarians agreed on the need to maintain a certain protection of IP rights, some supported the view that the current regulatory framework for IP rights protection does allow for an “excessive use” of patent extensions (referring to “ever-greening”) and that price-setting should be more transparent in order to make up for “unaffordable prices”.
In particular MEPs from the EPP went one step further, criticising the rapporteur for the use of erroneous data and the extent to which she would like to see more EU intervention. In particular, they clarified the role of national authorities in regulating and setting prices as well as how research is conducted in order to develop new drugs and therapies. In relation to Orphan Medicinal Products it was said that one should wait for the European Commission study called by the Council in June 2016, on the effectiveness of measures designed to incentivise research, before making any assumptions.
Still, there seemed to be general agreement in the room that cooperation between EU Member States in the setup of criteria for price-setting and reimbursement, as well as HTA, would be a natural next step.
Finally, Mr Schnichels, a representative of the EU Commission on topics related to medical products and innovation, welcomed the Draft Report and thanked the EU Parliament for its contribution to the current discussion on access to medicines.
Among the various points he touched upon, it is interesting to note Mr Schnichels insisted on:
- The improvements done in the field of OMPs towards the making available of several new treatments
- The importance of 3 criteria (quality, safety and efficacy) when assessing drugs before they receive market authorisation
- The Member States’ sovereignty for Health Technology Assessment, and the added value of cooperation between the 25 Member States involved in the voluntary programme
- The increased access to medicines more transparent pricing mechanismswill bring about
MEPs will now have until October 19th to table amendments.