Securing a safe and affordable supply of medicines for Europe

Focus on 3000 amendments

The European Union's (EU) pharmaceutical reform is gathering pace in the European Parliament after MEPs from the Health Committee tabled their numerous amendment motions to the draft reports by the two rapporteurs Tiemo Wölken (S&D, DE) and Pernille Weiss (EPP, DK). A total of 3563 amendments have been tabled to the draft report on the proposed regulation and the proposed directive. In principle, the number and range of content of the amendment submitted is very large. While the left-of-centre groups, i.e. the S&D, Greens and Left, are more critical of industry in their view of the draft reports, the amendment motions tabled by the EPP, the liberal Renew, ECR and ID are more industry-friendly.

The DSV is following the political discussions in the European Parliament and in its statement once again emphasises key points regarding the EU pharmaceutical reform:

Transparency in the financing of pharmaceutical innovations

Fortunately, many MEPs are in favour of more transparency in the financing of pharmaceutical innovations. In future, manufacturers of medicinal products will not only be required to disclose in databases whether and how much financial support they have received from public authorities, but also how much money they spend on researching and developing new medicinal products. This is crucial for pricing and reimbursement procedures.

Exclusivity periods

The political differences between the parliamentary groups are particularly evident in the amendments on the length and staggering of protection periods and the incentives for the manufacture of medicinal products under discussion. In view of this, the (DSV) warns against longer exclusivity periods for new medicinal products. Some of the proposed extensions will have a massive impact on pharmaceutical prices, as they extend the monopolies for blockbuster medicinal products far beyond the current legal framework and have a significant impact on the cost burden on healthcare systems, thus coming at the expense of affordable care for citizens.

Transparency about deadlines for regulatory and patent protection

MEPs attribute varying degrees of importance to increasing transparency regarding the expiry of the medicinal product’s exclusivity protection. While the liberal-conservative groups want to enable more transparency on market and data protection, the Greens, for example, go beyond this and also demand transparency on the expiry of patents. DSV shares this demand. It makes sense that the expiry of patent for regulatory protection, but also for patent protection, should be publicly accessible in order to promote competition between generics and biosimilars.

Expansion of the monitoring of medicine shortages via the EMVS

MEPs agree in principle on the need for improved monitoring of shortages in medicinal products. All groups are calling for stronger monitoring, for example via the European Medicine Verification System (EMVS). The DSV supports the proposals to use the EMVS for comprehensive monitoring of medicinal products in order to detect delivery and supply bottlenecks at an early stage. In addition, manufacturers of medicinal products should be more strongly obliged to report shortages of medicines. With regard to the depth of regulation, there are different demands between the left-green and liberal-conservative groups in the amendment motions received.

The entire DSV statement is available here.

What's next?

The rapporteurs and shadow rapporteurs of the respective political groups in the European Parliament are now negotiating compromises on content. The draft reports are to be submitted to the Committee on the Environment, Public Health and Food Safety (ENVI) for a vote on 7 March. The plenary meeting is expected to vote on the two draft reports on 10 April. This timetable can change at any time, and it is still unclear whether the European Parliament will be able to agree on a common position in this legislative period. This does seem to pose a challenge, given the diversity of opinions. Discussions in the Council's Health Working Group have only recently begun.