The Proposal to revise the EU Pharmaceutical legislation has generated unprecedented levels of attention, not only across the industry but also amongst Member States with some countries already positioning themselves in favour or against some of the measures included in the proposed Regulation and Directives. In this article we review some of these positions, which focus mostly on the incentives regime and on the management of shortages.
In March 2023, a month before the publication of the Commission’s Proposal to revise the EU Pharmaceutical legislation, the French government issued a policy document (“Non-paper”) sharing its views on some of the measures included in the leaked versions of the Package.
In this document, the French government expresses its support for harmonised measures to prevent shortages and to monitor such shortages at EU and national level. It also welcomes measures aimed at simplifying marketing authorisations and facilitating fast track procedures and it emphasizes the importance of supporting orphan and paediatric medicines. Measures aimed at raising awareness of prescribers and patients about the pharmaceutical industry’s impact on the environment are considered essential for as much as these measures “are proportionate and do not compromise the marketing authorisation of critical medicines”.
On the flip side, the French government is concerned about the changes to the incentives regime and its impact on innovation. In particular, the following measures raise concerns in the French capital:
(i) the 2-year reduction of the regulatory data protection period. The French fear this measure may hinder the attractiveness of the EU for innovation and calls for pragmatic solutions to ensure access to affordable medicines which take into account the supply capacity of companies and the financial implications for Member States.
(ii) the “transferable exclusivity vouchers” for antimicrobials which, according to the French government, could have a significant financial impact on Member States if, for instance, market exclusivity gained with the authorisation of an antimicrobial was transferred to a blockbuster.
In April 2023, days before the publication of the Commission’s Proposal, the German government issued a Position Paper on the impact the revision could have on the competitiveness of the EU pharmaceutical industry. The Paper welcomes the introduction of faster and more flexible authorisation procedures, such as the reduction in the number of scientific committees within the EMA and the abolishment of the 5-year renewal for marketing authorisations.
The German Paper also points out what it sees as the potential negative impacts of the reform on the pharmaceutical industry and in particular, the impacts of the new data protection periods (e.g., the reduction of the period by two years or the additional two years of data protection dependent on the supply of sufficient quantities of new medicines to all Member States). In Germany’s view, these revisions cannot be an effective incentive system for the pharmaceutical industry, as these measures would be difficult to reach. The availability of medicines depends, according to Germany, on other factors such as pricing and reimbursement procedures.
The German non-paper finally stresses the importance of a simple and understandable system for all stakeholders regarding orphan medicines, including clarification of certain terms, such as “well established use orphan products” and “high unmet medical need”.
Austria, Netherlands, Poland and Slovakia
These countries have reportedly sent a paper to the Commission arguing that the current pharmaceutical system does not meet the human rights of EU citizens for access to innovative treatments and positioning themselves in favour of the proposed reduction of incentives.
Belgium’s Non-Paper on shortages, co-signed with 18 other Member States
On 3 May 2023, the Belgian government published a non-paper, co-signed by 18 countries, on how to improve the security of medicines supply in Europe. The paper proposes three action points:
- Establishing a voluntary solidarity mechanism within the EU’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). This mechanism would allow Member States that find themselves in a situation of “extreme” shortage, where no alternative can be envisaged, to send a notification to the other countries to request voluntary temporary assistance.
- Accelerate the establishment of a European list of critical medicines whose supply, production and value chains must be monitored. The proposed pharmaceutical legislation mandates the MSSG to enact a “list of critical shortages of medicinal products”. The paper urges the MSSG to speed up the elaboration of this list arguing it should be practical and concise and take into account the work that was already done in this field by other stakeholders, including HERA and the WHO.
- Exploring the possibility of adopting a Critical Medicines Act to reduce dependencies for critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries. This Act would draw inspiration from the European Chips Act and the Critical Raw Material Act, and would complement the proposed pharmaceutical legislation by providing a “toolbox” composed of different instruments, such as appropriate financing mechanisms, to fight against shortages. The paper does not further detail on what the toolbox may look like and how it would operate: this will require further discussion.
What is the impact of these policy papers?
Although these papers are purely informative and have no binding effect, they offer valuable insights on the positions which Member States are likely to take in the legislative process. .
The new Regulation and Directive will be adopted following the “ordinary legislative procedure” which involves readings in both the Council and the European Parliament. The Council is the institution that represents EU Member States’ executive branch and thus, being aware of the views of Member States on the EU Pharmaceutical Package will help understand the different dynamics at play during the Council phase and any inter-institutional negotiations.
The papers we have seen so far show that regulatory data protection and orphan market exclusivity will be sensitive topics with different opinions between countries with a strong innovative industry and countries favouring the market access argument. On other topics such as shortages or regulatory flexibility there seems to be more alignment and the negotiations may not be as divided or controversial.
Whereas the overall direction of travel is unlikely to change, the package may still undergo significant changes in many areas including those of concern to the Member States. How precisely is hard to predict at this stage and the final adopted text is likely to be a compromise with creative new approaches.
We will continue to monitor Member States reactions to the Package and post relevant updates.
 “Germany clashes with other EU states on pharma regulation overhaul”, FT 22 April 2023.
 Belgium, Austria, Netherlands, Luxembourg, Hungary, Czech Republic, Spain, France, Germany, Estonia, Slovenia, Romania, Latvia, Lithuania, Greece, Malta, Poland, Italy and Portugal.