An independent study commissioned by the European Parliament in the context of the report on the reform of the EU pharmaceutical legislation, proposed by the Commission in recent months, was deleted from the institutional website three days after its publication. The study highlights the current drugs’ regulation and proposes a concrete options to solve some critical issues and in particular the current misalignment between the priorities of the pharmaceutical industry and public health objectives. ForumDD reposted the deleted study. Barca: “Surprising fact, make clear the origin of such a decision”.
An independent study commissioned by the European Parliament as part of the debate on the Commission’s proposal for the reform of the EU pharmaceutical legislation was deleted from the institutional website three days after publication. The study was built on the basis of a rigorous assessment of the advantages and disadvantages of different incentives to innovation and proposes a series of policy options, aimed at stimulating pharmaceutical innovation and ensuring the accessibility of medicines. It was presented in the context of a Strasburg debate on a draft report on the Commission’s proposal, submitted a new Directive and a new Regulation to the European Parliament. The objective of the reform is to improve in a timely, fair and affordable way the access to medicines and to promote innovation. In April 2024, MEPs in plenary will vote on the report, which will be endowed to the new EU Parliament, a starting point for negotiating with the Council and the Commission on the revision of the current legislation.
In this context, several proposals are on the table, including the creation of a Public European infrastructure for vaccines, medicines and biomedical innovation. This infrastructure would aim at establishing the health priorities of the EU, directing the research and development of drugs, with particular attention to those not sufficiently covered by the private sector. The proposal has been included under the name of European Medicines Facility as one of the amendments to the draft report on pharmaceutical legislation and follows one of the “15 proposals for social justice” launched in 2019 by the Forum on Inequalities and Diversity. It has been the object of a recommendation by the EU Parliament to the Commission and the Member States on July 12th, 2023. The discussion of the amendments to the draft report is scheduled for the first half of November in the European Parliament’s ENVI Committee.
Two independent studies requested by the Panel for the Future of Science and Technology (STOA) have already supported the establishment of the EU infrastructure (here are the first and second studies). On October 19th, again at the request of STOA, a new independent study was debated: “Improving access to medicines and promoting Pharmaceutical innovation”. It was drawn by three Italian academics: Simona Gamba, researcher in Finance at the University of Milan; Laura Magazzini, associate professor of Econometrics at the Scuola Superiore Sant’Anna in Pisa; Paolo Pertile, full professor of Finance at the University of Verona. They are authors of dozens of articles on drug economics published in the most prestigious international scientific journals, including Nature Reviews Drug Discovery, Health Economics, Health Policy, Journal of Health Economics, European Journal of Health Economics, Journal of the Royal Statistical Society, Research Policy, Management Science, and others.
The study is based on the analysis of over 230 publications and 24 interviews with authoritative stakeholders (five researchers and clinicians, six representatives of the pharmaceutical industry, three patient representatives, eight public health experts, and two public officers). It presents advantages and disadvantages of five policy options.
Based on this assessment, the study argues that the European Union would benefit from the creation of an active European public infrastructure, especially in those clinical areas where the private pharmaceutical sector does not invest sufficiently, together with further options: a greater coordination of intellectual property rights; and the possibility for Member States to join a centralized purchasing procedure at the European level. A review of current incentives, such as the reduction of the duration of certain forms of exclusivity would also be useful, considering the introduction of new incentives.
After the October 19th presentation, the study was published on October 27th on the EU’s institutional website, along with presentation slides and an interview with the main author, Simona Gamba. On October 30th, the turn of events: the study was deleted from the website. Politico.eu and Il Fatto Quotidiano have argued that this happened under the pressure of Danish MEP Pernille Weiss. Immediately after, STOA justified the deletion by writing on social media ‘X’ that the study “was published too early and by mistake” before the Panel’s approval procedure, which would be necessary for each publication. The decision on the re-publication, STOA writes, will be taken at the next meeting.
“The removal of the rigorous study commissioned by the European Parliament from the EU website is surprising”, comments Fabrizio Barca, co-coordinator of the Forum on Inequalities and Diversity. “We call on MEPs to make clear the reasons behind this decision and to make sure that no interference by pharmaceutical industry has taken place. It would be an infringement of democratic procedures”.
The Forum on Inequalities and Diversity has decided to make public the removed study.