The reform of EU pharmaceutical legislation, insufficient to maintain competitiveness with the US and Asia
The package recognises the strategic importance of medicines for health and the economy, but it lacks ambition and concrete measures to halt the loss of leadership and attract and stimulate biomedical innovation in Europe.
farmaindustria.es
Early this morning, the Council of the EU and the European Parliament finally reached a political agreement on the revision of European pharmaceutical legislation. Although the text of the agreement is not yet formally available, the three institutions – the Council of the EU, the European Parliament and the European Commission – have published press releases outlining some key aspects of the pharmaceutical package.
The provisional agreement on the European pharmaceutical package paves the way for the future of one of Europe’s most strategic sectors, which could strengthen the continent’s health and economic security and have an impact on patient care for decades to come.
While the package includes signs that the European Union recognises the importance of this legislation as a key driver of competitiveness for the innovative pharmaceutical sector in Europe, it is not ambitious enough to reverse the trend of declining competitiveness vis-à-vis other regions, one of this Commission’s key objectives.
If Europe truly wants to be competitive, it must increase investment in innovative medicines, strengthen—rather than weaken—intellectual property rights, and accelerate and improve the process that allows new medicines to reach patients.
The decision to maintain the status quo with eight years of regulatory data protection (RDP) is an improvement on the European Commission’s initial proposals, but it is not enough to attract and retain global investment in European R&D. The situation is even worse for rare diseases, due to the erosion of market exclusivity incentives (from 10 to 9 years), although this is offset by other positive provisions applicable to disruptive therapies.
The extension of the Bolar Clause is also an unnecessary measure that will hinder the enforcement of intellectual property rights and create legal uncertainty, further eroding the competitiveness of the innovative sector.
These commitments are a response to a previous political phase and will not bring about any change for a sector that is already losing ground. To compete in 2026 and beyond, Europe needs policies that can reverse the negative trends of recent years and, at the same time, counteract the impact of recent global trade and pricing policies, ensuring that we continue to lead global innovation in medicines and vaccines.
In this regard, the update of the European Union’s regulatory framework represents an important step forward, with encouraging measures such as the reduction of EMA deadlines and greater capacity to compete with the FDA and other international drug agencies.
The introduction of a regulatory sandbox strengthens Europe’s toolkit for supporting disruptive innovations. The industry also supports the transition to electronic package leaflets, which provide essential flexibility and align regulation with technological progress.
The introduction of a transferable exclusivity voucher (TEV), together with a voluntary subscription model aimed at stimulating research and development of new antibiotics and antimicrobials, is also an important step in addressing a serious health crisis, with Europe at the forefront. However, there are nuances, as specific conditions apply. Evaluation and implementation will be decisive.
Nathalie Moll, Director General of EFPIA, states that ‘Europe has lost a quarter of its global investment share to other parts of the world in two decades, while our share of clinical trials has halved. If this is the legislative framework that is expected to attract drug innovation to Europe over the next 20 years, the outcome of the trilogues is disappointing.’
Moll also states that ‘if Europe really wants to be competitive, it must increase investment in innovative medicines, strengthen—not weaken—intellectual property, and speed up and improve the process that allows new medicines to reach patients.’
The industry hopes that the future Biotech Act will include policies capable of reversing current trends, as well as a renewed enthusiasm for valuing and prioritising healthcare innovation in Europe.
