EU’s proposed General Pharmaceutical Legislation can future-proof science for society
Innovation in medicines is moving fast. Thousands of new treatments are in development globally1, offering hope to patients with a wide range of diseases. Europe’s regulatory system, which ensures that medicines are safe and efficacious, should keep pace with scientific progress. Regulators, whether centrally through the European Medicines Agency or through regulators in EU Member States, have a key role in fostering scientific excellence. They are at the heart of Europe’s innovation ecosystem.
European policymakers are taking bold steps to make regulatory pathways more efficient. Through the proposed revision to the General Pharmaceutical Legislation, they are promising faster decision-making, less bureaucracy and more digitalization. A regulatory sandbox, among the measures proposed in revised legislation, would enable real-world experimentation with medical and data science. The sandbox could provide a clear path for innovation to emerge even when there are gaps in the legislation. Legislation cannot move as fast as science so allowing space for experimentation helps to overcome regulatory hurdles. The sandbox incentivizes innovation.
These regulatory initiatives are important. Regulatory bodies across the EU should be better resourced, too, so that they can efficiently assess, and authorize, a surging medicines pipeline. We welcome the revision to the European Medicines Agency’s fees system. We fully support a targeted approach to ensuring sustainable funding for the EMA and the regulatory network. More agile processes, allied with adequate resources, are ways to improve the authorization of new medicines to all European citizens.
One reason is that the proposal fails to protect regulatory incentives that spur innovation. The European Commission wants to cut the period of Regulatory Data Protection (RDP) – which protects clinical trials data – from eight years to six.
The proposal makes additional RDP periods conditional. The conditions include the release and continuous supply of medicines in all markets within two years of European Union approval, developing medicines based on rigid criteria applied to unmet medical need and conducting comparative clinical trials without considering the scientific rationale for case-by-case development programs.
We agree that European citizens, no matter where they live, should have fast access to new medicines. The approach set out in the proposal - penalizing innovation if a medicine is not available in all Member States within two years - is flawed. It sets an extremely hard-to-meet target for innovators because it shifts the entire responsibility to them when they do not control all elements of the solution. That makes the operating environment for innovators in Europe much less predictable. We want to see improvements in the resourcing of health systems in Member States so that they can adopt more new medicines at speed and scale. We want to see RDP protected as a key part of Europe’s innovation proposition.
It is not just the industry that wants an innovation-based future for Europe. The European Commission has said Europe needs to “keep investing in strengthening our industrial base”. It wants to make Europe “more investment and innovation-friendly”, citing “aggressive attempts” by other parts of the world “to attract our industrial capacities”2.
We agree. Yet, most of the proposals the European Commission has brought forward for innovative medicines may accelerate precisely what it is warning against. What has been proposed by the European Commission is about the chance to recover what has been lost – two years of RDP – rather than the impetus to discover more scientific value. The proposal’s increased evidentiary requirements in areas like environmental standards, raw data and transparency of public funding for global research and development - and a restrictive definition of unmet medical need - are unlikely to spur innovation in Europe.
We want to see more European patients in clinical trials for these disease areas. They should have access to novel treatments, just like patients in other parts of the world. Our industry is constantly weighing investments, whether in research, manufacturing or commercial sites. Getting the operating conditions right for innovation is vital for the future of Europe. As the global landscape gets more competitive, Europe can remain attractive for innovation and investment.
That effort takes careful planning. We believe that there is much common ground between stakeholders, especially policy, patient, industry, clinical and scientific leaders. Faster, more equitable access to new medicines for Europe’s citizens is a shared priority. So, too, it is mitigating and avoiding medicines shortages. We align on ensuring that Europe should have a modern, first-class regulatory framework. Everyone is for having a thriving scientific ecosystem that yields better healthcare outcomes for Europe’s citizens. All of us want more and better jobs through continued investments, whether in research, manufacturing or commercial operations, by industries like ours.
So, there is a strong foundation on which to build a science-driven, patient-led future for Europe. Our industry, like many others in the ecosystem, has a stake in that endeavor. We should come together to make it happen.
References:
1. IFPMA, #AlwaysInnovating: The importance of pharmaceutical innovation, 5 June 2023.
2. Speech by Ursula von der Leyen, President of the European Commission, at the World Economic Forum, 17 January 2023.