14 November 2023
Industry perspective on the future of pharma legislation in the EU
The last major updates to our general pharmaceutical framework were in the early 2000s. As we heard during the presentation of the draft ENVI reports last week, the legislation must keep pace with the advancements of tomorrow. We need a solid legal framework that will provide certainty for research and adaptability for future challenges.
This revision is therefore a once-in-a-generation opportunity to shape the life sciences ecosystem in Europe and Johnson & Johnson (J&J) is fully aligned with the proposals’ aim to ensure that Europe remains at the forefront of medical innovation, allowing us to keep on bringing the best care to patients.
The legislation is ambitious in its scope, from recalibrating Intellectual Property incentives, or updating the regulatory framework, to introducing new supply chain or environmental requirements. It thus requires extensive dialogue between stakeholders.
Today only 22% of global new treatments emanate from Europe* (almost half come from the US) and competition from other regions is rising. To ensure that groundbreaking science stays in Europe and patients can quickly benefit from it, we need strong and predictable intellectual property and regulatory incentives that attract investment in high-risk and lengthy R&D processes for innovative medicines. Some proposals, however, risk eroding the EU’s industrial and research base, ultimately delaying patient access to cutting-edge science and innovation.
In many cases, for example with complex medical innovations which require longer development times, lower baseline incentives may prevent a new product, or indication from being developed. In the long run, this will impact the pipeline for off-patent medicines. It will be detrimental to collaborating with SMEs which cannot always adequately protect their assets through patents The draft ENVI report recognizes this and seeks to offer a more predictable incentive, while ensuring that companies file their medicines for pricing and reimbursement across Europe.
Stronger incentives are even more necessary for underserved areas, where patients are waiting for solutions. The proposal to better define what constitutes an Unmet Medical Need is a starting point for Europe to effectively steer research and ensure that no patient is left behind. It is encouraging that the ENVI rapporteur is pushing for a more patient-centred definition to help tackle not only life threatening or severely debilitating diseases, but also chronically debilitating ones (e.g. major depressive disorders), or those that significantly improve patient quality of life through incremental developments.
Proposed improvements to the EU regulatory framework will also support innovation, and make our system future proof and flexible enough to support the development of increasingly complex products and advanced therapies. They will make our framework more globally attractive and accelerate the availability of innovative medicines to European patients. Whether it is streamlining the EMA governance, the faster timelines, broader access to expedited pathways or the creation of a regulatory sandbox to test new innovations in a time-limited mechanism, these changes will ultimately help bring medicines more swiftly to patients. . Further dialogue will be needed on some elements, for example on imposed label updates and repurposing of our medicines, as well as paediatric research obligations to ensure these new requirements are more proportionate.
Tackling the growing cases of EU shortages of critical medicines is a priority, where we believe that global, diversified and open supply chains are essential to ensure a predictable flow of medical goods to patients. J&J has one of the world’s largest and most effective supply chains, with robust business continuity plans, safety stocks and diversified suppliers. Since shortages stem from multiple root-causes, actions to prevent them should also be adapted to each situation and require joint efforts from the various stakeholders concerned, reflecting their shared responsibility in ensuring continued access for patients in Europe.
While we support a European harmonised approach to tackling shortages, supply chain requirements in the pharmaceutical package need to be proportionate and fit for purpose. For example, the Shortage Prevention and Mitigation Plans should focus on critical medicines. Any additional prevention or mitigation requirements should also be subject to early and continuous dialogue between competent EU/national authorities, manufacturers and other supply stakeholders to collaboratively assess and address shortages. Policy measures should also focus on the demand side, improving visibility over local patient needs so we can anticipate changes.
As a science-based healthcare company, we do recognise concerns regarding the presence of pharmaceuticals in the environment and we are committed to addressing this issue by driving a cross-industry Eco-Pharmaco-Stewardship initiative. Through this framework we aim to close knowledge gaps on the environmental profile of APIs; support medicines disposal campaigns on the appropriate use, storage and disposal of medicines; and developed a new Responsible Manufacturing Effluents Management Guidance for the industry.
The draft legislation introduces the possibility to refuse a marketing authorisation for a medicine based on environmental grounds, or if its Environmental Risk Assessment (ERA) is incomplete. . While we fully subscribe to the importance of having more robust ERAs, we are concerned that this policy measure could delay access, and even prevent patients from accessing innovative medicines. A balance should be struck, taking into account patient needs and the possibility of post-authorisation, binding and time-limited risk mitigation commitments
As one of the biggest pharmaceutical companies globally, we are ready to contribute and discuss ideas about how to make the future pharmaceutical legislation work for everyone so that no patient, living in any corner of the EU, is left behind. We encourage all stakeholders to participate in the decision-making process so that we can collectively come to a framework that works for all #EUpharmalegislation #HealthofEurope
*The Pharmaceutical Industry in Figures, Key data 2021, Pharmaprojects & SCRIP, March 2021