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EU Pharmaceutical Strategy Roadmap

As discussed in a recent article, the next few years will define the future of life sciences and especially the regulation of breakthrough advanced therapy medicinal products (ATMPs) and orphan medicinal products (OMPs) in the EU. Here Senior Healthcare Director Emma Eatwell examines the impact of the recently-published European Commission Roadmap to develop an EU Pharmaceutical Strategy and considers what the the future looks like for ATMPs and OMPs.

The publication of the European Commission’s “New Industrial Strategy for Europe” in March has recently been followed by the roadmap to develop an EU Pharmaceutical Strategy.

The strategy is intended to create the right environment to ensure treatments and technologies actually reach the patients who need them. The Commission has identified a range of areas that need to be addressed, including market failures.

The strategy will create a regulatory framework and policy landscape to promote research and technologies that will respond to the therapeutic needs of patients. The debates around access, availability (including shortages) and affordability of medicines are not new. The roadmap itself references Council conclusions from 2016 that suggested measures to reconcile innovation with the need to ensure wide access to innovative products for unmet needs and the financial sustainability of health systems. Orphan Medicinal Products were a major focus. The European Parliament also adopted a resolution in 2017, on possible EU options for improving access to medicines.

As anticipated, the roadmap focuses on the availability, sustainability and security of supply of pharmaceuticals - a need highlighted by challenges around COVID-19. The Commission asserts that “there is a need to build a holistic, patient-centred, forward-looking EU Pharmaceutical Strategy which covers the whole life-cycle of pharmaceutical products.”

The Commission is undertaking a series of consultations with all stakeholders, including a public consultation on the Strategy. The consultation focuses on the key themes of strategic autonomy and manufacturing of medicines, access to affordable medicines, innovation, and environmental sustainability and health challenges. It is open until 15 September 2020. The Commission will also continue to hold targeted meeting and workshops with stakeholders.

EU Pharmaceutical Strategy

But what does this mean and what can we expect to be included in the strategy that is anticipated for late Q4 2020 or early 2021?

It seems that in the Roadmap, the Commission has responded to calls from industry, including the European Federation of Pharmaceutical Industries and Federations (EFPIA) and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), for a supportive legal and regulatory framework to reinforce the sector’s global competitiveness. The Commission’s document combines the need to ensure Europe’s supply of safe and affordable medicines meets patients’ needs, while supporting the European pharmaceutical industry to remain an innovator and world leader. However, proposals for the EU’s multi-annual budget could cut funding for healthcare spending and research.

EU OMP Regulation Review

Whilst the EU Regulation on OMPs is specifically referenced in the Roadmap, the document looks more at cancer and the unmet need that is perceived due to a lack of research. Whilst this is in line with the current priorities on the EU political agenda, it does not mean that OMPs will be ignored in the strategy. It does, however, indicate that the Commission is now looking beyond the immediate legislative changes that are already anticipated: the OMP Regulation, the EU Paediatrics Regulation and the legislation on fees for the European Medicines Agency.

The Commission is still evaluating the OMP Regulation. An internal analysis planned for Spring is now expected imminently, alongside a Staff Working Document and the publication of the ‘Technopolis Report’. We still expect a review of the current incentives that are in place, measures to increase innovation and to address market entry and the continuous supply of products.

If the OMP Regulation is reopened, we may see a new law proposed by 2021. Meanwhile, the industry and other stakeholders have an additional opportunity, to shape the proposal and the Commission’s thinking, through the consultation on the Roadmap and interaction based on the Staff Working Document.

Advanced Therapy Medicinal Products and other innovative treatments

Many of the requests to the Commission within the consultation address the broader challenges faced in researching, developing and bringing ATMPs to patients. This includes making sure the EU creates the right environment for innovation by retaining incentives for industry and creating a competitive intellectual property framework.

At the same time, innovative therapies need to be affordable and healthcare systems need to remain sustainable. Solutions should be developed collaboratively, building on the early dialogue processes that have been created to anticipate and address the challenges that new therapies may bring. Open dialogue and working together to develop innovative funding and payment models that reflect the true value of a therapy will greatly contribute to improving access to treatments for patients.

Significant scientific advances have taken place in recent years. Rather than opening existing legislation, industry is asking for more flexibility in regulatory processes, whilst maintaining the high standards we currently have in the EU.

There are other challenges in ATMPs and OMPs that stakeholders are hoping can be addressed in the Pharmaceutical Strategy. This includes securing more innovation where there is genuine ‘unmet need’ – a term that we may see officially defined – international collaboration and including the patient perspective at all points from research and development to access.

Data collection has also come through as a key element of the consultation and is particularly pertinent in ATMPs and OMPs. The challenges are well-known in OMPs, where patient populations are small and data are scarce. In ATMPs, the need for surveillance and long-term follow-up of patients will need to be addressed.

Any discussion around the Pharmaceutical Strategy will inevitably include the issue of pricing. Although this is not a competence of the European Commission, the EU is a platform for stakeholders to come together to look at all aspects of the healthcare ecosystem. And we continue to see the pricing and reimbursement challenges faced by ATMPs. Much work has already been done and this is likely to continue within the new Strategy.

The publication of the Commission’s Roadmap has provided additional insight into the direction of travel at EU level and what we might expect in the Pharmaceutical Strategy but also in forthcoming publications related to the OMP Regulation.

Companies, the industry and other stakeholders must take up this opportunity and continue to tell the compelling success story of innovation in the EU. Decision-makers need to see data that highlight the impact investment in this innovation has had in the EU, including on the lives of patients.

The environment is evolving quickly. An open and collaborative approach to developing the new Strategy will hopefully improve the situation for patients across the EU, ensure healthcare systems are sustainable and keep the EU as an attractive region for investment and innovation. It is a lot to ask but the opportunity is here. Working collaboratively with patients, industry and other stakeholders, we must seize this chance to shape the direction of healthcare in the EU.

28th July 2020

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