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In March 2020 the European Commission presented its New Industrial Strategy for Europe, which proposes to move the European Union towards climate neutrality and digital leadership. As part of this overarching approach, which includes measures to keep the EU at the leading edge of innovation, including in healthcare, the Commission is expected to publish a Pharmaceutical Strategy in Q4 2020. This will focus on the availability, sustainability and security of the supply of pharmaceuticals, a need highlighted by challenges around COVID-19. The Pharmaceutical Strategy is likely to include innovation-boosting measures and plans to revise the EU Regulation on Orphan Medicinal Products (OMP Regulation).

EU Pharmaceutical Strategy

The details of the Strategy are still unclear, with a Commission roadmap keenly awaited.

The potential legislation and initiatives have been hotly debated. The European pharma industry body, EFPIA, wants the Commission to support the industry to remain an innovator and world leader. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has highlighted funding the role of small and medium-sized pharmaceutical and medical technology companies, and a supportive legal and regulatory framework as top priorities.

EU OMP Regulation Review

The OMP Regulation is widely expected to be included in the Commissions plans. Member states and others have pressed the Commission to amend the current rules due to the perceived impact on prices. Last August, a Dutch health minister threatened to name companies that cannot offer a sensible and transparent explanation for the high prices of OMPs. Bruno Bruins said that OMP prices over 100,000 per year are no longer the exception not because the prices are justified, but because the rules allow them.

Leading voices in healthcare have highlighted incentives intended to stimulate innovation in medicine development as a whole and the perceived link to high prices. The European Public Health Alliance says the current rules delay competition for long periods, allowing companies to set prices as high as the market will bear. In 2017, two serving Dutch ministers wrote in The Lancet that the system is broken companies can ask the price they like.

The Commission is currently evaluating the OMP Regulation. An internal analysis is planned for Spring 2020, ahead of any publication of new OMP proposals. An internal Commission discussion has highlighted concerns with the current Regulation, especially regarding incentives and the diversity of authorised products.

If the OMP Regulation is reopened, we may see a new law proposed by 2021. Meanwhile, the industry and other stakeholders have a window to shape the proposal and say what it should or should not include.

A recent document prepared for the EUs advisory Pharmaceutical Committee gives clues on the Commissions thoughts.

The document undermines claims from industry and others that the Regulation has been a huge success, stating that of 142 OMPs authorised in the EU to 2017, only around 20 can be directly attributed to the OMP Regulation. The briefing questions the impact of the 1bn the EU has invested into rare disease research in the past decade. An assessment of the market exclusivity (ME) provision concludes that the mechanism is fair for OMPs with annual European sales of less than 50m, but OMPs with sales over 100m may have been overcompensated.

The Pharmaceutical Committee is exploring solutions to these challenges, including measures to direct R&D towards unmet needs (such as establishing a list of priority therapeutic areas and amending the definition of orphan diseases). Increasing transparency of R&D costs is being considered, to enable better analysis.

The criteria for OMP designation is also being considered and the Committee has been asked to consider mechanisms to improve access to therapies.

Conclusion

It is always easier to shape EU plans before publication than try to change them afterwards. The Commission values early industry alignment and proactivity rather than defensiveness and criticism of draft proposals.

Companies and the industry must take up this opportunity and tell the compelling OMP story. They must educate decision-makers about OMPs and use data to highlight the wider value of the OMP sector in the EU.

Working together with patients, industry and other stakeholders, the rare disease community has a once-in-a-decade chance to shape the direction of EU and possibly global orphan medicine regulation. Its time to seize it.

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Industry needs an aligned position on the future of the EU OMP Regulation - PMLiVE