On 2 June, the European Commission (Commission) published a roadmap (Roadmap) that will pave the way for the Commission’s communication on the EU pharmaceutical strategy, which is now due in the last quarter of 2020. The Roadmap should be read together with the Commission’s proposal for a recovery of the EU’s economy (Next Generation EU), which was published on 27 May and which includes a section on lessons learned from the COVID-19 pandemic for European health systems, governments, and pharmaceutical companies.
Key points of the Roadmap are:
1. Competing goals. The Roadmap builds further on the Commission’s existing rhetoric to ensure the access, affordability, and availability of medicines against the backdrop of an aging population, constrained healthcare budgets, increased R&D costs, the need for patient-centricity, and market access challenges for pharmaceutical companies. The unknown impact of a global pandemic can now be added to that.
Whilst the EU often advocates a holistic approach in its policy developments, it is to be seen if all of these objectives can be matched in a way that makes sense for the different stakeholders across the life sciences and health care sector. Different departments within the Commission will also not necessarily act in tandem when developing the EU pharmaceutical strategy. DG Sante is in the lead, but other Commission Directorate Generals (specifically DG RTD, DG GROW, DG Trade, and DG COMP) will be closely involved and will want to make their mark too.
2. Strategic autonomy. Considerable emphasis in the Roadmap is placed on securing the pharmaceutical supply chain and ensuring the EU’s strategic autonomy by reducing Europe’s dependency on imports of medicines and active pharmaceutical ingredients (APIs). This is not surprising in light of trade restrictions on medical supplies imposed by some EU countries as well as by third countries to deal with the COVID-19 pandemic. However, the outsourcing of the production of APIs to contract manufacturers located all over the world, most of them in India and China, had already been widely discussed in Commission circles (in particular the EU’s pharmaceutical committee) before the pandemic outbreak. The pandemic merely highlights the international dimension of the pharmaceutical manufacturing and supply activities and associated risks if there is a (serious) hitch in the supply chain. To that end, the Roadmap points out the need for EU manufacturing capacity for APIs and starting materials (though not specifying if this only concerns highly potent APIs, for example). In addition, existing work to ensure the security of drug and ingredient supply chains (e.g., through good manufacturing practice standards and on-site inspections) will continue.
3. Digital disruption. The Roadmap acknowledges the transformative impact of technology on the healthcare and life sciences sector, in particular AI and real-world evidence. However, the regulatory frameworks are lagging behind, resulting in possible barriers to value-based contracting and patient access to innovative products. The Roadmap mentions, by way of example, the support for such breakthrough innovation and emerging technology through “innovative procurement.”
4. Sustainability. Sustainability is a key EU objective across all sectors and policy areas and features prominently in the EU Green Deal, the Industrial Strategy, and the recovery plans as part of Next Generation EU. Adopting a full life-cycle approach, the Roadmap underlines the need for rational use of medicines with less resources, emissions, and pollution.
5. Market access. The Roadmap recognizes that pricing and reimbursement are Member States’ prerogatives, though emphasizes the need for more coordination and collaboration between countries on issues such as cost effectiveness and measuring added therapeutic value, including on health technology assessment. Drug pricing will be looked at too (and has been already by DG COMP) and the emphasis on “need-driven innovation” in the Roadmap is telling in that respect. The Roadmap further emphasizes the importance of the sound functioning of the internal market for generics and biosimilars.
6. EU funds. To assist companies and governments to implement the above objectives, EU funds will be made available (e.g., Horizon Europe, InvestEU, and Digital Europe Programs). Note that as part of its recovery plan, the Commission is also proposing to create a new standalone EU4Health program, with a budget of €9.4 billion.
The deadline for providing feedback on the Roadmap is 7 July 2020.
Reed Smith’s lawyers are ready to support companies and organizations in preparing their submissions to the consultation.
For further information, please contact me.