The New Pharmaceutical Strategy: Further Advances to Prevent Shortages in the EU

The European Commission (Commission) is launching what it has branded the “new Pharmaceutical Strategy.” The overall goal of this strategy is to help ensure that the EU has a supply of safe and affordable medicines to meet patients’ needs and support the EU pharmaceutical industry to remain an innovator and world leader. In particular, in light of the COVID-19 pandemic, the Commission is seeking to future-proof the EU approach to the life cycle of medicines, from research and development to authorization and patient access. The new pharmaceutical strategy is likely to lead to a review of the existing regulatory framework and policy, and legislative actions could include a targeted evaluation and subsequent review of the basic pharmaceutical legislation (including Directive 2001/83/EC and Regulation (EC) 726/2004), cf. the pharmaceutical strategy roadmap (here).

On June 16, 2020, the Commission launched an open consultation on this new strategy. The consultation takes the form of a questionnaire, requesting stakeholder views on four main topics: (i) international dependency and manufacturing, (ii) access to affordable medicines, (iii) innovation in early development and authorization, and (iv) environmental sustainability of medicines and health challenges.

The questionnaire, in particular, expresses the Commission’s concerns over shortages of essential medicines in the EU, both in but also outside the context of the COVID-19 pandemic. It acknowledges that a thorough examination is required of how supply chains can be made more secure and reliable — from the importing of active ingredients, raw materials, and medicines from third countries to internal EU production and distribution.

As previously reported (here), a focus of the questionnaire and the pharmaceutical strategy overall is to explore ways to encourage and support the production of essential medicines within the EU. In this vein, the questionnaire asks stakeholders which actions, in their view, would have the biggest impact on reducing shortages in the EU, including “stronger obligations on medicines producers, and other players in the supply chain to ensure medicines are available” and “providing incentives to companies to increase the production of medicines in the EU.” The questionnaire also asks stakeholders to identify what type of EU action or initiative could be most helpful to incentivize the production of active pharmaceutical ingredients for essential medicines (e.g., antibiotics, oncology medicines) in the EU. The questionnaire is available here. Stakeholders are asked to respond to the questionnaire by September 15, 2020.

Additionally, the Commission will hold a virtual workshop on July 14 and 15, 2020, to gather stakeholders’ views on specific areas of the pharmaceutical strategy.

The new pharmaceutical strategy is likely to have a significant effect on EU policy and may result in legislative changes. Pharmaceutical companies with products on the EU market should therefore follow the development closely and express their views in the public consultations and other forums the Commission offers.