The European Commission proposes a new Pharmaceutical Strategy for the EU

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand. It proposes concrete actions to ensure accessibility, availability, and affordability of innovative medicinal products. The proposal is also intended to support a competitive and innovative pharmaceutical industry in the EU. The Strategy also proposes actions to develop strategic autonomy in the EU, and to ensure a strong EU voice on the global stage.

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand. Each work strand provides initiatives and measures to ensure that the objectives deliver tangible results. The Strategy is intended to achieve the following objectives:

  • Foster patient access to innovative and affordable medicinal products;
  • Support the competitiveness and innovative capacity of the EU’s pharmaceutical industry;
  • Develop strategic autonomy and ensure robust supply chains, including in times of crisis; and
  • Ensure a strong EU voice on the global stage.

Foster patient access to innovative and affordable medicinal products

One of the Strategy’s priorities is to develop a framework that better addresses patient unmet medical needs. To achieve this, the Strategy proposes to modify the system of incentives provided by the current EU legislative framework in order to stimulate innovation in areas of unmet medical needs.

The European Commission also proposes a revision of the legislation on medicinal products for children and that on rare diseases. The objective is to improve the therapeutic landscape and to better address unmet medical needs.

Support the competitiveness and innovative capacity of the EU's pharmaceutical industry

The Strategy proposes a revision of the current pharmaceutical legislation to adapt to innovative products and scientific developments, such as genomics or personalised medicinal products.

A European Commission legislative proposal on a European Health Data Space is expected by 2021. The objective is to establish an interoperable data access infrastructure that facilitates secure cross-border analysis of health data by 2025. This infrastructure would be tested in 2021 with a pilot project involving the European Medicines Agency (“the EMA”) and national competent authorities.

The Strategy also proposes to modify current pharmaceutical legislation to provide more flexibility in order to address the challenges relating to the interplay of medicinal products and medical devices. A revision of the current legislation governing the EMA’s fees is also proposed.

Develop strategic autonomy and ensure robust supply chains, including in times of crisis

With the experience gained during COVID-19 pandemic, the European Commission proposes to revise current pharmaceutical legislation to enhance security of supply and better respond to shortages of medicinal products. This would be achieved through specific measures including stronger obligations for supply and transparency, earlier notification of shortages and withdrawals, enhanced transparency of stocks, and stronger EU coordination and mechanisms to monitor, manage, and avoid shortages of medicinal products.

The Strategy also proposes to establish an EU Health Emergency Response Authority (“the HERA”). The HERA would strengthen the coordination of operations across the whole value chain in health emergencies. In order to address supply chain vulnerabilities, it would monitor production capacity, raw material requirements, and availability of medicinal products.

Ensure a strong EU voice on the global stage

In its Strategy, the European Commission undertakes to continue working to promote international regulatory convergence to ensure access to safe, effective, high-quality, and affordable medicinal products globally. It also commits to support the work of the World Health Organisation to strengthen regulatory capacity globally.

Next steps

The Strategy was discussed at political level at the Employment, Social Policy, Health, and Consumer Affairs Council Meeting on 2 December 2020.

The Strategy’s various actions and measures will be implemented gradually, starting with the first proposals in the coming months. These early proposals include the revision of the EMA fees regulation and the EU orphan medicinal product legislation and paediatric legislation.

Depending on the evaluation process, the Strategy plans a proposal for a revision of the EU basic pharmaceutical legislation in late 2022.

 

Authored by Elisabethann Wright and Silvia Lopez Arnao

 

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