Improved Access to Affordable Medicines - EU Proposes Radical Action
EU Commission releases its Pharmaceutical Strategy for Europe, marking the first step in its proposed overhaul of the pharma regulatory framework.

The European Commission (Commission) has released a Pharmaceutical Strategy for Europe (Strategy) which presents a very different landscape for key players in the pharmaceutical industry.

The Strategy is ambitious, encompassing an agenda of both legislative and non-legislative actions which will be launched over the next three years. From navigating intellectual property (IP) rights in times of crisis, to expanding drug production in Europe, the changes envisaged are far-reaching.

The Strategy has been drafted to cover the whole ecosystem of pharmaceuticals and extends to aspects of medical devices. It also recognises the potential for digital transformation of healthcare, driven by technological advances in fields such as artificial intelligence and computational modelling.

The influence of the COVID-19 Pandemic

Although the Strategy markets itself as more than a crisis-response instrument, it undeniably draws lessons from the initial response to COVID-19 and seeks to make Europe's pharmaceutical sector better prepared and more resilient. 

The Objectives 

The main objectives (Objectives) of the Strategy are:

1. Delivering improvements for patients

Ensuring access to affordable medicines for patients and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, and rare diseases) are just some of the aims included in the proposed overhaul. The health systems' financial and fiscal sustainability will be at the forefront of this objective.

2. Supporting a competitive and innovative European pharmaceutical industry 

Supporting the competitiveness, innovation and sustainability of the EU's pharmaceutical industry is a multi-faceted objective, which encompasses:

  • developing high quality, safe, effective and greener medicines
  • providing a fertile environment for Europe's industry
  • enabling innovation and digital transformation, and
  • ensuring a sound and flexible regulatory system.

3. Enhancing resilience

In order to strengthen the EU pharma industry and protect Member States, the Commission is aiming to secure the supply of medicines across the EU and avoid shortages; create high quality, safe and environmentally sustainable pharmaceuticals; and amplify Europe's health crisis response mechanisms and preparedness.   

4. Ensuring a strong EU voice globally 

Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

How does the Commission propose to achieve these aims?

The Commission's Strategy is divided into four work strands which flow from the Objectives.  Each strand contains initiatives and measures to ensure the Objectives deliver tangible results.

The flagship proposals of the Strategy include:

  • revision of the basic regulatory frameworks of the pharmaceutical industry with a view to making this legislation future-proof and innovation friendly (the legislative proposal is expected in 2022);
  • establishing an EU Health Emergency Response Authority (expected 2nd semester 2021);
  • revision of regulations on medicines for children and rare diseases;
  • actions to simplify and streamline the EU pharmaceutical IP system – most notably, this action plan proposes tough measures on IP holders' rights such as compulsory licensing in times of emergency (IP Action Plan expected 2022);
  • cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability, cost-effectiveness of medicines and the national health system's sustainability;
  • commencing structured collaboration with all key players in the pharmaceutical industry to identify vulnerabilities in the global supply chain of critical medicines and formulate policy options to enhance the continuity and security of supply in the EU;
  • creation of a robust digital infrastructure, which will include a proposal for a European Health Data Space (proposal expected 2021);
  • increase in the support given to research and innovation, most notably via Horizon 2020 and EU4Health; and
  • actions to promote innovative approaches to EU R&D and public procurement for antimicrobials and their alternatives, and measures to restrict and optimise their use.

For stakeholders, the potential impact of these proposals on pharmaceutical companies across Europe is striking.  Understandably, concerns are being raised on areas of the Strategy that will undermine investment in medicine innovation.

When can we expect to hear more?

The Strategy will be explored at a political level by EU ministers on 2 December 2020, and its implementation is due to begin as soon as adoption takes place. 

The timeline for rolling out the various actions and projects will be gradual, starting with proposals such as the EU orphan and paediatric legislation in the coming months. 

We will track progress on the implementation of the Strategy and keep you updated.  

Connect with Laura Scott, Charleen O'Keeffe or your usual William Fry IP contact to discuss any questions about this article.

 

Contributed by John Sugrue & Louise Murray

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Laura Scott Partner

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