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The European Commission Publishes a New Pharmaceutical Strategy for Europe

25 November 2020

Today, Wednesday 25 November 2020, the European Commission has published its long awaited Communication setting out a new “Pharmaceutical Strategy for Europe”. The Strategy is available here.

Europe's Pharmaceutical Strategy has four main objectives:

  • Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
  • Supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high quality, safe, effective and greener medicines
  • Enhancing crisis preparedness and response mechanisms, and addressing security of supply;
  • Ensuring a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards.

The flagship actions of the Strategy include:

  • A revision of the basic pharmaceutical legislation* (target date for a proposal: 2022) with a view to making this framework future-proof and innovation friendly
  • A proposal for a EU Health Emergency Response Authority (proposal: 2nd semester 2021)
  • A revision of the regulations on medicines for children and rare diseases
  • Initiating a structured dialogue with and between all actors in the pharmaceutical manufacturing and public authorities to identify vulnerabilities in the global supply chain of critical medicines and shape policy options to strengthen the continuity and security of supply in the EU
  • Cooperation between national authorities on pricing, payment and procurement policies, to improve the affordability, cost-effectiveness of medicines and health system's sustainability
  • The creation of a robust digital infrastructure, including a proposal for a European Health Data Space (target date for a proposal: 2021)

 

Matti Aapro, President of the European Cancer Organisation, said:

“The new EU Pharmaceutical Strategy is an important development that we welcome. However, it should not forget existing expertise and some easy to reach priorities. Many oncology drugs are not used in the most cost-efficient way, even when studies show that dose/schedule changes could be safely introduced.  Safe and efficacious use of drugs in pediatric patients and older patients with various co-morbidities has to receive more attention.”

 

Mirjam Crul, a Board Member of the European Cancer Organisation, and Vice-President of the European Society of Oncology Pharmacy (ESOP), said:

“We can no longer accept inequity in access to anticancer medicines across Europe. This means that drug shortages have to end. But also that accessibility for all our patients to innovative treatments should be made possible. To achieve this, fair and transparent pricing must be at the forefront of the European Union’s endeavors.”

 

Denis Lacombe, Director General of the European Organisation for Research and Treatment of Cancer (EORTC), and Co-Chair of the European Cancer Organisation’s Health Systems and Treatment Optimisation Network, said:

“The needs of patients in health care systems should define the research priorities. Validation of treatments should not be limited to pharmaceuticals but embrace all therapeutic options in a newly established patient centric environment. Therapeutic progress should be delivered based on robust solid evidence and driven by the biology of the diseases. In that respect,  biomarkers thresholds for positivity should be measured independently from the treatment to be received. Pragmatic independent trials delivering health care relevant datasets should be structural to the process of access and contribute to solutions for addressing affordability through optimisation of treatments in health care systems. Re-engineering the process of treatment development in health care is long overdue.”