A smart digital pharmacovigilance system should:

  • Medicines for Europe is ready to actively contribute to the announced European pharmaceutical strategy and Beating Cancer Plan.
  • The new pharmaceutical strategy should integrate measures to:
    • ensure uptake of generic and biosimilar medicines for improved access
    • set up pan-European cooperation to prevent shortages by addressing the root causes;
    • deliver guidelines on procurement of medicines under the EU Procurement Directive, including how to acknowledge investments in manufacturing and reward security of supply;
  • The Beating Cancer Plan should recognize the key role that generic and biosimilar medicines can provide for earlier, broader and de novo access to which otherwise are not accessible to patients.

Equitable and sustainable access to medicines is a concern across the EU. Policy reforms were discussed during the seminar “A European Union that ensures Patient Access & Sustainability”, organised by the Hungarian Permanent Representation to the EU with the support of the Croatian Presidency of the European Council. The seminar assembled high-level experts from the European Commission, OECD, health economists and representatives from different health care stakeholders.

According to the WHO, cancer is responsible for 20% of deaths in Europe[i]. With more than 3 million new cases every year which is expected to increase to more than 4.3 million by 2035[ii].The Beating Cancer Plan should overcome access barriers to existing oncology treatments in all EU member states. Generic and biosimilar medicines offer valuable opportunities for expanding access to oncology treatment for patients, while delivering efficiency to health systems.   A well-designed EU cancer plan cannot conceivably succeed without robust policies for generic and biosimilar medicines use.

Reports of medicines shortages are increasingly prevalent in Europe. Ensuring the availability of essential medicines should be an EU priority. The EU should tackle the economic and regulatory root causes of shortages and establish a pan-European mechanism to coordinate EU and national policies to reduce the risk of shortages and to avoid spill over effects through which one country’s policy would create supply issues in another. Preventing supply issues becomes especially pertinent considering the ongoing COVID-19 outbreak globally.

Among the measures discussed were guidelines on medicines procurement under the EU Procurement Directive, including how to acknowledge investments in manufacturing and supply security for Europe, supported by strong industrial and competitive policies to stimulate investment for the benefit of European patients.

Christoph Stoller, President, Medicines for Europe, concluded his opening remarks by calling for a “focused, action-oriented high-level pharmaceutical forum, so that all together, policy-makers, regulators, payers, industry and other stakeholders concerned can achieve the right balance between health objectives and industry competitiveness in Europe. Europe can only succeed by breaking down silos to jointly define and implement policy reforms in support of patient access to medicines”

[i] http://www.euro.who.int/en/health-topics/noncommunicable-diseases/cancer/cancer