23 Nov 2020

In this series, the EU policy experts in Hanover Health’s International Policy and Market Access team will take you through the upcoming legislative and non-legislative pharmaceutical and healthcare proposals at EU level and help you decipher their impact and what to do.  

Hanover’s IPMA team is a leading international policy and market access team in Brussels. We work with businesses and trade associations to bridge the gap between their business objectives and the policy environment they operate in.

European Commission to set the pace for EU pharmaceutical legislation

It’s so close we can almost taste it – the long-awaited Pharmaceutical Strategy for Europe is expected to be published by the European Commission on Wednesday 25 November. In the Strategy, the Commission will outline its plans for the next 5 years – set to focus on improving patient access to medicines; boosting industry competitiveness and innovation; building up pharmaceutical supply chains; and ensuring a “strong EU voice on the global stage”.

For the first time in years, pharmaceutical and health policy will be prominent at EU level and the legislative framework will be reassessed. From industry to NGOs, everyone will be seeking to get their views understood and accepted by the EU institutions.

Unveiling of the European Health Union

Earlier this month Brussels got a taster of the direction of the upcoming Strategy with the European Health Union. The direction is clear: more competences for the European Union. This is hardly surprising, considering that the Commission has been slowly increasing its competence over the years.

The Health Union was announced by Commission President von der Leyen this September during her State of the Union speech. In the spring, the Socialists & Democrats Group – the second largest political group in the European Parliament – had already called for such a Union – and increasing EU competences in health.

Within the European Health Union, the Commission has proposed increasing and further strengthening the mandates of the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). This is as part of the project to better protect health, prevent and address future pandemics and improve the resilience of Europe’s health systems.  The new competences for the EMA could include:

  • Mitigate shortages of medicines and medical devices
  • Coordinate and advise on medicines with potential to treat, prevent or diagnose diseases that cause crisis
  • Coordinate studies and clinical trials to monitor the effectiveness and safety of vaccines

This expansion of the EMA’s competences as proposed by the Commission could add another channel for the development of centralised policy and harmonised guidance in the EU healthcare space.

Not quite a Treaty change, but…

The proposals made do not require Treaty change – nor is the Pharmaceutical Strategy expected to do so – but to quote Health Commissioner Stella Kyriakides: these proposals are just the beginning.

Increasing the Union’s competences in healthcare has been on the Commission’s radar for a long time (let us not forget the proposal on health technology assessment). With the lessons learnt from COVID-19 and the stated need for more coherence across the EU, getting member state approval for increased competences is becoming a more reasonable target.

As the EU continues to shape and possibly also harmonise European pharmaceutical and healthcare policy, it is important for all stakeholders to actively participate in these conversations. If the Commission’s proposals are as ambitious as rumoured, the debates are set to become heated. Member states are likely to resist any increased competences for the Commission. Industry will need to ensure that any new incentives structure will not only allow for continued medicine development, but will also increase patient access.

What’s coming up next and what Hanover can do to help

All healthcare stakeholders are excited and eager to understand the potential impact of the Pharmaceutical Strategy. In the coming days, Hanover will be assessing the Strategy and linked proposals, including the Commission’s Action Plan on Intellectual Property. These will all have an impact on the pharmaceutical industry and beyond.