Pharmaceuticals

Pharmaceutical Strategy for Europe

In June 2020, the European Commission released a Roadmap and then launched an online public consultation on the Pharmaceutical Strategy for Europe. The Strategy aims to improve and accelerate patients’ access to safe and affordable medicines and to support innovation in the EU pharmaceutical industry. 

HOPE answered the consultation, focusing on the need for a better affordability and availability of medicines, the necessity to tackle antimicrobial resistance and the need for better support for medical research at EU level. 

On 25 November 2020, the Commission adopted a Pharmaceutical Strategy for Europe. The Strategy will allow Europe to cover its pharmaceutical needs, including in times of crisis, through robust supply chains. 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 Pharmaceutical Strategy for Europe marks the beginning of a process: its implementation includes an agenda of legislative and non-legislative actions which will be launched over the coming years. Actions will cover the whole ecosystem of pharmaceuticals, but also some aspects of medical devices. It creates synergies with the Green Deal and EU actions under the EU Strategic approach of pharmaceuticals in the environment to reduce their environmental risk, address pollution from pharmaceutical residues and promote greener manufacturing, use and disposal. It is also linked to the action plan on Intellectual Property.

On 26 November 2020, Health Commissioner Stella Kyriakides presented the Pharma Strategy at the European Parliament plenary session where MEPs stressed the need to ensure access to safe and affordable medicines and support EU pharmaceutical innovation.

As part of the EU pharmaceuticals strategy, the Commission plans to evaluate and revise the EU’s general legislation on medicines for human use to ensure a future-proof and crisis-resistant medicines regulatory system.

The revision will aim to:

  • ensure access to affordable medicines
  • foster innovation, including in areas of unmet medical nee
  • improve security of supply
  • adapt to new scientific and technological developments
  • reduce red tape.

 

On 30 March 2021, the European Commission published a Roadmap, opened to feedback until 27 April 2021,  on the revision of the general pharmaceutical legislation.

 

Pharmaceutical in the Environment

From 22 November 2017 to 21 February 2018, the European Commission launched a consultation on pharmaceuticals in the environment. This consultation was part of a study gathering views on possible actions to address the risks from pharmaceuticals in the environment to support the development of a European Union (EU) strategic approach in this area.

HOPE answered the consultation in February 2018.

 

In relation with pharmaceuticals, HOPE also works on the following issues:

 

EU Projects

PHIS
Pharmaceutical Health Information System