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Health-EU newsletter 253 - Focus

Ambitious Pharmaceutical Strategy for Europe will help make safe and effective pharmaceuticals more available and affordable

Martin Seychell, Deputy Director General for Health and Food Safety, talks about the Pharmaceutical Strategy for Europe, which aims to help ensure Europe's supply of safe, efficacious and affordable medicines and support the European pharmaceutical industry to remain an innovator and world leader. As highlighted in the Industrial Strategy for Europe of 10 March 2020, the strategy will cover the availability, affordability, sustainability and security of supply of pharmaceuticals. A public consultation and a roadmap on the Pharmaceutical Strategy are now open and stakeholders can share their views to help shape this policy.

Why do we need a pharmaceutical strategy?

Medicines play an important role in diagnosing, treating and preventing diseases. People across Europe expect to receive new and existing treatments.

Health remains a top priority for all of us but patients across the EU still have different levels of access to medicines. A balanced pharmaceutical system is also a priority for Member States, as demonstrated by activities of the European Parliament and the Council.

There can be shortages of certain medicines in some Member States. Therapies for major unmet medical needs are still lacking. When available, they are not always affordable for patients and national health systems across the EU.

These issues concern all of us, shortages of crucial medicines may compromise patient care and have the potential to undermine health security across the EU. We need an ambitious pharmaceutical strategy to deliver an effective response to these challenges and make sure that patients receive the treatment they need.

Will the COVID-19 pandemic influence the strategy?

The coronavirus pandemic was a clear shock to the system. It greatly increased the risk of shortages for critical medicines. The pharmaceuticals system was pushed but held its ground. This highlighted issues that were already identified, an example is international dependency on active pharmaceutical ingredients and medicines from third countries and the lack of a competitive chemical industry in the EU. While safety, quality and efficacy remain essential principles, our system must be ready to respond in a timely and coordinated way to crises such as the COVID 19 pandemic. We intend to build on the learnings in the implementation phase of the strategy to strengthen our system.

How will the Commission achieve these ambitious goals?

The Pharmaceutical Strategy will create a strong, efficient and flexible system. There will be a targeted review of the existing regulatory framework and policy, aiming towards a crisis- and future-proof system.

We are not starting from scratch but building on ongoing work, such as the review of the legislation related to medicines for children and rare diseases, and study on shortages of medicines. It will be a holistic strategy that covers the whole ecosystem, for example, from research and development and clinical trials to regulatory issues, as well as competition, intellectual property and incentives. Creating synergies with other policies, such as Europe’s Beating Cancer Plan, research and innovation, the chemicals strategy and the Green Deal. More coordination will allow us to harness the opportunities already available.

This is the start of the process, and I invite all interested parties to share their views on this initiative. The roadmap is open for feedback through to 7 July, and the online public consultation will remain open through to early September.

Activities at EU level

Medicinal Products

European Commission – Health and Food Safety

Pharmaceutical strategy for Europe

European Commission – Health and Food Safety

Evaluation of the European Medicines Agency’s (EMA) fee system

European Commission – Health and Food Safety


European Medicines Agency


Commission launches public consultation on the Pharmaceutical Strategy for Europe

In the wake of the COVID-19 pandemic, the Strategy will aim to ensure Europe's supply of safe and affordable medicines to meet patients' needs and support the European pharmaceutical industry to remain an innovator and world leader. The consultation is open through 15 September 2020.

Help shape the EU’s Pharmaceutical Strategy by providing feedback and input!

As well as being invited to contribute to the public consultation (see above), the health stakeholders and the general public are invited to provide feedback on the Roadmap on the pharmaceutical strategy through 7 July 2020.

Call to stakeholders to express their interest in participating in an online workshop on the Pharmaceutical Strategy on 14 and 15 July 2020

Stakeholders in the field of medicinal products and related areas should respond by 5 July if they would like the chance to take part in the virtual workshop where they will share their views with national authorities and the Commission on specific areas of the Pharmaceutical Strategy.

Health Commissioner Stella Kyriakides mandated to ensure Europe has adequate supply of affordable medicines

In her mission letter to Commissioner Kyriakides, President von den Leyen asked the Commissioner to ensure Europe has the supply of affordable medicines to meet its needs” while “supporting the European pharmaceutical industry to ensure that it remains an innovator and world leader.

Webinar conference about the Guidance on the management of clinical trials during the COVID-19 pandemic held on 15 May 2020

The conference was hosted jointly by the European Commission, the European Medicines Agency and the Clinical Trials Coordination and Facilitation Group of Heads of Medicines Agencies. Find the agenda and more details here.

European Medicines Agency publishes Annual Report, also available as a digital version

The European Medicines Agency released its annual report that showcases the Agency’s efforts to protect and promote human and animal health in Europe and highlights the most significant achievements in 2019. For the first time, EMA’s annual report is available in a digital version.

Data gathering is ongoing for EMA fee system and evaluation of orphan and paediatric legislation

Various actions gather and analyse data and knowledge in support for an impact assessment of different options responding to the findings of the review of EU orphan and paediatric legislation and support future Commission action in the area of EMA fees charged by EMA.

Evaluation of the legislation on medicines for children and rare disease

This joint evaluation covers the legislation on medicines for special purposes, in particular medicines for children and medicines to treat rare diseases. It will assess how efficient and effective EU legislation is and if it is fit for purpose in the light of developments in pharmaceuticals.

The Commission and the EMA launch new action plan on advanced therapy medicinal products

The aim of the new action plan is to streamline the procedures and better address the specific requirements of advanced therapy medicinal products (ATMP) developers.

Commission continues follow up on ‘Strategic Approach to Pharmaceuticals in the Environment’

Last year the Commission adopted a Communication outlining a set of actions addressing the multifaceted challenges that the release of pharmaceuticals poses to the environment. Action areas cover all stages of the pharmaceutical life cycle, where improvements can be made.

Health Programme Projects

European Joint Action on antimicrobial resistance and associated infections

This Joint Action aims to ensure that policies for the control of antimicrobial resistance and healthcare associated infections are adopted and implemented across Member States in a coordinated way.

Support to OECD work on access to medicines

With the financial support of the EU Health Program, the OECD (Organisation for Economic Co-operation and Development) has undertaken several projects to further identify avenues to increase pharmaceutical expenditure efficiency and better prepare to changes in the market.

EURIPID - The EURopean Integrated Price Information Database project

This project supports cooperation on reference pricing methods and the set-up by the Member States of guidelines to mitigate unintended negative effects of international price benchmarking rules on access to care.

Accessibility of pharmaceutical care and trends in pharmaceutical spending: an analysis of pharmaceutical sales data for 2008-2018

The analysis of pharmaceutical sales data will help address key questions on the accessibility of pharmaceutical care across EU Member States as well as on trends in expenditures of public expenditures on pharmaceuticals, in line with the EU Agenda on health systems.

European Network for Health Technology Assessment (EUnetHTA) - Joint Action 3

EUnetHTA JA3 aims to increase the use, quality and efficiency of joint HTA work at European level to support evidence-based, sustainable and equitable choices in healthcare and health technologies and ensure re-use in regional and national HTA reports and activities.

Other interesting links

Joint action plan on paediatrics

Study on the economic impact of the Paediatric Regulations, including rewards and incentives

Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe

Evaluation of European Medicines Agency’s fees

Europe’s Beating Cancer Plan

Industrial Strategy for Europe

European Digital Strategy

European Green Deal

Council conclusions of 2016 on strengthening the balance in the pharmaceutical systems in the European Union and its Member States

European Parliament resolution 2017 on EU options for improving access to medicines

European Parliament resolution 2018 on antimicrobial resistance