EU Pharmaceutical Strategy

ECHAMP supports the European Commission’s aim to develop a stronger EU Health Union in which the EU pharmaceutical system can adapt to a changing global environment. The existing legislative framework provides a solid base to facilitate the evolution that is now needed.

However, the movement towards a stronger unification in the area of health should not result in the loss of any of the ‘established’ products. In order to continue to meet patients’ needs and expectations, access to such medicinal products, including homeopathic and anthroposophic medicines, should not be negatively or indirectly affected by the proposed changes. Only an inclusive system, which facilitates innovation and fully exploits the potential of existing products, in a regulatory framework that continues to respect national competence and national traditions, will deliver the best healthcare for every EU citizen.

ECHAMP considers the main body of the existing legislation ‘fit for purpose’. The current dual legislative framework of Directive 2001/83/EC and Regulation (EC) No 726/2004 provides a strong and coherent legal foundation. We advocate in favour of maintaining this established, inclusive structure to avoid counterproductive complexity and legal uncertainty. We encourage the Commission to support and accelerate research into self-medication and the use and benefits of integrative medicine. A conscious integration of pluralism into the EU health and care system will ensure that patients and health professionals have access to a wide choice of reliable, high quality medicinal products, including homeopathic and anthroposophic medicinal products.

Unmet medical need

One of the goals of the European Commission’s strategy is to stimulate innovation, especially in areas of ‘unmet medical need’. ECHAMP recommends that the safety profile of medicines should be specifically included in the definition. The management of side effects of pharmaceuticals can in itself be an unmet medical need, as they can have a high impact on patient quality of life. This should therefore be included in the scope.

Innovation

Central to the success of the strategy is the need to identify key elements to help drive innovation. ECHAMP recommends the inclusion of  a strategy for real world data that will help to improve understanding of treatment outcomes for both new and existing products, leading to better decisions on the role they can play in meeting patients’ needs.

Medicines shortages

Shortages of medicines and vulnerabilities in the pharmaceutical supply chain continue to be major concerns in the EU. It is a key objective to ‘achieve strategic autonomy,’ while preserving an open economy. 

We believe that a targeted approach should be applied in addressing this issue. Security of supply should only be enhanced for the predefined list of ‘critical’ medicines to avoid market distortion.

Environmental impact

While access to pharmaceutical products is a priority, the importance of reducing their environmental impact is also a major concern. ECHAMP acknowledges the high importance of this aspect. However it is imperative to ensure that measures being considered do not have an unduly negative impact on access to medicines. Preference should be given to a proportionate evidence-based approach.

Manufacture and distribution

The strategy proposes to revise the manufacturing and distribution provisions in the pharmaceutical legislation in order to improve the transparency and oversight of the supply chain. This includes clarifying responsibilities to safeguard the quality of medicines and ensuring preparedness for new manufacturing technologies.

Currently medicines manufactured for the EU market must comply with the principles and guidelines of good manufacturing practice (GMP), which requires them to be of consistent high quality, appropriate for their intended use and to meet the requirements of the marketing authorisation.

In our opinion any adaptation to the current standards should be limited to the facilitation of new innovative manufacturing methods.

For further information

• ECHAMP response to the Roadmap “Pharmaceutical Strategy - Timely patient access to affordable medicines”
• ECHAMP response to the survey on the Pharmaceutical Strategy - Timely patient access to affordable medicines
• ECHAMP response to the European Commission public consultation "Revision of the general pharmaceutical legislation - Combined Evaluation Roadmap/Inception Impact Assessment"
• ECHAMP response to survey "Open Public Consultation on the revision of the general pharmaceutical legislation"