Home / News

Europe: European Commission kicks off review of pharmaceutical legislation

2021/04/02  EC

The European Commission is building a stronger European Health Union, in which all EU countries prepare and respond together to health crises, innovative, safe and effective medicines are available at an affordable cost, and countries work together to improve prevention, treatment and aftercare for diseases such as cancer. On 25 November 2020, the Commission published a Communication on a Pharmaceutical Strategy for Europe. The unprecedented COVID-19 pandemic has clearly demonstrated the criticality of ensuring timely access to safe, high quality and affordable medicines at all times. The strategy is an ambitious, long-term project in the area of health. It is intended to make the European pharmaceutical system patient-centred, future-proof and crisis-resistant. The development and supply of medicines is a global operation. The EU pharmaceuticals system should ensure the quality and safety of medicines, while boosting the sector’s global competitiveness and creating a regulatory environment, which is attractive for innovation and investment and supported by international harmonised standards and, where possible, regulatory convergence. As such, the strategy is a key pillar of the Commission’s vision to build a stronger European Health Union.

The revision of the general pharmaceutical legislation is complementary to other ongoing initiatives in this context, such as the European Health Data Space (EHDS), which aims to provide high-quality healthcare while making the most of digital health and the work on the EU Health Emergency Preparedness and Response Authority (HERA). It also relates to the European Green Deal, notably through the impact of pharmaceutical substances on the environment. The Pharmaceutical Strategy is in line with the objectives of the Industrial Strategy, with a pharmaceutical related focus, such as the provision of an investment friendly environment for research and innovation, enabling key technologies, supporting industry and SMEs especially, creation of European Industrial ecosystems in areas of strategic importance, diversification of supply in the provision of starting and raw materials for the manufacturing of medicines. Other links include the adoption of the Health Technology Assessment Regulation (planned for 2021) which is expected to improve access by facilitating national decisions and creating a more predictable assessment process throughout the EU.

The Pharmaceutical Strategy proposes flagship initiatives and other actions to ensure the delivery of tangible results. As a part of the implementation of the strategy, the Commission is evaluating the current general pharmaceutical legislation and assessing the impacts of any changes intended to address the objectives outlined in this document.

In line with the ‘evaluate first’ principle, the initiative and the accompanying impact assessment will be based on Ref. Ares(2021)2185074 - 29/03/2021 2 the findings of an evaluation which will assess to which extent the general pharmaceutical legislation (namely Directive 2001/83/EC1 and Regulation (EC) No 726/20042 ) has delivered against its initial objectives. Using the effectiveness, efficiency, relevance, coherence and added value criteria, the evaluation will particularly assess:

  • the extent to which existing measures can still effectively reply to the problems identified within the pharmaceutical strategy, also taking into account the international context and regulatory developments globally;
  • the coherence and complementarity with other related pieces of legislation, including those on medical devices, medicines for children and rare diseases, the proposal for the European Health Data Space, the EU blood, tissues and cells legislation;
  • the mechanisms for the continuous and timely adaptation of technical requirements in light of emerging science and technologies; potential administrative burden and complexity linked to the implementation of this legislation.

The evaluation will cover the period from 2005 to present (date covering the last fundamental amendments to the Directive and Regulation). The geographical scope will be the EU Member States. The evaluation will not cover all the provisions of the legislations and focus on those that relate to the objectives of the Pharmaceutical Strategy for Europe and presented in this roadmap. The preliminary results of the evaluation will be used to establish the baseline situation for the impact assessment, refine the problem definition and the policy options and feed into their analysis.

To continue reading this article please go to EC .