26 April 2023
Commission adopted a proposal for a new Directive and a new Regulation, which revise and replace the existing general pharmaceutical legislation.
The proposal adopted by the Commission revises and replaces the existing general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively).
The revision aims to achieve the following main objectives:
- Make sure all patients across the EU have timely and equitable access to safe, effective, and affordable medicines
- Enhance the security of supply and ensure medicines are available to patients, regardless of where they live in the EU
- Continue to offer an attractive and innovation-friendly environment for research, development, and production of medicines in Europe
- Make medicines more environmentally sustainable
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach.
Consultations activities related to the revision of the general pharmaceuticals legislation
On 30 March 2021, the Commission published its Roadmap for revising the general pharmaceutical legislation.
Since the publication of the strategy roadmap in June 2020, the Commission has conducted a series of consultations and meetings to inform the designing of the strategy.
The Commission has considered the positions and priorities raised by interested parties and the public and has been working closely with Member State authorities in the context of its consultative committees.
As part of the consultation process experts from the European Medicines Agency and from national competent authorities (under the umbrella of the Heads of Medicines Network) drafted at the request of the Commission a series of ‘concept papers’* on technical aspects, based on their experience with operating under the current pharmaceutical legislation to inform the Commission services during the preparation of the legal proposals. The 13 concept papers* can be downloaded in this compendium.
*The views expressed in these concept papers are the product of experts’ reflection process on different possibilities, they do not necessarily represent positions of the organisations to which these experts are affiliated and may not be quoted as such. For the preparation of its legal proposals, the Commission took into account the options presented in the concept papers as part of the total available evidence.
For more on other activities please see below:
- Consultation strategy
- Online public consultation
- Thematic Workshops 2021
- Stakeholders’ dialogue on the pharmaceutical revision (10th May 2023)
Consultation activities related to the revision of the orphan and paediatric legislation
In November 2016, the Commission launched an online public consultation on the experience acquired from applying the paediatric regulation.
On 11 December 2017, the Commission launched an online public consultation for the roadmap evaluating orphan and paediatric legislation.
On 12 October 2018, the Commission launched an online public consultation on the evaluation of the orphan and paediatric legislation.
On 25 November 2020, the Commission published its roadmap revising the EU legislation on medicines for children and rare diseases.
- Roadmap/inception impact assessment on the revision of the EU legislation on medicines for children and rare diseases
- An online public consultation was conducted in 2021.
The Commission has also organised:
- In 2020, with EMA, a multi-stakeholder workshop on “How to better apply the Paediatric Regulation to boost the development of medicines for children”
Evaluation of legislation and impact assessments
The revision was based on the following evaluations and impact assessments:
- a ‘back to back’ evaluation and impact assessment of the general pharmaceutical legislation, started in April 2021 and ended in July 2022.
- an evaluation of the legislation on medicines for children and rare diseases
- an impact assessment of the legislation on medicines for children and rare diseases
- Studies in support of the evaluation and impact assessment of the EU general pharmaceuticals legislation
Consultation activities and studies related to security of supply
The reform of the pharmaceuticals framework also aims to address systemic shortages and ensure security of supply of critical medicinal products, at all times. It was informed by a Structured Dialogue with relevant stakeholders on the security of supply of medicines (launched in June 2021). A study on shortages of medicines (published in June 2021) analysed the root causes of shortages of medicines and analysed the current framework in that respect. It presented a series of 16 policy measures at EU and national level, which were considered in the reform of the pharmaceutical framework.