Last updated: 12 April 2024
See updates at the end of the post
The European Commission is proposing to revise the EU’s pharmaceutical legislation – the largest reform in over 20 years in order to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU.
What is the revision of the EU pharmaceutical legislation expected to achieve?
The revision will:
- make medicines more available, accessible and affordable
- support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards.
In addition to this reform, the Commission proposes a Council Recommendation to step up the fight against antimicrobial resistance (AMR).
What are the main objectives of the revision of the EU pharmaceutical legislation?
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
- Reduce drastically the administrative burden by speeding up procedures significantly reducing authorisation times for medicines, so they reach patients faster;
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
- Make medicines more environmentally sustainable.
Frequently asked questions about the revision of the legislation
A Q&A has been published on the commission website, with information provided under 14 headings. A summary is provided below for 11 out of the 14 headings.
1. What does the package consist of?
The reform includes two legislative proposals which constitute the EU regulatory framework for all medicines (including those for rare diseases and for children). They are:
- a new Directive which contains all the requirements for:
- authorisation
- monitoring
- labelling and regulatory protection
- placing on the market and other regulatory procedures for all medicines authorised at EU and national level.
- a new Regulation which sets:
- specific rules (on top of the ones in the Directive) for medicines authorised at EU level, in particular the most innovative ones.
- out the rules:
- on coordinated management of critical shortages and security of supply of critical medicines.
- governing the European Medicines Agency (EMA).
- The reform also includes a Council Recommendation on antimicrobial resistance (AMR).
Finally, these legislative proposals and Council recommendation are accompanied by a Communication that explains the rationale of the changes
How does the proposal adopted by the commission impact the current legislation?
As already stated above, the proposed revision of the pharmaceutical legislation will consist of two legislative proposals:
- a new directive, repealing and replacing Directive 2001/83/EC and Directive 2009/35/EC of the European Parliament and of the Council and incorporating relevant parts of the Paediatric Regulation (Regulation (EC) No 1901/2006)
- a new regulation, repealing and replacing Regulation (EC) No 726/2004, repealing and replacing the Orphan Regulation (Regulation (EC) No 141/2000) and repealing and incorporating relevant parts of the Paediatric Regulation (EC) No 1901/2006).
The merger of the Orphan Regulation and the Paediatric Regulation with the legislation applicable to all medicinal products will allow for simplification and increased coherence.
2. What is new in this reform?
The reform builds on the current high standards of quality, safety, and efficacy for the authorisation of medicines and proposes various new tools including in the following areas:
- Move away from a “one-size-fits-all” system of incentives for pharmaceutical companies to a modulated system of incentives that rewards companies that fulfil important public health objectives, such as:
- giving access to medicines in all Member States,
- developing medicines that address unmet medical needs,
- conducting comparative clinical trials and developing medicines that can treat other diseases as well
- Faster availability of generics and biosimilars and transparency of public funding
- A modern and simplified regulatory framework with faster authorisations of new medicines.
- For instance, for its assessment, EMA will have 180 instead of 210 days.
- For the authorisation, the Commission will have 46 instead of 67 days. This will help to reduce the current average of around 400 days between submission and market authorisation.
- For the assessment of medicines that are of major public health interest, EMA will only take 150 days regulatory sandboxes supporting the development of innovative medicines, electronic submissions and e-leaflets
3. How will the new legislation promote innovation?
Innovation will be provided in a variety of ways including the following:
- Early scientific advice by EMA will improve the quality of applications and tailored scientific support will be provided to SMEs
- Developers of innovative products will receive advice on their product even years before they actually apply for a marketing authorisation which will facilitate their decisions.
- The regulatory framework will be more agile to accommodate scientific advances, digitalisation, artificial intelligence and cutting-edge products
- Companies marketing innovative medicines will have a minimum period of regulatory protection of 8 years, which includes 6 years of data protection and 2 years of market protection. Companies may benefit of additional periods of protection, increasing the total period up to maximum 12 years, while it is maximum 11 years today. These additional periods of protection can be obtained if the companies launch the medicine in all Member States (+2 years), if the medicine addresses an unmet medical need (+6 months), or if comparative clinical trials are conducted (+6 months). A further year of data protection can be granted if the medicine can treat other disease(s) too.
- For medicines for rare diseases, the standard duration of market exclusivity will be 9 years. Companies can benefit from additional periods of market exclusivity if they address a high unmet medical need (1 year), launch the medicine in all Member States (+ 1 year), or develop new therapeutic indications for an already authorised orphan medicine (up to 2 extra years). The regulatory production periods can add up to maximum 13 years while today the maximum is 10 years.
4. Will the proposed reform have an impact on the Intellectual Property (IP) protection covering medicinal products?
No it will not have any impact on the Intellectual Property (IP) protection covering medicinal products?
5. What is the AMR “vouchers” system about?
It will provide ‘transferable data exclusivity vouchers’ to developers of ‘game changing’ novel antimicrobials, which they can either use themselves or sell.
The voucher will offer to the developer an additional year of data protection from competition for the medicine that the voucher applies to.
6. How will the new rules give patients access to more and innovative medicines?
- A central objective of the reform is to ensure that all patients across the EU have timely and equitable access to safe and effective medicines.
- The reform addresses this concern by making two years of data protection conditional on launching a medicine in all Member States.
- A reduction of the standard regulatory protection period by 2 years (compared to today) and measures that encourage early market access of generic and biosimilar entry will also provide more affordable options to patients and contain health systems’ pharmaceutical expenditure.
- Incentives for repurposing existing medicines and for using comparative trial data will give patients quicker access to new therapies that deliver on their needs. Using comparative trial data will help national authorities to better assess the cost effectiveness of a new medicine.
- A simplified decision-making system reduces authorisation times for new medicines
- Incentives will be offered for the development of innovative medicines addressing unmet medical needs.
- In addition to the existing paper leaflets, electronic product information will ensure accurate information to patients in their own language through electronic leaflets and help address shortages through the easier redirection of stocks to countries that need them.
7. Will the new rules impact the way medicines and vaccines are authorised in the EU?
Yes they will, by reducing the regulatory burden, with a leaner EMA structure. They will simplify procedures to:
- ensure efficient assessments,
- boost the scientific capacity of the EU regulatory network and
- reduce the time for authorisation of medicines
The voice of patients will be strengthened by adding patient representatives to the main scientific committee of the EMA.
8. How will changes to EMA’s work speed up the authorisation of medicines?
The legal proposal simplifies EMA’s structure to two main scientific committees for human medicines:
- the Committee for Human medicinal products and
- the Safety Committee (PRAC).
The orphan, paediatric and ATMP committees would be discontinued.
The mandate of the EMA and its Executive Steering Group on Shortages and Safety of Medicinal Products will be extended with respect to the management of critical shortages and the security of supply of critical medicines
An inspectorate will be established within EMA to reinforce Member States’ capacities, in particular for inspections in third countries to build efficiency in surveillance and support marketing authorisation procedures.
9. Will there be more transparency on the development of medicines?
Yes, there will be greater transparency on public support for the development of medicines which may strengthen the negotiating position of authorities responsible for pricing and reimbursement of medicines when negotiating prices with the pharmaceutical companies which may in turn help reduce prices and thereby improve access to medicines.
Pharmaceutical companies will be required to publish information on all direct financial support for the R&D of medicines received from public authorities or publicly funded bodies. This information will be easily accessible to the public on a dedicated webpage of the company and through the database of medicinal products for human use authorised in the Union.
10. Will the reform tackle shortages of medicines?
Yes it will.
The extension of EMA’s mandate as part of the European Health Union, allowed improving coordination and management of the supply of medicines shortages during crises.
The new legislation will enhance the monitoring and mitigation of medicines shortages, in particular critical shortages, at national level and by EMA.
Pharmaceutical companies will have to:
- report shortages of medicines more quickly and establish shortage prevention plans.
- address critical shortages, and report on the results of the measures taken (such as the increase or reorganisation of manufacturing capacity or the adjustment of distribution to improve supply).
In addition, an EU list of critical medicines – i.e. medicines considered to be most critical for health systems at all times – will be established.
The legislation will also allow the Commission to introduce, through an implementing act, measures to strengthen security of supply, including requirements to establish contingency stocks.
14. Impact of extending the duration of regulatory data protection in the new EU pharmaceutical legislation
Medicines for Europe has published a document which provides an economic analysis of the extension of regulatory data protection periods proposed in the European Parliament, which have strong political support. You can view it here.
15. Progress so far
Parliament adopts its position on EU pharmaceutical reform
On 11 April 2024, MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.
The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45 abstentions) and regulation (adopted with 488 votes in favour, 67 against and 34 abstentions)
You can read more about this here or in this blog post.
Source: European Parliament
Table mapping of some of the main Articles of Directive 2001/83/EC to the proposed new Directive
Using the mapping table below, you can compare the text in some of the main Articles of Directive 2001/83/EC with the text in the Articles of the proposed Directives
| Current | Proposed |
|---|---|
| Directive 2001/83/EC | Proposed Directive |
| TITLE III PLACING ON THE MARKET CHAPTER 1 Marketing authorization | Chapter II Application requirements for national and centralised marketing authorisations |
| Article 8 | Article 6 – General requirements for marketing authorisation applications |
| Article 12 | Article 7 Expert verification of detailed summaries |
| SPECIFIC REQUIREMENTS FOR ABRIDGED APPLICATIONS FOR MARKETING AUTHORISATION | |
| Article 10(1) , Article 10(2b) | Article 9 Applications concerning generic medicinal products |
| Article 10(3) | Article 10 Applications concerning hybrid medicinal products |
| Article 10 (4) | Article 11 Applications concerning biosimilar medicinal products |
| Article 12 Applications concerning bio-hybrid medicinal products | |
| Article 10a | Article 13 Applications based on bibliographic data |
| Article 10c | Article 14 Applications based on consent Following the granting of a marketing authorisation, the marketing authorisation holder may, by letter of access, allow use to be made of all documentation referred to in Article 6(2) with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form. |
| SPECIFIC REQUIREMENTS FOR APPLICATIONS FOR CERTAIN CATEGORIES OF MEDICINAL PRODUCTS | |
| Article 15 Fixed dose combination medicinal product, platform technologies and multi-medicinal product packages | |
| Article 18 Integral combinations of medicinal products and medical devices | |
| Article 19 Medicinal products in exclusive use with medical devices | |
| Article 20 Combinations of medicinal products with products other than medical devices | |
| TITLE V LABELLING AND PACKAGE LEAFLET | Chapter VI Product information and labelling |
| Article 55 | Article 66 Labelling of blister packs or small immediate packaging |
| Article 56a | Article 71 Accessibility for persons with disabilities |
| Article 57 | Article 72 Member States labelling requirements |
| Article 58 | Article 63 General principles on package leaflet |
| Article 59 | Article 64 Content of package leaflet |
| Article 60 | Article 78 Placing on the market of labelled medicinal products |
| Article 61 | Article 76 Approval of the labelling and package leaflet information |
| Article 62 | Article 73 Symbols and pictogram |
| Annexes The Directive has Two Annexes | Annexes The Directive has Eight Annexes |
| Annex I – Analytical, Pharmacotoxicological and clinical standards and protocols in respect of testing of medicinal products Annex II on Repealed Directives, with their successive amendments | Annexes – Eight annexes Annex I -Information referred to in the application Annex II – Analytical, Pharmacotoxicological and clinical standards and protocols in respect of testing of medicinal products Annex III – Conditions for qualification of a Qualified Person. Annex IV – Labelling particulars – on particulars that shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging Annex V– Contents of Summary of Product Characteristics Annex VI – Contents of package leaflet Annex VII– Areas for adapted frameworks Annex VIII – Correlation Table |
Sources:
European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines (European Commission) 26 April 2023
Reform of the EU pharmaceutical legislation (European Commission) 26 April 2023
Further information
- Proposed Amendments to the EU Regulatory Framework for Medicinal Products by Jackie Mulryne, Alexander Roussanov, Carla Schoonderbeek, Eleri Williams & Sofia Wilson (April 26, 2023), Bioslice Blog
- EU to link pharma incentives to public health objectives by Catherine Drew and Charlotte Weekes (27 April 2023), Pinsent Masons .
- Pharmavibes blog post, A closer look at some aspects of the proposed revision of the EU pharmaceutical legislation (19 May 2023).
- EMA webinar on revision of the pharmaceutical legislation (16 June 2023)
- Awareness session for SMEs on the revision of the pharmaceutical legislation (24 November 2023), EMA
- As time runs out, the European Parliament remains divided over pharma reform by Martin Greenacre (29 December 2023), sciencebusiness.net
Updates
| Date | Update(s) |
|---|---|
| 12 April 2024 | New section Progress so far added. |
| 18 Mar 2024 | Added new section 15 entitled Impact of extending the duration of regulatory data protection in the new EU pharmaceutical legislation. |
| 7 Feb 2024 | Added Item no 6 to the section Further Information. |
| 12 Dec 2023 | Added section entitled Table mapping of some of the main Articles of Directive 2001/83/EC to the proposed new Directive |
| 8 Dec 2023 | In the section Further Information, added item 5Item 5, a link to the EMA webinar entitled Awareness session for SMEs on the revision of the pharmaceutical legislation (24 November 2023) |
| 4 July 2023 | Section Further information updated with links to EMA webinar and Article on the Bioslice Blog. |
| 4 May 2023 | 1) In the section 1. What does the package consist of?, links have been added to the proposed Directive, Regulation and Communication that explains the rationale of the changes. 2) In the section 3. How will the new legislation promote innovation?, two further bullet points added. 3) New section entitled Further Information added. 4) Information under the heading Source updated. |
| 29 Apr 2023 | Section entitled How does the proposal adopted by the Commission impact the current legislation? added. |