EMA's 25th Anniversary
In 2020 EMA celebrated its 25th anniversary. Since the Agency’s creation on 26 January 1995, the environment in which EMA operates has undergone fundamental scientific, technological, legislative and social changes. But its mission has remained: bringing the best experts from around the EU together to create an efficient and robust system for the evaluation and supervision of human and veterinary medicines that serves citizens throughout the EU. This has allowed EMA to remain agile and adapt to continuous extensions of its legal mandate and to deliver for public and animal health in Europe.
25 years of advancing public and animal health
To mark its 25th anniversary, EMA organised a series of events in 2020 together with its stakeholders. Due to the pandemic restrictions, not all planned events could take place. The meetings and conferences that had not to be cancelled were held virtually, underlining EMA’s successful transition into an online-based meeting environment.
Programme of events to celebrate EMA’s 25th anniversary
2-3 April 2020: International awareness session on science and regulation for animal health and welfare, public health and the environment
22 September 2020: Workshop on benefit-risk of medicines used during pregnancy and breastfeeding
22 October 2020: 25 Years of EMA: building, learning and adapting to new challenges
29 October 2020: EMA 25th anniversary symposium: New approaches in patient-focused cancer drug development
30 November 2020: Workshop on regulatory support for development of orphan medicines
The main anniversary event in 2020 was a virtual conference titled ‘25 Years of EMA: building, learning and adapting to new challenges’, organised on 22 October 2020. The aim of the meeting was to highlight key achievements and learnings from recent years as well as to elaborate further on key strategic areas looking forward, given the challenges and continually evolving landscape.
EMA’s 25th anniversary coincided with anniversaries in a number of policy areas of EMA.
20 years of orphan medicines regulation
December 2020 marked the 20th anniversary of the Orphan Regulation. The EU’s orphan designation programme offers incentives to encourage the development of medicines that otherwise would not be developed to help diagnose and treat patients with rare diseases. These are often debilitating and life-threatening diseases that place a huge burden on the patients, their families and carers, and represent an enormous challenge for countries’ public health systems.
Since the EU orphan regulation entered into force in 2000, EMA has given orphan status to over 2,300 medicines. By the end of 2020, 192 medicines with orphan status received a marketing authorisation. The European Commission completed an evaluation of the Regulation in August 2020. It has been an EU success story and it is delivering in public health terms. It has helped many, but many disease areas have still not attracted sufficient attention and more dedicated research is needed to help patients to access new or better treatments. The findings from this evaluation are being considered as part of the recently launched Pharmaceutical Strategy for Europe.
On 30 November 2020, EMA held a workshop with academia, companies, patients and healthcare professionals. The aim was to review and raise awareness of the range of currently available development support tools and encourage early and efficient interactions with the regulators. A meeting report outlines the key findings.
With the establishment of the Committee for Orphan Medicinal Products (COMP) in 2000, EMA opened its doors to patients and healthcare professionals and their contributions. Today, representatives of patients, healthcare professionals and civil society take part in most of EMA's scientific committees as full members, adding their unique perspective and experiences to the debate. They play an increasingly important role in the assessment of the risks and benefits of medicines.
15 years of SME regulation
The 15th anniversary of the implementation of the SME regulation was another policy milestone in 2020. EMA held a virtual round-table meeting with stakeholders on 27 November 2020 to mark the introduction of this successful initiative. The objectives of the meeting were to:
- provide an update on EU support for small and medium-sized enterprises (SMEs);
- highlight the achievements of EMA’s SME initiative;
- present the results of an SME survey launched by the Agency in 2020;
- exchange views on achievements, challenges and future opportunities to support SMEs and innovation in the pharmaceutical sector.
Representatives of the European Commission, the European Investment Bank (EIB), the EU Agencies Network, industry organisations representing SMEs and service providers in the human, veterinary and med-tech sectors participated in the round-table meeting. The outcomes of the discussion are summarised in a meeting report.
10 years of minor use minor species (MUMS)/limited market policy
In March 2020, EMA published a report looking at the main achievements of the policy for classification and incentives for veterinary medicinal products indicated for MUMS/limited market over the last ten years.
The MUMS/limited market policy is a joint activity between EMA and the European medicines regulatory network. It was established to stimulate the development of new veterinary medicines for minor species and for rare diseases in major species that would otherwise not be researched under current market conditions. The incentives provided by the policy include reduced data requirements as well as fee exemptions or reductions.
The experience over the last 10 years has shown that the MUMS/limited market scheme is successful in incentivising the development of new medicines or addition of new indications for existing medicines intended for MUMS/limited market. These medicines are starting to fill some gaps in animal health, meeting the objective of increasing availability of veterinary medicines.
The new Veterinary Medicines Regulation (EU) 2019/6, which entered into force in January 2019 and will become applicable in January 2022, will introduce specific provisions in the EU legislation to further boost the development of new medicines for limited markets, building on the success of EMA’s experience applying the MUMS/limited market policy over the last ten years.