European Medicines Agency

The EMA operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. More specifically, it coordinates the evaluation and monitoring of centrally authorised products and national referrals, develops technical guidance and provides scientific advice to sponsors. Its scope of operations is medicinal products for human and veterinary use including biologics and advanced therapies, and herbal medicinal products. The agency is composed of the Secretariat (ca. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, orphan drugs, paediatrics, advanced therapies and pharmacovigilance risk assessment) and a number of scientific working parties. The Secretariat is organised into five units: Directorate, Human Medicines Development and Evaluation, Patient Health Protection, Veterinary Medicines and Product Data Management, Information and Communications Technology and Administration. The Management Board provides administrative oversight to the Agency: including approval of budgets and plans, and selection of Executive Director. The Board includes one representative of each of the 28 Member States, two representatives of the European Commission, two representatives of the European Parliament, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations. The Agency decentralises its scientific assessment of medicines by working through a network of about 4500 experts throughout the EU. The EMA draws on resources of over 40 National Competent Authorities (NCAs) of EU Member states.

The centralised procedure allows companies to submit a single application to the agency to obtain from the European Commission a centralised (or 'Community') marketing authorisation (MA) valid in all EU and European Economic Area (EEA)-European Free Trade Association (EFTA) states (Iceland, Liechtenstein and Norway). The centralised procedure is compulsory for all medicines derived from biotechnology and other high-tech processes, as well as for human medicines for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, and viral diseases, and for veterinary medicines for use for growth or yield enhancers. The centralised procedure is also open to products that bring a significant therapeutic, scientific or technical innovation, or is in any other respect in the interest of patient or animal health. As a result, the majority of genuinely novel medicines are authorised through the EMA.

For products eligible for or requiring centralised approval, a company submits an application for a marketing authorisation to the EMA.

The Agency carries out a number of activities, including:

• Pharmacovigilance: The Agency constantly monitors the safety of medicines through a pharmacovigilance network and EudraVigilance, so that it can take appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised.
• Referrals: The Agency coordinates arbitration procedures relating to medicinal products that are approved or under consideration by Member States in non-centralized authorisation procedures.
• Scientific Advice: Companies wishing to receive scientific advice from the CHMP or CVMP on the appropriate tests and studies to carry out in the development of a medicinal products can request it prior to or during the development program.
• Telematics projects: The Agency is responsible for implementing a central set of pan-European systems and databases such as EudraVigilance, EudraCT and EudraPharm.

Following the 2016 decision of the United Kingdom to leave the European Union ("Brexit"), the EMA chose to search for another base of operations. According to EU Law the European Commission had to decide on the fate of the EMA's location. The EU ministers met to vote on their preferred successor.[9] The EU's Health Commissioner Vytenis Andriukaitis said that the preferred choice would be a location where an "easy set up and guarantee of smooth operations" would be available. Member states who had expressed their bid for the new EMA location were Austria,[10] Belgium, Bulgaria,[11] Croatia,[10] Cyprus,[10] Czech Republic,[10] Denmark,[10] Finland,[12] France,[10] Germany,[10] Greece,[10] Hungary,[10] Ireland,[10] Italy,[10] Malta,[10] the Netherlands,[13] Poland,[11] Portugal,[14] Romania,[15][16] Slovakia,[10] Slovenia,[10] Spain,[10] and Sweden.[17][18][19]

It had also been speculated that the Strasbourg-based seat for the European Parliament could be moved to Brussels, in exchange for the city to host the EMA.[20] Others speculated on the merits of Amsterdam, well before the final decision was made.[21][22]

The decision on the relocation was made on 20 November 2017, during the EU General Affairs Council meeting,[22] after three voting rounds and finally drawing of lots. After the first round of voting, Milan (25 votes), Amsterdam (20 votes) and Copenhagen (20 votes) were the only contenders left.[23] After the second voting round, two cities were left: Milan (twelve votes) and Amsterdam (nine votes). These two cities tied in the subsequent vote (thirteen votes each), after which a drawing of lots identified Amsterdam as the host city of EMA.

It is unclear what future arrangements the United Kingdom proposes to make for its own medicinal evaluation after leaving the EU. Paul Workman, the president of the London-based Institute of Cancer Research, has suggested that pharmaceutical companies would naturally seek regulatory approval for new drugs in the biggest markets first, leaving the UK facing delays in approval if they set up independent arrangements.[24]

The review process of the European Medicines Agency regarding medical issues has been criticized for its lack of transparency and issues of conflict of interest.[25] In a rebuttal of an EMS review that included her work, Louise Brinth, a Danish physician, noted that "experts" reviewing data remain unnamed and seem to be bound to secrecy. Minutes are not released and diverging opinions are not reported suggesting that all the "experts" are of the same opinion. In her view the process is unscientific and undemocratic.[26]

The EMA is roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA),[27] but without centralisation.[28] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA to evaluate a product.[29]

• McCormick, John (2004). The European Union: Politics and Policies. Boulder, Colo: Westview Press. ISBN 0-8133-4202-3.

• Official website
• EMA Annual Report 2018
• Heads of Medicines Agencies
• The Rules Governing Medicinal Products in the European Union (EudraLex)
• Health-EU Portal official public health portal of the European Union