European Medicines Agency

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European Medicines Agency
EMA
 

Vivaldi building in Amsterdam-Zuidas
as the headquarters of the EMA since 2019
English name European Medicines Agency
French name Agence européenne des médicaments
Organization type European Union Agency
status Establishment of European public law with its own legal personality
Seat of the organs since March 2019: Domenico Scarlattilaan 6,
1083 HS Amsterdam , Netherlands to February 2019: London , United Kingdom
NetherlandsNetherlands 

United KingdomUnited Kingdom 
Chair Guido Rasi
founding

July 22, 1993

EMA

The European Medicines Agency ( EMA , English E uropean M edicines A gency ) is an agency of the European Union responsible for the evaluation and supervision of medicines is responsible. Its previous name was the European Agency for the Evaluation of Medicinal Products (EMEA) .

The EMA has been based in Amsterdam since March 2019. Before that, she operated based in London . Due to Brexit , however, it became necessary to relocate the agency's headquarters. In November 2017, the new location was decided in Amsterdam .

tasks

The European Medicines Agency is responsible for maintaining and promoting public health in the European Union (EU). It coordinates the evaluation and supervision of all human and veterinary use and makes use of the scientific resources of the national regulatory authorities (National Competent Authorities (NCA)) of the 30 Member States of the European Union and EEA -Staaten.

The European Medicines Agency plays a central role in drug approval in the European Union and the EEA countries. On the basis of its scientific assessment, the European Commission issues an affirmative or negative decision on the approval applications submitted by pharmaceutical manufacturers in the centralized procedure .

Another focus is the ongoing monitoring of the safety of drugs that have already been approved in the EU ( pharmacovigilance ). The European Medicines Agency defines safety standards and coordinates the pharmacovigilance system of the European Union ( EudraVigilance ).

The European Medicines Agency works closely with international bodies, for example with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) for global Harmonization of drug approval conditions.

Legal basis

Based on Regulation (EC) No. 2309/93, the agency was set up at the end of 1993 under the name of European Agency for the Evaluation of Medicinal Products , and started work in February 1995. The current legal basis for the European Medicines Agency is Regulation (EC) No. 726/2004 . In November 2009 the European Medicines Agency announced that it would no longer use the acronym EMEA as an abbreviation. At the same time, the agency presented changes to the internal organizational structure and a new visual appearance.

organization

The EMA was based at Westferry Circus in London until 2014.
From 2014 to 2019, the EMA was located on Churchill Place in London's Canary Wharf .

Functional areas

The following functional areas report to the responsible director of the European Medicines Agency:

The work of the European Medicines Agency is supervised by a management board . The administrative board is made up of representatives from the EU (and associated) countries, supplemented by representatives of the European Parliament, representatives of the European Commission and representatives of medical, veterinary and patient associations. The Board of Directors is particularly responsible for the budget. The representatives of the associated countries have observer status on the Management Board.

In 2013 the European Medicines Agency had 785 employees. In 2017, 890 employees were cited on the occasion of Brexit.

Directors

  • Fernand Sauer (1994-2000)
  • Thomas Lönngren (2001-2010)
  • Guido Rasi (2011-2014)
  • Andreas Pott (2014–2015 temporarily)
  • Guido Rasi (2015-2020)
  • Emer Cooke (from July 13, 2020)

Budget and funding

The EMA's budget for 2015 was € 302.1 million. It is fed by three sources:

  • An average of 83 percent of the budget comes from fees that pharmaceutical companies have to pay for processing approval applications.
  • The European Union contributes an average of 11 percent, for example through programs on rare diseases or drugs for children as well as the promotion of small and medium-sized companies.
  • The remaining 6 percent come from other sources.

Committees

Within the agency, key tasks in assessing and monitoring medicinal products are performed by various committees. These are made up of representatives from all EU countries and from the EU-associated countries Iceland, Liechtenstein and Norway. The members are usually high-ranking officials from the national drug authorities. The secretariat supports and coordinates the work of these committees. The agency currently comprises the following scientific committees:

In the committees and working groups, the EMA consults around 3700 external scientists for the central approval process; around 5000 video conferences and 600 meetings take place every year.

Central Services

The European Medicines Agency provides various central medicinal product databases:

Avoidance of conflicts of interest

The work of the European Medicines Agency is based on a number of principles that are intended to ensure that the scientific experts, including committee members, as well as employees and members of the administrative board, are not impaired in their impartiality by financial or other interests. They are based on a code of conduct adopted in 1999. For example, all EMA experts, employees and members of the board of directors must annually disclose their interests in a declaration (“declaration of interest, DoI”) .

At the end of 2010 there were reactions of surprise to outrage when it became known that the then Executive Director of the EMA, Thomas Lönngren, would switch to a consulting firm in the pharmaceutical industry immediately after leaving the agency, for whose supervision and control he was previously responsible was. Lönngren had been responsible for drug approval at EMA for 10 years, so that because of his insider knowledge, a conflict of interest was feared. Five international organizations protested in an open letter to the responsible EU health commissioner, John Dalli , demanding a review of Lönngren's activities. In a press release on March 21, 2011, the EMA's board of directors emphasized that the agency had to make every effort to maintain its good reputation and independence. At the same time, she noted that Lönngren's new activities, where indicated, did not involve any conflicts of interest. The late information from the EMA about Lönngren's new activities was regretted. For two years after leaving the EMA, Lönngren was obliged not to contact any members of the EMA in his new role and not to hold any positions in the pharmaceutical industry that could represent a conflict of interest.

In 2012, the EMA Board of Directors approved revisions to the principles and guidelines for avoiding conflicts of interest. He also approved a procedural regulation which regulates the handling of breach of trust by members of the Board of Directors (“breach-of-trust procedure”) .

Move to Amsterdam

The UK's exit from the EU (“Brexit”) required a relocation of the agency's headquarters, as Great Britain will not remain a member of the EU.

In April 2017, the EMA held an initial information event on the consequences of Brexit. The press release stated: “ Although negotiations on the terms of the UK's departure have not yet officially commenced and one cannot prejudge their outcome, work will now start on the basis of the scenario that foresees that the UK will no longer participate in the work of EMA and the European medicines regulatory system as of 30 March 2019. ”In August 2017, the EMA published a business continuity plan with the aim that the agency would maintain its ability to ensure public health, but with relocation-related activities that did not change have a direct impact on patient safety, such as setting up a web portal with information on all approved drugs.

Vivaldi building in Amsterdam-Zuidas during construction, May 2019
Construction site sign, May 2019

19 applications were received for the new location, in addition to the German-speaking candidates Bonn and Vienna also Amsterdam, Athens, Barcelona, ​​Bratislava, Brussels, Bucharest, Copenhagen, Dublin, Helsinki, Lille, Malta, Milan, Porto, Sofia, Stockholm, Warsaw and Zagreb . The EMA itself emphasized the need for good accessibility of the new location for its visitors, who annually cause around 30,000 hotel overnight stays. Amsterdam ranked first in an employee survey and concerns were expressed about being transferred to a country where same-sex partnerships would not be recognized by EMA employees.

On 20 November 2017, the decision was amended by the General Affairs Council in the Council of the European Union met. All 27 remaining EU members were entitled to vote. Of the 19 candidate cities, only Copenhagen, Milan and Amsterdam made it to the second round. The fact that another agency was not assigned to a new member country and that Bratislava was eliminated in the first round meant that Slovakia abstained in the following rounds. In the second round Copenhagen was eliminated, in the last round there were then 13 votes each for Milan and Amsterdam, so that Amsterdam was finally chosen by drawing lots.

The EMA still has a lease without an exit clause for the building in London until 2039. Until then, a total rent of 347.6 million euros is due, and a British court confirmed the validity of the contractual obligation in early 2019. What made the move more difficult was that the new building in Amsterdam could not be completed on time, so that the move had to be carried out in two stages. In March 2018 the EMA and the Netherlands reached a “Seat Agreement”, and on May 28, 2018 the foundation stone was laid in Amsterdam's Zuidas business district .

On January 25, 2019, the EMA employees took down the 28 EU flags and symbolically said goodbye to their London office, and on March 1, 2019, they left their premises in London. According to a report in The Guardian newspaper, around 900 jobs are being lost in Great Britain, and many employees have moved to the Netherlands with their families.

Operations officially started on March 13, 2019 in Amsterdam , the Netherlands . However, the EMA initially moved into offices in the Spark Building (Orlyplein 24) in the north of Amsterdam, before moving into the newly constructed Vivaldi Building in Zuidas in the south of Amsterdam. The new building was officially handed over to EMA on November 15, 2019, and EMA employees moved there permanently in January 2020. 1,300 workplaces are planned on 18 floors. After moving from London, however, the EMA only had 728 employees, which is why it would not be able to fulfill all tasks on time during the transition period, especially when implementing the new Medical Device Directive ( Directive 93/42 / EEC on medical devices) that will apply from May 2020 ) and there may be delays with questions about the contamination of drugs with nitrosamines .

The expansion of capacities, which became necessary due to the discontinuation of the work carried out by the British Medicines Agency MHRA , is seen as a challenge . The MHRA carried about 20 percent of the workload in the EMA's scientific committees.

As a small side effect of the move, the opening and contact times of the EMA as well as the deadlines for submission had to be changed. While these times or deadlines were previously based on UTC , CET is decisive with the move .

See also

Web links

Wiktionary: European Medicines Agency  - explanations of meanings, word origins, synonyms, translations

Individual evidence

  1. ↑ a b First General Report on the Activities of the European Agency for the Evaluation of Medicinal Products (PDF; 158 kB), January 15, 1996.
  2. ↑ Regulation (EEC) No. 2309/93 of the Council of July 22, 1993 laying down Community procedures for the approval and monitoring of human and veterinary medicinal products and establishing a European Agency for the Evaluation of Medicinal Products , accessed on June 1, 2013
  3. ↑ Regulation (EEC) No. 2309/93 of the Council of July 22, 1993 laying down Community procedures for the authorization and monitoring of human and veterinary medicinal products and the creation of a European Agency for the Evaluation of Medicinal Products in the consolidated version of October 1, 2003 (PDF; 132.79 kB), accessed on June 1, 2013 .
  4. ^ New visual identity, web / e-mail addresses and organization chart of the European Medicines Agency. Communication to all Agency partners, stakeholders and the public ( Memento of the original dated October 12, 2017 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. (PDF) of November 30, 2009; on the website of the European Public Health Alliance (epha) . @1@ 2Template: Webachiv / IABot / v3.epha.org
  5. ^ Visual identity of the European Medicines Agency. December 8, 2009.
  6. ^ Organization Chart of the European Medicines Agency. (PDF; 115 kB) January 13, 2015; Retrieved February 7, 2015.
  7. ↑ Annual Report 2013 (pdf).
  8. ↑ United Kingdom's withdrawal from the European Union , PM EMA of March 29, 2017, accessed on May 11, 2017
  9. ↑ European Medicines Agency: What's next with Guido Rasi? . In: Deutsche Apotheker Zeitung online . December 2, 2014. Retrieved February 7, 2015.
  10. ↑ European Medicines Agency: Rasi returns to his post as Director . In: Deutsche Apotheker Zeitung online . October 2, 2015. Accessed December 8, 2015.
  11. ^ Emer Cooke nominated as new EMA Executive Director . In: EMA Press release . June 25, 2020. Accessed July 6, 2020.
  12. ^ European Medicines Agency - Funding , accessed December 8, 2015.
  13. ↑ a b Heike Korzilius: From Canary Wharf to Zuidas Deutsches Ärzteblatt 2017, Volume 114, Issue 50 of December 15, 2017, Page A-2390
  14. ^ European Medicines Agency - Handling conflicts of interests .
  15. ^ EMA under fire from European Parliament. INPharm, May 13, 2011, accessed September 12, 2012 .
  16. ^ Ex-head of Europe's drug regulator set up consultancy while still in office. corporateeurope.org, December 19, 2011, accessed September 12, 2012 .
  17. ↑ European drug regulator challenged over revolving door case involving former director. (PDF; 215 kB) ISDB , February 25, 2011, accessed on September 12, 2012 (English).
  18. ↑ Open letter to EU Commissioner John Dalli February 24, 2011. (PDF; 345 kB) ALTER-EU, BEUC , EPHA, HAI-Europe, ISDB, accessed on September 12, 2012 (English).
  19. ↑ Activities of former EMA Executive Director Thomas Lönngren. EMA, March 31, 2011, accessed September 12, 2012 .
  20. ↑ Management Board completes framework for conflicts of interests , June 8, 2012.
  21. ↑ Bizarre relocation debate: Brexit would lead to a tug-of-war over the drug agency. In: Frankfurter Allgemeine Zeitung . June 17, 2016, accessed July 30, 2016 .
  22. ^ EMA prepares for Brexit . (PDF) PM EMA, August 1, 2017; accessed on August 10, 2017
  23. ↑ a b B. Sträter: Brexit . Pharm. Ind. 79, No. 6 (2017), pp. 756-757.
  24. ↑ Germany misses out on the awarding of EU authorities. www.welt.de, November 20, 2017, accessed on November 20, 2017 .
  25. ↑ EMA to relocate to Amsterdam, the Netherlands , EMA press release of November 20, 2017.
  26. ↑ Council of the European Union: Relocation of the European Medicines Agency to Amsterdam (Netherlands) Press release 688/17 of November 20, 2017, 6:20 pm, [1]
  27. ↑ Carmen Paun, Sarah Wheaton: Amsterdam's EMA win brings relief to health sector Politico Volume 3, Issue 42 of November 23, 2017, page 12
  28. ↑ EMA press release
  29. ↑ EU agency in London has a lease until 2039. In: Spiegel Online . April 27, 2017. Retrieved May 11, 2017 .
  30. ↑ H. Blasius: No exit from the lease: EMA threatens double rent for 21 years , DAZ.online, February 25, 2019.
  31. ↑ Statement by Executive Director Guido Rasi in The Hague , PM EMA of January 29, 2018, accessed on February 28, 2018
  32. ^ The European Medicines Agency and the Netherlands agree on Seat Agreement , PM EMA, April 24, 2018, accessed May 20, 2018
  33. ↑ Construction of new EMA building in Amsterdam on track , PM EMA of May 29, 2018, accessed on June 22, 2018
  34. ↑ EMA staff lowered the 28 EU flags , EMA Twitter report of January 25, 2019, accessed on January 27, 2019
  35. ↑ EMA closes London office on January 27, 2019. Accessed January 28, 2019.
  36. ↑ EMA now operating from Amsterdam , EMA website, accessed on March 15, 2019
  37. ↑ relocatema.nl , accessed on February 1, 2020.
  38. ↑ Falk Osterloh: More side effects reported Deutsches Ärzteblatt 2019, Volume 116, Issue 48 of November 29, 2019, Page A2228
  39. ↑ Change of time zone due to EMA's relocation in March 2019 , EMA website, accessed on March 15, 2019

Coordinates: 51 ° 30 ′ 13 ″  N , 0 ° 0 ′ 53 ″  W.