European Commission sees gaps in information in Bulgarian bid to host European Medicines Agency after Brexit

Written by on September 30, 2017 in Bulgaria - Comments Off on European Commission sees gaps in information in Bulgarian bid to host European Medicines Agency after Brexit

The European Commission released on September 30 its assessments of the 19 bids by EU countries to host the European Medicines Agency after Brexit, noting gaps in information in the offer by Bulgaria.

By EU rules, the European Medicines Agency and European Banking will have to be moved out of the UK with Brexit.

EU agencies must be based in the EU. “As the United Kingdom has notified the European Council under Article 50 of the Treaty on European Union of its intention to leave the Union, it is necessary to move the two United Kingdom-based Agencies to other locations within the Union’s territory,” the Commission said.

“Agencies cannot be located outside the territory to which their competences apply,” the EC said. The United Kingdom will have no say when it comes to the location of the EU agencies.

The announcement of the assessments on September 30 did not include a shortlist. The EC said that assessments were made on the basis of information supplied by the bidding countries.

As to Bulgaria, the EC said that the offer to host the European Medicines Agency indicates proposed premises in the Technology + Innovative Network complex (30 000 sq m), to be made available by January 1 2019 at the latest. “The offer does not indicate how these premises fulfil EMA requirements.”

The offer indicates the availability of flights between Sofia and 18 EU capitals, but “does not provide information on the frequency or duration of such flights”.

Bulgaria’s offer does not provide information on the availability of public transportation connections between the proposed location and the airport. The offer confirms the availability of 12 000 hotel rooms at different price levels.

The offer indicates the existence of [Bulgarian language and] foreign-language (German and French) nurseries and schools in Bulgaria, without specifying their availability of places or capacity of linguistic offer, the EC said.

“The offer indicates general plans for the establishment of a European school, without specifying the timing for these plans.

“The offer indicates the existence of foreign-language programmes in English, French and German in Universities, without indicating availability of places. The offer provides additional information on access to state and municipal schools free of charge.”

The EC said that Bulgaria’s offer indicates access to social security and medical care for children and spouses of EMA staff and on the existence of medical establishments in Sofia.

“The offer does not provide information on job opportunities in Sofia.”

The offer does not provide information on the timeframe for ensuring EMA business continuity. The offer refers to EMA’s possibility to recruit new staff from Bulgaria’s talent pool, including from a short list of experts, so as to ensure its smooth transition to the new location.

“The offer does not provide specific information on the ability for EMA to retain staff. The offer does not provide specific information on how the agency would remain operational during the transition.”

Bulgaria’s offer indicates the proposed premises being made available by January 1 2019. The offer does not provide specific information on how the relocation will take place and on how the Agency would remain operational, except for a reference to the establishment of a short list of experts for possible employment by EMA.

The EC said that Bulgaria’s offer does not provide information on the financial terms for EMA’s use of the proposed premises. The offer indicates Bulgaria’s intention to pay 1 year of rent for the proposed premises.

The offer provides general information on the intention to offer special conditions for the maintenance, upgrading and extending of the building, without specifying these conditions.

Bulgaria’s offer does not provide information on special conditions to be offered with regard to costs and dedicated infrastructures, the EC said.

Bulgaria is not hosting any EU decentralised agency, the EC noted.

Among the other 18 countries that bid to host the medicines agency, the Commission also found gaps in information in the offers by Croatia, Finland, France, Germany, Greece, Italy, Malta, Poland, Portugal, Romania, Spain, though in most cases, the list of shortcomings was shorter.

The European Commission said that the European Medicines Agency (EMA) plays an essential role in protecting human and animal health in the EU, by evaluating and supervising human and veterinary medicinal products in the Single Market.

While it does not conduct research itself, the EMA evaluates new medicines before they are authorised in the European Union and monitors their safety. It also stimulates research and innovation by giving scientific advice and guidance to developers of medicines.

On the basis of the Commission’s assessment, the European Council will have a political discussion at the General Affairs Council in October 2017. A final decision on the EMA and the European Banking Agency will be taken at the General Affairs Council in November 2017.

(Aerial photos of Sofia: Boby Dimitrov)

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