Novembre 2017 · solo inglese
On 20 November, the General Affairs Council of the European Union will decide in which European city the European Medicines Agency (“EMA”), currently located in London, will be relocated by March 2019 as a consequence of Brexit. Milan is competing to host EMA among other 19 European cities. Hosting EMA would be a great opportunity both for Milan and for the entire pharma sector.
EMA is the European Union’s agency in charge of evaluating applications for European marketing authorization, monitoring the safety of medicines, facilitating access to medicines and providing information to healthcare professionals and consumers. It was established in 1995 in order to harmonize the activities of the national medicine regulatory bodies.
The agency is governed by an independent management board. Day-to-day operations are run by its 900-people staff, currently based in London, under the supervision of an executive director (currently, Mr. Guido Rasi). EMA has seven scientific committees, which are responsible of evaluating different categories of medicines.
EMA plays a major role in the European centralized procedure of marketing authorization of medicines1. EMA is responsible for conducting a scientific assessment over the request of a marketing authorization and issuing a recommendation to the Commission on whether the medicine should be marketed or not.
EMA is also in charge of the pharmacovigilance in the EU, i.e. monitoring the safety of medicines that have been authorized in the EU. EMA develops guidelines and technical standards, coordinates the monitoring of pharma companies' compliance and cooperates in international pharmacovigilance activities with non-EU authorities.
Moreover, EMA (i) promotes early access to medicines (e.g. reducing the review timeframe of an application for marketing authorization for medicines of major public health interest), (ii) grants the status of orphan medicine2 and (iii) provides medicines developers with scientific advice.
EMA is also in charge of publishing information about medicines and their approved uses, including European public assessment reports for every medicine granted with a central marketing authorization.
The selection process agreed upon by the Member States is currently ongoing. If the required majority will not be reached on 20 November, 2017, a second voting round will take place in order to decide among the three most-voted cities. A third round might also be possible if no majority is reached at the second round.
Italian politics and diplomacy have been lobbying hard for the city to host the EMA. Also the business and academic communities – Milan universities, Italian pharmaceutical industries, entrepreneurs’ unions – have strongly engaged in the race, through a series of public initiatives to support Milan’s nomination.
Milan’s candidacy relies on several points: (i) the Pirelli building, which has been offered to host EMA, meets all technical requirements and is ready-to-use. This would ensure a smooth transition and operational continuity. Pirelli building is extremely well positioned, in the very center of Milan and near to its main transportation hub, Milan Centrale train station; (ii) Milan benefits from a strategic geographical position in Europe and from good and efficient connections to main international destinations, mainly thanks to three major airports; (iii) Milan is internationally recognized as a leading center for research, since it hosts some of the most preeminent European universities, hospitals and research centers, (iv) today, Milan is one of the most advanced and economically developed European cities and can offer brilliant career opportunities and high quality of life standards to EMA’s staff and their families; and (v) Milan has a long-standing tradition in the pharmaceutical industry and it is home to leading players of this market.
A European Commission assessment of the candidate cities released in September confirmed that Milan fits all the requirements. Such an assessment – albeit formally neutral – de facto evaluated Milan as one of the best four options, together with Amsterdam, Copenhagen and Stockholm. A recent survey of EMA staff’s preferences produced a similar outcome.
EMA’s relocation would fall within the deep change Milan is currently experiencing: the transformation of the Expo Area through the establishment of the cutting-edge Human Technopole research center and of a new hospital; the building of the Città della Salute hospital complex in Sesto San Giovanni; and the requalification of the hinterland rail yards.
EMA’s relocation to Milan, with its 900-people staff, would have a strong economical impact on the local economy. EMA is estimated to attract millions of dollars in pharmaceutical investments and create a new international base for drug development. EMA’s presence in Milan, combined with the Joint Research Center based nearby in Varese, and the European Food Safety Authority based in Parma, would create a new pharmaceutical scientific pole of primary international significance.
1All medicines in Europe need to be authorized before they are placed on the market. Basically two routes can be followed by the applicant: a national route, which grants the applicant with an authorization for the national market only; or a centralized one, which grants the applicant with a sole authorization, issued by the European Commission, through which the medicine can be marketed throughout the EU Member States and the other European Economic Area countries, i.e. Liechtenstein, Iceland and Norway. The centralized procedure is compulsory for certain categories of medicines, such as those referring to treatment of cancer, diabetes, HIV, AIDS, neurogenerative diseases, medicines derived from biotechnology process and genetic engineering, advanced-therapy medicines, medicines for rare diseases (the so-called orphan medicines) and veterinary medicines for growth or yield enhancement.
2Medicines suitable for being rated as “orphan” are those intended for use against a rare disease or condition, when it is unlikely that marketing of the medicine would generate sufficient returns to justify the investment needed for their development.
La presente Newsletter ha il solo scopo di fornire informazioni di carattere generale. Di conseguenza, non costituisce un parere legale né può in alcun modo considerarsi come sostitutivo di una consulenza legale specifica.