Ministry of Foreign Affairs of the Italian Republic

08/03/2017 | Press release | Distributed by Public on 08/03/2017 04:32

Articolo di “The Lancet” sull’Agenzia europea del farmaco

Offline: Medicines leadership-Britain's loss, Europe's gain (The Lancet)

Richard Horton

The shadow of Brexit continues to darken. One consequence is the loss of the European Medicines Agency (EMA) from London to continental Europe. The EMA, together with the European Banking Authority (EBA), is one of the prized institutions of the European Union. It is responsible for evaluating medicines use across 28 member states. It provides a single route for the authorisation of new medicines, avoiding the duplication of separate member-state approvals. Since its inception in 1995, the EMA has authorised over 1000 products. It employs 900 staff, and attracts 36 000 experts each year, including 4000 non-EU visitors. It holds more than 500 meetings annually. The concentration of medicines expertise in the UK brings many additional benefits. The EMA enhances Britain's reputation as a scientific centre for drug discovery. It expands the nation's capacity in medicines research-from the epidemiology of drug safety to randomised trials to assess the efficacy of new medicines. And it strengthens the country's global leadership role in medicines regulation. All that will now be lost to Britain.

The deadline for applications to host the EMA is July 31, 2017. An early leader was Milan. Italy has a distinguished reputation in basic science (consider, for example, the international standing of the Mario Negri Institute for Pharmacological Research). It has built formidable clinical trial networks (eg, the GISSI studies into survival after myocardial infarction). And Italy has produced some of the most creative life scientists of modern times, from Rita Levi-Montalcini (who discovered nerve growth factor; Nobel laureate, 1986) to Mario Capecchi (who pioneered the use of knockout mice; Nobel laureate, 2007). Italian clinical scientists have made important contributions to medicines regulation. Silvio Garattini, who co-founded the Mario Negri Institute, was one of the most radically engaged members of the EMA's Committee for Proprietary Medicinal Products. But the prospect of attracting such a jewel in the European crown has inevitably led to a rush of competitors. 16 countries have declared an interest in hosting the EMA. The slew of cities in the running is a compendium of European urban chic-Amsterdam, Barcelona, Copenhagen, Dublin, Lille, Lisbon, and Stockholm. But there is a contender that could beat all of these candidates: Bratislava, the capital of Slovakia. In February, Slovakia's Minister of Foreign and European Affairs indicated that his country had 'ambitions to host the EMA'. In April, Prime Minister Fico wrote to the Presidents of the European Council (Donald Tusk) and European Commission (Jean-Claude Juncker) to notify them formally of Bratislava's application. Slovakia is the only country from central Europe not to host a European institution. But how will this decision be made?

The new EMA has to be up and running by April 1, 2019. On June 22, the EU published its 'Procedure leading up to a decision on the relocation of the European Medicines Agency and the European Banking Authority.' It set out six criteria. First, 'The assurance that the agency can be set up on site and take up its functions at the date of the United Kingdom's withdrawal from the Union'. Second, 'The accessibility of the location'. Third, 'The existence of adequate education facilities for the children of agency staff'. Fourth, 'Appropriate access to the labour market, social security, and medical care for both children and spouses'. Fifth, 'Business continuity'. And finally, 'Geographical spread'. The European Commission will publish an analysis of candidate cities in September. A debate will follow in October, with a vote in November. But the decision will not be technical. It will be political. There is already strong suspicion that a deal has been struck. Could it be true, for example, that Angela Merkel has agreed to support Bratislava in return for the EBA being housed in Frankfurt? There is, perhaps, one further consideration. Italy has been on the front-line of humanitarian efforts to help the tens of thousands of refugees flowing into Europe. It has done so with compassion and commitment, while many EU nations have refused to offer comparable assistance. Prime Minister Fico has said that, 'Islam has no place in Slovakia'. The Slovakian Government has taken legal action to block the EU's refugee quotas for the country. It would be scandalous for the EU to reward Slovakia with the EMA given its racist immigration policies. Italy deserves more serious consideration, on moral as well as medical grounds.