Pink Sheet: global policy and regulatory coverage
By John Davis 31 Mar 2020
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the...
Massimo Scaccabarozzi, president of Italy’s Farmindustria and Janssen Italy’s MD, warns that the EMA could lose almost all of its current staff if it moves to a country they do not want to go to, and has called for a shortlist of candidate countries to be drawn up.
Janssen Italy managing director and Farmindustria president Massimo Scaccabarozzi naturally enough feels the northern Italian city of Milan would be a good choice for the EMA’s future seat. He says it is vital to ensure that the decision, which will be made in November, is based firmly on “objective and valid” criteria. He fears, though, that political bargaining might win the day.
The six criteria on which the new location will be chosen were formally published by the European Council on Jun. 22. As well as five “objective” criteria, such as international connectivity, suitable premises and educational facilities for families of EMA employees, the list includes “geographical spread” – i.e., the need to take account of the fact that some member states do not currently have an EU agency.
Most of these countries are in eastern Europe, and some of those that bid for the EMA – including Bulgaria, Croatia and Slovakia – cited the geographical spread factor when explaining why they should be chosen to host the EMA. By contrast, other member states, such as Belgium, Denmark, Ireland and the Netherlands, said this consideration should apply only in the case of new agencies, not an established one like the EMA where business continuity is paramount. (Also see "Bids For EMA Show East-West Split Over Principle of Fair Spread Of Agencies" - Pink Sheet, 7 Aug, 2017.)
Fears have already been expressed that the geographical criterion could lead to political horse-trading trumping the “objective” criteria, and that the EMA’s ultimate destination will have a bearing on how many employees decide to remain with the agency.
“We must choose a city that meets all the objective criteria” – Massimo Scaccabarozzi, Farmindustria president
A total of 19 countries have formally bid to host the EMA. Scaccabarozzi suggested that many of them stood no chance and had entered the fray simply to be able to withdraw at the voting stage and support a given country, in the expectation of something in return. But the EMA’s future location, he said, had to be chosen on the basis of objective and valid criteria, not by supporting one country in exchange for a “favor”.
In an interview with the Pink Sheet, Scaccabarozzi said that the “geopolitical criterion” should be abandoned so as to guard against the EMA ending up in “a city where nobody from the EMA wants to go.”
If this happened, “800 people” might refuse to move with the EMA, and it would no longer be able to do its work, so “we must choose a city that meets all the objective criteria,” he said. The EMA is a “very, very important agency and it would be a shame if, for non-objective reasons, the EMA should disappear or lose value.”
Similar concerns have been expressed by the EMA itself, which last month said it was planning for “potentially significant” job losses depending on its future location, and that “unexpected higher, faster or more permanent loss of staff as a consequence of the agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.” (Also see "EMA Suspends Some Activities & Warns That High Job Losses Could Halt Its Operations" - Pink Sheet, 2 Aug, 2017.)
Scaccabarozzi suggested that a committee be formed to draw up a shortlist of, say, four or five candidates “based not on political but on objective criteria.” As to how this suggestion might be received at EU level, he said he would like politicians and diplomats from Italy and other countries to push for such a shortlist.
Milan, he believed, would “certainly make it” onto the list because it met all the criteria. It had good air connections, housing and schools, and there was a suitable building ready for the EMA to move straight into.
Other Italian voices have been calling for the decision to be taken on the basis of objective criteria. The president of the European Parliament, Antonio Tajani, recently met with Guido Rasi, executive director of the EMA, to discuss the EMA’s role and the relocation question.
“Choosing the new headquarters of the EMA must be based on objective criteria drawn up at the European level whose aim must be to make its running as economical and efficient as possible, in the interests of our citizens,” Tajani declared, adding: “Some candidate cities fully fulfil the criteria required.”
Tajani went further, claiming that the European Parliament would “ensure that the new headquarters will be chosen with due regard for these objective criteria, in full transparency, in the interests of safeguarding the health of our citizens while promoting innovation.”
Just how the parliament would go about ensuring this happened is unclear, though, given that it has no formal role in the selection procedure, which is now under way after bidding ended on July 31.
The European Commission is currently assessing the 19 bids, and will submit its assessment to the council by Sept. 30 and make it publicly available. The final decision on the EMA’s new location will be taken by the other 27 EU member states, with the vote scheduled to take place in the margins of the General Affairs Council (Article 50) meeting on Nov. 15.
Pink Sheet: global policy and regulatory coverage
By Ian Schofield 31 Mar 2020
As part of its efforts to preserve patient access to medicines amid the COVID-19 pandemic, Russia is planning to cap...
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