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European drugs' industry says mutual recognition agreement with UK is vital

by Peter O'Donnell
BRUSSELS, 19 June (APM) - Fear of the combined consequences of a no deal Brexit and an ongoing pandemic has impelled the heads of six European health industry associations to appeal to EU leaders to at least secure a mutual recognition agreement with the UK covering their products.
A mutual recognition agreement (MRA) could cover batch and import testing by manufacturers and official medicines control laboratories, as well as inspections based on global good manufacturing practice standards and CE-marking of medical devices and technologies, they say in a just-released letter dated 17 June, addressed to the presidents of the European Commission, the Council and the European Parliament, as well as to trade commissioner Phil Hogan and the EU's negotiator with the UK, Michel Barnier.
It could also ensure simplified and rational rules of origin, based on common, defined chemical, pharmaceutical and biotechnology processing activities, which would permit smooth import clearance processes and avoid disruption in the delivery of sensitive goods.

Deadlines and disease

"We appreciate your efforts to constructively negotiate with the UK to come to an EU-UK agreement," they write, adding they are "extremely concerned about the lack of progress with only six months until the end of the transition period, which could lead to a failure to reach a negotiated outcome".
That would disrupt medicine supply chains, cause delays in access to medicines for both EU and UK patients and, in the long term, reduce the competitiveness of the EU and UK life science hubs vis-à-vis the U.S., Japan and China.
In addition to Brexit, Covid-19 has underlined the importance of global medicine supply chains, says the letter.
"The crisis has highlighted the need for closer international health collaboration and dialogue and the need for governments to work together with industry to ensure a resilient health sector and medicine supply chains."
Failing to agree key medicine provisions, such as an MRA, will introduce unnecessary uncertainty and divert resources at a time when governments and industry need to fully focus on finding a solution to end this pandemic.

Cooperation

"It is crucial to ensure as much cooperation as possible with regard to regulatory processes and the import and export of medicines and medical supplies across UK/EU borders," says the industry letter, urging EU leaders to "prioritise health and patients' access to medicines in the EU-UK negotiations and shield them from larger political considerations."
An MRA and regulatory cooperation could be negotiated outside of the political trade talks, in a close dialogue between the respective regulatory authorities, it claims.
It cites the TTIP negotiations between the EU and the U.S., when FDA and EMA engaged in a direct dialogue and closed an MRA outside of the TTIP negotiations, despite the fact that the TTIP talks themselves were never concluded.
"We hope that you are able to eliminate additional complexities and favour cooperation and close dialogue, based on international definitions," say the heads of Medicines for Europe, EFPIA, Eucope, AESGP, Europabio and Vaccines Europe.
The pharmaceutical and biotechnology industries "need the support of the European Union to ensure that we can fulfil our promise to the patients who we serve".
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