Regulatory alignment and mutual recognition for the manufacture of medicines, needs of the pharmaceutical industry in the face of ‘Brexit’

Pharmaceutical companies are working to ensure seamless access to medicines ahead of the UK’s exit from the EU, due in January
Farmaindustria and the British Embassy organize a new seminar focused on preparations for the end of the transitional period


On December 31, the transitional period marked by the European and British authorities to materialize the departure of the United Kingdom from the European Union (EU) ends. Faced with this reality, the British Embassy in Madrid and Farmaindustria organized a meeting this Wednesday to analyze the most relevant aspects and the processes that still need to be carried out, as well as the needs of the pharmaceutical industry to guarantee access without disruption to medicines for patients Spanish, British and European.

Having the necessary regulatory and alignment and the inclusion of a mutual recognition agreement for correct manufacturing standards are the main demands of pharmaceutical companies to maintain a correct supply of medicines, as highlighted by the CEO of Farmaindustria, Humberto Arnés, at the opening of the seminar.

“It is everyone’s responsibility to guarantee the continuity of treatment for patients,” stressed Arnés. “During this time, we have been able to verify how Brexit can have health consequences, but also economic and biomedical research, at such a crucial time for drug R&D,” he said, referring to the coronavirus pandemic.

It is now about “minimizing damage” – he continued. From this objective of alleviating the impact of Brexit on patients, on the economy and on research, “we are concerned about some things at the time of the negotiations in which we find ourselves. The first and immediate is the possibility that there is no mutual recognition agreement on good manufacturing standards. And this is very important, because the inclusion of an agreement in this area would allow national drug agencies to save significant resources, avoiding duplication, easing efforts in terms of batch release, in terms of inspections of production plants or in analysis import ”, explained the CEO of Farmaindustria.

A second concern of the pharmaceutical sector is that, as of next January, “there will not be sufficient collaboration in border, regulatory or industrial property matters. These aspects are especially relevant for a sector as heavily regulated as ours and where trade flows are so intense ”, he added.

Lastly, “we are also concerned that, less than nine weeks after the UK’s departure from the EU, there are no clear guidelines on regulatory changes on medicines with Northern Ireland. This means that, as of January 1, 2021, the medicines that patients need to deal with their disease from any Member State will not be legally available on the Northern Irish market, ”she explained.

Patients, first concern

In short, in these scarce two months of negotiation, the aim would be to guarantee the continuity of commercial relations to avoid an impact on the health of European citizens and on public health in general. In this sense, Arnés highlighted the great collaboration of the pharmaceutical industry with all the institutions to facilitate said continuity, and the effort of the sector in the face of the challenge posed by the United Kingdom’s departure from the EU, which “has been of high responsibility and commitment , as the contingency plans carried out since March 2019 have shown up to now, the technical adaptation and regulations, not to mention the duplication of production plants or quality control laboratories ”.

“The ultimate goal that the pharmaceutical industry has had during this challenge has been to ensure patient safety and public health. An agreement that contemplates the maximum regulatory convergence and also the maximum scientific collaboration is essential in that desire that in terms of research we do not lose the competitive race that we have with the United States and with Asian countries, “he said.

At this point he recalled the great challenge that Europe faces to regain lost ground in biomedical research. Barely two decades ago, the drugs developed in the United States accounted for 25%, compared to 50% of those developed in the European Union, “and now this proportion has been totally reversed,” he lamented.

The seminar, held under the title Preparations in the pharmaceutical sector before the end of the Transitional Period, is the second organized by the British Embassy and Farmaindustria, as part of the Association’s work to keep its companies informed and facilitate the task of adapt to the new European scenario without the presence of the United Kingdom in the EU. Precisely and in view of the need for Spanish companies to prepare to continue their commercial activity with the United Kingdom as of January 2021, the British Government

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