Following the Kinapse Brexit Summit, our multinational forum of patient group and biopharmaceutical industry representatives makes four practical recommendations for the UK government, European Commission and EU27 to consider to help ensure the continued well-being of patients across the UK and EU27. The aim: to minimise uncertainty for patients across Europe.
Our recommendations are consistent with the findings of both EFPIA’s 2017 report on ‘Prioritising patient safety and public health across Europe post-Brexit’ and the November 2017 report ‘Public Health and Economic Implications of the United Kingdom Exiting the EU and the Single Market’ commissioned by the ABPI and BIA.
- Harmonisation of medical-scientific data assessment
The existing system for approval of new medicines rests on an objective and apolitical assessment of medical-scientific data. A separation of the UK from the EU27 would add extra costs from duplicating this process and delay access to life-saving medicines for patients. The UK would become a “second wave” country for new drug launches, and other European countries with English language requirements such as Ireland and Malta would be similarly disadvantaged. Maintaining harmonisation of medical-scientific data assessment would thus protect Irish and Maltese as well as British patients.
- Alignment of existing manufacturing standards
Patients in both the UK and EU27 would benefit from continued recognition of each other’s high manufacturing standards, so medicines produced in each geography would be recognised and pre-approved for frictionless travel across the post-Brexit border. As your January 7 article cited above rightly notes, 45 million packs of drug products are shipped from the UK to the EU27 every month, while 37 million packs are transported from the EU27 to the UK, so there is significant benefit to health systems across the EU27 in facilitating this movement of medicines.
- Continued EU-UK collaboration in Pharmacovigilance
Continued UK participation in the European drug safety system EudraVigilance will help protect patients in both the UK and EU27. The UK will benefit from continued access to a vast pool of patient data. The EU27 would also benefit from the data generated by the 66 million people in the UK, as well as the expertise of the many UK pharmacovigilance professionals who have helped make EudraVigilance a success in ensuring patient safety.
- Enabling the exchange of talent and ideas
The UK and EU both currently benefit from the exchange of talent in Life Sciences and across the Healthcare sector. We recommend that the UK government and their EU counterparts seize every opportunity to allow this to continue.
Historically, medical and pharmacological research has been able to transcend borders and politics with the noble goal of delivering life-saving medicines to patients. Brexit does not have to be a reason for that to change.
To read more about Brexit, and how your Life Sciences organisation should prepare for it, download the free thought pieces below.
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The regulatory impact of Brexit on the Life Sciences Industry
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