Pharmacovigilance Science in the UK and Europe in the years to come

Saad Shakir

19th July 2016

The UK has been a major player in medicines regulations in the EU since the establishment of the CPMP in 1975. This contribution increased immensely after the single market was established and the EMEA became operational in 1995.

Medicines Regulation in the UK is regulated by the Medicines Act 1968 and its related legislation as well as by compliance with many EU directives, regulations and guidelines.  Medicinal Licences in the UK are national, approved by mutual recognition in the EU and are centralised European Licences.

The UK scientific and regulatory expertise in the EU regulatory structures are well recognised and highly regarded.UK staff at the MHRA and the large number of experts who are involved in the regulatory process are highly respected by European colleagues.  There is reciprocal respect by UK regulatory and scientific community to their European colleagues.

It is almost unthinkable and certainly against the interest of patients in the UK and in Europe for the UK regulatory and scientific establishment to be detached from Europe.The benefits of maintaining the current partnerships are too important to lose. Whatever the political decisions will be regarding the relationship between the UK and the EU in terms of market access, it will be key to maintain scientific and regulatory collaborations, continued involvement in the decision making process and mutual recognition of scientific efforts. Whether this will be governed by separate treaty or agreement or by any other way is a matter for politicians, but the key point from a scientific and public health prospective is to maintain the partnership between the UK and European countries.