Preparing for Brexit
In the summer of 2016, citizens of the UK voted to withdraw from the EU. Considering the volume of trade, pan-European regulation of medicines and notable contribution of the UK to science, research and development, there are likely to be implications for biopharmaceutical and medical device companies, the contract research organization (CRO) industry and the wider research, regulatory and healthcare communities. In view of the economic importance of the biopharmaceutical industry to Europe and the UK, as well as the potential impact on public health, LabCorp supports the industry-wide position that it is crucial that Brexit does not result in any reduction in patient access to safe and effective medicines. This position is aligned with LabCorp’s mission to improve health and improve lives.
In order to leave sufficient time for approval by the Council of the European Union and both the UK and the European Parliaments before the UK exits the EU on 29 March 2019, the Withdrawal Agreement needs to be negotiated by March 2019. While it is possible that the exit date could be extended, doing so would require the approval of all remaining 28 EU member states.
Source: Association of the British Pharmaceutical Industry (ABPI)
LabCorp is continuously monitoring Brexit developments to understand the impact the UK leaving the EU will have on its organization and its clients; to coordinate its efforts related to Brexit and to develop contingency planning in case of a “hard Brexit” in March 2019. LabCorp has worked closely with industry associations such as the Association of the British Pharmaceutical Industry (ABPI), the European Federation of the Pharmaceutical Industry and Associations (EFPIA), the Association of Clinical Research Organizations (ACRO) and the Food and Drink Federation (FDF) to propose solutions to the challenges of Brexit and to support advocacy efforts.
Aligned with the industry priorities, LabCorp established clear priorities in the following areas:
- Supply chain/trade
- Innovation/tax incentives
The activities undertaken include a survey of Brexit readiness of our suppliers, a full trade analysis and a Brexit-specific plan for UK staff. LabCorp is continuously reviewing and if necessary adapting its Brexit readiness plans as the negotiations between the EU and the UK progress.
LabCorp has a long-standing presence as an employer in the UK through Covance and Chiltern, in providing global drug development services. We are, therefore, very invested in the outcome of the UK’s negotiations with the EU and the country’s creation of its own medicines regulation.
Key Areas of Focus - Example of Activities
EU= European Union
UK= United Kingdom
GDPR= General Data Protection Regulation
CTR= Clinical Trial Regulation
FTAs= Free Trade Agreements
IMP= investigational medicinal product
HBS= Human Biological Sample
AEO= Authorized Economic Operator
LabCorp will continue to be well positioned to offer our clients the services and solutions they need, no matter how Brexit negotiations develop. We are:
- Using an internal task force (with an external law firm in an advisory capacity) to stay abreast of developments and continuously assesses the business risk they pose
- Working directly with industry associations to advocate minimizing the potential impact on the industry to UK government and EU institutions
- Putting action and contingency plans in place, where necessary, to address potential impacts on our business
For More Information
For more information, please contact us at CovanceBrexit@Covance.com.