Changes in Pharma Licensing- Post Brexit

The UK is one of the world's leading innovators for medical advancements and exporters of pharmaceuticals. In 2015, it was reported that the UK life sciences sector contributed 30 billion pounds to the economy and supported 482,000 jobs. After years of integration between UK and EU supply chains, it was anticipated that Brexit would cause major disruptions. At the beginning of 2021, new medical legislation came into force in the UK as a result of the trade agreement reached between the UK and EU in December last year.


As a result of this legislation, pharmaceutical companies are working on unravelling years of integration between the UK and the EU. This raises concerns for UK-based businesses that hold market licences for thousands of medicines across the EU and how they would be able to continue manufacturing and distribution.


One of the big factors influencing the pharmaceutical industry is the MHRA, UK Medicines and Healthcare products Regulatory Agency, which prepared pharmaceutical companies for the end of the Brexit transition period. This guidance provided rules for; clinical trials, imports and exports, licensing matters, and pharmacovigilance, along with other concerns that surround the industry. This agency will be the sole regulator for medicine and medical devices and the guidance has been implemented domestically as a result of the end of the Brexit transition period.


As a result of this guidance, there have been substantial changes to ensuring that the UK has a steady framework, to functioning with the withdrawal agreements and implementing some policy changes introduced by UK statutory instruments.

Clinical Trials

In relation to clinical trials, it was decided that all sponsors, - responsible people that are chosen by Pharma companies, must be established within the UK, or a country on the approved country list as provided in the guidance. This also includes all EEA states. These chosen sponsors will need to appoint a responsible person to oversee the medicine supply to the UK clinical trials by the end of 2021.


Licencing

Community marketing authorisations, known as CAPS, that were previously authorised by a centralised procedure by the EU, will now be automatically converted to UK marketing authorisations. Existing CAPS within the UK will not have to apply for separate marketing authorisation but would have a period of one year to submit baseline data to the MHRA. Additionally, with non-UK based marketing authorisation holders, these would have to be converted into UK MA through the use of a legal presence or a ‘qualified person’.


The guidance also provides a number of marketing authorisation routes, which are used as a way to prioritise access to new forms of medicine, and evaluate new products and biotechnology being used in the UK. This provides companies with new routes for expedited regulatory approvals between the UK and the EU;

1- An accelerated assessment procedure- this is a 150-day procedure that was created to reduce the amount of time that patients have access to new medicine.

2- A rolling review route- this is to enhance the development of novel medicine, by providing ongoing regulatory feedback which further enables companies to perfect new novel medication.

3- The reliance route- where the UK will adopt medicine authorised by the EU, and has the power to take marketing authorisation decisions of the EU under consideration.

4- Conditional marketing authorisation- this scheme is for products that fulfil where comprehensive clinical data is not yet complete.

5- Exceptional circumstances schemes- available where medicines cannot be provided with a data package, due to the condition being rare or the collection of information surrounding the medication is not supplied or is unethical.


Pharmacovigilance

This is the effects of medicine after they've been approved/licensed for use. From the beginning of the year, UK marketing agency holders would have to be required to operate pharmacovigilance and have a system specifically for UK authorised products. Marketing authorisations would have to have qualified people responsible for this process operating in the EU or in the UK they must have a national contact person who is an operator in the UK. This MA holder has to maintain and make available a pharmacovigilance system for UK authorised products, and would have to be located either at the site within the European Union where the system is being conducted or at the site where the QPPV operates. For marketing authorities that are specific to the UK, this file containing pharmacovigilance has to be accessed electronically and always be available for inspection.


Imports and Exports

With regards to imports and exports of medication from EU countries into the UK, from January 1st 2021, a qualified person would have to be assigned to handle certified medication from the European Economic Area. These medicines will only be accepted into the UK where certain checks are made. They would have to take into consideration whether such medicines were imported and checked by a wholesale dealer in the UK properly and would not require retesting or recertification by the UK.


Existing wholesale dealers would have to notify the MHRA of the company's intention to continue imports of medicinal products from a country in the European Economic Area and would have to nominate a responsible person for imports. This person would then be on the wholesale dealer’s licence and would be able to carry out specific functions. These would have to be within 6-months from January 1st or 2 years from January 1st respectively. This requirement for responsible persons on a wholesale dealers licence will also apply to new licence applications made after the 1st of January.


With regards to preventing Brexit-related medicine shortages, the European medicines agency, along with the European Commission, has been working closely together to minimise the impact of Brexit on the supply of medicines. They have advised companies on applying for and implementing the necessary changes that come with Brexit and enables them to take action early.


The Skills Gap


There's also the issue of skills shortage. The UK would become a less attractive and accessible environment for international medical professionals. This would lead to loss of talent overseas to other countries due to the instability Brexit brings, and we would therefore need to develop national employees with the critical skill-set needed.

Pharma executives would have to be aware of their workers, in the sense of utilising their eagerness to learn the skills needed in this sector. To address the skills gap, organisations can use a tripartite response; scouting, shaping and shifting. This would allow for organisations to identify the skills needed between supply and demand, design a program to close the skills gap and start the process of hiring, reskilling, or upskilling those across the company.


Conclusion

Organisations have to keep track of updates within the pharmaceutical supply chain and make significant changes with regards to conforming to MHRA standards. This requires addressing the skills gap in this sector and taking advantage of technological advances to better their internal practices and the pharmaceutical supply chain. OCI continues to monitor updates in order to fully utilise MHRA standards for our partner companies, and provide better-conformed solutions for our current and future clients.