The impact of Brexit on pharmaceutical raw materials testing

Butterworth Laboratories Ltd (BLL) was established in 1974 and has always operated in a UK that has been a member of the EEA/EU; since its foundation, BLL has evolved from its beginnings as an elemental microanalysis laboratory to QC testing to support the pharmaceutical industry

Although finished product testing accounts for approximately 10% of its business, BLL also performs GLP studies and testing to support clinical trials. The majority of its business by far is the GMP testing of raw materials and APIs for clients based in the UK, EU and the rest of the world.

As the testing of raw materials often involves analyses that may be difficult to perform and/or requires expensive equipment that might not be fully utilised elsewhere, it may not be cost-effective for clients to perform these procedures in-house; this is especially true for those companies that may only have to test three or four batches a year.

This type of testing relies on an expert knowledge of chemistry and the various pharmacopeia gained from the experience of performing a variety of tests, for many years, that often only a contract laboratory can offer.

The recent developments resulting from the Brexit situation — and the subsequent uncertainty and lack of clarity — has caused many business sectors throughout the UK and EU alike to become unsettled. Many organisations now have serious concerns regarding the regulatory impact that a no-deal Brexit will have on their businesses.

However, one certainty is that raw material QC testing will not be impacted by the same regulatory restrictions that may be placed on final drug products, post-Brexit, even in the event of a no-deal.

To quote the MHRA: “You only need to name contract laboratories on a manufacturing authorisation if they are performing an inspectable activity.” Contract laboratories only need to be named if they are undertaking the following testing of medicinal products or an investigational medicinal product for human use:

  • microbiological, biological and chemical/physical testing of finished medicinal products
  • stability testing of finished marketed medicinal products
  • environmental monitoring and/or process simulation work for sterile product manufacture
  • biological testing if it needs to be done in accordance with the GMP Guide as described in Annex 2 of EU GMP.

Contract laboratories that undertake all other testing (such as raw material and API testing) or produce research data for products that are not intended to be released onto the market or used in clinical trials do not need to be named on a manufacturing authorisation.

This means that even in the event of a no-deal Brexit, the world of raw material testing will continue as it does today. Clients who currently send raw materials manufactured in the UK, EU or the rest of the world for testing may continue to do so without the need to change anything.

This provides obvious comfort for contract laboratories such as BLL, but should also provide equal levels of security for clients that have established long-term partnerships — based on honesty, trust and reliability — in the services provided by Butterworth Laboratories and its competitors in the analytical chemistry industry.

Thinking ahead

This does not mean to say that BLL has not been doing extensive Brexit planning. Like many businesses, Butterworth has been planning for the worst case, no-deal scenario as this may have an effect on other areas of its business, such as finished product testing.

The recent technical notices and updates from the UK and EU on what will happen to medicines regulation post-Brexit should a no-deal situation be reached have revealed that the MHRA will continue to accept batches of medicines tested and released in EEA/EU countries for distribution into the UK market.

This stance will allow the MHRA to ensure the continuity of supply of vital medicines to the UK. The EU, by contrast, has stated that it will not continue to accept batches of medicines manufactured, tested and released in the UK into the EU single market.

Clearly, this presents a number of issues for final drug product manufacturers based in the UK that release their products into the EU. Do they simply get their products tested in both the UK and the EU? Or does it make more sense to their business model to relocate their site of manufacture to the EU?

The situation regarding the GLP and GCP regulations is a little clearer. BLL has done an assessment on the potential effects of Brexit and is confident that as GLP/GCP are regulated at the national level, nothing of significance should change. In conclusion, the majority of Butterworth’s work should continue as normal, irrespective of whether a no-deal Brexit occurs or not.

Light at the end of the tunnel

There is one great positive to be taken from the current situation, regardless of the outcome of the final deal; the uncertainty created by the referendum result has driven the BLL senior management team to develop some very alternative, disruptive and quite aggressive plans to mitigate any adverse impact.

Although it now seems that these may not be required to mitigate the impact of Brexit, they are not being cast aside … but rather being reassessed for incorporation into an existing 5-year vision.

As a result, this has had a very positive impact on the creative thinking of the leadership team and allowed them to develop some exciting and innovative new projects that otherwise may have been deemed to be too high risk. Ultimately, whatever the future holds, BLL feels confidently prepared to meet the challenges presented by the UK’s departure from the EU with the same high levels of service and expertise as it has done during the last 45 years within the EU.

Butterworth prides itself on forging strong working relationships with its clients. Fundamental to this is an open dialogue and discussion of any issues of concerns our clients might have. If you have any questions about how Brexit might affect your relationship with Butterworth, please contact our Business Development team. As always, we are happy to help.

NB: This article will appear in the March 2019 issue of Manufacturing Chemist. A recent digital edition is available online.

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