Written by Kate Krachai, Director of Quality Context
Recently, I penned some thoughts about the realities of Brexit and the likely impact on the UK pharmaceutical industry. For a short article it provoked quite a reaction.
This topic will continue to dominate professional meetings and symposiums for years to come. What happens as we potentially break away from the Single Market and the Customs Union? As this saga unfolds all eyes will be on our relationship with the European Union. But what about our relationship with the rest of the world? What about our relationship with the United States?
In March the European Union and USA finally agreed a Mutual Recognition Agreement. I will not rehearse what that agreement covers. You can read a summary and answers to questions here. In simple terms it means that the EU and US authorities formally trust each other. It means that if you are inspected by an EU Health Authority you will only receive a visit from the FDA in exceptional circumstances.
What interests me is where does this leave the UK? If or when we leave the European Union we will not be covered by the Agreement. In simple terms, this could very quickly leave the UK industry at a disadvantage. UK companies and suppliers will not have automatic access to EU markets. In the context of the MRA, by leaving the European Union, we will not be covered. Our European colleagues will enjoy the benefits but we will be caught in the mid-Atlantic. Cut off from Europe and not fully integrated with the US regulatory regime.
Many will argue the solution will be to agree our own MRA. This may well be possible but do not expect any agreement quickly. The EU and US have taken 19 years to come to their agreement. Now clearly agreeing our own MRA with the US will not take that time. We will start out with regulatory regimes that are broadly equivalent. That said, do not expect any new MRA to happen overnight.
I will stop there. The rest is purely conjecture. No one can predict precisely the likely outcome of the Brexit negotiations. The key to navigating through these uncertain times is to stick to what our industry knows best. Risk management and quality principles.
Risk management begins with assessing the risks and then having a plan to mitigate the risks. Quality management begins and ends with the requirement for rigour and clear thinking.
It is this clear thinking that is driving our decision-making. We operate a Contract Laboratory and also hold our own MIA and MIA IMP. People have been asking how we see these areas of the business being affected by Brexit. The answer is simple. We do not know precisely but what we do know, is that whatever happens, companies will still need their products testing and releasing in the UK. That will be either involve the UK being a member of the Single Market or not. We also know that the UK remains one of the world’s largest markets for pharmaceutical products, which is why the phone keeps ringing with clients asking about our reliable and cost-effective testing services. This does not mean we are complacent. It means we are focussed on delivering an exceptional service in an increasingly complex world.
In my next article I will be exploring in more detail how we are helping our clients to manage the complexity being triggered by Brexit.