Change is inevitable no matter what happens so if you are a RP in a small wholesaler or one of many in a quality department I would expect you to be considering the different scenarios and how they might affect you personally, your team and your company. It is over seven months since the British public voted “Out “and that they no longer wished to be part of the EU. But what does this mean? We have heard of “Hard” and “Soft “Brexit but what does this mean to the lay public or to us as wholesalers or RPs? What will happen to the free market and to immigration? Where do we now buy, or sell out medicines and will we be able to keep our staff?
It is not a simple solution, it is very complex and not all the knock-on scenarios were explained to the public at the time nor are they completely clear now! However, what is sure is that change is about to happen and standing still is not an option. Brexit will impact on governance, assurance, commerce and quality. RPs and QAs should be considering the consequences, the risks and what mitigating steps are required and when. It would be prudent to sit round the table with the commercials teams and directors to discuss what steps are required once Article 50 of the Lisbon Treaty is triggered.
RPs should take time out to consider the different scenarios and what each will mean for the company. They should assess their teams and ensure they are fit for purpose. Do they have the right skills and training? The Quality system should be reviewed, does it have all the necessary processes in place.
Reviews of these assessments should be triggering debates, stimulating discussions and possibly arguments. Do we need to change our policy or some processes, what will our future strategy be? Do we have the budget to make these changes? What will affect our reputation? How can we maintain our margins and ensure we hit our future budgets?
The thoughts of all the staff should be captured, evidence gathered where possible so that all risks can be assessed. Mitigating steps need to be defined and if not taken, then the thought process needs to be recorded. Assumptions should be tested and if they are proven to be incorrect then they should be revisited. You need to be nimble and ready for all eventualities.
RPs and the Quality team are well placed to guide the company into safe waters, they have visibility of all departments and they also capture commercial risks. They can affect change in a controlled and safe manner.
These negotiations may well strengthen relationships within the company and prevent silo working.
What is hoped is that triggering Article 50 will help the UK to strengthen relationships with the rest of the world and there are many scenarios but the main forerunners are:-
- EU and UK will have less robust trade deals
- The UK and USA will have stronger trade deals
- The UK and the rest of the world will have stronger trade deals
- Different countries will form better relations
- Major cities across the world will develop better relations.
All medicine wholesalers must be ready for all eventualities and ensure that they can maintain a safe and secure supply chain, which may have to be global.
The MHRA have trained their inspectors in many more aspects of Export. They are gearing up for more export and to ensure that we are all doing it properly.
Procurement teams must be more mindful of the fluctuations in currency to ensure that maintain their margins in a fickle market. They must talk to their logistics suppliers to ensure the products are shipped in a compliant manner and at an affordable cost. Cultural differences must be considered and standards in different countries must be investigated.
It took 19 years to develop the new GDP guidelines as we know them today and it will be a great shame to throw them away with an uncertainty of what will replace them. It will take time for the dust to settle but RPs and QAs must be prepared and start to plan now as their role has never been more important.