As Brexit draws ever nearer but seemingly without a definite plan or deal in the bag the implications for industry and for the pharmaceutical sector, in particular, could not be more worrying.

Prospects of a shortage of certain medicines including some cancer drugs and even painkillers has prompted companies like AstraZeneca and France’s Ipsen to start increasing stockpiles of drugs in the event of a no-deal Brexit. It is feared that leaving the single market and the EU could lead to stricter border checks and in turn to very real delays in bringing medicines into the UK. The impact on patients who need access to medicines and medical technologies is such a grey area right now that Pharma companies are urging UK politicians to accept Prime Minister Teresa May’s deal. As Nathalie Moll, DG of Pharmaceutical Industries and Associations (PIA) has said: “the deal on the table is infinitely better than leaving without a deal”.

One of the big questions for pharmaceutical companies is this: are they adequately communicating their ‘no deal’ preparations to their corporate customers, investors, staff and the public and could market access consultants help with this?

The Brexit Withdrawal Agreement and Pharma

The pharmaceutical industry has set out what it thinks is best for the continuation of the safe supply of medicines and for patient safety. Simply put, this means frictionless trade between the UK and Europe facilitated by a single set of rules and a role for the UK regulators in managing Europe-wide standards. The good parts of the Withdrawal Agreement, as far as Pharma is concerned, are the transition period, currently up to the end of 2020 with an option to extend to 2022 and protection of the employment and residence rights of EU/EEA/Swiss nationals in the UK.

‘No Deal’ Preparations Urged

European and UK Pharma are calling for urgent action to prevent a risk to public health and ensure patients are able to get access to medications. Representations from the pharmaceutical industry have been made to the Commons Health Committee that patients could stockpile their own medications to tide them over in the event of a ‘no deal’. Actions could include fast track routes into ports and airports and allowing checks and paperwork to be completed away from the border to prevent delays and disruption. Raw materials for medicines and active pharmaceutical ingredients could be exempt from border checks to enable manufacturing to continue.
Another danger comes from the potential disruption to safety testing, development and manufacture of medicines. This could be remedied by the EU recognition of UK-based testing as a temporary measure.

Political Uncertainty Affecting Prices and Availability

According to BBC reports pharmacies are stockpiling generic drugs to avoid a break in supply. Manufacturers are also stockpiling products in response to Government policy should there be a ‘no deal’ Brexit. However, the result of all this is that availability and pricing is already affected. This has led to the Pharmaceutical Services Negotiating Committee along with the Department of Health and Social Care to do their best to ensure a solid six week supply of drugs is maintained.

Although UK pharmacies pay an agreed tariff-set price for generic drugs they can find themselves paying higher prices in times of shortages and increased demand. This has a knock-on effect on the NHS which has to pick up the tab for any price fluctuations caused by a disruption in supply.

The pharmaceutical industry continues to worry about the consequences of a ‘no deal’ Brexit and it has been pointed out to the government that because around 50% of medicines in wholesaler’s depots have been through the EU before they reach the UK the prospect of shortages is very real. Unfortunately, the government continues to be complacent in their reliance on French border checks.