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Pharma Supply Chain Urged to Plan for All Brexit Scenarios as Some Start Stockpiling Medicines

on Wednesday, 08 August 2018.

There continues to be different messages coming out of the Brexit negotiations for the pharma supply chain to digest.

The UK Government's Chequers plan and White Paper in July was widely praised by many in the pharma industry, who saw it as a big step in the right direction in terms of maintaining regulatory alignment with the European Union, and notably a unilateral statement of intent to work with and accept the rules of the European Medicines Agency. The offer also included a desire to contribute towards the EMA's costs, and mutual recognition of qualified persons and qualified persons for pharmacovigilance in each territory and the regulatory experts at the Medicines and Healthcare products Regulatory Agency.

Despite the positivity around the Chequers White Paper, there remains uncertainty over the whole of the Brexit process, including what happens to medicines and the pharma industry. The European Commission has said that it is closely considering the UK's proposals, but there has been no open embracement of the UK Government's plans by Michel Barnier, the lead negotiator. Meanwhile, Liam Fox, the UK Government's International Trade Secretary, has put the chances of crashing out of the EU without any deal as greater than 50/50. And the UK Government is still in a precarious position politically, particularly after the high-profile departures of senior ministers involved with Brexit, David Davis and Boris Johnson.

So, with all this going on, the UK pharma supply chain can try to be optimistic and hope for the best, but they must plan for all scenarios.

Sanofi, one of the largest insulin suppliers, has been stockpiling its insulin drugs in the UK in case of a no-deal Brexit. It has been building up its stocks of medicines to 14 weeks' supply from its previous level of 10 weeks. Hugo Fry, Sanofi UK's MD, said it was making arrangements for additional warehouse capacity to stockpile products and ensure patient safety. He said, "From the first day of Brexit, our obligation is to ensure that we can continue to supply our medicines to all patients who need them both in the UK and across the EU. In the absence of any transition agreement, the European Medicines Agency (EMA) will deem the UK to be a 'third country'."

The Chair of the MHRA, Sir Mike Rawlins, highlighted that this issue has got the attention at the highest level. "We make no insulin in the UK," he said. "We import every drop of it. You can't transport insulin around ordinarily because it must be temperature-controlled. And there are 3.5 million people [with diabetes, some of whom] rely on insulin, not least the prime minister."

Sanofi is not the only player in this position. Pascal Soriot, the Chief Executive of AstraZeneca, has called for more progress in talks to avoid a no-deal, and said his company was also increasing its stores of medicines. It is increasing its medicine inventory in the UK from three months' supply to four. He said, "We are doing all we can to make sure patients don't run out of medicines. But all parties need to find a way to negotiate with the EU to clarify things."

Meanwhile, Matt Hancock, the new Health Secretary, has confirmed that the Department of Health and Social Care was looking at options for stockpiling to prepare for a no-deal Brexit, and discussing the position with industry.

The British Medical Association has also reported that Simon Stevens, the NHS Chief Executive, has revealed that there are plans to ensure continued supply of drugs and medical equipment in the event of no-deal. In addition to medicines and vaccines, the Government is investigating the stockpile of medical devices, clinical consumables and blood products.

Community pharmacists are concerned where this could leave them if they are going to be asked to stockpile medicines. Ash Soni, the President of the Royal Pharmaceutical Society (RPS), has warned that small community pharmacies cannot afford to purchase and store large amounts of medicines on behalf of the NHS in advance, and it would be unfair to expect them to do so. There would also be an issue of where to store the extra medicines, some of which have a short shelf life, and whether it would be necessary to obtain new fridges and space. He said, "If the NHS wants to stockpile medicines, it should take the responsibility to make sure they're paid for."

The issues are not just for the UK, but the European Union too. It is estimated that 45 million packs of medicine are exported to the EU from the UK each month, with 37 million packs going the other way. The EU is exposed to shortages of medicines, claims Martin Sawer, the Executive Director of the Healthcare Distribution Association. "The UK exports more packs than it imports - there is trade both ways, so it's important that there is alignment in the market," Mr Sawer said. He added, "Companies are putting extra medicines into the UK already in buffer stocks. The essential medicines, the Government buys and stores them, but that's not the case here. The supply chain would have to sort it out. Pharmacies need to be told about the plans as soon as possible."

Community pharmacy has organised a forum to discuss Brexit issues, with the Chief Executives of all the major pharmacy representative bodies coming together through the Pharmaceutical Services Negotiating Committee, to hold internal discussions to identify relevant issues and concerns that Brexit may present. The forum will provide a platform for stakeholders to share thoughts and compile advice for community pharmacy teams. The members of the forum joining the PSNC include the National Pharmacy Association, the Company Chemists’ Association, the Association of Independent Multiple pharmacies, the RPS, the Pharmacists’ Defence Association, the Dispensing Doctors Association and the HDA.

Comment

These comments from right across the pharma supply chain chime with what we are hearing from clients and what was said at the annual PING event in June, which was on Brexit this year. At the packed PING event, the NSF's Dr Pete Gough gave some practical insight into what pharma businesses should be doing to prepare now.

I hope that a sensible outcome is reached where there is a deal between the UK Government and the European Commission that ultimately benefits patients and players within the pharma supply chain. I want to see the EMA and MHRA continuing to work together, with continued ease of access to medicines and to regulatory talent. I feel that that is in the interests of pharma businesses and patients in both the UK and the rest of Europe. A sensible deal is now on the table from the UK Government, and I hope that the EU will take that up.

However, in the meantime, the whole of the pharma supply chain needs clarity as to what to do, and take steps to plan and seek reassurances of planning for all scenarios. Time is getting short. Everyone's first priority must be to protect patients. Pharma suppliers should be taking contingency planning for all scenarios. At the other end of the supply chain, pharmacies need help - if the Government would like the pharmacies to stockpile for the NHS, they should be given fair recompense to do so.


If you have any thoughts or questions around the issues affecting the pharma supply chain in light of Brexit, please contact Paul Gershlick in our Pharmaceuticals and Life Sciences team on 01923 919 320.

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