Brexit red tape set to create weeks of delay for patients awaiting

Pharmaceutical industry leaders have fired a salvo into the Brexit trade talks, warning that patients face weeks of delays in securing vital medicines amid the coronavirus pandemic unless negotiators agree to cut red tape to smooth exports between the UK and the EU.

In a rare joint intervention, ahead of the resumption of trade talks on Tuesday, the bodies representing the UK and European pharma industries called for a “mutual recognition agreement” to ensure tests and inspections on medicines carried out on one side of the English Channel are considered valid on the other, as currently happens through the UK’s membership of the European Medicines Agency.

The processes will otherwise have to be duplicated after the end of the Brexit transition period on December 31, risking delays of up to six weeks in obtaining medicines for patients, the Association of the British Pharmaceutical Industry and the European Federation of Pharmaceutical Industries and Associations told the Financial Times.

The ABPI and the EFPIA also called for proposed regulatory changes to medicines in Northern Ireland to be phased in over the course of a year, saying that just 15 weeks before Britain’s full departure from the EU, the industry was still “in the dark” about how they were to be implemented.

Without further guidance from the UK government and European Commission on how the changes will work in practice, medicines may not be able to be legally dispensed in Northern Ireland from January 1, the trade bodies said.

Richard Torbett, ABPI chief executive, said it was “absolutely inexplicable a mutual recognition agreement for medicines has not been prioritised and cleared up already” by UK and EU negotiators.

He described the changes as technical, involving neither side surrendering leverage during the negotiations on a trade deal.

Mr Torbett also said medicine supply chains were already under strain from coronavirus. Failing to agree a mutual recognition agreement would risk introducing additional delay, complexity and cost.

“That would be asking for trouble — and it beggars belief we are asking for trouble at a time when we have a global health crisis,” he added.

Under the Northern Ireland protocol, designed to avoid a hard border on the island of Ireland after the transition period, medicines there will be subject to EU rules but the regulations are to be enforced by a UK watchdog.

The ABPI and the EFPIA said companies were still unclear how the EU rules will be interpreted and implemented, however, as they try to prepare for the end of the transition period and finalise their supply routes to Northern Ireland.

Mr Torbett said that, for example, it was unclear whether medicines would have to be tested again after reaching Northern Ireland from the EU. “Those facilities don’t exist in Northern Ireland and we’re not clear at all how that would happen,” he added.

Nathalie Moll, the EFPIA director-general, said it was “imperative” that the EU and UK negotiators agreed to both a mutual recognition agreement, and to the phasing in of the application of the Northern Ireland protocol to medicines.

The UK’s Department of Health and Social Care said it was doing everything possible ahead of the end of the transition period “to prepare for all scenarios and protect NHS patients over the coming months”. 

It added that, according to “our contingency plans, we have asked suppliers to stockpile at least six weeks’ worth of medicines, as part of a robust and flexible multi-layered approach”.

However, the ABPI said that, without a mutual recognition agreement, problems would continue long after the stockpile — which only covers the UK — had run out.

Nor was it possible to stockpile every type of medicine, and current global demand for some treatments amid the Covid-19 crisis would only make this more difficult, it added.

The ABPI and the EFPIA underlined the potential economic cost if no mutual agreement on medicines was negotiated, suggesting it would deal a blow to Europe’s pre-eminence in life sciences.

The additional complexity of doing business in the UK and the EU would “mean that investors begin to look elsewhere to set up new medicine research and manufacturing sites”.

The more the EU and UK diverged, the more the US and Asia would benefit, said the ABPI and the EFPIA.

According to their calculations, a trade deal without a mutual recognition agreement would lower EU gross domestic product each year by €1.3bn compared to if one had been finalised. UK GDP would be €2.5bn lower each year.

Pointing to the importance of the pharma industry to the post-Brexit UK economy, Mr Torbett said the country had been “one of the global homes of the pharma industry for many years”, generating exports worth about £23bn a year.

“We are one of the only sectors in the economy talking about growth”, he added.

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