HDA UK Media And Political Bulletin – 13 February 2017

Media Summary

Brexit could delay drug launches, former MHRA chief warns

Pharma Phorum, Richard Staines, 10 February 2017

The former chair of the UK’s drug regulator Sir Alasdair Breckenridge is the latest figure to warn that Brexit could cause delays to new drug launches in the UK.  Breckenridge, who used to head the Medicines and Healthcare products Regulatory Agency (MHRA) said on Radio 4’s Today programme that the comparatively small size of the UK market compared to the EU market, and the extra cost of engaging with a separate regulatory system, could mean that the UK  loses out when the pharmaceuticals industry markets new drugs. Responding to the programme, the Association of the British Pharmaceutical Industry’s executive director – Research Medicine and Innovation, Virginia Acha, said: ‘If we don’t find a way to continue to align the UK regulatory system with the EU through cooperation, patients in the UK and in Europe both face the real risk of disruption and delay’.

Pharmacist and drug associations want better data on medicine shortages

The Pharmaceutical Journal, 6th February 2017

European bodies representing pharmacists, drug manufacturers and distributors are calling for better use of data on medicines shortages. In a joint statement from a number of European associations, it was noted that there exists ‘no universally accepted definition of a medicine shortage in Europe’. Recommendations include compulsory reporting of potential supply disruption for drug firms and collecting more up-to-date information about medicines shortages.

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Brexit could delay drug launches, former MHRA chief warns

Pharma Phorum, Richard Staines, 10 February 2017

The former chair of the UK’s drug regulator Sir Alasdair Breckenridge has become the latest high-profile figure to warn that Brexit could delay launch of new drugs in the UK.

In an interview on Radio 4’s Today programme, Breckenridge backed industry figures who have warned that the likely divorce of the UK’s drugs regulator from the European system could deter pharma companies from launching new medicines in the UK.

Senior figures from regulation, politics and pharma warned in the programme that the government must ensure the UK secures a good deal for drug regulation after Brexit.

The pharma industry, along with public sector and academic partners involved in life sciences, had campaigned for the UK to remain in the EU because of the benefits of the European Medicines Agency (EMA) and its centralised drugs regulation system.

But the EMA looks almost certain to leave its headquarters in London because of Brexit, and the government has indicated that it does not want to remain part of the agency as this would mean staying under the influence of the European Court of Justice.

Breckenridge, who used to head the Medicines and Healthcare products Regulatory Agency (MHRA) said the comparatively small size of the UK market compared to the EU market, and the extra cost of engaging with a separate regulatory system, could mean the country falls down pharma’s list of priorities when marketing new drugs.

Breckenridge said: “Therefore there will be a delay in getting new drugs imported, anti-cancer drugs, anti-infective drugs for patients in the UK.”

“Since there will be a second application, as well as the European application, the cost will be greater.”

And former MHRA chief executive, Sir Kent Woods, warned that public health could suffer if drugs regulation gets dragged into any political fighting over Brexit and the shape of the UK’s trade agreement with the EU.

David Jefferys, senior vice president at Eisai Medical Research, agreed. He said: “The UK will be in the second or third wave, UK patients may be getting medicines 12, 18 or 24 months later than they would if we had remained in the European system.”

Scottish Nationalist MP Philippa Whitford and member of the health select committee added that Theresa May had “looked utterly blank” when she had raised the matter during parliamentary questions.

Whitford raised the matter in parliament last month after health secretary Jeremy Hunt admitted at a committee hearing that he did not expect the UK to remain part of the EMA after Brexit.

Whitford said she feared pharma will see the UK as a “hostile market” because of NICE’s rejection of drugs and Brexit.

Hunt is not on the Brexit cabinet, and Whitford fears that matters such as the health insurance card, and the right of pensioners to have healthcare, will not be on the agenda during negotiations.

Responding to the programme, the Association of the British Pharmaceutical Industry’s executive director – Research Medicine and Innovation, Virginia Acha, said: “If we don’t find a way to continue to align the UK regulatory system with the EU through cooperation, patients in the UK and in Europe both face the real risk of disruption and delay.

“Securing cooperation between the UK’s medicines agency and the EMA is a sensible solution, and we will continue to make the case for an agreement to be reached.”

Pharmacist and drug associations want better data on medicine shortages

The Pharmaceutical Journal, 6th February 2017

European bodies representing pharmacists, drug manufacturers and distributors have issued recommendations on how data on medicines shortages could be better used to mitigate the impact on patients.

“There is no universally accepted definition of a medicine shortage in Europe,” the associations point out, going on to call for an approach in which suspected shortages are flagged, regardless of whether they are already in short supply or apply to single or multi-source products.

The organisations also say that making more up-to-date information about medicines shortages available will improve the ability of health systems to solve supply issues as they arise. This would enable existing stocks to be better managed and distributed and contingency measures deployed, which may involve urgent communication to prescribers, pharmacies and wholesalers and preparation of bespoke out-of-license or magisterial products, to minimise the impact to patient care, they add.

The recommendations were issued in a joint statement from the Association of the European Self-Medication Industry, the European Association of Euro-Pharmaceutical Companies, the European Association of Hospital Pharmacists, the European Industrial Pharmacists Group, the European Federation of Pharmaceutical Industries and Associations, the European Healthcare Distribution Association, Medicines for Europe and the Pharmaceutical Group of the European Union.

The recommendations also say that drug firms are obliged to report potential supply disruption owing to manufacturing/quality issues to the authorities, but information systems should be open to reports from wholesalers, parallel traders, pharmacists and other healthcare professionals.

“Signals of medicine shortages” can then be periodically assessed by a panel of supply chain members to establish if they are suspected or actual shortages, the statement says, adding that access to information on verified shortages should be generally made available to the public, and patient organisations can have a useful role in supporting patients with information and advice.

If the medicine suspected to be in shortage has an alternative (for example, generic substitute or product with same ingredient), the unavailability could still be reported as a suspected shortage, because “wholesalers are not allowed to substitute orders and, in some cases, pharmacists require proof of a shortage in order to enable substitution”.

“This could facilitate the work of pharmacists in finding the appropriate replacement therapy or action, and treatment of patients will not be interrupted,” the statement adds. “Pharmacists, with their knowledge of medicines and products, may be in position to offer training or support to other professionals on the correct selection and use of substituted products.”

From Factory to Pharmacy

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