Wholesalers also affected by pregabalin ‘market shock’
Chemist and Druggist, Annabelle Collins, 7 August 2017

Both wholesalers and pharmacists have been hit by the price changes affecting pregabalin, the Healthcare Distributors Association has said. Pregabalin has entered category M, two months after the NHS announced in could be prescribed “in accordance with normal practice”. Contractors have told C+D that they are being ‘forced’ to pay up to £20 for the drug from wholesalers, even though it ranges between £1.87 to £4.17 per pack. In response, HDA executive director Martin Sawer said “Not only will pharmacists be losing out in the short term, but so will wholesalers, as the market adjusts.” At the moment, there is a shortage of the pregabalin molecule, which will hopefully be rectified in the next few months.

Brexit relocation of EU medicines regulator ‘will hit UK researchers hard’
The Guardian, Daniel Boffey, 8 August 2017

Two of the UK’s foremost research institutions, the Veterinary Medicines Department (VMD) and the Medicines Health and Regulatory Agency (MHRA) are set to lose out quite substantially in the relocation of the EMA. The MHRA currently receives about 20 to 30% of the EMA regulatory and research work, known as “licensing and vigilance work”. The UK government has said it expects to maintain “a close working partnership” in medical regulation, but what is clear is that Amsterdam has made quite a persuasive case for EMA relocation. As the Dutch PM, Mark Rutte said, “We are not that different… we also have a very stylish Queen and enjoy fish and chips. Besides our grasp of your language is outstanding.” 19 countries have applied to host the EMA.

Medicines watchdog warns leaving EU is threat to health
The Times, Caroline Wheeler, 6 August 2017

The MHRA has warned that leaving the EU could “impact on the ability of the agency to undertake its public health protection role”. Currently, the EU provides a third of MHRA income. Experts already fear that leaving the EU could mean that UK citizens have to wait an extra two years for drug approval, but the MHRA recent warnings compound uncertainty. The Department of Health responded to the announcement by stating that “we continue to play a full role in the EU medicines regulatory framework, and we will work closely with our European counterparts to ensure continued cooperation, in the best interests of business, citizens and patients across the EU and the UK.” The MHRA noted that such cooperation needed to find a successor regime, once the terms of Brexit are fully negotiated.


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Brexit relocation of EU medicines regulator ‘will hit UK researchers hard’
The Guardian, Daniel Boffey, 8 August 2017

Two of the UK’s foremost research organisations will lose much of their business to Amsterdam if the city is successful in securing the relocation of the EU’s medicines regulator, the Netherlands’ formal bid for the prized agency claims.

Amsterdam, which has been tipped as an early favourite to secure the European Medicines Agency (EMA), says in its application submitted to the European commission that losing the agency will prove a double blow to London when Brexit forces its move.

“The relocation of the agency will have considerable impact, not only because it has to move its headquarters and personnel, but also because the relationship with the UK Medicines Health and Regulatory Agency [MHRA] will change and potential risks need to be minimised in the event of a hard Brexit”, the document says.

The MHRA, which regulates UK medicines and healthcare products, enjoys a lucrative relationship with the EMA, for which it currently carries out between 20% and 30% of the vigilance and licensing work the agency is responsible for. The Amsterdam bid says this could change after Brexit and that the Netherlandswas well-placed to provide an alternatives.

“Brexit will not only result in the relocation of EMA to another EU member state, but also very likely in a dramatic reduction, or withdrawal, of the work of the MHRA and the Veterinary Medicines Department [VMD] in the assessment of medicinal products for human and veterinary use.

“The MHRA and VMD currently also provide various services to the agency, including scientific support and [small] research assignments, regulatory advice to EMA experts and the uptake of unclaimed scientific procedures. The Dutch Medicines Evaluation Board is able to provide a similar level of service to EMA in the event of its relocation to the Netherlands.”

Nineteen countries have lodged official applications to host the EMA once the UK leaves the bloc in March 2019. A decision on the winner will be made in November.

A spokesman for the MHRA said it did not necessarily believe the work it currently carried out would be lost post-Brexit.

“We currently lead between 20% and 35% of the EMA’s licensing and vigilance work. However, the outcome of the negotiations are currently unknown and the final location of the EMA will not necessarily led to a direct transfer of the scale of that work.

“On 4 July the UK government gave a clear, public statement of its desire to retain a close working partnership in respect of medicines regulation after the UK leaves the EU, in the interests of public health and safety. The question of the scale of that arrangement remains open to discussion.”

The EMA and the European Banking Authority (EBA), both based in Canary Wharf, east London, offer prestige to their host and an influx of high-spending officials and experts on visits.

Britain has been given no option on retaining the organisations, which employ about 1,000 staff, despite some demurring by the Brexit secretary, David Davis. The British government is expected to stump up the bill for the removal costs.

Amsterdam’s bid, fronted by its prime minister, Mark Rutte, made much of the similarities between the UK and the Netherlands in a tongue-in-cheek video accompanying its application. “We are not that different,” the narrator of its official video says. “We also have a very stylish Queen and enjoy fish and chips. Besides our grasp of your language is outstanding.”


From Factory to Pharmacy

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