IPEC e-newsletter - Excipients Insight June/July 2016 - 31-07-16


Inside this issue


Impact of the EU referendum on pharma still unclear

The European pharmaceutical industry faces a prolonged period of uncertainty in the wake of the UK referendum vote on EU membership, with the future location of the European Medicines Agency (EMA) high on the list of questions raised by the leave vote.

As the EMA is located in London, Brexit means that the agency will likely be relocated to an EU member state, with Italy and Spain the latest candidates to throw their hats into the ring. At the moment around 890 staff work at the EMA's building in Canary Wharf.

For its part, the EMA has tried to soothe anxieties, issuing a statement earlier this month insisting that its "procedures and work streams are not affected by the outcome of the referendum". The regulatory authority added that will "continue ... operations as usual, in accordance with the timelines set by its rules and regulations."

On the issue of the EMA's location, it said this would be agreed among the remaining EU member states.

"We are confident that the member states will take the most appropriate decision on EMA's location and arrangements in due course, taking also into account the complex political and legal environment generated by the outcome of the UK referendum," said the agency.

The location of the EMA has grabbed the headlines, but there are other important implications for the pharma industry aside from the effect Brexit will have on the economy.

The Unified Patent Court - which was due to be sited in London - will almost certainly now be located elsewhere and the implications on intellectual property are unclear. Moreover, it remains to be seen for example whether the UK will continue to operate within the parameters laid out by the EMA or the national regulator - the Medicines and Healthcare products Regulatory Agency (MHRA) - will take a different path.

Sir Andrew Witty, the chief executive of GlaxoSmithKline (GSK) - has said he can see positives and negatives associated with both scenarios including the possibility that new drugs could be made available to patients more quickly by an independent authority. GSK has just affirmed its commitment to the UK with as £275m investment programme in manufacturing sites.

For its part, the MHRA has said it will continue to focus on its public health role, but a critical question will be how the EMA and MHRA will work together on foreign and domestic manufacturing and clinical trial site inspections, amongst other functions.

"Working closely with government we will consider the implications for the work of the Agency. We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research," the MHRA said.

There are also fears that a separate regulatory system could push the UK to the back of the queue for new medicines if pharma companies prioritise EU regulatory filings, affect the position of the UK as a hub for clinical trials, and undermine UK science by denying researchers access to EU funding.

Meanwhile, Brexit raises questions about parallel trade and the free movement of goods between the UK and continental Europe, according to Sir Andrew, who said around a third of all GSK products sold in the UK market are re-imports. If parallel trade ends there will be a net benefit to GSK but consequences for the National Health Service, he added.

With so much uncertainty, it will be important for the UK government to move swiftly on regulatory alignment - whatever form it will take - and maintain a stable business environment for pharma manufacturers and their suppliers.

Government officials and industry leaders have set up a task force to address regulatory and other problems facing the pharmaceutical sector in the wake of the referendum.




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