Brexit
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Dec
4
Sandeep Singh Dhillon
Brexit impact on UK pharma industry to be investigated – BBC News
Pharma News, Pharma Notables
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By Bill Wilson
Business reporter, BBC News

Brexit may affect the cost of medicines and hit UK pharmaceutical investment, a Commons committee head has warned.
Rachel Reeves, who chairs the Business, Energy and Industrial Strategy (BEIS) committee, says access to new medical products may also be at risk.
She said the uncertainty around Brexit was “very concerning”, as MPs prepare to examine its effects on the industry.
They include the sector’s access to highly skilled workers after the UK leaves the European Union.
Ms Reeves said the evidence MPs had received suggested Brexit could threaten “the cost of medicines, investment in the UK and access to new and innovative research and products”.
“There are serious concerns raised around the future regulation of pharmaceuticals, mutual recognition of medicines, and the prospect of damaging disruption to cross-EU drug supply chains,” she said.
“This is very concerning, with uncertainty risking the UK becoming a less desirable place for investment and development in a growing, productive industry.
“We are keen to examine the detail of these concerns and to hear from the industry what it wants from the government to ensure the smoothest possible transition as we leave the EU.”
Brexit will mean the relocation of the European Medicines Agency from London to Amsterdam.
The MPs’ inquiry comes despite the announcement last week of two big deals in the UK’s pharma sector.
The government said then that the decisions by MSD, known as Merck in North America, and Germany’s Qiagen illustrated confidence in its recently announced industrial strategy for when the UK leaves the EU.
The industrial strategy white paper outlines the government’s plans to support more research and development, encourage firms to embrace new technology and boost the economy.
A report in the Sunday Times said more major investment for the sector is due to be announced soon, with GlaxoSmithKline expected to reveal a new research partnership.
The Business committee has been seeking views from across the sector and has received written submissions from big pharmaceutical companies, trade unions, industry bodies and the government.
The submissions have been published ahead of a public evidence session on Tuesday when the committee will question witnesses from the industry on the impact of Brexit.
It will consider different outcomes relating to future cross-border customs and trading arrangements, and consider what the government should aim to achieve in negotiations.
Those appearing before the committee will include the Association of the British Pharmaceutical Industry (APBI) and Belgian-headquartered Janssen Pharmaceutical, part of US giant Johnson & Johnson.
The ABPI said the inquiry was important.
“The written evidence received by the committee highlights how regulatory cooperation, a frictionless system for trade and access to research funding, collaboration and talent, underpin the successful development and delivery of medicines,” a spokesperson said.
“Evidence also shows that 45 million packs of medicines go from Britain to the EU every month and 37 million come the other way. With this whole system at stake, clarity on medicines regulation and trade is urgently required for all patients across Europe.”

Full article at http://www.bbc.com/news/business-42213937

Mar
6
Sandeep Singh Dhillon
Drugmakers pose Brexit Britain withdrawal risk – Reuters
Pharma Extra, Pharma News
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Neil Unmack

Drugmakers could lump Britain with a withdrawal problem. They aren’t publicly threatening to pull staff out of the UK, as the automotive and financial industries have done. But Britain’s looming exit from the European Union gives them renewed negotiating power – especially after Prime Minister Theresa May’s gushing endorsements of the industry.

Britain’s life sciences sector is a success story. It employs over 100,000 people, and generates 40 billion pounds of sales – and is at the heart of a fuzzy industrial strategy outlined by the Conservative government on Jan. 23. Yet apart from locally listed companies like GSK and AstraZeneca, there’s nothing inherently British about it: global companies can move research and manufacturing easily to other countries.

That might happen. Years of austerity mean the health service is not a big market to sell to. Britain invests less in healthcare than counties like Denmark or Belgium, according to the Organisation for Economic Co-operation and Development. Some clinical trials are already being shifted to other countries more likely to use the drugs, according to one pharmaceutical company executive.

Brexit makes things worse in several ways. Border controls could deprive hospitals of staff, and laboratories of scientists. If Britain can’t persuade Europe’s regulator, the European Medicines Agency, to see it as equivalent, pharma groups might have to undergo a separate process to get drugs licensed – and such a small market would be far down the list of priorities.

The government, which announces its annual budget on March 8, can throw money at the problem. It could buy more innovative high-priced drugs, and make procurement quicker. It could simply give tax breaks to drug companies. Yet Europe may be even less tolerant of aggressive tax practices when the UK has left: it recently clamped down on the so-called “patent box” introduced by the last government.

Paying for drugs is less politically toxic than helping bankers. But in any case, Theresa May could have little choice if they decide to exploit their advantageous position. One of her first moves as leader was to complain that AstraZeneca was almost bought by U.S. group Pfizer, threatening – in words that may come back to haunt her – to defend an “important” sector. She cannot easily go cold turkey.

Jul
27
Sandeep Singh Dhillon
UK Biopharma: Life After Brexit – PharmExec.com
Pharma News, Pharma Notables
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By Paul Ranson

It may come as no surprise that a pre-referendum ‘Brexit” poll conducted by the UK Pharmaceutical Directors Club of senior management within the UK pharmaceutical industry resulted in a vast majority in favour of “Remain” with local management and head offices concerned about the possibility of the UK exiting the European Union (EU) and negative implications for their businesses.

Planning for regulation post-referendum

The EMA and other EU medicinal product organizational and licensing arrangements are restricted to EU and EEA members, so the UK, if outside the EEA, will be excluded.

Indeed, the EMA will, in these circumstances, be expected to move its headquarters out of the UK and relocate in one of the remaining EU countries. Nor will rapporteurs from the UK be accepted.

However, as part of the forthcoming negotiations, it would seem sensible for the UK to agree a Mutual Recognition Agreement — such agreements already exist between the EU and Switzerland, Canada and Australia.

The EMA will certainly regret the loss of the UK competent authority, the Medicines and Healthcare Products Regulatory Agency in so far as it is one of the most respected member state competent authorities and the most used rapporteur under the centralized system and reference member state under the mutual recognition and decentralised systems.

A particular irony is that the new Clinical Trials Regulation which introduces the possibility of a single approval for a pan-EU clinical trial which has been sought after for many years and may now come too late for the UK to benefit. The Regulation will probably come into force in October 2018.

For medical devices, a question arises whether they should retain an authorized representative or manufacturer in the UK? Similarly, should manufacturers continue to use a UK notified body? However, joining the EEA or entering into a mutual recognition agreement under EFTA, could mean that UK-originating devices would still benefit from access to the EU market.

The likelihood of an extended negotiation period means there may be little material change for at least two years and probably substantially longer.  However, before any action is considered, it would be appropriate to identify all applied for or granted marketing authorisations, clinical trial approvals or legal representative status, orphan designations and supply chain licences held by UK affiliates as well as any key regulatory functions performed by them including qualified or responsible persons and siting of databases. For medical devices, one would similarly identify those products for which a UK company is either the manufacturer (CE-marking holder) or the authorised representative and where the selected notified body is based in the UK.

If the UK goes the EEA route, little will need to change, even after Brexit, as all EU rules will apply within the UK wholesale with UK companies able to apply for and hold the requisite approvals and licences. An exception is that MA approvals under the centralised route would need to be nationally implemented as they would not apply automatically in the UK.

Were the UK to go the Swiss route or WTO, much of UK life sciences law is derived from EU law either through Directives implemented nationally in the UK or through EU Regulations which have direct effect. Accordingly, transitional measures could well be brought in to ensure that both the UK implementing laws and the EU Regulations would remain in force until amended or revoked. However, the MHRA would have to transfer marketing authorisation applications for which they are either rapporteur or the reference member state to other member state regulatory authorities.

With goodwill on both sides, an easy solution might be a series of mutual recognition agreements in relation to both medicinal products and medical devices – as UK governance in both sectors is widely respected throughout Europe there is little reason (other than possibly political mischief making) why this would not be achievable. This would be particularly important for the supply chain to ensure importers and manufacturers would be able to release product for EU supply – and vice versa. By way of precedent, Switzerland has an agreement with the EU mutually recognizing GMP licences to facilitate this. It also has a similar agreement leading to mutual recognition of CE-marking for medical devices. Similarly, UK notified bodies can point to existing mechanisms in place for non-EU countries including mutual recognition agreements involving the US, Canada, Australia, Switzerland and Japan.

Whatever way negotiations go, there is an argument for the industry not taking precipitous action as, at worst, any regulatory approvals, licences or functions could be transferred to an affiliate within the EU prior to the effective date of the UK actually leaving the EU. [Ian Hudson, Chief Executive of the MHRA, stresses that the Agency is “open for business as usual in terms of its routine regulatory work whilst the Agency works with the UK Government, industry and other EU and international regulators to consider and take forward the results of the UK referendum.  This continuity is also recognised and endorsed by its EU partners and EMA leadership.”]

Conclusions

As an acknowledged ‘jewel in the crown’ of the UK economy, the new Government will be anxious to mitigate the impact on the UK life sciences sector and will be open to ideas as how to exploit UK industry and research base strengths in a post-EU world.  The life sciences industry therefore has a real opportunity to gain a greater share of voice through a concerted lobbying camping to achieve its aims.