It is difficult indeed to summarise the hectic situation and the possible out comings of the Brexit procedure, as what we are writing today, December 11th, it might be completely outdated once this newsletter will be published at the end of the month. Yesterday UK Prime Minister Theresa May decided to postpone the vote of the Parliament on the withdrawal agreement negotiated with the EU, and already endorsed on November 25th on the European side during the special meeting of the European Council. Too many contrary votes were expected by PM May, officially attributed mainly to the difficulties to reach a clear agreement on the future management of the Northern Ireland borders. The backstop clause would not have been approved by the Parliament, claimed Theresa May.

All possibilities are open

But the situation is far more complex, just enough to say that the same day PM May made her announcement to postpone the vote, the European Court of Justice ruled the UK can unilaterally cancel the Brexit, without asking permission to the other 27 EU member States and without altering the terms of Britain’s membership to the Union. After the Court decision, the UK government confirmed by now the intention to proceed leaving the EU on 29 March 2019, under the terms of the EU’s Article 50 process.

But the process is very fluid, and as we are writing Theresa May is due to meet with several European leaders and EU officials to further – and urgently – negotiate the agreement. On the other side of the fence, the president of the European Council, Donald Tusk, said the EU would “not renegotiate” but just try to help “facilitate UK ratification“. It’s hard to say how the game will close, all possibilities are open by now, including a new referendum in UK or a “no deal” exit of Britain on 29 March 2019. We will keep readers posted in the new issues of the newsletter, as the date of the Brexit will become closer.

The political base of the withdrawal agreement

The European Council of 25 November also approved the political declaration on the future EU-UK relationship.  “The better deal possible”, according to Prime Minister Theresa May, and very favourable to the EU party. But in Britain many people would have preferred a more clear cut, as proved by the two UK ministers that resigned after the announcement of the withdrawal agreement.
According to the EU’s approved agreement, after 29 March 2019 a new transition phase would begin, extending at least up to 31 December 2020 (but it might be prolonged). Nothing would change at least up to the end of 2020, as UK would continue to follow all EU rules during the transition period in order to negotiate all details and prepare for long term changes.
The future interactions between the EU and Britain, according to the declaration, should be based on an “ambitious, broad, deep and flexible partnership”. Just focusing on science and innovation, being the central pillar of the biopharmaceutical industry, the “intended breadth and depth of the future relationship” should allow UK to continue its participation in Union programmes. “The Parties will also explore the participation of the United Kingdom to the European Research Infrastructure Consortiums (ERICs), subject to the conditions of the Union legal”, states the declaration. The identification of new opportunities of cooperation in science, innovation and education is also foreseen.
The document also recognises the “complex and integrated supply chains” existing between UK and continental Europe. The envisaged economic partnership should be “ambitious, wide-ranging and balanced”, and based on wider sectoral cooperation where it is in the mutual interest of both parties. The creation of a “free trade area, combining deep regulatory and customs cooperation” is expected to facilitate the movements of goods across borders. The declarations states that no tariffs, fees, charges or quantitative restrictions across all sectors should be put in place.
Regulatory aspects, particularly for disciplines on technical barriers to trade (TBT) and sanitary and phyto-sanitary measures (SPS), “should set out common principles in the fields of standardisation, technical regulations, conformity assessment, accreditation, market surveillance, metrology and labelling”. The declaration clearly states that it will be evaluated the possibility of cooperation of UK and EU agencies such as the European Medicines Agency (EMA) and the European Chemicals Agency (ECHA). “In this context, the United Kingdom will consider aligning with Union rules in relevant areas”, says the document, thus opening the door to the conservation of the current regulatory framework for pharmaceuticals.

Comments from the pharmaceutical world

Positive reactions came from the pharmaceutical industry after the endorsement of the Brexit withdrawal agreement by the European Council. EFPIA welcomed the transition period, the reference to the free trade area and the possible cooperation between the respective agencies, including EMA. “Our hope is that the deal is ratified and then immediate and intense focus is given to regulation and supply of medicines in the post-Brexit relationship. We, along with many others in the healthcare community and across the life sciences sector, believe that an explicit commitment to securing long-term, extensive cooperation around the regulation of medicines and medical technologies is in the best interests of patients and public health”, wrote EFPIA in a note.

The Federation of the European Pharmaceutical Industry Association released a new note to comment PM May’s decision to postpone the vote. “A disorderly exit from the EU by the UK has very real and tangible consequences for patient safety and public health in both the UK and across Europe. We hope that politicians in the UK take this into consideration when the vote occurs.”, said EFPIA’s director general, Nathalie Moll. From the pharma industry perspective, the provision of a transition period is critical to provide time for companies to adapt to the new regulatory requirements, manufacturing and supply issues including customs arrangements, as well as to manage the implications for the international staff.

A position paper describing the contingency plan and actions needed in the case of a “no deal” scenario for the Brexit has also been published by EFPIA. Among the main points of the plan shared with the Commission and Member States are the introductions of measures to recognise UK based testing at least until it can be transferred to the EU and to enable the continued UK participation in key data sharing platforms that protect public health and medicines safety. Discussions with relevant authorities are also envisaged to plan fast track lanes or priority routes for medicines into ports and airports. Custom exemptions should also be temporarily provided fort medicines and clinical trial materials, and paperwork and regulatory checks should to be completed away from the physical border. EFPIA also asked that the European Air Safety Authority (EASA) should recognise certificates issued in the UK to ensure that planes can continue to fly. A further discussion should better explore the possible exemption also for active pharmaceutical ingredients (API) and raw materials for medicines from border checks to ensure manufacturing of medicines continues with limited disruption.

The position of the UK pharma industry

The Association of the British Pharmaceutical industry confirmed with a note published after the decision to postpone the vote its commitment to work as closely as possible with the Government on ‘no deal’ planning and continue to look for further guidance on how medicines will be prioritised as new supply routes are put in place. “But we reiterate that a ‘no deal’ Brexit would present very serious challenges and this must be avoided.  Politicians need to find a way through the current impasse and reassure patients that medicines will not be delayed or disrupted come March 2019.”, said ABPI’s chief executive, Mike Thompson. The Association had a positive reaction to the endorsement of the withdrawal agreement made by the European Council, asking to move swiftly to confirm the closest cooperation in regulation and scientific research which will maximise Europe’s ability to compete globally. “Without this, the US and China will continue to attract the major share of new life sciences investment”, said Mike Thompson.

ABPI also commented on UK government contingency plan for a “no deal” exit, asking more details on how to manage the intention to prioritise the flow of medicines and vaccines announced by the government. “Pharmaceutical companies continue to do everything in their power to make sure that patients get access to medicines whatever the Brexit scenario. This includes duplicating processes, changing supply routes and stockpiling medicines in line with the Government’s guidance. However, we have been clear that there are things which are out of our control. Today’s update on potential border delays for six months in a no deal scenario is stark. Stockpiling more medicines is not the solution to this problem“, said Mike Thompson, asking for alternative supply routes between the UK and Europe.

A similar position on the government’s contingency plan has been expressed also by UK’s BioIndustry Association (BIA). “Today’s letter makes clear that the six-week stockpiling activities now need to be supplemented with additional actions. The letter states that there will be significantly reduced access across the shorts straits (Dover/Calais), for up to six months“, said BIA’s CEO Steve Bates. According to him, a ‘no deal’ Brexit would mean the biggest disintegration of the complex regulated medicines market across Europe in terms of regulation, cross border movement of goods, comparative pricing and intellectual property. “On behalf of patients we encourage all participants to be as prepared as possible for a scenario industry really does not want. We should be under no illusions that this will be easy or smooth and today the challenge of ensuring UK medicine supply through 2019 in a No Deal Brexit scenario got harder not easier.”, he added.

The desires of UK stakeholders for the future relationships with the EU have been also explained by a note signed by ABPI, together with the BioIndustry Association (BIA) and the National Health Service (NHS). Preventing fake or fraudulent medicines from entering the legal supply chain, sharing data and ‘signals’ between EU countries that flag potential problems with medicines, preventing and controlling infectious diseases across Europe, and ensuring the safety and supply of almost 1 billion packets of medicines are the main critical areas identified by the coalition. “It is vital that patients are a priority for discussions to ensure public health and patient safety are not negatively affected by Brexit – both day 1 post-Brexit and in the future.”, said BIA CEO, Steve Bates.

Niall Dickson, chief executive of the NHS Confederation, which represents organisations across the healthcare sector, added: “We understand that there is still much detail to be worked out on the future relationship between the UK and the EU, and we are pleased that the withdrawal agreement preserves key safeguards for patients during the implementation period. But we need assurances from the UK and the EU authorities that they will put patients first as they negotiate details of the long-term relationship”