News

HDA UK Media and Political Bulletin – 7 April 2021

Media Summary

Welsh patients to be first in UK to receive Moderna Covid vaccine

The Guardian, Harry Taylor, 7 April 2021

 

The Guardian reports that Welsh patients will be the first in the United Kingdom to receive doses of the Moderna vaccine outside of clinical trials. The rollout of the third approved vaccine for COVID-19 was described as a “significant” addition to Wales’ vaccination campaign by Welsh Health Minister, Vaughan Gething.

 

Scottish authorities are due to begin administering doses of the same vaccine later this week, having received the first delivery of the circa one million doses ordered through the centralised procurement scheme on Monday. According to Vaccines Minister Nadhim Zahawi rollout in England will begin in “the third week of April”. It is unconfirmed when delivery or administration of the Moderna vaccine will begin in Northern Ireland.

 

The first fallout

PharmaTimes Magazine, Stuart Evans, April 2021

 

Writing in the PharmaTimes Magazine, Stuart Evans explores the rising tensions between the European Commission and AstraZeneca as the first major contractual disagreement in cross-border pharmaceutical trade after Brexit.

 

Evans concludes that, as a vaccines dispute, this particular case benefited from being a high-profile issue requiring a workable solution. Factors for consideration for future cross-border pharmaceutical trade include anticipating potential differences in legal interpretation between countries, and the increasing importance of force majeure clauses and dispute resolution processes.

Parliamentary Coverage

New £20 million fund to grow UK life sciences manufacturing opens for applications

Department for Business, Energy and Industrial Strategy, Office for Life Sciences, Nadhim Zahawi MP, and The Rt Hon Kwasi Kwarteng MP, 7 April 2021

 

Applications are now open for the Medicines and Diagnostics Manufacturing Transformation Fund, a new £20 million fund to boost life science manufacturing across the United Kingdom. This fund will provide capital grant funding for investments related to the manufacture of human medicines, medical diagnostics, and MedTech products.

 

The fund is designed to build national healthcare resilience by improving domestic supply chains and creating high value manufacturing jobs in the sector. The deadline for applications to the fund is 30th June 2021, with any awarded funding to be defrayed by March 2022.

 

Full Coverage

Welsh patients to be first in UK to receive Moderna Covid vaccine

The Guardian, Harry Taylor, 7 April 2021

 

Patients in Wales will from Wednesday become the first in the UK to receive the Moderna vaccine as part of a mass vaccination programme, with the first doses in Scotland set to come later this week.

 

The initial jabs would be given at the West Wales general hospital in Carmarthen, the Welsh government said.

 

It added that 5,000 doses of the Moderna vaccine – the third to be approved for use in the UK – had been sent to centres in the Hywel Dda University Health Board area, covering Ceredigion, Pembrokeshire and Carmarthenshire, on Tuesday.

 

It comes as Scotland received its first delivery on Monday, and a spokesperson told the Guardian that the doses would start to be administered later this week.

 

Scotland is set to get more than a million of the 17m jabs ordered by Westminster, with vaccine procurement centralised rather than devolved.

 

England is yet to receive its first batch for general distribution, with vaccines minister Nadhim Zahawi saying on Tuesday it would be rolled out around “the third week of April”. A spokesperson for the Department of Health and Social Care on Tuesday said it would be rolled out “as soon as possible this month”.

 

The Guardian asked the UK, Welsh and Scottish governments for further details about how the vaccine supply had been divided between the four nations – but none were able to provide details.

 

It has not been confirmed when the jab will be received in Northern Ireland and start to be used to vaccinate people there.

 

The Moderna vaccine was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) on 8 January, with phase 3 trials showing it had 94.1% efficacy against Covid, and 100% against severe illness. Like the Pfizer/BioNTech and Oxford/AstraZeneca jabs, it requires two doses for full protection, according to tests.

 

The Welsh health minister, Vaughan Gething, said it was a “significant” addition to the country’s vaccination programme.

 

“Every vaccine given to someone in Wales is a small victory against the virus and we would encourage everyone to go for their vaccine when invited.”

 

Ros Jervis, director of public health for Hywel Dda said: “We are incredibly lucky to have a third vaccine in Wales, with a long shelf-life and the ability to be easily transported, to help deliver the vaccination programme to small clinics across our rural communities.”

 

The health secretary, Matt Hancock, said he was “delighted we can start the UK rollout of the Moderna vaccine in west Wales”.

 

He added: “Three out of every five people across the whole UK have received at least one dose, and today we start with the third approved vaccine. Wherever you live, when you get the call, get the jab.”

 

The first fallout

PharmaTimes Magazine, Stuart Evans, April 2021

 

Taking a look at the recent dispute between the EU Commission and AstraZeneca over the ins and outs of its contract, Stuart Evans, commercial litigation expert and partner at law firm BLM, examines what this could represent for EU/UK cross-border pharma relations.

 

Earlier this year we saw reports of the EU commission and AstraZeneca coming to loggerheads over vaccine roll-out across the bloc. Amidst criticism of the speed of the EU’s vaccine roll-out programme, AstraZeneca reported production problems in its Netherlands and Belgium plants, claiming it as a reason for a shortfall in vaccine delivery to the EU.

 

An initial deal was struck in August 2020 for 300 million doses to be delivered into the EU, post-regulatory approval, with the option for an additional 100 million. Come late January, EU projections showed a potential shortfall of around 75 million doses by March.

 

Amongst growing pressure to speed up its vaccine roll-out, production issues at AstraZeneca’s European plants threatened delivery further. As attention turned to the company’s agreement with the bloc, the EU announced AstraZeneca had been instructed to share doses from its UK plants, though AstraZeneca argued its UK contract prevented this.

 

The EU maintained that its own contract meant AstraZeneca was obliged to send UK-produced supplies to account for a shortfall within the EU. Commission President Ursula von der Leyen claimed the company had “explicitly assured us in this contract that no other obligations would prevent the contract from being fulfilled”, subsequently sharing extracts of its contract with the company.

 

At such a critical time for the industry, with all efforts focused on vaccine delivery, does this row represent one of the first major contractual fall-outs in our post-Brexit world, and what could it mean for cross-border pharma going forward?

 

Contractual conundrum

 

Much attention has been paid to whether the wording of the initial contract was open for debate. The 42-page document, of which portions were redacted, endeavoured to deal with a large and complex transaction for the supply of millions of vaccines across multiple countries. There has been particular focus on the contract’s reference to ‘best reasonable efforts’. Whilst this particular contract is governed by Belgian law and is therefore subject of detailed local advice, English law by comparison also wrestles with the concepts of ‘best endeavours’ and ‘reasonable endeavours’, with the former more stringent than the latter.

 

In broad terms, ‘best endeavours’ requires the responsible party to take all available steps to achieve the desired results, whilst “reasonable endeavours” requires the responsible party to act by reference to what a reasonable person, acting prudently and commercially, could do to get such results. The AstraZeneca contract introduces slightly different wording, ‘best reasonable efforts’, in a lengthy definition for each party, which may fall somewhere between the two. What this means in the particular circumstances of this case is a matter for debate, reflecting the possibility that the parties could not agree on something more specific.

 

Ultimately, should this be one of the issues litigated by the parties in the Belgian courts, interpreting what exactly that term means under Belgian law is likely to tax legal minds and generate vast amounts of argument. And that’s just one provision in a 42-page document.

 

‘Vaccine War’

 

As the debate escalated, the EU Justice Commissioner stated the UK was in danger of starting a ‘vaccine war’ between itself and the 27 members of the bloc, claiming that Brexit had made it clear ‘the UK doesn’t want to show solidarity with anyone’. Setting aside how true that assertion is, what is clear is that Brexit may complicate contractual obligations and litigation as a result of any alleged breach of those obligations.

 

Whilst in this instance, this was a dispute between the EU and a Swedish company, this should be a prompt to pharmaceutical companies to look at their commercial contracts in terms of cross-border trade.

 

For example, given the problems caused by the pandemic, firms should look closely at force majeure clauses, whether doing business with an EU or non-EU counterpart. A force majeure clause typically operates to excuse performance of the contract by one or both parties upon the occurrence of certain events. Force majeure clauses may exclude foreseeable events, even if such events would put performance of a contract beyond the control of a party. The logic being that if an event is foreseeable, the contracting party should allow and provide for it, rather than relying on a force majeure clause.

 

In respect of contracts which might be affected by Brexit-related developments (which again could include contracts with non-EU counterparts), parties should also consider expressly providing for situations in which their ability to perform – or their costs of performing – the contract are affected by Brexit. Parties are wise to remember that their business could be affected not only by their inability to perform a contract, but also non-performance (whether driven by Brexit or otherwise) of businesses elsewhere in their supply chain. A force majeure clause or a so called ‘Brexit’ clause may be helpful in forgiving non-performance were this to occur, but protection from litigation is likely to be small comfort if a wider supply chain collapses. This is aside from the need to be on top of EU procurement and public law issues.

 

If litigation with an EU counterpart does become necessary, we currently find ourselves in a legal grey area. The UK and EU are now in a situation where reciprocal arrangements when dealing with jurisdiction, and the recognition of judgments under the Brussels Recast legislation, are no longer applicable for cases begun in 2021. Until there is a replacement regime that can clearly provide which national courts have jurisdiction in cross-border disputes, and depending on the dispute resolution terms agreed by the parties, it is possible that litigation with an EU counterpart may become more costly and time-consuming, both to get it up and running and then to enforce any judgment.

 

What are the EU’s options for future vaccine disruption?

 

After much back and forth once the contract was made public, the EU and AstraZeneca have now come to a resolution. The company agreed to supply an additional nine million doses by March, and the EU sought to distance itself from the possibility of legal action at this stage. The bloc will no doubt be focused on seeking to regularise the supply of vaccines from AstraZeneca and looking at viable contingency plans, rather than taking a lengthy route through the courts.

 

There is a resolution clause in the contract that requires the parties to go through an informal dispute resolution process, and there is now at least a short term solution focused on a programme of delivery that representatives from both sides have signed up to, possibly leaving important but less pressing contractual issues to another day.

 

Whilst this particular row looks to be resolving, it’s clear that the forces of COVID-19 and Brexit could continue to cause complications in cross-border pharma trade. In the particular race to control COVID-19, people ultimately want vaccines, rather than to hear about contractual wrangling by their respective governing bodies and external contractors, so in these situations there will be pressure on the affected parties to reach a workable solution if that is feasible.

 

New £20 million fund to grow UK life sciences manufacturing opens for applications

Department for Business, Energy and Industrial Strategy, Office for Life Sciences, Nadhim Zahawi MP, and The Rt Hon Kwasi Kwarteng MP, 7 April 2021

 

  • Applications open for new £20 million fund to support the manufacture of medicines, diagnostics and MedTech in the UK
  • fund will boost the UK offer in life sciences manufacturing, creating economic opportunities and highly skilled jobs across the country
  • supports the government’s ambitions to build back better, ensuring greater resilience in UK supply chains

 

Announced last November by the Prime Minister and opening for applications today, the Medicines and Diagnostics Manufacturing Transformation Fund is designed to boost the country’s ability to respond to future pandemics and put UK companies ahead of global competitors.

 

With two-thirds of life science manufacturing jobs already outside London and the South East, the new £20 million fund will also open up economic and investment opportunities for manufacturers across the whole of England, Northern Ireland, Scotland and Wales, improving our domestic supply chains and safeguarding and creating hundreds of highly skilled manufacturing jobs.

 

The UK has one of the strongest and most productive health and life sciences industries globally, with a turnover of £80 billion and supporting 256,000 jobs, underpinned by a powerful research landscape and high-quality science base.

 

Business Secretary Kwasi Kwarteng said:

 

This £20 million investment will harness the best in UK manufacturing and fund cutting-edge medical technologies to protect the British public in 2021 and beyond.

 

This will not only boost the UK’s already strong vaccine and medicine portfolio but support top quality, local jobs across the country and put the UK in a formidable position to continue responding to the most pressing global challenges of our time.

 

Life Sciences Minister Nadhim Zahawi said:

 

Our life sciences sector is world leading and its incredible response to COVID-19 has reminded us of the crucial importance of the sector to the UK.

 

I am thrilled to see this fund opening for applications and would encourage companies to make the most of the opportunity to expand their operations and create good jobs as we build back better from the pandemic.

 

The pandemic has shown the importance of having a strong domestic medicines and diagnostics manufacturing industry. This new fund has been established to grow and strengthen the UK’s capabilities, as well as encouraging companies to deploy new technologies, build new factories and harness new advances, including bioprocessing, data and using greener manufacturing processes.

 

To date, the UK government has invested over £300 million into manufacturing a successful vaccine, and through the work of the Vaccine Taskforce, established in April 2020, facilities across the UK are working at pace to supply the world’s most promising vaccines so far as part of the biggest vaccination programme in NHS history.

 

Today’s announcement forms part of the government’s plans to bolster secure and resilient onshore UK manufacturing capacity, ensuring universal and equitable access to safe, efficacious and affordable vaccines, medicines and diagnostics for this and future pandemics, taking advantage of our world-leading genomics expertise.

HDA UK Media and Political Bulletin – 7 April 2021

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