News

HDA UK Media and Political Bulletin – 26 May 2021

Media Summary

Northern Ireland tensions are inevitable consequence of Brexit, EU chief suggests
Independent, Adam Forrest, 25 May 2021

The Independent reports that on the first day of the EU Council, the European Commission President Ursula von der Leyen said recent tensions in Northern Ireland were a consequence of Brexit.

She said: “If we see problems today we should not forget that they do not come from the protocol but they result from Brexit. That is the reason why the problems are there.”

The Northern Ireland Protocol requires new checks on goods at ports in the province, which has angered unionists who feel Northern Ireland is being separated from the rest of the UK.

While talks are continuing between the EU and the UK to resolve some Protocol issues, both the outgoing Democratic Unionist Party (DUP) leader Arlene Foster and her successor Edwin Poots have demanded it is removed.

European Commission President Ursula von der Leyen added that the Protocol was “the only possible solution” to ensure peace and stability in Northern Ireland while protecting the integrity of the EU’s single market.

“Now, it’s our common duty with the United Kingdom to do whatever we can to reduce tensions in Northern Ireland and that is why we are exploring practical solutions to help to minimise the disruptions to the everyday life in Northern Ireland.”

Industry hustling to ensure supply of recombinant vector COVID-19 vaccines
European Pharmaceutical Review, Hannah Balfour, 25 May 2021

The European Pharmaceutical Review reports that a new study has shown that pharma is working hard to combat the worldwide viral vectors shortage that could threaten the COVID-19 vaccine rollout.

The report shows that biopharmaceutical and pharmaceutical industries are experiencing shortages of viral vectors used in gene therapies and gene-modified cell therapies, as well as certain COVID-19 vaccines – namely, Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and the Janssen COVID-19 Vaccine (sometimes referred to as Johnson & Johnson’s COVID-19 Vaccine).

It is understood that there are currently 14 therapies or vaccines that use a viral vector marketed in the EU, Japan, US and/or UK that could be affected.

Fiona Barry, Associate Editor of GlobalData PharmSource, commented: “We predict that this number will soar in the near future. We anticipate that over 100 more gene therapies and gene-modified cell therapies will be approved over approximately the next six years. These therapies will all need viral vectors and will exacerbate the manufacturing shortage.”

She added: “A second and more immediate stress on the viral vector supply chain is their use in some COVID-19 vaccines, specifically recombinant vector vaccines. AstraZeneca’s and Johnson & Johnson’s vaccines, as well as some COVID-19 vaccines in use in Russia and China, are of this molecule type.”

Three-quarters of pharmacies accessing RTEC
P3 Pharmacy, Pharmacy Magazine, 25 May 2021

P3 Pharmacy reports that the Pharmaceutical Services Negotiating Committee (PSNC) said over three-quarters of pharmacy organisations have now registered to access real time exemption checking.

Data from the NHS Business Services Authority show that a majority of pharmacy organisations have registered for the system, which allows pharmacies to digitally check if patients are eligible for free prescriptions on the NHS.

The PSNC said pharmacies using the RTEC system have saved their staff time and reduced their use of paper, “decreasing the risk of transmission of infection during the COVID-19 pandemic”.

This was also reported by Pharmacy Business.

 Parliamentary Coverage

Written Question – House of Lords, 12 May 2021

Lord McCrea of Magherafelt and Cookstown (Democratic Unionist Party): To ask Her Majesty’s Government what steps they are taking to address the economic impact of the Protocol on Ireland/Northern Ireland.

Written Answer – House of Lords, 25 May 2021

Lord Frost (Conservative): We have provided extensive support for businesses, including through the Trader Support Service and the Movement Assistance Scheme. We have also invested in promoting growth and opportunities in Northern Ireland, including through £500m of funding for the PEACE Plus programme over seven years and through our £400m New Deal for Northern Ireland.

However, we recognise the significant impact that the Protocol has had on businesses in Northern Ireland, despite the extraordinary efforts they have made to adapt to new requirements. Indeed it is hard to see that the way the Protocol is currently operating can be sustainable for long. That is why we are committed to working urgently and in good faith, through the structures of the Withdrawal Agreement, to find pragmatic ways forward on the issues that have been identified. We hope that, in order for those discussions to make the progress we need, there can be a common sense, risk-based, approach from the EU. We continue to consider all our options in meeting our overriding responsibility for sustaining the peace and prosperity of everyone in Northern Ireland.

Full Coverage

 Northern Ireland tensions are inevitable consequence of Brexit, EU chief suggests
Independent, Adam Forrest, 25 May 2021

Recent tensions in Northern Ireland are not a result of the protocol but flow from Brexit itself, the European Commission president Ursula von der Leyen has said.

Protocol arrangements mean a new raft of checks on goods at ports in the province, sparking anger among unionists who feel Northern Ireland is being separated from the rest of the UK.

While talks are continuing between the EU and the UK to resolve some protocol issues, both the outgoing DUP leader Arlene Foster and her successor Edwin Poots have demanded it is scrapped.

The EU chief added: “If we see problems today we should not forget that they do not come from the protocol but they result from Brexit. That is the reason why the problems are there.”

The commission president was speaking following the first day of the EU Council – the first such meeting since the introduction of the EU-UK trade and cooperation agreement at the beginning of May.

Ms Von der Leyen reiterated that the protocol was “the only possible solution” to ensure peace and stability in Northern Ireland while protecting the integrity of the EU’s single market. “The beginnings are not easy,” she added on post-Brexit arrangements.

“Now, it’s our common duty with the United Kingdom to do whatever we can to reduce tensions in Northern Ireland and that is why we are exploring practical solutions to help to minimise the disruptions to the everyday life in Northern Ireland.”

The outgoing leader of the DUP accused the EU chief of having a “tin ear” to concerns about the protocol on Tuesday.

She added: “The fact that there are more checks from Great Britain into Northern Ireland than there are in Rotterdam; that still the European Union and the European Commission have had a tin ear to the concerns and the absolutely genuine concerns of the people in Northern Ireland.”

Boris Johnson’s Brexit minister David Frost suggested last week that the way the protocol was operating was to blame for recent violence and could “undermine the Good Friday Agreement” .

Mr Frost said trading problems in Northern Ireland must be solved before the “turbulence” of marching season in mid-July.

The Brexit deal negotiator also made clear the UK would not strike a new agreement with the EU on food and plant rules to minimise checks, saying: “We are not doing dynamic alignment.”

Industry hustling to ensure supply of recombinant vector COVID-19 vaccines
European Pharmaceutical Review, Hannah Balfour, 25 May 2021

A new report suggests pharma is working hard to combat worldwide viral vectors shortage that could threaten the COVID-19 vaccine rollout.

According to a new report the biopharmaceutical and pharmaceutical industries are experiencing shortages of viral vectors used in gene therapies and gene-modified cell therapies, as well as certain COVID-19 vaccines – namely, Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) and the Janssen COVID-19 Vaccine (sometimes referred to as Johnson & Johnson’s COVID-19 Vaccine).

GlobalData’s report revealed that viral vector production is limited by insufficient manufacturing capacity, an inefficient manufacturing process and the requirement for complex specialist facilities.

The company stated that there are currently 14 therapies or vaccines that use a viral vector marketed in the EU, Japan, US and/or UK that could be affected.

Fiona Barry, Associate Editor of GlobalData PharmSource, commented: “We predict that this number will soar in the near future. We anticipate that over 100 more gene therapies and gene-modified cell therapies will be approved over approximately the next six years. These therapies will all need viral vectors and will exacerbate the manufacturing shortage.

“A second and more immediate stress on the viral vector supply chain is their use in some COVID-19 vaccines, specifically recombinant vector vaccines. AstraZeneca’s and Johnson & Johnson’s vaccines, as well as some COVID-19 vaccines in use in Russia and China, are of this molecule type.”

She added: “The pharmaceutical industry is working to solve this shortage through scaling up facilities and developing more efficient processes. Top contract manufacturing organisations are investing in more sites and the industry is working on increasing the efficiency of viral vector production by improving upstream and downstream processes.”

Although these are not the first or only COVID-19 vaccines to reach the public – messenger [m]RNA vaccines made by Pfizer/BioNTech and Moderna were first to be administered in North America and Europe under Emergency Use Authorizations [EUAs] or equivalent temporary authorisations – there is a significant need for recombinant vector vaccines. Moreover, governments have placed orders for approximately 900 million doses for AstraZeneca’s and Janssen’s COVID-19 vaccines.

On top of the already approved drugs, there are more than 3,000 gene therapies, gene-modified cell therapies and recombinant vector vaccines in the development pipeline.

Barry concluded: “Regulatory changes would also ease the viral vector bottleneck. If agencies approve standardised viral platforms that could be used interchangeably by therapy developers, this would speed up development, approval and technology transfer to [contract manufacturing organisations] CMOs.”

Three-quarters of pharmacies accessing RTEC
P3 Pharmacy, Pharmacy Magazine, 25 May 2021

Over three-quarters of pharmacy organisations have now registered to access real time exemption checking, the PSNC has revealed.

The negotiator said data from the NHS Business Services Authority showed that a majority of pharmacy organisations have registered for the system, which allows pharmacies to digitally check if patients are eligible for free prescriptions on the NHS.

The PSNC said pharmacies that have been using the RTEC system have saved their staff time and reduced their use of paper, “decreasing the risk of transmission of infection during the COVID-19 pandemic”.

“Before RTEC can be activated for an individual pharmacy, the pharmacy contractor must confirm they agree to the terms of the RTEC user agreement,” the PSNC said.

“Contractors can now read the RTEC user agreement and confirm their acceptance of it via an RTEC registration form in the NHS Business Services Authority’s Manage Your Service application.”

HDA UK Media and Political Bulletin – 26 May 2021

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