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HDA UK Media and Political Bulletin – 18 May 2021

Media Summary

Northern Ireland faces ‘huge’ rise in generic medicine prices
Financial Times, Laura Noonan and Sarah Neville, 18 May 2021

The Financial Times reports that generic drugs in Northern Ireland will be significantly more expensive from January. Under the Northern Ireland Protocol, once the Brexit grace period ends in December medicines made in Great Britain will have to be licensed separately for use in Northern Ireland.

Steve Aiken, former leader of the Ulster Unionists Party (UUP), said he has “real concerns” about what will happen once the region has to test and license medicines under the EU, while the rest of the UK implements national standards.

Aiken said that Northern Ireland may no longer be able to get drugs at the “very reasonable prices” secured by the NHS. Aiken questioned “why can’t [the population of Northern Ireland, as British citizens]  have the same opportunities as the rest of the UK has in terms of bulk purchasing?”

Northern Ireland already has some of the longest treatment waiting lists in the UK and its health department recently warned it would need an extra £400m this year on top of its annual £6.5bn “just to stand still”.

The Department of Health and Social Care (DHSC) said Northern Ireland would continue to benefit from price caps on branded medicines under the 2019 voluntary scheme for branded medicines pricing and access between the Government and industry, which limits price rises of branded medicines at 2 per cent a year for five years.

Mark Samuels, British Generic Manufacturers Association (BGMA) Chief Executive said: “Without political intervention, patients will face drug shortages, significantly reduced treatment choice and restrictions on access to new products.”

Government launches £5bn PPE procurement drive to prepare for winter covid surge
HSJ, Jack Serle, 18 May 2021

HSJ reports that the Government has launched a new £5bn procurement framework which is being developed for personal protective equipment. The framework aims to meet current demand and any potential winter surge in covid cases.

The procurement will be managed by the NHS Supply Chain. The agency had some of its responsibilities for PPE procurement taken over during the coronavirus pandemic, but it has now resumed its responsibilities.

The four-year framework will be jointly issued by NHSSC and the Department of Health and Social Care’s PPE unit, and will be confirmed by October 2021.

It will be for single-use PPE and other medical consumables, including masks, gowns, drapes, and eye protection.

The framework is being developed as a “a short-term fix” while NHSSC develops a longer-term strategy involving greater use of re-usable supplies.

5 things we learned on ‘bumpy’ post-Brexit relations from UK’s David Frost
Politico, Cristina Gallardo, 17 May 2021

Politico reports that Britain will continue to face some post-Brexit challenges and the UK’s former Chief Brexit Minister, David Frost, told MPs that he wants to get it on a “decent footing.”

Following continued disagreement over the Northern Ireland Protocol, Lord Frost was questioned by MPs on the House of Commons European scrutiny committee.

Lord Frost said that there is “a bit of momentum” in talks with the EU over the Northern Ireland Protocol, but the discussions are “not hugely productive” yet.

Frost confirmed that the European Commission rejected UK proposals on sanitary and phytosanitary (SPS) measures. In order to reduce tensions over trade in Northern Ireland, Brussels suggested that Britain should align with the EU on food, plant and environmental standards.

Frost told MPs that he is responsible for making sure post-Brexit legislation that was announced in the Queen’s Speech is “genuinely consistent with de-regulation and the spirit of Brexit and goes forward on that basis.”

Frost warned there is a “risk of gaps opening up” in regulation between Northern Ireland and the rest of the UK. The UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has licensed the drug, Osimertinib for early-stage lung cancer patients across the country, but this treatment has not been approved for patients to use in Northern Ireland for the same indication under EU rules.

 Parliamentary Coverage

There was no parliamentary coverage today.

 Full Coverage

Northern Ireland faces ‘huge’ rise in generic medicine prices
Financial Times, Laura Noonan and Sarah Neville, 18 May 2021

This article is subject to copyright terms and conditions. Please access the full article here.

Government launches £5bn PPE procurement drive to prepare for winter covid surge
HSJ, Jack Serle, 18 May 2021

A new £5bn procurement framework is being developed for personal protective equipment, aimed at meeting current demand and any potential winter surge in covid-19 cases.

The procurement will be handed by NHS Supply Chain. The agency had some of its responsibilities for PPE procurement taken over amid a “completely chaotic” response to the coronavirus pandemic, but has now had its remit restored.

The four-year framework will be jointly issued by NHSSC and the Department of Health and Social Care’s PPE unit, and will be confirmed by October 2021.

It will be for single-use PPE and other medical consumables, including masks, gowns, drapes, and eye protection, according to a prior information notice published last week.

The framework is designed to be “a short-term fix” while NHSSC develops a longer-term strategy involving greater use of re-usable supplies.

Around £15bn had to be allocated for PPE procurement in 2020-21.

The government moved PPE procurement out of NHSSC into a new dedicated “cell” last year, amid criticism of the early response to the pandemic.

According to an NHSSC statement, the government is now working on transferring the PPE cell “into the management function of NHS Supply Chain [and] Supply Chain Coordination Ltd” [the company which is wholly owned by DHSC and manages NHSCC].

The transfer is intended to “retain the existing expertise, knowledge and relationships with suppliers”. The private firm Clipper Logistics, that was contracted to distribute PPE during the pandemic, will continue to run the logistics service managed by SCCL.

The decision comes as SCCL looks for a new chief executive, following the resignation of Jin Sahota last year, and prepares to be transferred into NHS England.

The new CEO will lead on “the embedding of SCCL, transforming and shaping the organisation in order to meet the future demands for the NHS Supply Chain and customers, and incorporating the PPE buying cell”.

The recruitment process is now closed to applications, with prospective candidates being assessed before interviews in May and June, with a final decision expected in mid-June.

NHS procurement professionals were frustrated that the PPE framework would be for single-use kit rather than reusable supplies, which was seen as in contradiction with the NHS’ sustainability ambitions and green agenda.

NHSSC told HSJ that sustainability criteria will be included in the award criteria for the single-use PPE framework.

The criteria “will include questions on details of suppliers’ roadmaps, policies, and workplans”, it said.

“The areas of focus will be around reduction of packaging and recyclable packaging, sustainable solutions and future innovations.”

It is also working on a second procurement framework for reusable kit, for which it said details would be outlined later this year.

5 things we learned on ‘bumpy’ post-Brexit relations from UK’s David Frost
Politico, Cristina Gallardo, 17 May 2021

LONDON — Britain’s relationship with the EU will be “bumpy for a time” but the country’s top Brexit minister, David Frost, wants to get it on a “decent footing,” he told MPs Monday.

Amid ongoing disagreement over the Northern Ireland protocol, the U.K.’s former chief Brexit negotiator faced a string of questions from MPs on the House of Commons European scrutiny committee. POLITICO walks you through the key points.

NI talks ‘not hugely productive’

Frost said there is “a bit of momentum” in talks with the EU over the Northern Ireland protocol, a cornerstone of last year’s post-Brexit trade agreement aimed at avoiding a hard border between Ireland and Northern Ireland. But fresh from landing a combative op-ed in Britain’s Mail on Sunday, he said the discussions are “not hugely productive” yet.

Frost confirmed the European Commission had rejected U.K. proposals on sanitary and phytosanitary (SPS) measures, a key sticking point in discussions over the future of the protocol. In order to reduce trade friction in Northern Ireland, Brussels has argued that Britain should commit to align with the EU on food, plant and environmental standards — a non-starter for London.

“Obviously, from the EU’s point of view the easiest solution to any border problem is that we should operate the same rules, laws as they do and that solves the problem,” he said. “Obviously, that doesn’t work for us. That is not going to be the solution.”

Frost said there were “well-precedented arrangements around equivalence of SPS standards” that did not require alignment but saw both sides “accept that you are pursuing high standards,” thereby reducing the need for checks. “We have consistently said we’d like to do something like that with the EU but they have not wished to do so,” he told MPs.

He admitted “unsettledness” in Northern Ireland is higher than the U.K. government had expected. But he claimed this was in part caused by an “unfortunate intervention” from the Commission in January, when the bloc threatened to invoke Article 16 of the Brexit Withdrawal Agreement to control the export of coronavirus vaccines.

The U.K. has not ruled out taking fresh unilateral action on the protocol by triggering Article 16 if it is not possible to reach a deal with Brussels in the coming weeks — a message an Irish government official has described as “irresponsible.”

“We continue to consider all the options,” Frost said. “I’d like to think that if we were to take measures of any kind that support the stability of the Good Friday Agreement in Northern Ireland, that the EU would not make that more difficult by reacting to it.”

‘Lighter’ regulation push

Frost told MPs he is responsible for making sure post-Brexit legislation announced in the queen’s speech earlier this month is “genuinely consistent with de-regulation and the spirit of Brexit and goes forward on that basis.”

He announced the creation of a new unit reporting to him, focused on regulatory reform in areas like financial services. Recruitment for the unit will start soon, he said, and it might be headed by someone outside government.

Britain wants to move on from the EU’s “very prescriptive arrangements” to “a lighter touch” approach to regulation, adapting to changing circumstances. This process might take some time, he said, but the government is “absolutely committed” to making sure the U.K. does not function as part of the EU’s “regulatory orbit.”

Drugs warning

Frost warned there is a “risk of gaps opening up” in regulation between Northern Ireland and the rest of the U.K., pointing to a row over the use of a new lung cancer drug.

The U.K.’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has licensed the drug, called Osimertinib, for use in lung cancer patients across the country but not in Northern Ireland. There have been reports this was not possible because of the grace period on medicines agreed with the EU, due to expire at the end of the year. But a spokesperson for the Commission denied this weekend that the Northern Ireland protocol is to blame.

Frost accused the EU of “asserting their right to regulate cancer drugs in Northern Ireland rather than the U.K. doing that”.

Bilateral deals up in the air

Frost expressed a desire to reach bilateral agreements with individual EU countries on issues left unresolved in the U.K.-EU trade negotiations last year, including on mobility arrangements for services and the return of asylum seekers.

But he acknowledged these conversations are at an embryonic phase despite appetite among some EU countries to get going. And he accused Brussels of getting in the way. “The Commission has ways of influencing that,” he said.

Gibraltar talks

Frost told the committee he expects to play an active role in the EU-U.K. negotiations for a treaty on Gibraltar, describing these negotiations as a “joint operation” with the U.K.’s Foreign, Commonwealth and Development Office. The treaty is expected to allow the British Overseas Territory to associate with the Schengen passport-free area — removing the need for a physical border with Spain.

The Commission is likely to conclude its mandate for the negotiations this month, allowing for talks to start by the end of June, he said.

HDA UK Media and Political Bulletin – 18 May 2021

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