News

HDA UK Media and Political Bulletin – 13 December 2021

Media Coverage

EU shoots itself in foot as bloc’s OWN rules would scupper plot to control Brexit Britain
The Express, Aleks Phillips, 12 December 2021

The Express reports that a unilateral move by the EU to regulate Northern Ireland would not be instantaneous as the legislation required would need to go through the European Parliament and the Council of the EU.

Last week, Maroš Šefčovič, Vice-President of the European Commission, suggested that the EU could move on the issue of medicines without an agreement with the UK, and unilaterally impose EU regulation on medical goods entering Northern Ireland.

Martin Sawer, Executive Director of the HDA, commented that the EU “have some legislation which they could start off moving through the European system in January, which would implement the EU’s version of the regulations that they want to have.” He continued: “But the consequences of that, depending on the start date, might be that we might see withdrawal of companies supplying Northern Ireland and the reduction of medicines for Northern Ireland patients.”

Mr Sawer believes that Mr Šefčovič made his threat “to remind everybody that they also have unilateral capabilities, and Article 16 isn’t the only one on the table.”

Medicine suppliers ‘can’t compete with Amazon’ over lorry drivers – Government must act
The Express, Aleks Phillips, 11 December 2021

The Express reports that Martin Sawer, Executive Director of the HDA, has highlighted the difficulties the medicines distribution sector is facing following the shortages of HGV drivers in September, as companies such as Amazon are offering increased pay and signing-on bonuses.

Mr Sawer explained that following the coronavirus pandemic, “half the retail economy’s gone online. [So] there’s a lot of demand for drivers”. He said that the medicines distribution sector “can’t compete with that, because the NHS is our customer, we can’t charge the NHS suddenly a load more whereas these companies can. So we’ve had great challenges on that front.”

Mr Sawer called for the Government and the departments to recognise the problems faced by the medicines distribution companies and the crucial role of the sector in the UK health system.

Post-Brexit medicines regulation must have international scope
Pharmaphorum, Amanda Barrell, 9 December 2021

Pharmaphorum reports that the Association of the British Pharmaceutical Industry (ABPI) has published a new vision paper, in which it calls for post-Brexit Britain to create a regulatory framework that both defines and aligns with international standards. Otherwise, Britain risks being left behind.

If companies need to make multiple dossiers and submissions it could lead to “profound implications for UK patients needing access to innovative and novel therapies” said the ABPI.

Britain, it continued, needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured”.
The vision paper focuses on how to boost the “global competitiveness” of the UK’s life sciences, and make it a “go-to destination for innovation”.

The full report can be read here.

Parliamentary Coverage

There was no parliamentary coverage today. 


Full Coverage

EU shoots itself in foot as bloc’s OWN rules would scupper plot to control Brexit Britain
The Express, Aleks Phillips, 12 December 2021

A UNILATERAL move by the EU to regulate Northern Ireland “wouldn’t be instantaneous” as the legislation required would need to go through the European Parliament and the Council of the EU.

Were it to make such a move, it might be that there is a “reduction of medicines for Northern Ireland patients”, a medicine supply chain chief has told Express.co.uk. However, “it’s not something either side wants.”

Last week, Maros Sefcovic, European Commission vice president, suggested that the EU could move on the issue of medicine without an agreement with the UK, and unilaterally impose EU regulations on medical goods entering Northern Ireland.

Speaking to a Northern Ireland Assembly committee on December 1, Mr Sefcovic said: “I would 100 percent prefer if we can present this good solution as a joint approach.

“But I’m fully conscious of time. I have to be very, very clear that we are ready to move on our own if it’s not possible at this stage to push on a joint approach.”

However, owing to the bureaucratic nature of the EU, the European Commission can only propose draft legislation.

This is then put to the European Parliament and the Council of the EU. It is then the job of the Commission to act on the will of the two decision-making organs.

Martin Sawer, chief executive of the Healthcare Distribution Association, commented that because of this bureaucracy “it wouldn’t be instantaneous.

“They have some legislation which they could start off moving through the European system in January, which would implement the EU’s version of the regulations that they want to have.

“But the consequences of that, depending on the start date, might be that we might see withdrawal of companies supplying Northern Ireland and the reduction of medicines for Northern Ireland patients.

“So it’s not something either side wants.”

Mr Sawer believes that Mr Sefcovic made his threat “to remind everybody that they also have unilateral capabilities, and Article 16 isn’t the only one on the table.”

He noted that triggering Article 16 would also be subject to a delay before any unilateral move could be made.

According to the Institute for Government, the Northern Ireland Protocol stipulates that once Article 16 is triggered, both the UK and the EU should enter negotiations to find a solution.

No measures can be implemented during the initial one-month negotiating period. However, if negotiation fails, either party may adopt unilateral measures.

Mr Sawer commented: “I think both sides are saying these things to show they have autonomy, a bit, publicly […] but it’s not quite as straightforward as that.”

Last week, Mark Samuels, chief executive of the British Generic Manufacturers Association (BGMA), warned that the EU’s current proposals on revising the Protocol were “ultimately unworkable” for medicine suppliers.

He said that an “extremely low” number of new licenses being issued for the country meant there was “a force nine gale heading Northern Ireland’s way”.

He called for a UK-wide license as “the only way to avoid this storm”.

Mr Sefcovic reportedly told the Northern Irish Assembly that the Protocol is “not perfect but it is the best response to the UK’s decision to withdraw from EU and the form of Brexit the [UK] Government has chosen”.

Mr Sawer told the Express that in the immediate future, medicine supply to Northern Ireland would remain “business as usual” in an Article 16 scenario.

He commented: “If there’s regulatory simplicity, then it’ll make us have access to more medicines, you know, and more healthcare going forward.”

Mr Sawer said that “unilateral approaches” to the issue “might be okay, for medicine supply, but just in the short term.

“But in the longer term – I’m talking in six months or more – the repercussions for medicines access, for the whole of the UK would be affected.”

Medicine suppliers ‘can’t compete with Amazon’ over lorry drivers – Government must act
The Express, Aleks Phillips, 11 December 2021

THE MEDICINES supply chain “can’t compete” with internet retailers like Amazon when it comes to lorry drivers’ pay and conditions, an industry chief has said, calling for the Government to help.

The UK-wide shortage of HGV drivers created “huge challenges” for medicines wholesalers earlier in the year, with logistics staff being retained out of the companies’ pockets. However, as the funding they receive to supply medicines to the NHS is fixed, a warning has been issued that “we can’t charge the NHS suddenly a load more whereas these companies can”.

Martin Sawer, chief executive of the Healthcare Distribution Association, said the sector “can’t keep on a war footing forever” after the coronavirus pandemic.

He called for the Government – which has said it wants to see shortages in the supply chain resolved by better pay and conditions – to step in.

In September, a shortage of hauliers across Europe affected supply chains.

In the UK, a Road Haulage Association (RHA) survey of its members estimated there was a deficit of more than 100,000 qualified drivers.

Transport Secretary Grant Shapps said at the time that even though the Government had put in place some measures, “the industries must also play their part with working conditions continuing to improve and the deserved salary increases continuing to be maintained in order for companies to retain new drivers.”

In the private sector, the market adjusted, with pay packets for HGV drivers massively increasing as companies tried to meet demand.

However, Mr Sawer said that the same could not be done by medicine distribution companies, as only the Government could increase what the NHS pays for medicines.

He explained that following the coronavirus pandemic, “half the retail economy’s gone online. [So] there’s a lot of demand for drivers”.

Mr Sawer added: “Those companies can pass their costs on to consumers by charging them more.

“We understand that at Christmas time, some drivers for the delivery companies are getting £20 pound an hour, for example. Amazon do signing-on bonuses of £3,000.

“We can’t compete with that, because the NHS is our customer, we can’t charge the NHS suddenly a load more whereas these companies can. So we’ve had great challenges on that front.”

After “huge challenges in September”, every member company now has “a business continuity plan and they’ve put various measures in place to encourage and incentivise retention of staff and recruitment.”

He noted: “But as a consequence, we’re sort of acting as a public service to deliver NHS medicines.”

In the UK, the NHS pays a certain price for medicines, which includes a share for the manufacturer and some for the distribution company.

As such, the only way for manufacturers and distributers to be paid more is for the Government to increase the fee it pays.

Mr Sawer said that the issue may be intensified further by manufacturing costs going up, which may prompt manufacturers to demand a higher fee.

He told the Express: “I think probably what needs to happen in the short term is a recognition of this by the Government, and that medicines [distribution] is a very vital part of the UK health system.”

The companies Mr Sawer represents “just want the Government and the departments to recognise this and see if, because the NHS is their body, the NHS can help with that in any way.

“And that doesn’t have to be financial.”

A Department of Health and Social Care spokesperson said: “We have well established procedures to deal with any disruption to the supply chain and work closely with industry, the NHS and others to make sure patients can access the medicines they need.”

Post-Brexit medicines regulation must have international scope
Pharmaphorum, Amanda Barrell, 9 December 2021

Post-pandemic, post-Brexit Britain must create a regulatory framework that both defines and aligns with international standards, or risk being left behind.

If the UK creates regulatory frameworks that drastically diverge from those of its “science allies”, it could become a late – or even no – launch market for new treatments.

The need for companies to make multiple dossiers and submissions could lead to “profound implications for UK patients needing access to innovative and novel therapies”, says a new Association of the British Pharmaceutical Industry (ABPI) vison paper.

Instead, Britain needs to “strike a balance between forging its own path as a sovereign regulator whilst ensuring strategic partnerships with other leading regulators, including the European Medicines Agency (EMA), are nurtured” it recommends.

“As the government begins to set out what Britain being a science superpower outside of the EU means, this is the perfect time to look at the important policies which attract companies to launch their products here in the UK,” said Colette Goldrick, the ABPI’s Executive Director, Strategy and Partnerships.

The decoupling of the Medicines and Healthcare Products Regulatory Agency (MRHA) from much of Europe’s regulatory architecture has allowed the UK to independently shape its own policies.

However, this needs to be done in a way that maintains international competitiveness, argues the report, UK Medicines Regulatory Policy and Global Influence in a Post-Pandemic World.

Opportunities and pitfalls
Goldrick said that there were “opportunities and pitfalls” to this new landscape. The UK can, for example, now shape polices that place the MHRA at the forefront of developing ‘gold standard’ regulatory frameworks and innovative practices for new technologies.

However, this must be done in a way that ensures the country remains internationally competitive – drastically diverging from the international direction of travel could have negative consequences, said the report.

The COVID-19 pandemic, Goldrick said, had demonstrated what friction could do to global supply chains.

“The same principle applies to regulation,” she went on. “Diverging from global medicines standards for the sake of it would be destructive and undermine the attractiveness of the UK.

“That’s why we want ministers to instead look at areas where we can do things faster and set the agenda for new types of medicines and vaccines, so that NHS patients can be some of the first in the world to benefit.”

Prerequisites for global competitiveness
The vision paper focuses on how to boost the “global competitiveness” of the UK’s life sciences, and make it a “go-to destination for innovation”.

“The ABPI believes that there are several ways in which the UK can progress towards an internationally competitive regulatory framework. The key elements to achieve this rely on being patient-focused, innovation-focused, and forward-looking,” said the authors, adding that Britain must remain an “effective player on the main stage”.

“The MHRA is in a position to capitalise on the UK’s unique capabilities to help define and set international standards and rules, contributing to the reputational strength of the UK life sciences sector, and supporting the export of UK innovation to major trading partners.”

To achieve this vision, the sector must have the right resources and funding, as well as an open dialogue with stakeholders from across the regulatory and life sciences ecosystem.

“The industry stands ready to partner with government to ensure the success and international recognition of this agenda.”

Recommendations
The paper, which was compiled following a series of interviews and workshops with ABPI members and representatives from organisations including the MHRA, NICE, and UK Research and Innovation (UKRI), makes a range of recommendations.

They include strengthening processes and partnerships that allow for the inclusion of the patient voice in policy development.

It recommends, for example, that the MHRA publish an annual report outlining how patient and public engagement has been embedded in regulatory processes, and work with the International Conference on Harmonisation (ICH) to develop guidelines on measuring patient-reported outcomes in clinical trials.

To help create a fit-for-the-future landscape, the MRHA could also develop regulation to enable more environmentally sustainable processes, and work with NHS Digital and NHSX to integrate digital approaches into clinical research.

In terms of trade policy, the UK should “pursue opportunities for regulatory cooperation with key trading partners” to “secure the position of the MHRA as a gold-standard regulator”.

A recurring theme in the report is the importance of maintaining, nurturing, and deepening international relationships.

For instance, it recommends the MRHA remain an “active and strategic” member of international forums, such as the ICH and the International Coalition of Medicines Regulatory Authorities (ICMRA).

“UK regulators should seek to be leading voices in World Health Organisation (WHO) networks, including through being full and active members of the WHO’s Coalition of Interested Parties Network for Regulatory Systems Strengthening, sharing its expertise to improve global health and health security,” it said.

Underpinning these recommendations is the need for the resources, funding, and engagement channels the MRHA needs to make this vision a reality, said the authors.

Life sciences future
The UK’s life sciences sector, which employs more than 250,000 people, makes an important contribution to the country’s economic growth, while also underpinning the health and resilience of the population. But it also has a role in leading international regulatory policy.

Strong regulatory frameworks which define gold standards while also aligning to the international direction of travel are essential to maintaining both functions.

“Oversight by effective, independent regulators not only gives patients and clinicians confidence that medicines are safe, high-quality, and effective, but will also contribute to the international competitiveness of the UK relative to other countries,” said the paper.

HDA UK Media and Political Bulletin – 13 December 2021

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

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