Media and Political Bulletin – 21 September 2020

Media and Political Bulletin

21 September 2020

Media Summary

EU must step up efforts to tackle medicine shortages, say MEPs

The Pharma Letter, 18 September 2020

The Pharma Letter reports that the European Parliament, at the Plenary session on 17 September 2020, called for the European Union to be more self-sufficient when it comes to medicines and medical equipment so that affordable treatments are available at any time.

Parliament welcomed the new EU health program EU4Health and asked the Commission to use the upcoming pharmaceutical strategy to ensure that safe medicines in Europe can be made available, accessible and affordable and to examine ways to restore pharmaceutical manufacturing in Europe.

Priority needs to be given to boosting domestic production of essential and strategic medicines as currently 40% of medicines marketed in the EU originate in non-EU countries, while 60%-80% of active pharmaceutical ingredients are produced in China and India, MEPs said.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

EU must step up efforts to tackle medicine shortages, say MEPs

The Pharma Letter, 18 September 2020

The European Parliament at yesterday’s Plenary session called for the European Union to be more self-sufficient when it comes to medicines and medical equipment so that affordable treatments are available at any time.

Parliament adopted by 663 votes to 23 and 10 abstention a resolution addressing the root causes of recent medicine shortages. MEPs called for an increased EU response to a problem that has been exacerbated by the COVID-19 health crisis across Europe with a direct negative impact on patients’ health, safety and the continuation of their treatment.

Parliament welcomed the new EU health program EU4Health and asked the Commission to use the upcoming pharmaceutical strategy to ensure that safe medicines in Europe can be made available, accessible and affordable and to examine ways to restore pharmaceutical manufacturing in Europe.

The resolution also calls on the Commission to propose a directive setting minimum standards for quality healthcare systems in member states.

Return to EU independence in the health sector

Priority needs to be given to boosting domestic production of essential and strategic medicines as currently 40% of medicines marketed in the EU originate in non-EU countries, while 60%-80% of active pharmaceutical ingredients are produced in China and India, MEPs said.

They also mentioned the need to screen foreign direct investment in pharmaceutical manufacturing plants, which are part of Europe’s critical health infrastructure and encourage the introduction of financial incentives to persuade companies to produce active pharmaceutical ingredients and medicines in Europe.

After the vote, the rapporteur Nathalie Colin Oesterle (EPP, FR) said: “Public health has become a geostrategic weapon that can bring a continent to its knees. Our dependence on non-EU countries has been exposed by the current pandemic. Certain types of production must be relocated, legislation must be harmonised and cooperation between member states must be strengthened in order to achieve greater solidarity and to regain our independence.”

EFPIA raises some issues

Speaking about the vote, European Federation of Pharmaceutical Industries and Associations (EFPIA) director general, Nathalie Moll said: “We are acutely aware of the impact medicine shortages can have on patients. Addressing them is a priority for the European research-based pharmaceutical industry, as was acutely exemplified industry’s frontline role over the past eight months to avoid any shortages of medicines during this pandemic.” She went on to say. “While some of the recommendations put forward by the European Parliament could have a positive impact in reducing medicines shortages, we are deeply concerned that other measures proposed not only fail to address the root causes of this emerging problem, but if implemented, could severely undermine the ability of our companies to innovate.”

While the Parliament has recognized patent protection as a key incentive for companies to invest in innovation, the EFPIA notes with concern that several suggestions made in the report, such as changes to EU intellectual property rules, as well as pricing and procurement policies, are disproportionate and unbalanced. Similarly, in calling for a number of regulatory reforms and sanctions for manufacturers, the European Parliament does not consider the extreme complexity of the issue, and the need to produce additional evidence and knowledge about the key drivers and extent of medicines shortages.

Media and Political Bulletin

15 September 2020

Media Summary

There was no media coverage today.

Parliamentary Coverage

The law must change to improve medicine shortages

The Royal Pharmaceutical Society, 14 September 2020

The Royal Pharmaceutical Society has joined together with the BMA, the Royal College of GPs and patient group National Voices to call on Health Secretary Matt Hancock to amend medicines legislation.

They are calling on the Government to amend legislation to enable all pharmacists to alter prescriptions in order to minimise the impact of medicine shortages on patient care. The letter asks for pharmacists to be able to provide a different quantity, strength, formulation or generic version of the same medicine on a prescription if it is in short supply.

President of the Royal Pharmaceutical Society Sandra Gidley said the change was urgently needed ahead of a second wave of COVID-19, flu season and a potential no-deal Brexit, which would place heavy demands of the medicines supply chain and primary care services.

Full Coverage

There was no media coverage today.

Media and Political Bulletin

11 September 2020

Media Summary

Government in talks to offer drugs manufacturers incentives to diversify supply chains

The Pharmaceutical Journal, Carolyn Wickware, 10 September 2020

The Pharmaceutical Journal reports that the British Generic Manufacturers Association is in talks with the government over incentivising drugs firms to obtain active pharmaceutical ingredients from more than one source to avoid future supply problems.

Warwick Smith, director general of the BGMA, told The Pharmaceutical Journal that the trade body was “intensively” discussing measures with the government that would make it easier for companies to diversify their API production.

“The concentration of API supply over the years is a greater risk to resilience of the generics supply chain than having manufacturing plants in other parts of the world,” he added.

Responding to Smith’s comments, a spokesperson for the Department of Health and Social Care said: “We have robust systems in place to prevent and manage medicine shortages and we are constantly looking at ways to further enhance the resilience of supply chains.”

Parliamentary Coverage

Funding boost to help healthcare suppliers improve cyber security

Department for Digital, Culture, Media & Sport, National Cyber Security Centre, and Matt Warman MP, 10 September 2020

The UK government announced that small and medium-sized businesses in the healthcare sector, such as medical suppliers and primary care providers, can apply for part of the new £500,000 funding to improve their cyber security.

The government will cover all consultancy and certification costs, and it will also offer guidance and support to small and medium-sized businesses in the healthcare sector to get accreditation from the government’s Cyber Essentials certification.

The government support will include training to make sure all phones, tablets, laptops or computers are kept up-to-date, proper firewall usage to secure devices’ internet connections, and user access controls to manage employee access to services.

This comes after the National Cyber Security Centre (NCSC) identified a heightened cyber threat to the UK health sector in relation to the pandemic, with cyber crime groups attempting to steal sensitive intelligence, intellectual property and personal information from pharmaceutical companies and medical research organisations.

Full Coverage

Government in talks to offer drugs manufacturers incentives to diversify supply chains

The Pharmaceutical Journal, Carolyn Wickware, 10 September 2020

Talks are taking place between the British Generic Manufacturers Association and the government over incentivising drugs firms to take action to prevent future shortages.

The British Generic Manufacturers Association (BGMA) is in talks with the government over incentivising drugs firms to obtain active pharmaceutical ingredients (APIs) from more than one source in an effort to avoid future supply problems.

Warwick Smith, director general of the BGMA, told The Pharmaceutical Journal that the trade body was “intensively” discussing measures with the government that would make it easier for companies to diversify their API production.

It comes after critical care medicines — such as atracurium and cisatracurium — faced supply issues in April 2020 because of significantly increased demand from COVID-19 patients, with the Royal College of Anaesthetists forced to issue guidance that provided alternative medicines to those that were out of stock.

Smith said the demand meant that “one company with one product, [sold] what they would normally sell in 12 months in two weeks, and they only manufacture one batch a year”.

“What wasn’t appreciated at the time is that the volumes [of intensive care medicines] that are typically used are quite low,” he said, adding that this means there are “comparatively few suppliers of those medicines”.

Some manufacturers responded by halting production of other medicines to produce those that are more urgently needed, while one company “changed the production from mainland Europe to the UK for one product because that made them respond more flexibly,” he said.

Manufacturer Accord Healthcare told The Pharmaceutical Journal in May 2020 that it had plans to move production of hydroxychloroquine — which was being trialled as a COVID-19 treatment at the time — to the UK from abroad to combat potential shortages.

However, Smith said shoring up supply chains is more “nuanced” than building more factories in the UK.

“In fact, if all the factories were in the UK and the UK had a problem, that will be no use at all. What we need is diversity,” Smith explained.

“The concentration of API supply over the years is a greater risk to resilience of the generics supply chain than having manufacturing plants in other parts of the world,” he added, noting that “around a quarter of all generic medicines used in the UK are made here, but the supply of API is focused in places such as Italy, China and India.”

In August 2019, The Pharmaceutical Journal revealed that half of all safety warnings issued by European and US drug regulators are issued to drug manufacturers in India and China, raising concerns about the fragility of the global supply chain.

When asked whether companies were now looking at diversifying their API production, Smith said the BGMA was “talking to the government quite intensively about trying to get a programme of measures, which would make it easier for companies to do that”.

Smith clarified that these measures “could be government incentives to encourage manufacturers to have more than one API supplier and manufacturing location”.

“Hospitals buy the cheapest product, but it costs money to have more than one API supplier on your licence, so maybe we need to look at procurement and invest more in companies that have got more resilient supply chains,” he said.

“If it’s just about price, you’ll get cheap medicines, but when the excrement hits the air conditioning you might find we’re less able to step up than if we’d had a broader view of value.”

Responding to Smith’s comments, a spokesperson for the Department of Health and Social Care said: “We have robust systems in place to prevent and manage medicine shortages and we are constantly looking at ways to further enhance the resilience of supply chains.”

In July 2020, it was announced that the government had launched ‘Project Defend’, led by the Department for International Trade, “to identify vulnerabilities in global supply chains”.

Media and Political Bulletin

10 September 2020

Media Summary

MHRA investigates medicines that left supply chain as FMD alert issued

Chemist+Druggist, Eliza Slawther, 09 September 2020

Chemist+Druggist reports that the Medicines and Healthcare products Regulatory Agency (MHRA) is investigating circumstances under which multiple medicines left the supply chain before entering it again.

The products were reintroduced into the supply chain by Kingsley Specials after it purchased them from a company that does not “hold a wholesale dealers authorisation”, the MHRA said in the alert. The company subsequently “sold [them] on to a number of other wholesalers”, it added.

Wholesalers and healthcare professionals have been told to check their stocks and all the listed products – available in full on the alert – for the relevant batches supplied from wholesalers Smartway Pharmaceuticals, Drugsrus and Optimal Pharma.

Parliamentary Coverage

UK Internal Market Bill introduced today

Office of the Secretary of State for Scotland, Cabinet Office, Department for Business, Energy & Industrial Strategy, The Rt Hon Michael Gove MP, The Rt Hon Alister Jack MP, and The Rt Hon Alok Sharma MP, 09 September 2020

The UK Internal Market Bill – a new Bill to protect jobs and trade across the whole of the UK after the Transition Period ends – was introduced to Parliament yesterday.

From 1 January 2021, powers in a range of policy areas previously exercised at an EU level will flow directly to the devolved administrations in Holyrood, Cardiff Bay and Stormont, guaranteeing companies can trade unhindered across all 4 parts of the UK.

The Bill will also set out steps to ensure that the government is able to deliver on its commitments to the people of Northern Ireland.

A new independent Office for the Internal Market (OIM) is to be set up within the Competition and Markets Authority (CMA) to monitor the smooth running of trade within the UK.

Full Coverage

MHRA investigates medicines that left supply chain as FMD alert issued

Chemist+Druggist, Eliza Slawther, 09 September 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) is investigating circumstances under which multiple medicines left the supply chain before entering it again.

The medicines watchdog is “investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via [the wholesaler] Kingsley Specials”, it said as a falsified medicines directive (FMD) alert was issued last week (September 1).

The products were reintroduced into the supply chain by Kingsley Specials after it purchased them from a company that does not “hold a wholesale dealers authorisation”, the MHRA said in the alert. The company subsequently “sold [them] on to a number of other wholesalers”, it added.

Kingsley Specials has had its license to trade suspended while the watchdog investigates the incident, an MHRA spokesperson told C+D last week (September 3). C+D has contacted Kingsley Specials, but the company declined to comment while the investigation is ongoing.

The products involved “appear to be genuine, with legitimate batch numbers and safety features”, the MHRA said. However, they “are thought to have left the legitimate supply chain and been reintroduced between March and August,” it added.

“This means that the correct transport and storage conditions cannot be guaranteed and, while unlikely, could impact their effectiveness,” the MHRA explained.

The affected products are listed in appendix two of the MHRA’s alert. Some of the products included in the alert are Eliquis, Stelara and Zebinix.

Affected medicines should be quarantined and reported

Wholesalers and healthcare professionals have been told to check their stocks and all the listed products – available in full on the alert – for the relevant batches supplied from wholesalers Smartway Pharmaceuticals, Drugsrus and Optimal Pharma.

The three companies – who did not purchase directly from Kingsley Specials but via intermediate companies – are “not implicated in any wrongdoing and are co-operating with the MHRA to resolve the matter,” the MHRA stressed.

Smartway Pharmaceuticals, Drugsrus and Optimal Pharma have also “implemented safety measures by decommissioning the impacted packs [and] changing the status to stolen/inactive in the National Medicines Verification System”, the MHRA said.

If any affected products are identified by healthcare providers, they are asked to quarantine these packs, and notify the Defective Medicines Report Centre, the MHRA said.

Healthcare professionals dispensing the affected products should “ensure that appropriate scanning takes place at the point of dispensing” and not dispense goods that flag as “stolen” or “inactive”, the MHRA said.

“Where there is no ability for scanning, healthcare professionals and wholesalers should consider using the unique serial number or product code or global trade item number information available on the outer packaging of the product,” it added.

Smartway: Customers have been alerted

Smartway has “effective traceability for the affected stock”, which has allowed it “to identify affected customers”, a spokesperson for the company told C+D yesterday (September 8).

It has “contacted this small group [of customers] with specific instructions” and if any customers “did not receive information” from Smartway on August 21, they can “assume that any products from [it] are unaffected”, the spokesperson added.

However, pharmacy teams should “check to see whether they have purchased products from other wholesalers named on the alert and follow the instructions,” the spokesperson added.

Drugrus told C+D today (September 9) that it can “confirm that Drugsrus had no part in any wrongdoing and is co-operating fully with the MHRA to help resolve the matter”.

C+D also contacted Optimal Pharma, who declined to comment as the matter is still under MHRA investigation.

Media and Political Bulletin

08 September 2020

Media Summary

Medical leaders warn no-deal could exacerbate health crisis

The Times, Oliver Wright, 08 September 2020

In a letter to The Times, senior medical leaders have warned Boris Johnson that the health service risks being “overwhelmed” by the combination of a no-deal Brexit, winter pressures and Covid-19.

They said a failure to strike a deal with the EU could jeopardise the health of patients and warned that no-deal disruption could lead to shortages of medicines.

Last month the government wrote to medicine suppliers warning them that a “reasonable worst-case scenario” for a no-deal Brexit was for “significant disruption” to trade across the Channel for six months. Ministers urged suppliers to make sure that they had at least six weeks of supplies on “UK soil” and to investigate alternative shipping routes.

The pharmaceutical industry has warned that disruption from Covid-19 has meant stockpiles meant for no-deal have been “used up” and that it may be impossible to replenish them before December.

Matt Hancock wants to ‘drive more money towards pharmacy’

Chemist+Druggist, Eliza Slawther, 07 September 2020

Chemist+Druggist reports that health secretary Matt Hancock said on LBC’s Call The Cabinet television segment that he “want[s] to drive more money towards pharmacy” from within the NHS budget, which he said “is going up”.

“I want to do a deal with pharmacies where we offer more NHS services to be delivered in pharmacies and we pay people for that,” he explained.

A DH spokesperson said: “We are continuing to engage with the sector on funding to meet extra costs incurred during the peak of the pandemic.”

Last week, a report by accountancy firm Ernst & Young warned that under the current funding model, the provision of services may be financially unviable for pharmacies in England. In response this report, pharmacy bodies have called for greater funding to avoid closures and financial ruin for pharmacy contractors.

UK plan to undermine withdrawal treaty puts Brexit talks at risk

Financial Times, 07 September 2020

The Financial Times reports that sections of the internal market bill — due to be published this Wednesday — are expected to “eliminate the legal force of parts of the withdrawal agreement” in areas including state aid and Northern Ireland customs, according to three people familiar with the plans.

The UK internal market bill, outlined in a 100-page white paper in July, is designed to secure the “seamless functioning” of trade between England, Wales, Scotland and Northern Ireland after the UK leaves the EU’s single market and customs union at the end of this year.

But some clauses in the bill will effectively override parts of the Northern Ireland protocol, which was signed alongside the withdrawal agreement in October.

This was also covered by Sky News.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Medical leaders warn no-deal could exacerbate health crisis

The Times, Oliver Wright, 08 September 2020

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

Matt Hancock wants to ‘drive more money towards pharmacy’

Chemist+Druggist, Eliza Slawther, 07 September 2020

Health secretary Matt Hancock wants to “drive more money towards pharmacy” within the NHS budget, he said on LBC’s Call The Cabinet television segment today (September 7).

The health secretary was asked by interviewer Nick Ferrari if he will be asking Rishi Sunak, the chancellor of the exchequer, for more money for the sector after Mr Hancock described himself as a “massive, massive fan of pharmacists”.

Mr Hancock said that he “want[s] to drive more money towards pharmacy” from within the NHS budget, which he said “is going up”.

“I want to do a deal with pharmacies where we offer more NHS services to be delivered in pharmacies and we pay people for that,” he explained.

“I think that pharmacists can do far more, and they are the front door to the NHS in the community,” Mr Hancock added.

£370m advance funding

A DH spokesperson said: “During this unprecedented pandemic, £370 million has been made in advance payments to support pharmacies in maintaining medicine supplies and providing health advice.

“We are continuing to engage with the sector on funding to meet extra costs incurred during the peak of the pandemic.”

Last week, a report by accountancy firm Ernst & Young warned that under the current funding model, the provision of services may be financially unviable for pharmacies in England.

In response this report, pharmacy bodies have called for greater funding to avoid closures and financial ruin for pharmacy contractors.

UK plan to undermine withdrawal treaty puts Brexit talks at risk

Financial Times, 07 September 2020

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

Media and Political Bulletin

04 September 2020

Media Summary

Proposed legislation could see government ‘broaden’ use of data collected through the Falsified Medicines Directive

The Pharmaceutical Journal, Corrinne Burns, 03 September 2020

The Pharmaceutical Journal reports that members of the House of Lords have warned that proposed legislation for a UK version of the Falsified Medicines Directive (FMD) “considerably broadens” how medicines data collected through the system would be used.

The proposals, set out in Clause 3 of the Medicines and Medical Devices Bill, would enable provisions to be made for “the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines”.

Lord Bethell, one of the sponsors of the Bill, said that “our objective is to fully consult with industry, patient groups, pharmacists and all interested parties on any regulatory changes before they are implemented”.

Parliamentary Coverage

Report: Impacts of current funding, policy and economic environment on independent pharmacy in England

EY, September 2020

According to a new report from EY, almost three quarters of family-owned pharmacies in England could be forced to close over the next four years. Some of the key findings are:

  • The report estimates that the average pharmacy will be making an annual loss of £43k by 2024.
  • Having undertaken a detailed economic analysis of the sector’s finances, EY concluded that, without intervention from NHS England, many pharmacies will be unable to survive.

This report comes only weeks after the Health Secretary, Matt Hancock told an online National Pharmacy Association (NPA) conference that he is against widespread closures and wants more investment in the sector.

Chair of the APPG on Pharmacies, Jackie Doyle-Price, wrote: “going forward if the NHS is to deliver a truly 24-hour seven day a week service, then pharmacies must be at the forefront of that.”

The EY report was commissioned by the NPA and drew on financial research conducted among NPA members. The NPA Board will be meeting on 7 and 8 September to give detailed consideration to EY’s findings.

APPG on Access to Medicines and Medical Devices

04 September 2020

Today at 12:00, the APPG on Access to Medicines and Medical Devices is holding a virtual session titled, ‘What challenges and opportunities does Brexit bring to the Access to Medicines and Medical Devices agenda and how can they be respectively limited and leveraged?’.

External speakers will include representatives from DIT, MHRA, ABPI, ABHI, Bird & Bird, Gilead & Takeda. For further information, please contact Jonny Haseldine at haseldinej@parliament.uk.

Medicines and Medical Devices Bill, Second Reading

House of Lords, 02 September 2020

Earlier this week the Medicines and Medical Devices Bill underwent its Second Reading in the House of Lords. Lord Bethell reiterated the importance of this Bill to the development of a modern, safe, medical regulation regime. He specifically highlighted the following:

  • On medicines and medical devices, Lord Bethell highlighted that this Bill is vital, providing the necessary powers that will allow the UK to make regulatory changes in the interests of patient safety and confidence. He said the Government is determined to deliver regulatory change to the current UK system for medical devices to increase patient safety and drive pre-market scrutiny, and that it will continue to assess opportunities to improve the wider regulatory system at the end of the transition period.
  • Referring to the guidance published this week on standstill arrangements, the importance of continued access to medicine and medical devices was highlighted. Lord Bethell reiterated that to ensure continuity of supply of medicines and medical devices from 1 January 2021, the UK will unilaterally recognise certain EU regulatory processes for a time-limited period.
  • On EU exit, he reiterated his commitment to ensuring that the UK has one of the best regulatory regimes that ensures patient safety, and that ensures patients benefit from innovative products.
  • With regards to co-operation with the EU and EMA, the goal remains to ​agree with the EU an annexe on medicinal products to facilitate trade and support high levels of patient safety.
  • Referring to arrangements in Northern Ireland, Lord Bethell underscored that the implementation of the Northern Ireland Protocol is a top priority for the Government.
  • This Bill provides a power to make regulations about the use of data collected for the purpose of preventing the supply of falsified medicines. Lord Bethell said that plans on how to improve the regulation of software-driven devices, including AI and algorithms, were being considered.

Full Coverage

Proposed legislation could see government ‘broaden’ use of data collected through the Falsified Medicines Directive

The Pharmaceutical Journal, Corrinne Burns, 03 September 2020

Members of the House of Lords have warned that proposed legislation for a UK version of the Falsified Medicines Directive (FMD) “considerably broadens” how medicines data collected through the system would be used.

The FMD is an EU directive that came into effect on 9 February 2019, requiring UK pharmacies to register with SecurMed and have hardware in place to scan 2D barcodes that must feature on all new packs of prescription medicine sold in Europe as a safety measure.

The MHRA said that the FMD will cease to apply in the UK if there is a no-deal Brexit, because UK pharmacies will no longer have access to the database that holds FMD information.

But the Medicines and Medical Devices Bill aims to incorperate some EU directives into domestic law and address any regulatory gaps that could occur after Brexit.

The proposals, set out in Clause 3 of the Medicines and Medical Devices Bill, would enable provisions to be made for “the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines”.

However, during the second reading of the Bill in the House of Lords on 2 September 2020, Lord Clement-Jones described the measures as “legislative creep” with regard to how any such data could be used.

He said the clause “considerably broadens the original data-collection provisions of the Falsified Medicines Directive”.

Describing data as “sensitive, commercial currency”, he added that, currently, under the FMD “access to pack information, which could highlight purchasing decisions and margins being made, is restricted to details such as the name, batch, expiry, serial number and active/inactive status”.

Baroness Masham of Ilton added in the same reading that the Company Chemists’ Association (CCA) had also raised concerns around Clause 3.

Malcolm Harrison, chief executive officer of the CCA, told The Pharmaceutical Journal that he has “grave concerns about the wording of Clause 3(1)(b) of the Medicines and Medical Devices Bill, which relates to the development of a UK system to prevent the supply of falsified medicines”.

“To avoid unintended consequences of data being used for purposes other than to ensure that medicines are safe, we are asking ‘for any purpose’ to be amended to ‘in an agreed framework’,” he explained.

“We are pleased that the government intends to consult on any regulatory changes before they are made but believe that changing the wording of the Bill itself is needed to ensure this data is only used to ensure that medicines are safe.”

In response to Clement-Jones’ comments, Lord Bethell, one of the sponsors of the Bill, said that “our objective is to fully consult with industry, patient groups, pharmacists and all interested parties on any regulatory changes before they are implemented”.

Jerome Bertin, general manager of SecurMed UK, said that, based on what was written in the Bill, “it is hard to determine if this would broaden the rights of access to such data, but the use of ‘for any purpose’ might suggest wider access rights, though for which stakeholders or regulators is unclear”.

Bertin added that the Bill, as it currently stands, “does not go anywhere near the detail of the EU directives (2001/83/EC superseded by 2011/62/EU) so it is hard to assess whether the FMD style protections would be diluted in a UK-only falsified medicines regulation”.

First announced in the Queen’s Speech in December 2019, the Bill is intended — in part — to introduce delegated powers, allowing existing regulatory frameworks to be updated following Brexit. It will now go through a third House of Lords reading before any amendments are considered.

World academies network urge politicians to curb falsified, substandard medical products

News Medical Life Sciences, 03 September 2020

Falsified and substandard medical products – products such as vaccines, medical devices and veterinary products that are ‘fake’ or of poor quality – are an increasing global scourge that threaten life, health and security in significant ways. This is because patients receiving these products not only get ineffective treatment but are also often exposed to serious harm.

Today, under the InterAcademy Partnership (IAP), medical, scientific and engineering academies from around the world urge political decision-makers at all levels, in concert with regional and international organisations, to work with medical product regulatory authorities, national and international law enforcement agencies, manufacturers, importers, distributors, health professionals and patients to solve this urgent issue.

The new IAP Statement ‘A Call to Action: Furthering the fight against falsified and substandard medical products’ (available online at www.interacademies.org/medical_products) supports the call for a comprehensive, well-resourced, international effort to address this devastating problem.

A global problem

It is difficult to give precise numbers but it appears that in many low-income countries a large proportion of the medical products available are falsified or substandard. Estimates of 20-30% in some African and Asian countries seem realistic.

Some estimates for particular products are even higher, including an extremely worrisome 30-50% for anti-malarial drugs in south-east Asia.

Of note, some 50% of all reports of substandard and falsified medicines received by the WHO Global Alert system are from sub-Saharan Africa, and 80% of these are for essential medicines like anti-malarials and antibiotics.

High-income countries are also impacted. For example, in the United States, several instances of falsified dugs are detected each year. The US Food and Drug Administration (FDA) has launched an alert system, publishing these cases to warn the public.

In Europe, a link has been established between unregulated distribution chains and the number of falsifications detected. Some 50% of the products proposed for sale on the internet are also believed to be false.

“The right of people to health is unalienable: manufacturing, carrying, stocking and selling falsified and substandard medical products, including drugs, vaccines, medical devices, and other medical products are crimes. Due to their severe consequences on public health and individual healthcare, these crimes must be prosecuted and punished to the fullest extent possible,” said Yves Juillet, member of the French National Academy of Medicine, who co-chaired the working group responsible for preparing the statement.

World academies’ recommendations

Given that this activity affects every country in the world, IAP emphasises that governments, regulatory authorities and industry must oversee and regulate the supply chain effectively. The continuity of the supplies of medical products must be always guaranteed, especially in countries most burdened by the problem of falsified and substandard drugs.

The IAP Statement strongly affirms the importance of warning the public about the risk of buying prescription medicines over the internet and of advising online purchase only through certified internet pharmacies.

It also decries the delays and the insufficient resources invested in this fight, and underscores the fact that the prevention of this threat requires improved access to legitimate, quality medical products, including equitable pricing policies and better healthcare coverage.

IAP recommends strong consideration of a substantive, comprehensive and well-resourced policy and programme to address this scourge as a priority action of national authorities and international organizations in charge of public health.

Lastly, IAP agrees that the World Health Organization (WHO) is uniquely situated, through its membership and global remit, to provide leadership and coordination to combat this pressing problem.

The IAP Statement ‘A Call to Action: Furthering the fight against falsified and substandard medical products’ was officially launched at the EuroScience Open Forum (ESOF), the biennial, pan-European, general science conference dedicated to scientific research and innovation, that in 2020 took place in Trieste, Italy, from 2 to 6 September.

Media and Political Bulletin

02 September 2020

Media Summary

ABPI response to MHRA guidance for the end of the transition period

ABPI Press Office, 01 September 2020

Following the publication of MHRA guidance for industry and organisations preparing for the end of the Brexit transition period, the ABPI has published its response.

Richard Torbett, Chief Executive of the ABPI, said: “Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation.

“However, we have always said that the best way to avoid disruption in the long term is for both sides to consider the impact on patients in the UK and the EU and agree a deal.”

The ABPI stressed that more guidance and detail would be needed, and that it will continue to seek more engagement with the Government in areas including the Northern Ireland protocol.

Parliamentary Coverage

MHRA post-transition period information

Medicines and Healthcare products Regulatory Agency, 01 September 2020

Following the email circulated to HDA members yesterday, we wanted to re-share the MHRA’s guidance published yesterday on the regulation of medicines and medical devices at the end of the Transition Period, in both a negotiated and non-negotiated outcome with the EU.

To help ensure the continuity of supply of medicines and medical devices from 1st January 2021, especially in a non-negotiated outcome with the EU, the UK will unilaterally recognise certain EU regulatory processes for a time limited period. This recognition is known as ‘Standstill’.  You can find more detail on the guidance here.

In addition to the guidance, the DHSC and the MHRA will be hosting a webinar from 9:30 to 10:30am on Thursday 3rd September to talk through the guidance and answer any questions. Click here to register to attend the webinar: https://www.workcast.com/register?cpak=3123752941732861.

Stephen Lightfoot to become Chair

Medicines and Healthcare products Regulatory Agency, 24 August 2020

As of 1st September 2020, Stephen Lightfoot has become Chair of the Medicines and Healthcare products Regulatory Agency (MHRA). Stephen has been a Non-Executive Director of the Agency since September 2015 and is also Deputy Chair of Sussex Community NHS Foundation Trust and Non-Executive Chair of Sussex Primary Care Limited.

Before joining the Board, Stephen had a 30-year career in the life sciences industry working on the development and commercialisation of a wide range of medicines and medical devices in UK and global healthcare companies. His most recent executive roles were General Manager of the global pharmaceutical diagnostics business of GE Healthcare, Managing Director of the UK pharmaceutical business of Daiichi Sankyo and Commercial Director of the UK pharmaceutical and medical device business of Schering Healthcare.

House of Commons, Oral Question – 01 September 2020

Kirsten Oswald (East Renfrewshire): In just four months’ time, new customs bureaucracy will lead to increased drug costs for the NHS, including for insulin, which the UK does not produce. Pharmaceutical and medical supply firms report that they are struggling to rebuild last year’s stockpiles because of global shortages due to covid. How does the Minister plan to ensure that patients will not face shortages next year?

Health Minister Edward Argar: The Department is putting in place a multi-layered approach to help to ensure continuity of supply of medicines and medical products in any case ​that might fall out of the negotiations and the end of the transition period. We are confident that we will maintain continuity of supply.

House of Commons, Written Questions Tabled – 28 August 2020

Martyn Day (Linlithgow and East Falkirk):

  • To ask the Secretary of State for Health and Social Care, what steps he is taking to support the Medicines and Healthcare products Regulatory Agency to uphold quality and safety standards after the end of the transition period.
  • To ask the Secretary of State for Health and Social Care, what steps he is taking to support the Medicines and Healthcare products Regulatory Agency (MHRA) to uphold quality and safety standards following the UK’s withdrawal from the EU.

Full Coverage

ABPI response to MHRA guidance for the end of the transition period

ABPI Press Office, 01 September 2020

The guidance provides some information on how to operate from 1 January 2021, including on licensing of medicines and devices, clinical trials, exporting active substances for medicines, importing medicines and investigational medicinal products, pharmacovigilance procedures and new IT systems.

Companies will welcome the important detail included in this guidance which will support them in planning for the end of the transition period.

Whilst the guidance is largely similar to the Brexit ‘no deal’ guidance published in 2019 (which was withdrawn as a deal was secured), there are some additions relating to the added complexity of the Northern Ireland protocol and a more time-restricted acceptance of EU batch testing and release. The ABPI will continue to seek more engagement with the Government in these areas.

In response, Richard Torbett, Chief Executive of the ABPI, said:

“Our members will be reassured that Government has provided some critical information to help them continue preparations for the end of the transition.

“Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation.

“However, we have always said that the best way to avoid disruption in the long term is for both sides to consider the impact on patients in the UK and the EU and agree a deal.”

What is needed

More guidance

Pharmaceutical companies are still waiting for the MHRA to provide additional technical information on other issues such as the handling of Decentralised [DCP] and Mutual Recognition Procedures [MRP], how variations to Marketing Authorisations (MAs) will be handled and new assessment routes from 1 January 2021.

Companies are also still waiting for detailed guidance on the regulation of medicines in Northern Ireland.

More detail

Even with the guidance published today pharmaceutical companies are going to face a significant change in the way they need to operate and will have to work through the practicalities of implementing the guidance. The MHRA will need to be available to work through the detail on an individual company basis, given the complexity of medicines regulation.

In the future

Alongside planning for the end of transition, industry is working with the MHRA to ensure that the UK remains at the forefront of medicines regulation.

By expanding the work it does with other regulators around the world to quickly adopt new breakthroughs, exploring new routes for approving medicines and aligning standards with the best in the world, the UK would be an attractive destination for pharmaceutical companies to submit their research.

Media and Political Bulletin

27 August 2020

Media Summary

CEOs make government Brexit deal plea after Covid cash squeeze curbs stockpiling

Evening Standard, Alex Lawson, 26 August 2020

The Evening Standard reports that industry bosses have called on Government to agree a post-Brexit deal, warning that the cash crunch caused by coronavirus had left businesses unable to stockpile, with talks between the UK and EU having stalled last week. The next round of negotiations kicks off on September 7th, with October the deadline for an agreement to be ratified before the end of the transition period this year.

David Watson, ABPI’s interim executive director for commercial policy, said the industry needed support from Government to plan an end to the transition period, after months of strain to ensure drugs to treat Covid patients were still available.

He said: “Detailed guidance is still urgently required from Government on issues like freight capacity, ferry routes and the Northern Ireland Protocol. Coronavirus has only strengthened our belief that the best possible outcome is for both sides to reach a deal that includes an MRA to protect patients and public health.”

The pharmaceutical industry has called for negotiators to seek a Mutual Recognition Agreement – which would see both sides accept each other’s drug safety testing and inspections before export –in order to avoid duplication, supply chain disruption or delays to patient access to medicine.

PSNC asks government for ‘urgent uplift’ in pharmacy funding

P3 Pharmacy, Pharmacy Magazine, 26 August 2020

P3 Pharmacy reports that the PSNC has said it has put the case to health minister Jo Churchill for “an urgent uplift” in funding for the community pharmacy contractual framework.

“(This) has been an extremely challenging year for community pharmacies. They have done an incredible job in meeting the increasing health needs of their patients [..] but the financial toll that this tremendous effort has taken on pharmacy businesses of all shapes and sizes is now being felt, and PSNC’s job is to make that case effectively to (the) government,” said PSNC chief executive Simon Dukes.

“Now that the initial health emergency has passed, all PSNC Committee Members are focused on the financial emergency facing their businesses.”

Mr Dukes said the PSNC had given the government “comprehensive data” on the cost of the pandemic to pharmacies and said the £370m in advance funding given to pharmacies in England during the outbreak should be written off.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

CEOs make government Brexit deal plea after Covid cash squeeze curbs stockpiling

Evening Standard, Alex Lawson, 26 August 2020

Industry bosses today called on Government to thrash out a post-Brexit deal, warning that the cash crunch caused by coronavirus had left businesses unable to stockpile.

Manufacturers, retailers and their suppliers are facing the prospect of a no-deal Brexit, but without the firepower to stockpile to ensure goods continue to flow as they did last year before an anticipated cliff-edge Brexit.

Talks between the UK and EU stalled last week. The next round of negotiations kicks off on September 7 with October the deadline for an agreement to be ratified before the end of the transition period this year.

The ADS, which represents more than 1100 UK businesses operating in the aerospace, defence, security and space sectors, warned a “disruptive Brexit is an unwelcome additional challenge” to a sector thrown into crisis by the grounding of the aviation industry in lockdown.

ADS chief executive Paul Everitt said: “Supply chain companies across the UK are focused on survival and the crisis has put severe pressure on cashflow, restricting their ability to rebuild the stockpiles that were their primary mitigation measure.

“It is important that the Government and the EU work to reach a deal that avoids any further damage. A no-deal Brexit would cause industry in the UK and in Europe further damage.”

Retailers could also be squeezed, as the Covid outbreak has deterred shoppers from physical stores, and ratcheted up demand for warehouse space to service online customers.

Andrew Opie, director of food and sustainability at the British Retail Consortium, said: “Retailers continue to face unprecedented challenges after months of store closures, slow sales and increased costs. As the end of the transition period draws closer, retailers are working incredibly hard to mitigate the disruption that is likely to arise from leaving the EU single market.

“However, with retailers focused on preparing for the all-important golden quarter, warehouses will be at full capacity in the run up to Christmas leaving little room to build up additional supplies ahead of the 1st January. A no-deal Brexit at the end of the year would result in price increases from tariffs and reduced consumer choice.”

The issue is likely to affect any industry with “just in time” speedy supply chains. The Food and Drink Federation has said suppliers impacted by the closure of the hospitality industry may struggle if they don’t have the cash to stockpile short shelf-life ingredients or finished products.

Security of supply of medicines has been a key issue for Government, and this month Steve Oldfield, chief commercial officer at the Department of Health wrote to suppliers asking them to “stockpile to a target level of six weeks’ total stock on UK soil”.

David Watson, ABPI’s interim executive director for commercial policy, said the industry needed support from Government to plan an end to the transition period, after months of strain to ensure drugs to treat Covid patients were still available.

He added: “Detailed guidance is still urgently required from Government on issues like freight capacity, ferry routes and the Northern Ireland Protocol.

“Coronavirus has only strengthened our belief that the best possible outcome is for both sides to reach a deal that includes an MRA to protect patients and public health.”

The pharmaceutical industry has called for negotiators to seek a Mutual Recognition Agreement – which would see both sides accept each other’s drug safety testing and inspections before export–in order to avoid duplication, supply chain disruption or delays to patient access to medicine.

PSNC asks government for ‘urgent uplift’ in pharmacy funding

P3 Pharmacy, Pharmacy Magazine, 26 August 2020

The PSNC has said it has put the case to health minister Jo Churchill for “an urgent uplift” in funding for the community pharmacy contractual framework.

While talks are ongoing with the Government over funding and services, the negotiator announced today that it has told Churchill, whose health brief includes community pharmacy, that the five-year deal needed to contain more money.

The agreement was struck in July last year and saw funding frozen at £2.592bn annually from 2019-20 to 2023-24.

The PSNC also said talks have begun on contractors’ remuneration for costs related to the Covid-19 pandemic and revealed a hepatitis C testing service was “imminent” while it was expected that the discharge medicines service will start in January.

Details on the 2020-21 flu vaccination service have not yet been released but the PSNC said those should be published before the service commences on Tuesday.

The PSNC also said discussions on extending referrals to the community pharmacy consultation service from GP practices have resumed after talks were interrupted by the pandemic.

“(This) has been an extremely challenging year for community pharmacies. They have done an incredible job in meeting the increasing health needs of their patients and providing a walk-in clinical advice service for their local communities during the Covid-19 pandemic. As well as helping people in need, this has supported other primary care and NHS services during a critical time,” said PSNC chief executive Simon Dukes.

“But the financial toll that this tremendous effort has taken on pharmacy businesses of all shapes and sizes is now being felt, and PSNC’s job is to make that case effectively to (the) government.

“As contractors and LPCs know, during the initial pandemic peak in the UK, PSNC was working round the clock to finalise new services and arrangements that supported contractors through the lockdown period – emergency funding injections, flexibility in opening hours, and a new national delivery service were some of the key outputs from the negotiations at that time.

“Now that the initial health emergency has passed, all PSNC Committee Members are focused on the financial emergency facing their businesses.”

Mr Dukes said the PSNC had given the government “comprehensive data” on the cost of the pandemic to pharmacies and said £370m in advance funding given to pharmacies in England during the outbreak should be written off.

“Although ministers have heaped praise on the sector throughout the pandemic, many officials still question the value of pharmacies and this is what PSNC and others are working hard to convince them of,” Mr Dukes said.

“We are also increasingly working alongside our GP negotiating colleagues to share leverage where we can. I know that it is incredibly frustrating for contractors as they await the outcomes of these business critical conversations, but do not mistake a failure to make fast agreements for a lack of activity.

“We have been and will continue to do all that is needed to battle for the best deals and for fair treatment of community pharmacies at every stage.

“If that means rejecting offer after offer from (the) government and doing all that we can to reach a satisfactory position on every single negotiating point, then that is what we will keep doing.”

Media and Political Bulletin

18 August 2020

Media Summary

Brexit: UK hopeful of EU trade deal next month, says No 10

BBC News, 18 August 2020

BBC News reports that the UK still believes it can agree a post-Brexit trade deal with the EU next month, according to Downing Street.

This week’s talks are the last scheduled negotiating round ahead of the autumn, although both sides have previously said talks would continue in September.

EU chief negotiator Michel Barnier said that an agreement would be needed by October “at the latest” so it could be ratified before the current post-Brexit transition period ends in December.

This was also reported by City A.M, i News and Daily Express.

Parliamentary Coverage

Cross-government reasonable worst case scenario

On 13 August, the recent DHSC letter to manufacturers and suppliers was updated – see https://www.gov.uk/government/publications/letter-to-medicines-and-medical-products-suppliers-3-august-2020 . There is now mention of the Reasonable Worst Case Scenario (RWCS) Government is using (there is no change to DHSC plans). This includes the following:

…The cross-government reasonable worst case scenario (RWCS) for our contingency planning indicates a risk of significant disruption across the short straits for 6 months following the end of the transition period, with a particular risk during the first 3 months. As a large percentage of medical supplies come from the EU or have a supply touchpoint there, the first priority of any contingency should be to maintain replenishment rates at necessary levels including by securing capacity to reroute freight away from potential disruption, especially during the first 3 months following 1 January 2021 when, under the government’s RWCS, the most significant disruption is anticipated. Companies are encouraged to review their own logistics arrangements and consider the appropriateness of using existing supply chain routes during this period as a matter of priority.

In 2019, the Department for Transport (DfT) put in place a 4-year procurement framework for freight capacity for ‘Category 1’ goods, which includes all health supplies. This framework is still in place. DHSC is seeking to secure capacity on the government secured freight capacity (GSFC) to support the health and social care sector. More information will be provided when possible, including updates on the procurement timescales and when companies can expect to be able to register and access the service.

In addition, DHSC has retained its express freight service arrangements with 3 specialist logistics providers to support the urgent movement of medicines and medical products to care providers and patients if other measures experience difficulties. This service will be in place for deployment at the end of the TP as required.

Full Coverage

Brexit: UK hopeful of EU trade deal next month, says No 10

BBC News, 18 August 2020

The UK still believes it can agree a post-Brexit trade deal with the EU next month, according to Downing Street.

The PM’s spokesman said UK negotiators would “continue to plug the gaps” when talks enter their seventh round in Brussels on Tuesday.

The two sides remain divided over competition rules, fishing rights and how a deal would be enforced.

The UK has ruled out extending the December deadline to reach an agreement.

This week’s talks are the last scheduled negotiating round ahead of the autumn, although both sides have previously said talks would continue in September.

EU chief negotiator Michel Barnier will have dinner with UK counterpart David Frost on Tuesday evening, with talks set to conclude on Friday.

After the last negotiation round in London, Mr Barnier accused the UK of not showing a “willingness to break the deadlock” over difficult issues.

He added that an agreement would be needed by October “at the latest” so it could be ratified before the current post-Brexit transition period ends in December.

Mr Frost said EU offers to break the deadlock had failed to honour the “fundamental principles which we have repeatedly made clear”.

But he said the UK, which has so far insisted on a series of separate deals in different areas, was also willing to consider a “simpler” structure for an agreement.

He added the EU had shown a “pragmatic approach” over British demands to limit the role of the European Court of Justice after the transition period ends.

Among the issues the negotiating sides will discuss this week are transport, police co-operation, fishing rights and rules on investment.

They will also discuss post-Brexit rules on competition and state support for companies, one of the thorniest issues in the talks to date.

The UK is due to stop following EU rules on so-called “state aid” at the end of the transition period, and has not unveiled details of its subsequent regime.

Mr Barnier has said the EU will require “robust” guarantees in this area if it is to agree a deal, and has called for more details on the UK’s future plans.

Media and Political Bulletin

07 August 2020

Media Summary

Government to spend £200m on helping GB goods flow to N Ireland

Financial Times, Peter Foster and George Parker, 07 August 2020

The Financial Times reports that the UK government is to spend an initial £200m on a new service to help businesses in Northern Ireland comply with the bureaucratic costs of bringing in goods from Great Britain after Brexit.

The new “Trader Support Service” will be offered free of charge to help traders with the burden of new paperwork needed to move goods across the Irish Sea from Great Britain as a result of the Northern Irish Protocol, which aligns the region to both the EU customs code and the UK customs territory.

In addition, Michael Gove, Cabinet Office minister, will announce £155m to fund digital technology to help smooth the new internal UK border created under the government’s Brexit deal from January 2021.

Parliamentary Coverage

Major £650 million investment for Northern Ireland

Cabinet Office, Northern Ireland Office, The Rt Hon Michael Gove MP, and The Rt Hon Brandon Lewis MP

On a visit to Northern Ireland today, a major £650m package of investment will be announced to help traders in Northern Ireland, and support peace, prosperity and reconciliation projects on the island of Ireland.

At the centre of this package is a new, free-to-use Trader Support Service (TSS) – an end-to-end support service to deal with import and safety and security declarations on behalf of traders. The new service will be available to businesses bringing in goods from Great Britain or the rest of the world, providing guidance as well as dealing with their requirements for moving goods into Northern Ireland. A procurement exercise for the service has now been launched.

The service is outlined as part of the publication of new guidance on the Northern Ireland Protocol for businesses moving goods into and from Northern Ireland. Find out how you can register an interest in the Trader Support Service and keep up to date with other changes due to the implementation of the Northern Ireland Protocol here.

Moving goods under the Northern Ireland Protocol

Cabinet Office, 07 August 2020

At the end of the transition period, the Northern Ireland Protocol will take effect. The Cabinet Office has published guidance to provide support for businesses engaging in new processes under the Northern Ireland protocol. View the guidance here.

National flu immunisation programme for 2020 to 2021

Department of Health and Social Care, Public Health England, and NHS England, 05 August 2020

The annual flu letter describes the national flu immunisation programme for 2020 to 2021 and outlines which groups are eligible for flu vaccination.

This year there are 2 letters setting out the details of the programme. The second letter contains further detail on the implementation of the programme. Read the letters here.

Full Coverage

Government to spend £200m on helping GB goods flow to N Ireland

Financial Times, Peter Foster and George Parker, 07 August 2020

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

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