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Media and Political Bulletin – 04 September 2020

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 – 04 September 2020

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