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

23 July 2020

Media Summary

Coronavirus: Warning over illegally imported fake medicine

BBC News, 22 July 2020

BBC News reports that Northern Ireland’s Health Minister Robin Swann has warned people about the dangers of taking illegal medications which claim to treat coronavirus.

Mr Swann said the Department of Health’s medicines regulatory group was made aware that unlicensed anti-viral drugs had been illegally imported into the country. The unauthorised drugs have not undergone regulatory approvals, which are required in the UK.

Chief Medical Officer for Northern Ireland Dr Michael McBride said the risk to the public due to unlicensed medicines was “significant”. He warned against sourcing medicines from anywhere other than a registered pharmacy.

Parliamentary Coverage

There is no parliamentary coverage to report today.

Full Coverage

Coronavirus: Warning over illegally imported fake medicine

BBC News, 22 July 2020

Robin Swann has warned people about the dangers of taking illegal medications which claim to treat coronavirus.

The health minister said he had been made aware of unlicensed anti-viral drugs being illegally imported into Northern Ireland.

The unauthorised drugs have not undergone regulatory approvals, which are required in the UK.

“I urge the public not to be fooled by online offers for medical products,” Mr Swann said.

No further coronavirus-related deaths were recorded by the Department of Health in Northern Ireland on Wednesday, but there were nine new cases of the virus.

Mr Swann said the Department of Health’s medicines regulatory group was made aware that unlicensed anti-viral drugs had been illegally imported into the country.

“This fake medicine claims to be for the treatment of Covid-19,” he said.

“Some of these so called medicines could potentially do more harm than the virus.

“Be in no doubt, medicines sourced in this way present a real danger to those taking them.”

The minister said the problem was not something “we can tackle in isolation” and that his department would continue to work with other agencies to disrupt the supply of the illegal medicines.

‘Be vigilant’

Chief Medical Officer Dr Michael McBride said the risk to the public due to unlicensed medicines was “significant”.

Dr McBride said people should only take prescription medicines after an appropriate consultation with their GP or other healthcare professionals.

He warned against sourcing medicines from anywhere other than a registered pharmacy.

Dr McBride urged the public to “be vigilant” and “avoid putting their health at risk by using medication from an unknown source”.

Media and Political Bulletin

27 May 2020

Coronavirus (COVID-19): travellers exempt from UK border rules

UK Home Office, 22 May 2020

Last Friday Home Secretary Priti Patel announced new public health measures for all UK arrivals to guard against a second wave of coronavirus infections. Measures include 14 days’ self-isolation for anyone entering the UK, bar a short list of exemptions. Of particular importance to our sector, the below exemptions have been granted:

  • Qualified persons and responsible persons for human medicines, clinical trials and pharmacovigilance.
  • A worker with specialist technical skills, where those specialist technical skills are required for essential or emergency works or services (including commissioning, maintenance, and repairs and safety checks) to ensure the continued production, supply, movement, manufacture, storage or preservation of goods.

These arrangements are due to come into effect on 8 June, and measures will be subject to review every three weeks.

Media Summary

Fake formulations: How pharma is fighting counterfeit drugs

European Pharmaceutical Journal, Lu Rahman, 26 May 2020

European Pharmaceutical Manufacturer’s Lu Rahman looks at the anti-counterfeiting measures pharmaceutical companies are having to undertake to fight the rise of fake drugs.

She explores both the financial and organisation impact of FMD on pharmaceutical manufacturing, the benefit of partnership in serialisation, and the role of anti-counterfeiting technology.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Fake formulations: How pharma is fighting counterfeit drugs

European Pharmaceutical Journal, Lu Rahman, 26 May 2020

The threat that counterfeit medicines pose to the global pharmaceutical sector is immense. From fake formulations to issues in the manufacturing process, some industry figures believe we could be looking at revenue losses up to as much as 27 billion euros in Europe alone.

Ensuring integrity of products can be a challenge for many pharmaceutical businesses. There are European and US regulations to adhere to as well as additional global regulations. Business models and supply chain operations can differ from one contract manufacturing organisation (CMO) to another, adding an extra layer of complexity to the issue of adherence. However, we know that supply chain security is crucial in the fight against fake products and protecting consumers and manufacturers.

From last year, the EU Falsified Medicines Directive (EU FMD) Safety Features Delegated Regulation, made the serialisation of licensed drugs in Europe a legal requirement.

According to the guidance from Gov.uk, these safety features are “a unique identifier (a 2D matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain” and anti-tampering technology on the pack.

The unique identifier is a “a product code which allows the identification of at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size, and the pack type; a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated; a batch number and an expiry date”.

In The US, the Drug Supply Chain Security Act (DSCSA) had a compliance cut-off point in 2018. Despite Brexit, it looks as though FMD is here to stay, in the short term at least, so adherence is vital if you want to sell your products in Europe.

Implications for pharma manufacturing

These changes have had implications for pharmaceutical manufacturing – financial, as well as organisational. The two-part process of FMD for example, means that pharmaceutical companies must send serialisation data back to Europe via a barcode system as well as place a tamper-proof seal on every package. The impact of this on businesses has been immense, requiring a re-think of major elements within an organisation – financial, manufacturing operational, IT, regulatory, for example. The scale of data integration required should not be under-estimated either, particularly for those businesses where IT infrastructure has not been a key priority.

The benefit of partnership

The key to successful serialisation can often be found in partnership with a company that has industry expertise, longevity and drug serialisation expertise. Contract development & manufacturing organisations (CDMO) understand the challenges facing clients and have the knowledge to help them deal with the issues that come when working within global regulatory frameworks. CDMOs understand the need for supply chain transparency and how damaging fake goods are to the global pharmaceutical market.

When choosing a serialisation partner, it’s important that they understand your exact needs. It’s not a ‘one-size fits all’ approach that you want but a tailored solution that works well for your business and one which can accommodate changes to your global reach should that be required and understands European, US or other regional regulations.

It’s also a good idea to examine your potential partner’s approach and preparation. One of the requirements of the EU FMD is that serialisation data is submitted to the European Hub of European Medicines Verification Organisation (EMVO). How far down the line with that process are they and what expertise have they drawn upon to ensure complete success? We know that some companies are still in the pilot stage of submission to the EU Hub.

Compliance is a crucial aspect of the pharmaceutical supply chain. Choosing the right serialisation expertise and working with a valued and well-organised partner can make a huge difference to your overall experience.

The role of anti-counterfeiting technology

The International Hologram Manufacturers Association (IHMA), is a good source of expertise in this field and highlights an industry report that indicates continued growth for anti-counterfeiting packaging technologies.

According to the IHMA, the ‘Anti-counterfeiting, Authentication and Verification Technologies’ report signals the added expertise holography brings to the authentication of packaging products.

Coming at a time when international business is struggling with the impact of the coronavirus pandemic, the trade body says the report offers reassurance that the market for packaging authentication technologies will remain strong for the next few years.

The worldwide market for holograms is expected to grow by an estimated 27% over the next five years, at a time when the global anti-counterfeiting packaging market is expected to reach US$ 133720 million by the end of 2026.

Companies looking to protect their products against brand piracy and reduce the levels of counterfeiting are adopting advanced authentication and verification technologies.

And technological innovation within the anti-counterfeiting, authentication and verification technologies market is a major factor contributing to the growth of the market, says the IHMA.

Commenting on the report, IHMA chair Dr Paul Dunn stated as brand owners face a range of threats, suppliers are developing and adopting integrated platforms that allow brands to comprehensively address physical retail, supply-chain and online threats.

“Digital solutions are a clear and growing addition to authentication solutions, sometimes in isolation, but within the holographic industry it’s the combination with packaging track and trace systems among other solutions, that’s seen as the foreseeable future. In doing so, the opportunities for holograms to be at the forefront will drive sector growth.”

Media and Political Bulletin

20 May 2020

Media Summary

 

Supplies of sedative used for COVID-19 patients diverted from France to avoid potential shortages

The Pharmaceutical Journal, 19 May 2020, Carolyn Wickware

The Pharmaceutical Journal reports that supplies of the sedative midazolam have been diverted from France as a “precaution” to mitigate potential shortages in the NHS caused by COVID-19, according to the Department of Health and Social Care (DHSC).

Matt Hancock, the UK health secretary, told the House of Commons Health and Social Care Select Committee on 17 April 2020 that intensive therapy unit medicines — including midazolam — are part of “a delicate supply chain” as they “are made in a relatively small number of factories around the world”.

A spokesperson from Accord Healthcare told The Pharmaceutical Journal on 11 May 2020 that it was out of stock of midazolam after the NHS requested it “place all of its stock of midazolam — equivalent to around two year’s forecasted supply — into its wholesale partners”, even though the manufacturer “does not currently have any NHS contracts in England” to supply the drug.

Q&A: The rise in counterfeit medicines during Covid-19

European Pharmaceutical Manufacturer, Reece Armstrong, 19 May 2020

European Pharmaceutical Manufacturer reports that there is a rise in counterfeit medicines during the Covid-19 pandemic. The article involves an interview on this matter with Rami Cassis, the executive chairman of pharmaceutical serialisation company, Advanco.

The World Health Organisation has recently warned against a surge in fake medicines, notably in the developing world, and Interpol’s global pharmaceutical crime fighting unit has reportedly made 121 arrests across 90 countries in just seven days, resulting in the seizure of dangerous pharmaceuticals worth over $14m (£11m).

COVID-19 LATEST: Pharmacy bid for extra COVID-19 funding submitted to government

The Pharmaceutical Journal, 19 May 2020

The Pharmaceutical Journal reports that community pharmacy’s bid for extra funding to cover costs associated with COVID-19 has been submitted to the Treasury, the Pharmaceutical Services Negotiating Committee (PSNC) has said.

The PSNC would not disclose to The Pharmaceutical Journal how much funding it has requested from the government.

In a statement published on 19 May 2020, the PSNC said the government plans to increase medicine reimbursement prices by £15m in June 2020 as part its annual adjustments to ensure community pharmacy receives a margin payment of £800m.

Parliamentary Coverage

 

There was no parliamentary coverage today.

 

Full Coverage

 

Supplies of sedative used for COVID-19 patients diverted from France to avoid potential shortages

The Pharmaceutical Journal, 19 May 2020, Carolyn Wickware

Supplies of the sedative midazolam have been diverted from France as a “precaution” to mitigate potential shortages in the NHS caused by COVID-19, the Department of Health and Social Care (DHSC) has told The Pharmaceutical Journal.

A spokesperson from Accord Healthcare, one of five manufacturers of the drug, told The Pharmaceutical Journal that it had to gain regulatory approval to sell French-labelled supplies of midazolam injection to the NHS, after having already sold two years’ worth of stock to UK wholesalers “at the request of the NHS” in March 2020.

The DHSC said the request for extra stock was part of “national efforts to respond to the coronavirus outbreak”, which included precautions “to reduce the likelihood of future shortages”.

Midazolam is listed by the Royal College of Anaesthetists as a “first-line” sedative in the management of COVID-19 patients, and warns in guidance published on 2 April 2020 that it “may be subject to demand pressure”.

Matt Hancock, the UK health secretary, told the House of Commons Health and Social Care Select Committee on 17 April 2020 that intensive therapy unit medicines — including midazolam — are part of “a delicate supply chain” as they “are made in a relatively small number of factories around the world”.

While the DHSC confirmed that midazolam is still available to both primary and secondary care, it added that some suppliers of the sedative had limited or no stock availability.

A spokesperson from Accord Healthcare told The Pharmaceutical Journal on 11 May 2020 that it was out of stock of midazolam injection after the NHS requested it “place all of its stock of midazolam — equivalent to around two year’s forecasted supply — into its wholesale partners”, even though the manufacturer “does not currently have any NHS contracts in England” to supply the drug.

“As a result of the NHS request [in March 2020], we are subsequently out of stock,” said Peter Kelly, managing director of Accord Healthcare.

However, he added that the Medicines and Healthcare products Regulatory Agency (MHRA) had given the manufacturer approval “for some French label stock — another 22,000 packs — to be sold into the NHS and [we] are currently waiting for the MHRA’s direction on where to place the stock”.

The manufacturer said the French stock only includes midazolam at the strength of 1mg/mL in 5mL, while the initial supply in March 2020 contained a variety of four different strengths.

A spokesperson for the DHSC said it was “working closely with industry, the NHS and others in the supply chain to help ensure patients can access the medicines they need and precautions are in place to reduce the likelihood of future shortages”.

The DHSC confirmed that its request for additional midazolam stock from Accord Healthcare was one of these precautions.

“As part of our national efforts to respond to the coronavirus outbreak, we are doing everything we can to ensure patients continue to access safe and effective medicines,” they added.

Q&A: The rise in counterfeit medicines during Covid-19

European Pharmaceutical Manufacturer, Reece Armstrong, 19 May 2020

EPM speaks to Rami Cassis, executive chairman of pharmaceutical serialisation company  Advanco and CEO of Parabellum Investments about the rise in counterfeit medicines during the Covid-19 pandemic.

EPM: Has there been a rise in counterfeit medicines during the Covid-19 pandemic?

Cassis: It certainly seems so. The World Health Organisation has recently warned against a surge in fake medicines, notably in the developing world, and Interpol’s global pharmaceutical crime fighting unit has reportedly made 121 arrests across 90 countries in just seven days, resulting in the seizure of dangerous pharmaceuticals worth over $14m (£11m).

EPM: How are criminals exploiting the crisis to sell/distribute fake medicines?

Cassis: Criminals and counterfeiters are able to profit from the current situation through a combination of exploiting people’s desperation to have a Covid-19 cure and, at the same time, established supply chains are breaking due to current circumstances.

EPM: Are people at risk more because of scams/counterfeit schemes due to the pandemic?

Cassis: Yes, because, as the WHO has warned, when supply does not meet the demand, it creates an environment where poorer quality or fake medicines will try to meet those needs – and we are already seeing that happening in many countries. By consuming fake medications posturing as a Covid-19 cure or as a fake alleged Covid-19 treating drug (eg; Chloroquine). Many people are obviously being put at risk.

EPM: How is serialisation helping the pharmaceutical industry track medicines throughout the supply chain?

Cassis: Medicines are tracked right from the shop floor all the way through the supply chain and ultimately to dispensation, so it is possible to trace each batch number and ensure the authenticity and source of supply. This gives peace of mind and also enables medicines to be verified.

EPM: What kinds of serialisation software are in place within the industry?

Cassis: For more than a decade now, GS1 Standard solutions have been implemented by over 80 countries

EPM: Is enough being done via regulation to ensure pharmaceuticals are properly tracked and to fight counterfeiting?

Cassis: The technology is there but the adoption and speed of implementation is slow in certain regions/countries. As a result of the current situation, things may accelerate – let’s hope so.

EPM: Does more need to be done currently to fight a rise in fake medicines during the pandemic?

Cassis: Serialisation as a process is mandated in many parts of the globe but the policies and speed of implementation greatly varies. Robust tech solutions like that from Advanco can help, but ultimately their effectiveness is dependent on a number of moving parts working together.

EPM: In regards to the pharma supply chain, what can we learn from Covid-19?

Cassis: The largest new thing after Covid-19 will be de-globalisation of the supply chain with serialisation used more widely across pharmaceutical medicines and products. We believe that as a result of this pandemic, many manufacturers will look to pull back from China, and establish local or regional production capacity, which will effectively reduce the dependence of the West on China and strengthen the US and European economies.

COVID-19 LATEST: Pharmacy bid for extra COVID-19 funding submitted to government

The Pharmaceutical Journal, 19 May 2020

Community pharmacy’s bid for extra funding to cover costs associated with COVID-19 has been submitted to the Treasury, the Pharmaceutical Services Negotiating Committee (PSNC) has said. Speaking in a video to contractors on 15 May 2020, Simon Dukes, chief executive of the PSNC, said community pharmacies “need more money, simple as that,” adding that the PSNC’s “bid for more money is with Treasury… being scrutinised and as soon as we get a response from them we will let you know”. The PSNC would not disclose to The Pharmaceutical Journal how much funding it has requested from the government.

In a statement published on 19 May 2020, the PSNC said the government plans to increase medicine reimbursement prices by £15m in June 2020 as part its annual adjustments to ensure community pharmacy receives a margin payment of £800m. Dukes said he was “pleased to have agreed these increases” but added that “this is not enough – all pharmacies are facing significant and wide-ranging financial issues as a result of the COVID-19 pandemic, and we are continuing to press for urgent additional investment in the sector”.

Media and Political Bulletin

13 May 2020

Government guidance published to help ensure workplaces are as safe as possible. The government, in consultation with industry, has published guidance to help employers, employees and the self-employed understand how to work safely during the coronavirus pandemic.

There are 8 guides, including on Factoriesplants and warehouses and on Vehicles. 

Media Summary

 

MHRA shuts down more ‘bogus’ Covid sites

P3 Pharmacy, 12 May 2020

P3 Pharmacy reports that the Medicines and Healthcare products Regulatory Agency (MHRA) has warned people against buying online medicines and health products that claim to cure and prevent Covid-19, and says it has shut down a total of 11 websites and social media accounts since the pandemic began.

The regulator is warning the public that products being marketed as ‘miracle cures’, ‘divine cleansing oils’ and ‘antiviral misting sprays’ are unlicensed and not authorised to be sold on the UK market.

The MHRA has launched a #FakeMeds campaign to ensure medical products bought online are purchased from legitimate sources and have encouraged people to report any suspect medicines or medical devices to its Yellow Card scheme.

Parliamentary Coverage

 

House of Commons – Written Answer, 12 May 2020

Alexander Stafford (Rother Valley): To ask the Secretary of State for Health and Social Care, what plans he has for the future funding of community pharmacies.

Jo Churchill: In July 2019, we set out our landmark five-year Community Pharmacy Contractual Framework (CPCF) deal to deliver an expanded role for community pharmacy. The deal commits £2.592 billion per year to community pharmacy from 2019-20 to 2023-24. This amounts to almost £13 billion across the five years.

We set out that we would reprioritise funding, moving to a more service based contractual framework. The Department and NHS England and NHS Improvement will continue to work with the Pharmaceutical Services Negotiating Committee to develop and deliver this joint vision. A more detailed breakdown of the funding can be found in the Community Pharmacy Contractual Framework at the following link: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/819601/cpcf-2019-to-2024.pdf

 

Full Coverage

 

MHRA shuts down more ‘bogus’ Covid sites

P3 Pharmacy, 12 May 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned people against buying online medicines and health products that claim to cure and prevent Covid-19, and says it has shut down a total of 11 websites and social media accounts since the pandemic began.

The MHRA said in early April it had shut down nine websites and social media accounts selling fake or unlicensed Covid-19 products. The Agency told Pharmacy Network News today it has “now removed a further two websites”.

“Working with our partners from law enforcement agencies we are closing media accounts, removing social media posts and suspending domain names,” it told PNN, adding that more investigations are currently underway.

The regulator is warning the public that products being marketed as ‘miracle cures’, ‘divine cleansing oils’ and ‘antiviral misting sprays’ are unlicensed and not authorised to be sold on the UK market.

The MHRA declined to say how prevalent the issue is, instead offering the following statement: “We are living in unprecedented times and people are understandably anxious which leads them to seek cures, preventions and diagnostics online. We are seeing a small number of products making such claims and will investigate where there is non-compliance with legal requirements.”

‘Safety cannot be guaranteed’

The MHRA has launched a #FakeMeds campaign to ensure medical products bought online are purchased from legitimate sources and have encouraged people to report any suspect medicines or medical devices to its Yellow Card scheme.

“You may have heard about products claiming to treat or cure covid-19. At this time there is no medicine licensed specifically to treat or prevent covid-19,” said Lynda Scammell, senior enforcement advisor at the MHRA.

“We want to caution people that products claiming to do so are not authorised and have not undergone regulatory approvals required for sale on the UK market. We cannot guarantee the safety or quality of these products and this poses a risk to your health.

“Don’t be fooled by online offers for medical products to help prevent or treat covid-19. One of the risks of buying medicines and medical devices from unregulated sources is that you just don’t know what you will receive.

“You could be risking your health, and this could further spread the virus and increase pressure on our NHS and social care systems.”

Media and Political Bulletin

13 May 2020

Government guidance published to help ensure workplaces are as safe as possible. The government, in consultation with industry, has published guidance to help employers, employees and the self-employed understand how to work safely during the coronavirus pandemic.

There are 8 guides, including on Factoriesplants and warehouses and on Vehicles. 

 

Media Summary

 

MHRA shuts down more ‘bogus’ Covid sites

P3 Pharmacy, 12 May 2020

P3 Pharmacy reports that the Medicines and Healthcare products Regulatory Agency (MHRA) has warned people against buying online medicines and health products that claim to cure and prevent Covid-19, and says it has shut down a total of 11 websites and social media accounts since the pandemic began.

The regulator is warning the public that products being marketed as ‘miracle cures’, ‘divine cleansing oils’ and ‘antiviral misting sprays’ are unlicensed and not authorised to be sold on the UK market.

The MHRA has launched a #FakeMeds campaign to ensure medical products bought online are purchased from legitimate sources and have encouraged people to report any suspect medicines or medical devices to its Yellow Card scheme.

 

Parliamentary Coverage

 

House of Commons – Written Answer, 12 May 2020

Alexander Stafford (Rother Valley): To ask the Secretary of State for Health and Social Care, what plans he has for the future funding of community pharmacies.

Jo Churchill: In July 2019, we set out our landmark five-year Community Pharmacy Contractual Framework (CPCF) deal to deliver an expanded role for community pharmacy. The deal commits £2.592 billion per year to community pharmacy from 2019-20 to 2023-24. This amounts to almost £13 billion across the five years.

We set out that we would reprioritise funding, moving to a more service based contractual framework. The Department and NHS England and NHS Improvement will continue to work with the Pharmaceutical Services Negotiating Committee to develop and deliver this joint vision. A more detailed breakdown of the funding can be found in the Community Pharmacy Contractual Framework at the following link: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/819601/cpcf-2019-to-2024.pdf

 

Full Coverage

MHRA shuts down more ‘bogus’ Covid sites

P3 Pharmacy, 12 May 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned people against buying online medicines and health products that claim to cure and prevent Covid-19, and says it has shut down a total of 11 websites and social media accounts since the pandemic began.

The MHRA said in early April it had shut down nine websites and social media accounts selling fake or unlicensed Covid-19 products. The Agency told Pharmacy Network News today it has “now removed a further two websites”.

“Working with our partners from law enforcement agencies we are closing media accounts, removing social media posts and suspending domain names,” it told PNN, adding that more investigations are currently underway.

The regulator is warning the public that products being marketed as ‘miracle cures’, ‘divine cleansing oils’ and ‘antiviral misting sprays’ are unlicensed and not authorised to be sold on the UK market.

The MHRA declined to say how prevalent the issue is, instead offering the following statement: “We are living in unprecedented times and people are understandably anxious which leads them to seek cures, preventions and diagnostics online. We are seeing a small number of products making such claims and will investigate where there is non-compliance with legal requirements.”

‘Safety cannot be guaranteed’

The MHRA has launched a #FakeMeds campaign to ensure medical products bought online are purchased from legitimate sources and have encouraged people to report any suspect medicines or medical devices to its Yellow Card scheme.

“You may have heard about products claiming to treat or cure covid-19. At this time there is no medicine licensed specifically to treat or prevent covid-19,” said Lynda Scammell, senior enforcement advisor at the MHRA.

“We want to caution people that products claiming to do so are not authorised and have not undergone regulatory approvals required for sale on the UK market. We cannot guarantee the safety or quality of these products and this poses a risk to your health.

“Don’t be fooled by online offers for medical products to help prevent or treat covid-19. One of the risks of buying medicines and medical devices from unregulated sources is that you just don’t know what you will receive.

“You could be risking your health, and this could further spread the virus and increase pressure on our NHS and social care systems.”

Media and Political Bulletin

07 May 2020

Media Summary

 

GPhC warns seven online pharmacies over illegal COVID-19 tests

Chemist+Druggist, Eliza Slawther, 06 May 2020

Chemist+Druggist reports that the General Pharmaceutical Council (GPhC) has written to seven online pharmacies to request they remove illegal COVID-19 home testing kits from sale.

While it is legal for pharmacies to sell tests where samples are subsequently analysed in a laboratory, it is currently illegal to supply tests with rapid results for testing and diagnosing at home or in community pharmacies.

MHRA head of operations for enforcement Tariq Sarwar said the regulator was “committed to working together with law enforcement to protect public health and prevent unsafe medicines and medical devices getting to the public.”

EXCLUSIVE: Hancock pledges more support for pharmacy but rules out writing off £300m uplift

Pharmacy Business, Pri Mandav, 06 May 2020

Following the announcement of the £300 million “advance funding” to alleviate immediate pharmacy cashflow issues, Pharmacy Business reports that Matt Hancock has said he is “working with the pharmacy sector on how to make sure that pharmacies are sustainable in these really difficult times, and feel supported”.

Acknowledging the vital role of pharmacists in the pandemic whilst also pledging more support for the sector, Hancock noted that his enthusiasm for the sector led him to making it “a big part” of his priority as health secretary, adding: “We are going to put more and more support into pharmacy.”

Parliamentary Coverage

 

There was no parliamentary coverage today.

 

Full Coverage

GPhC warns seven online pharmacies over illegal COVID-19 tests

Chemist+Druggist, Eliza Slawther, 06 May 2020

The General Pharmaceutical Council (GPhC) has written to seven online pharmacies to request they remove illegal COVID-19 home testing kits from sale.

It is legal for pharmacies to sell tests where samples are subsequently analysed in a laboratory,

It is currently illegal to supply tests with rapid results for testing and diagnosing at home or in community pharmacies.

The GPhC told C+D last month (April 29) that it had written to the seven pharmacies to underline the Medicines and Healthcare products Regulatory Authority (MHRA) guidance that it is “illegal to sell home test kits without a CE mark” . It also requested that the tests were removed from sale, it said.

“We expect pharmacy owners to comply with the law and consider relevant guidance from appropriate bodies such as the MHRA, Public Health England (PHE) and the Royal Pharmaceutical Society,” the GPhC added.

“MHRA advice is that there are currently no CE-marked tests for home use, and it is illegal to supply such products,” it explained.

In March, PHE advised against the use of coronavirus tests in community pharmacies and at home, citing that there was “no published evidence” of their efficacy.

However, some pharmacies are selling home sampling kits, which involve collecting a sample at home that is then processed by an accredited laboratory. Such tests are legal if they have a CE mark.

Last month (April 15), the National Crime Agency (NCA) said it had arrested a pharmacist from Croydon on suspicion of illegally selling coronavirus testing kits.

In the same NCA statement, MHRA head of operations for enforcement Tariq Sarwar said the regulator was “committed to working together with law enforcement to protect public health and prevent unsafe medicines and medical devices getting to the public.”

EXCLUSIVE: Hancock pledges more support for pharmacy but rules out writing off £300m uplift

Pharmacy Business, Pri Mandav, 06 May 2020

Health secretary Matt Hancock has acknowledged the vital role of pharmacists in the pandemic whilst pledging more support for the sector.

“There is a vast proportion of people working in pharmacies from BAME backgrounds. Pharmacy would fall over without these communities,” Hancock told Eastern Eye’s executive editor Shailesh Solanki in an exclusive interview on Tuesday (May 5).

He added: “We are going to put more and more support into pharmacy.”

£300m cash advance

After a number of independent pharmacists complained that they were paying tens of thousands of pounds to keep their businesses afloat during the pandemic, the government announced a £300 million “advance funding” to alleviate their immediate cashflow issues.

While the government announcement was categorical that the cash injection would be “reconciled at a later date,” just days later, the health secretary wrote off £13.4 billion in historical debts for the NHS to help it respond to the Covid-19 pandemic, raising renewed hopes for pharmacists fighting the conronavirus pandemic from the frontline.

Asked if this ‘advance’ could be written off and if he was looking at additional funding for community pharmacy, Hancock said: “Unfortunately, as tempting as it is, the Chancellor of the Exchequer wouldn’t be very pleased if I did that on this call.

“But it is something that I’m working with the pharmacy sector on – how to make sure that pharmacies are sustainable in these really difficult times, and feel supported.

“I get the fact that if people aren’t buying things from the store, which are normally cross subsidised, some of the services that you are giving as part of the pharmacy offer.

“I get the fact that that leads to an extra pressure on the bottom line. It is something that I’m talking to the trade associations about and that we are working on.

“I am very alive to this and I’m alive to the fact that community pharmacies are sometimes the only stores open in some communities. Especially where a GP or a walk-in centre isn’t open during the crisis.

Massive fan of pharmacy

“So, there is an even bigger role for community pharmacies than ever before. I am a massive fan of community pharmacy. There is so much more than they can offer and give everybody.

“They work to the absolute top of their qualifications and there is a bigger role beyond this crisis for community pharmacy.

“If anything, my instinct is to support pharmacies and community pharmacies have been really borne out and my determination to drive that forward has been redoubled and we’ve got to support pharmacy through so there is a strong pharmacy sector coming out of this, ready to serve the nation.”

Reiterating that pharmacy cutbacks did not “happen on my watch,” he noted that his enthusiasm for the sector led him into making it “a big part” of his priority as health secretary.

Media and Political Bulletin

06 May 2020

Media Summary

 

Wholesale depots closed this Bank Holiday Friday

Dispensing Doctors’ Association, Ailsa Colquhoun, 05 May 2020

Dispensing Doctors’ Association reports that wholesalers have confirmed that depots will be closed this Friday (May 8), which has been designated the early May Bank Holiday.

HDA wholesalers will have in place the normal out-of-hours procedures and emergency deliveries for Friday. Normal deliveries will be made on Thursday 7 May and Saturday 9 May.

Each Bank Holiday will be reviewed during the current COVID-19 pandemic on a case-by-case basis.

MHRA launches website to report side effects of drugs and faulty devices used in Covid-19 treatment

Pharmacy Business, Pri Mandav, 05 May 2020

Pharmacy Business reports that the Medicines and Healthcare products Regulatory Agency (MHRA) has launched a website dedicated to reporting adverse effects of medicines or medical devices while treating Covid-19 patients.

The regulator noted that any healthcare product used in the treatment of COVID-19 can be reported, including medical devices such as ventilators and respiratory support devices, testing kits, some protective personal equipment and medicines falsely claiming to cure a patient.

Dr June Raine, chief executive of the MHRA, said: “We appreciate that healthcare professionals are under pressure at this challenging time, but reporting remains essential both to understand the safety of existing medicines and medical devices used in treating COVID-19, and to identify new safety issues.”

 

Parliamentary Coverage

 

House of Commons – Oral Question, 04 May 2020

Naz Shah (Bradford West): For what reasons the UK did not join the EU joint procurement programme for personal protective equipment.

The Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office (Michael Gove): I thank the hon. Lady for her question. Owing to an initial communication problem, the UK did not receive the invitation in time to join the four EU joint procurements, including on PPE. We will, however, participate in the EU joint procurement scheme on therapeutics that is soon to launch, and we will consider participating in future schemes, including any on PPE, on the basis of public health requirements.

Naz Shah (Bradford West): The UK has left the EU, but the NHS Confederation and other top health officials have warned that failing to continue co-operation would be a disaster for public health. Does the failure of working together over PPE signal a new approach by the Government that puts ideology before the nation’s health?

Michael Gove: No.

House of Commons – Oral Question, 04 May 2020

Paul Blomfield (Sheffield Central): It was good to hear reports this morning that the Government are getting behind the EU-led international initiatives to find a coronavirus vaccine. Given this approach, can the Minister confirm reports that the Government are now seeking to retain participation in the EU’s early warning and response system for pandemics, as requested by the Department of Health and Social Care and NHS Providers, and will they look again at participation in the European Medicines Agency?

Michael Gove: I am grateful to the hon. Gentleman for making that point. We will co-operate not just with our European neighbours, but with other countries in the fight against covid-19. He is right to say that the Prime Minister is joining the call today to ensure that we can support the effort to secure a vaccine. The effort to secure a vaccine is necessarily an international one. We will of course look pragmatically at how we can co-operate with our European friends and partners, but participation in the European Medicines Agency would involve, certainly at the moment, the acceptance of the European Court of Justice’s oversight, and that is not something the British people voted to do.

House of Commons – Written Question, 04 May 2020

Justin Madders (Ellesmere Port and Neston): To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the availability of generic drugs since the start of the covid-19 outbreak; and what assessment he has made of the effect of the outbreak on the supply of medicines.

Jo Churchill: As part of our concerted national efforts to respond to the COVID-19 outbreak, we are doing everything we can to ensure patients continue to access safe and effective medicines.

The Department is working closely with the pharmaceutical industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines they need. and precautions are in place to reduce the likelihood of future shortages, including access to United Kingdom stockpiles of a range of generic medicines.

The Department shares regular information about impending supply issues and management plans with the NHS via networks in primary and secondary care and will liaise with relevant patient groups about issues affecting specific medicines.

 

Full Coverage

 

Wholesale depots closed this Bank Holiday Friday

Dispensing Doctors’ Association, Ailsa Colquhoun, 05 May 2020

Wholesalers have confirmed that depots will be closed this Friday (May 8), which has been designated the early May Bank Holiday.

According to their trade body, HDA wholesalers will have in place the normal out-of-hours procedures and emergency deliveries for Friday. Normal deliveries will be made on Thursday 7 May and Saturday 9 May.

Each Bank Holiday will be reviewed during the current COVID-19 pandemic on a case-by-case basis.

Dispensing Doctors will have their delivery schedules communicated to them by their wholesaler.

MHRA launches website to report side effects of drugs and faulty devices used in Covid-19 treatment

Pharmacy Business, Pri Mandav, 05 May 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a website dedicated to reporting adverse effects of medicines or medical devices while treating Covid-19 patients.

According to the MHRA, reporting on the Yellow Card website will enable the regulator “to rapidly identify” new and emerging side effects of medicines on patients and “medical device issues which may not have been previously known about, including diagnostics tests for Covid 19.”

“This includes any medicines taken by patients to manage long-term, or pre-existing conditions that may influence the disease or have any potential interactions,” the MHRA added.

The regulator noted that any healthcare product used in the treatment of COVID-19 can be reported, including medical devices such as ventilators and respiratory support devices, testing kits, some protective personal equipment and medicines falsely claiming to cure a patient.

In a communication published on Tuesday (May 5), Dr June Raine, chief executive of the MHRA, said: “We appreciate that healthcare professionals are under pressure at this challenging time, but reporting remains essential both to understand the safety of existing medicines and medical devices used in treating COVID-19, and to identify new safety issues.”

Media and Political Bulletin

09 April 2020

Media Summary

Coronavirus fuels a surge in fake medicines

BBC News, Sam Piranty, 09 April 2020

The World Health Organization (WHO) has warned of a growing numbers of fake medicines linked to coronavirus being on sale in developing countries. A BBC News investigation found fake drugs for sale in Africa, with counterfeiters exploiting growing gaps in the market.

In the same week the WHO declared coronavirus a pandemic last month, Operation Pangea, Interpol’s global pharmaceutical crime fighting unit, made 121 arrests across 90 countries in just seven days, resulting in the seizure of dangerous pharmaceuticals worth over $14m (£11m).

According to the WHO, the broader falsified medicines trade, which includes medicines which may be contaminated, contain the wrong or no active ingredient, or may be out-of-date, is worth more than $30bn in low and middle-income countries.

UK and Europe tackle false COVID-19 medicinal products

European Pharmaceutical Review, Victoria Rees, 08 April 2020

European Pharmaceutical Review reports that the MHRA and Council of Europe have both announced measures to prevent the spread of falsified or unlicensed COVID-19 medical products.

The UK MHRA has announced it is currently investigating 14 cases of fake or unlicensed COVID-19 medicinal products. According to the regulatory authority, a number of falsified medical products are being sold on unauthorised websites claiming to treat or prevent COVID-19.

Meanwhile, the Council of Europe has called on governments to be extremely vigilant against counterfeit or falsified medicines and medical products during the COVID-19 pandemic. In an opinion published yesterday, the MEDICRIME Committee warns of the increased risk, in these times of shortage, of the sale of falsified medical products.

EU authorities agree new measures to support the pharma supply chain during COVID-19 pandemic

European Pharmaceutical Review, Hannah Balfour, 08 April 2020

European Pharmaceutical Review reports that EU authorities, including the EMA, have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic, to help support the availability of medicines during the COVID-19 pandemic.

According to the EMA, some EU Member States have reported shortages of medicines, including those used in intensive care units (ICUs), such as anaesthetics, antibiotics and muscle relaxants and some medicines used off-label for COVID-19.

While the number of medicine shortages has been increasing over a few years, the pandemic is exacerbating the issue, primarily due to lockdowns of countries and factories who typically supply medicines to the EU, export bans, logistical complications caused by border closures and stockpiling at state, hospital and citizen levels.

EU urges states to lift drug export bans to prevent shortages

Reuters, Francesco Guarascio, 08 April 2020

Reuters reports that the head of the European Commission, Ursula von der Leyen, on Wednesday urged European Union states to lift export bans on medicines to avoid causing shortages in the bloc as it tackles the coronavirus crisis.

Half of EU states have designated long lists of drugs that cannot be exported during the coronavirus emergency. The lists include medication used to treat COVID-19 patients such as muscle relaxants, painkillers and hydroxychloroquine.

“We ask that national governments lift any export ban on medicines. Such restrictions can lead to shortages elsewhere in the EU,” von der Leyen said in a statement. She also called on governments to avoid stockpiling.

PDA: NHS England should match support given to Scottish pharmacies

C+D, Rachael Carter, 08 April 2020

C+D reports that the Pharmacists’ Defence Association (PDA) is calling on NHS England to match the support given to Scottish pharmacies to help fight the COVID-19 outbreak.

It comes after the Scottish government announced it would meet in full the extra costs faced by community pharmacies to support the NHS during the pandemic. The support includes an “initial” funding boost of £5.5 million to help cover the costs of equipment, additional staffing, premises adaptations and locum cover for staff absence.

In a statement published yesterday, the PDA said resources given to pharmacies in England are “woefully inadequate” in comparison. This is despite the fact that they are responding to the same pressures but on a larger scale and against the backdrop of significant funding cuts in recent years, the PDA added.

In England, the government last week (March 31) announced £300m in “advance funding” for community pharmacy to help alleviate the pressures created by the COVID-19 outbreak. The £300m is not new money for the sector and the PSNC has said it will have to be “reconciled at a later date”.

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Coronavirus fuels a surge in fake medicines

BBC News, Sam Piranty, 09 April 2020

Growing numbers of fake medicines linked to coronavirus are on sale in developing countries, the World Health Organization (WHO) has warned.

A BBC News investigation found fake drugs for sale in Africa, with counterfeiters exploiting growing gaps in the market.

The WHO said taking these drugs could have “serious side effects”.

One expert warned of “a parallel pandemic, of substandard and falsified products”.

Around the world, people are stockpiling basic medicines. However, with the world’s two largest producers of medical supplies – China and India – in lockdown, demand now outstrips the supply and the circulation of dangerous counterfeit drugs is soaring.

In the same week the World Health Organization (WHO) declared coronavirus a pandemic last month, Operation Pangea, Interpol’s global pharmaceutical crime fighting unit, made 121 arrests across 90 countries in just seven days, resulting in the seizure of dangerous pharmaceuticals worth over $14m (£11m).

From Malaysia to Mozambique, police officers confiscated tens of thousands of counterfeit face masks and fake medicines, many of which claimed to be able to cure coronavirus.

“The illicit trade in such counterfeit medical items during a public health crisis, shows a total disregard for people’s lives,” said Interpol’s Secretary General Jurgen Stock.

According to the WHO, the broader falsified medicines trade, which includes medicines which may be contaminated, contain the wrong or no active ingredient, or may be out-of-date, is worth more than $30bn in low and middle-income countries.

“Best case scenario they [fake medicines] probably won’t treat the disease for which they were intended”, said Pernette Bourdillion Esteve, from the WHO team dealing with falsified medical products.

“But worst-case scenario they’ll actively cause harm, because they might be contaminated with something toxic.”

The supply chain

The global pharmaceutical industry is worth more than $1 trillion. Vast supply chains stretch all the way from key manufacturers in places such as China and India, to packaging warehouses in Europe, South America or Asia, to distributors sending medicines to every country in the world.

There is “probably nothing more globalised than medicine” said Esteve. However, as the world goes into lockdown, the supply chain has already begun to uncouple.

Several pharmaceutical companies in India told the BBC they are now operating at 50-60% of their normal capacity. As Indian companies supply 20% of all basic medicines to Africa, nations there are being disproportionately affected.

Ephraim Phiri, a pharmacist in Zambia’s capital Lusaka, said he was already feeling the strain.

“Medicines are already running out and we are not replenishing them. There is nothing we can do. It’s been really hard to get supplies… especially essential medicines like antibiotics and antimalarials.”

Producers and suppliers are also struggling as the raw ingredients to manufacture tablets are now so expensive, some companies can simply not afford to keep going.

One producer in Pakistan said he used to buy the raw ingredients for an antimalarial drug called hydrochloroquine for about $100 a kilo. But today, the cost has increased to $1,150 a kilo.

With an increasing number of countries going into lockdown, it’s not only the reduction in production that’s problematic, it’s also the increase in demand, as people around the world anxiously stockpile basic medicines.

It’s this unstable combination of reduced supply and increased demand that has led the WHO to warn of a dangerous spike in the production and sales of fake drugs.

“When the supply does not meet the demand,” said Esteve, from the WHO, “it creates an environment where poorer quality or fake medicines will try to meet that demand.”

Fake medicine

Speaking to pharmacists and drug companies around the world, the global supply of antimalarials is now under threat.

Ever since US President Donald Trump began referring to the potential of chloroquine and a related derivative, hydroxychloroquine, in White House briefings, there has been a global surge in the demand for these drugs, which are normally used to tackle malaria.

The WHO has repeatedly said there is no definitive evidence that chloroquine or hydroxychloroquine can be used against the virus that causes Covid-19. However, at a recent news conference, whilst referring to these antimalarials, President Trump said: “What do you have to lose? Take it.”

As the demand has soared, the BBC has discovered large quantities of fake chloroquine in circulation in the Democratic Republic of Congo and Cameroon. The WHO has also found the fake medicines for sale in Niger.

The antimalarial chloroquine is normally sold for about $40 for a pot of 1,000 tablets. But pharmacists in the DRC were found to be selling them for up to $250.

The medicine being sold was allegedly manufactured in Belgium, by “Brown and Burk Pharmaceutical limited”. However, Brown and Burk, a pharmaceutical company registered in the UK, said they had “nothing to do with this medicine. We don’t manufacture this drug, it’s fake.”

As the coronavirus pandemic continues, Professor Paul Newton, an expert in fake medicines at the University of Oxford, warned the circulation of fake and dangerous medicines would only increase unless governments around the world present a united front.

“We risk a parallel pandemic, of substandard and falsified products unless we all ensure that there is a global co-ordinated plan for co-ordinated production, equitable distribution and the surveillance of the quality of the tests, medicines and vaccines. Otherwise the benefits of modern medicine… will be lost.”

UK and Europe tackle false COVID-19 medicinal products

European Pharmaceutical Review, Victoria Rees, 08 April 2020

The MHRA and Council of Europe have both announced measures to prevent the spread of falsified or unlicensed COVID-19 medical products.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced it is currently investigating 14 cases of fake or unlicensed COVID-19 medicinal products.

According to the regulatory authority, a number of falsified medical products are being sold on unauthorised websites claiming to treat or prevent COVID-19. These include self-testing kits, ‘miracle cures’, ‘antiviral misting sprays’ and unlicensed medicines.

At this time, there are currently no medicines licensed specifically for the treatment or prevention of COVID-19 and there are no CE marked self-testing kits approved for home use.

The MHRA has disabled nine domain names and social media accounts selling the fake products.

Lynda Scammell, MHRA Enforcement Official said: “There is no medicine licensed specifically to treat or prevent COVID-19, therefore any claiming to do so are not authorised and have not undergone regulatory approvals required for sale on the UK market. We cannot guarantee the safety or quality of the product and this poses a risk to health… We are working alongside other law enforcement agencies to combat this type of criminal activity.”

This advice is part of the MHRA’s ongoing #FakeMeds campaign which aims to encourage people who buy medical products online to make sure they are purchasing from legitimate sources.

Meanwhile, the Council of Europe has called on governments to be extremely vigilant against counterfeit or falsified medicines and medical products during the COVID-19 pandemic. According to the council, states can rely on the MEDICRIME Convention to safeguard public health and target the criminal behaviour of those who, like criminal networks, take advantage of the loopholes in regulatory systems.

In an opinion published today, the MEDICRIME Committee warns of the increased risk, in these times of shortage, of the sale of falsified medical products.

It also makes a number of recommendations:

  • Online platforms offering medical products to the public health system or to individuals should be monitored and states should work together to break the supply chain of falsified medical products that are traded between their territories.
  • Staff should be assigned to hot spots to detect and stop the trafficking of falsified medical products.
  • In order to prevent criminals from exploiting shortages, measures must be taken to prevent the unauthorised diversion of essential medical products from state health systems and supply channels.
  • Close co-operation between national agencies and services is necessary to ensure that measures to prevent falsified medical products from entering the health services do not affect the legitimate supply of medical products needed by beneficiaries. Similarly, health professionals and health services must ensure that they do not obtain medical products from unverified sources.
  • National and international co-operation must be intensified to gather evidence of the criminal nature of medical product-related offences committed during the pandemic.
  • The rights of victims, including the right to be informed of the effects of falsified medical products on their health, must be guaranteed.

EU authorities agree new measures to support the pharma supply chain during COVID-19 pandemic

European Pharmaceutical Review, Hannah Balfour, 08 April 2020

The European Medicines Agency (EMA) and other authorities have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic.

EU authorities, including the European Medicines Agency (EMA) and European medicines regulatory network, have agreed new measures to help support the availability of medicines during the COVID-19 pandemic.

According to the EMA, some EU Member States have reported shortages of medicines, including those used in intensive care units (ICUs), such as anaesthetics, antibiotics and muscle relaxants and some medicines used off-label for COVID-19. To mitigate the effect of the COVID-19 pandemic on the pharmaceutical supply chain, the EU authorities are putting in place additional measures.

While the number of medicine shortages has been increasing over a few years, the pandemic is exacerbating the issue, primarily due to lockdowns of countries and factories who typically supply medicines to the EU, export bans, logistical complications caused by border closures and stockpiling at state, hospital and citizen levels.

To mitigate supply disruptions, the EMA’s EU Executive Steering Group on Shortages of Medicines Caused by Major Events (EU Executive Steering Group) is setting up a new reporting system: the i-SPOC (industry single point of contact) system, designed to fast-track interaction on shortages between industry and the EMA. Each pharmaceutical company will appoint an i-SPOC to report directly to the EMA on anticipated shortages or current shortages of critical medicines used in the context of COVID-19. The regulatory body notes that in parallel, companies will continue reporting these shortages to the appropriate national competent authorities.

The agency hopes the i-SPOC system will enable improved oversight of ongoing supply issues irrespective of the licensing route and that the quicker flow of information with the pharmaceutical industry will prevent shortages due to the COVID-19 pandemic.

The EMA and European medicines regulatory network are also considering other measures, including regulatory actions to support increased manufacturing capacities, e.g., speeding up the approval of a new manufacturing line or site and looking for areas where regulations could be applied more flexibly to secure supply of critical medicines. Further information will be given in a question-and-answer document, currently under development.

Information on ongoing medicine shortages in the EU is available in the relevant national shortages registers and the EMA’s shortages catalogue.

EU urges states to lift drug export bans to prevent shortages

Reuters, Francesco Guarascio, 08 April 2020

The head of the European Commission, Ursula von der Leyen, on Wednesday urged European Union states to lift export bans on medicines to avoid causing shortages in the bloc as it tackles the coronavirus crisis.

Half of EU states have designated long lists of drugs that cannot be exported during the coronavirus emergency. The lists include medication used to treat COVID-19 patients such as muscle relaxants, painkillers and hydroxychloroquine.

“We ask that national governments lift any export ban on medicines. Such restrictions can lead to shortages elsewhere in the EU,” von der Leyen said in a statement. She also called on governments to avoid stockpiling.

Bans are usually justified with the need to fulfil national needs, but Europe has so far faced only limited supply problems from the coronavirus crisis.

Temporary shortages have been recorded mostly for drugs used to treat critically ill COVID-19 patients, such as anaesthetics, antibiotics and muscle relaxants that allow people to receive breathing support from ventilators.

But national lists comprise many more drugs, including some that have wider uses such as the painkiller paracetamol and insulin, used by diabetics.

The European Commission on Wednesday adopted new guidance on drugs supplies, which calls on governments to refrain from export bans and from requisitioning medicines.

“Whilst it is understandable that countries wish to ensure the availability of essential medicines nationally, export bans are detrimental to the availability of medicines for European patients even when they are legally justifiable,” the non-binding document says.

France, Poland, Belgium and the Czech Republic are among the EU countries with the longest lists of drugs which are temporarily banned from export. The bans apply mostly to distributors, which cover a large part of the EU market and provide the biggest share of supplies to pharmacies.

The new guidelines also called on states to stop excessive stockpiling, which the Commission said could contribute to supply shortages. It warned the worst effects on supplies from stockpiling emerge when countries compete among themselves.

The Commission is setting up an EU reserve of critical medicines and medical gear to address future needs.

PDA: NHS England should match support given to Scottish pharmacies

C+D, Rachael Carter, 08 April 2020

The Pharmacists’ Defence Association (PDA) is calling on NHS England to match the support given to Scottish pharmacies to help fight the COVID-19 outbreak.

It comes after the Scottish government announced it would meet in full the extra costs faced by community pharmacies to support the NHS during the pandemic yesterday (April 7).

The support includes an “initial” funding boost of £5.5 million to help cover the costs of equipment, additional staffing, premises adaptations and locum cover for staff absence.

In a statement published yesterday, the PDA said resources given to pharmacies in England are “woefully inadequate” in comparison. This is despite the fact that they are responding to the same pressures but on a larger scale and against the backdrop of significant funding cuts in recent years, the PDA added.

In England, the government last week (March 31) announced £300m in “advance funding” for community pharmacy to help alleviate the pressures created by the COVID-19 outbreak.

The £300m is not new money for the sector and the Pharmaceutical Services Negotiating Committee (PSNC) has said it will have to be “reconciled at a later date”.

An initial £200m was paid as an uplift to contractors on April 1, with the remaining £100m due to be paid on May 1.

“Lack of support”

PDA chairman Mark Koziol said: “Pharmacists working in England will be dismayed that NHS England attributes so little value to their incredibly hard work.

“Last week, while the minister of health persuaded the chancellor to write off £13.4bn of central NHS debt, he offered community pharmacists only a loan, the size of which does not even cover the cost of the additional drugs bill.”

Mr Koziol added that the lack of support and recognition for the hard work of pharmacy teams in England was a “travesty” that should not be allowed to continue any longer.

“We demand that NHS England provides at least the same support to the pharmacy frontline teams as has the NHS in Scotland,” he said.

Media Summary

Exports and customs procedures

MHRA Blog, Cheryl Blake, 14 February 2017

MHRA events in December 2016 discussed the Unified Customs Codes (UCC) and their latest article elaborates on this by explaining the central export procedures and requirements. The need to provide accurate and correct information on customs declarations is underscored. To facilitate this, export documentation must be carefully managed to prevent problems with poor control or lack of visibility within the supply chain. Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) will be routinely requesting full export documentation at inspection to support these measures.

Hub on EU falsified medicines directive developed for UK pharmacists

The Pharmaceutical Journal, 13 February 2017

A website has been launched to inform community pharmacists about the introduction of the EU Falsified Medicines Directive (FMD). It outlines new authentication systems and dates of implementation, as well as offering information on how to implement changes. The UK database will be developed by SecurMed UK. Chair of the UK FMD working group for community pharmacy and dispensing entities director of SecurMed UK, said: “FMD aims to reduce [falsification] by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process”.

Revealed: 23 trusts chosen for new Carter review

HSJ, Joe Gammie, 14 February 2017

Twenty-three trusts have been selected for the first phase of Lord Carter’s new review on productivity at mental health and community service organisations. The review will follow a similar format to Lord Carter’s previous investigation into hospital productivity. The engagement phase will include a focus on what ‘good’ looks like, how to drive existing efficiency measures, and what metrics and indicators are required to support the development of the model for these sectors. Benchmarking criteria for an ‘optimal model’ NHS community or mental health care trust will also be created.

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Exports and customs procedures

MHRA Blog, Cheryl Blake, 14 February 2017

Those of you who attended our symposiums in either Glasgow or London during December 2016 will have heard Jane Sewell – International Trade Development Liaison Officer from HMRC speak about the Unified Customs Code.

This is a major change in customs legislation affecting the international freight industry and businesses making customs declarations. The Union Customs Code (UCC) was introduced across the European Union on 1st May 2016 and consequently it introduced a number of changes to how goods cross EU borders.  Jane spoke of the importance of providing accurate and correct information on customs declarations and also touched upon the Incoterm Ex Works and the difficulties of proving export has taken place when entering into trade agreements in this manner.

Those of you who are regular attendees at these events will have heard me speak on similar themes over the years.  The changes brought about by the introduction of the UCC are important and far reaching and may have been new to many delegates and to many of you that may be reading this post.

Also at the symposium delegates heard a shocking, but interesting, presentation by my colleague Naseem Hudroge, Senior Intelligence Analyst, which gave further insight into the importance of getting customs declarations correct and also highlighted the need for you to be able to present such export documentation when it is asked for during an inspection. Both the MHRA and HMRC will expect these declarations to be correct, accurate and available.

In this, my first blog post, I shall attempt to put this information into context and to suggest ways in which you can actively prevent your company receiving deficiencies in the area of lack of documentation and poor control, or lack of visibility within the supply chain, simply by making small changes to and increasing your understanding of export procedures and requirements.

When exporting a medicinal product, a declaration must be made to HMRC to indicate exactly what is being shipped, who is making the shipment and where the product is ultimately going.

The product should be accompanied by a commercial invoice – proforma invoices are to be avoided as this can, and has led to misleading customs declarations being completed. A false declaration may result in seizure of the product and may also lead to a fine.

It is the responsibility of the exporter to enquire into the import and export regulations (any prohibitions, restrictions, trade embargoes, etc.) that may be in force in relation to the destination country. The exporter must ensure that certificates of origin, export licenses and the like which may be required in relation to the trade in the particular commodity within the destination country are applied for and that the correct documentation accompanies the shipment. Copies of this documentation should routinely be retained.

HMRC paperwork

The exporter (consignor) is also responsible for ensuring that:

  • medicinal products remain in the legal supply chain,
  • export paperwork is correctly completed,
  • proof of export is obtained and retained,
  • the consignee is entitled to receive the product, and
  • the product has been stored, handled and shipped in accordance with GDP.

Your freight forwarder or shipping agent is a key partner. It is best practice to routinely provide the freight forwarder, shipping department or freight agent with the following:

  • your Economic Operator Registration and Identification (EORI) number
  • details of whom the goods are to be consigned to (name and address in full)
  • commercial reference to be incorporated into the Declaration Unique Consignment Reference (DUCR) to assist with export audit trails
  • details of the country of final destination
  • shipping or flight details
  • correct value of goods in the correct currency code
  • the Commodity Code and a clear and unambiguous description of the goods, their quantity, marks and numbers.
  • any reference numbers already issued by HMRC – such as any previous declarations made in respect of the product. For example, the declaration made when the product was ‘introduced’.

Whilst on inspection, upon asking for documentation relating to an export to a third country we are frequently presented with invoices which show the Incoterm ‘Ex Works’. This generally causes issues at inspection as the consignor may have handed the product over for export to a representative of a company appointed by the consignee. Where this is the case, the consignor generally will be unable to demonstrate GDP compliance or indeed produce any paperwork showing the product has been exported as claimed. Companies should request copies of the documentation (which is interchangeably referred to as the SAD, C88 or export declaration) from their shipping agent and check this for accuracy.

The Incoterm EXW (Ex Works) puts the onus on the consignee to arrange the pre-carriage from the seller’s premises to the point of export, and to complete and pay for the export formalities.  In most export scenarios this presents practical difficulties. Realistically for all export transactions the exporter needs to be involved in export reporting formalities and cannot realistically leave this to the consignee.

A lesser used but more practical Incoterm when an exporter does not wish to pay for the carriage of the product, is FCA – Free Carrier (named place of delivery). Generally the named place of delivery will be the port through which the product is leaving. With this Incoterm, the seller has control regarding the transport and customs formalities prior to the goods leaving the territory, and the buyer pays for the main transport.

Since it is the legal responsibility of the declarant to ensure that the goods are accurately declared when presented to HMRC, using this Incoterm gives the seller the control required. Crucially the seller also takes responsibility for arranging the transport to the point of shipment (or consolidation) and can therefore control where the goods are held and by whom prior to shipment, hence ensuring that the product remains within the legal supply chain and under GDP

control up to the point of main transport, which will have risk assessed according to Chapter 9 of 2013/C 343/01.

Both the GDP and GMP inspectorate will be routinely requesting full export documentation at inspection – and this extends to the CHIEF (Customs Handling of Import and Export Freight) entry – bills of lading or airway bills, export licences where applicable, and any certificates of origin that may be required for that particular commodity to be sent to the destination country. For exports we still expect that you can show the same due diligence.

Finally, I would like to leave you with the thought that, as the exporter, the responsibility in ensuring the information you provide to HMRC rests with you.

I intend to produce a second post during 2017 on the subject of introduction.

Hub on EU falsified medicines directive developed for UK pharmacists

The Pharmaceutical Journal, 13 February 2017

A website containing information to help community pharmacists prepare for the introduction of the EU Falsified Medicines Directive (FMD) has been launched by the UK FMD working group for community pharmacy, which includes representatives of all the main bodies in community pharmacy.

The website’s aim is to help UK pharmacies prepare for whatever new authentication systems are developed and introduced, and has been tailored to reflect the way UK pharmacies operate, rather than a theoretical ‘European’ model.

Under the FMD, all new packets of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique barcode and an anti-tamper device.

The website says that it is likely that FMD scanning will come into effect before the UK leaves the EU. Any changes made to the 2012 UK Human Medicines Regulations to implement FMD would remain in place until the UK government decides to change them.

At present, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA), have stated that they are continuing with work to implement FMD in the UK and this is “business as usual” for them.

The UK database will be developed by SecurMed UK, a new organisation representing all the main supply-chain bodies for manufacturers, wholesalers and pharmacies. SecurMed UK represents pharmacy jointly with the National Pharmacy Association and the Company Chemists’ Association.

Raj Patel, a member of the National Pharmacy Association board, who is also chair of the UK FMD working group for community pharmacy as well as the dispensing entities director of SecurMed UK, comments: “Falsification of medicines is a major threat to patient safety and cases of falsification continue to be discovered by authorities. FMD aims to reduce this by allowing pharmacists to verify the authenticity of prescription medicines during the dispensing process.

“We recognise that this will be a big change for everyone in the medicines supply chain, especially community pharmacists. That’s why we’ve been working closely with the Department of Health

and the MHRA to ensure that this is implemented in a proportionate way that fully reflects the UK’s unique dispensing models.”

Revealed: 23 trusts chosen for new Carter review

HSJ, Joe Gammie, 14 February 2017

More than 20 trusts have been chosen to be part of a new NHS efficiency review led by Lord Carter.

The Labour peer and a team from NHS Improvement will look into organisational productivity and performance at mental health and community service organisations.

In a letter seen by HSJ, NHSI said the review will follow a similar structure and methodology to Lord Carter’s previous investigation into acute hospital productivity, published last year.

The letter was written by NHSI director of sector development Luke Edwards, and was sent to all mental health and community trust chief executives and chairs last week.

It reveals the 23 mental health and community service providers that will begin six months of detailed engagement in the first phase of the review with Lord Carter and a team from NHSI’s operational productivity directorate.

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.

See the Infographic

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