News

Media And Political Bulletin – 09 April 2020

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trade, which includes medicines which may be contaminated, contain the wrong or no active ingredient, or may be out-of-date, is worth more than $30bn in low and middle-income countries.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 And Political Bulletin – 09 April 2020

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

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?