News

Media And Political Bulletin – 26 March 2020

Media and Political Bulletin

26 March 2020

Media Summary

European Commission draws up plans to postpone MDR implementation

Med-Tech News, 26 March 2020

Med-Tech News reports that the European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.

The new regulation was due to come into force on 26th May this year but in light of the pandemic, and calls from trade bodies, the Commission has confirmed it is working on a proposal to postpone the application date.

The Commission said: “With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May, its deadline for entry into force. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the Coronavirus crisis.”

Medicine shortages: what’s going on?

Which?, Anna Studman, 25 March 2020

Paracetamol and ibuprofen are just some of the items that are increasingly hard to get hold of as people stock up on everyday essentials in the wake of the coronavirus crisis and UK government lockdown. But Which? reports that even before the pandemic hit, there were issues with prescription medicine shortages in the UK.

Which? members were surveyed in December 2019, and it was found that one in four people had experienced problems getting hold of the medicines they needed because of stock shortages in the past year.

The article explores some of the reasons behind these shortages.

India to set up $1.3bn pharma manufacturing fund, says report

European Pharmaceutical Review, Victoria Rees, 25 March 2020

European Pharmaceutical Review reports that, due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.

Published in Bloomberg, the report highlights that the disruptions to the supply chain because of the outbreak revealed the extent to which India relies on China for APIs and how easily medicine shortages could occur.

Reportedly, a government statement outlined that the funding will go towards infrastructure for drug manufacturing facilities and financial incentives of up to 20 percent incremental sales value over the next eight years.

COVID-19 update: Eli Lilly assures security of insulin supply

European Pharmaceutical Review, Hannah Balfour, 25 March 2020

European Pharmaceutical Review reports that, having become aware of insulin shortages in pharmacies, Eli Lilly has stated that its products are not backordered and should be available for delivery by wholesalers.

The company previously stated that it does not source any active pharmaceutical ingredients (APIs) for their approved medications from China. Therefore, it does not expect to be impacted by reduced manufacturing from the Asia Pacific market.

Lilly stated that it has a network of global manufacturing sites, and that at current, those producing insulin in Europe and the US are still operational, with increased precautions in place to protect the supply of medicine and the welfare of employees from COVID-19. The company say it is continually monitoring the situation for possible impact on the supply of their medicines.

Diamorphine 5mg and 10mg supply update

Dispensing Doctors’ Association, Ailsa Colquhoun, 25 March 2020

Dispensing Doctors’ Association reports that healthcare professionals are asked to plan for a permanent move to morphine sulphate injection as opioid of choice, where clinically appropriate, in place of diamorphine 5mg and 10mg.

Suppliers Wockhardt and Accord have indicated that full supply of these items are unlikely before Summer 2020. Manufacturers of diamorphine hydrochloride 30mg ,100mg, 500mg, which remain available, say they are unable to support an increase in demand on these strengths.

View the alert.

Contractors make urgent plea to chancellor on wholesale bills

P3 Pharmacy, Pharmacy Network News, 25 March 2020

P3 Pharmacy reports that community pharmacy contractors are warning the Government that they will be unable to keep providing vital medicines to patients unless they receive urgent funding assistance to help pay their wholesaler bills.

Amid an extraordinary period in which pharmacies throughout the UK have dispensed record numbers of scripts and contended with shortages and price fluctuations, many are in pressing financial straits.

Mark Lyonette, NPA chief executive told Pharmacy Network News: “We have already appealed to the Government for immediate support to help pharmacies remain operational. We’ve requested a number of emergency measures, including an advance payment scheme for NHS income. Many pharmacies are small businesses with existing cash-flow problems and COVID-19 is dramatically exacerbating this situation.  Above all, we need urgent, substantial new funding to keep pharmacies open.”

Coronavirus: harmonised standards for medical devices to respond to urgent needs

European Commission, 25 March 2020

Yesterday, the European Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure.

The revised harmonised standards play a pivotal role in the current coronavirus pandemic because they relate to critical devices such as: medical face masks; surgical drapes, gowns and suits; washer-disinfectors and sterilization.

Stella Kyriakides, Commissioner for Health said: “With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market. This equipment is fundamental for our health professionals – the brave and resilient women and men at the front line – to keep saving lives”.

 

Parliamentary Coverage

House of Commons – Written Answer, 25 March 2020

James Murray (Ealing North): To ask the Secretary of State for Health and Social Care, if he will make it his policy to recognise the marketing authorisation by the European Medicines Agency of any coronavirus (2019-nCoV) vaccine to ensure there is no risk of delay in the UK acquiring the vaccine in comparison to countries in the EU.

Ms Nadine Dorries (answered on 25 March 2020, holding answer received on 23 March 2020): As of 31 January 2020, the United Kingdom is in the Transition Period. During this time the UK will continue to follow EU legislation which includes European Medicines Agency processes and decisions until 31 December 2020. As such any European Union centrally authorised medicines, including any COVID-19 vaccine, would also be authorised in the UK.

The UK is a world leader in preparing for and managing public health incidents and on 3 March the Government published its action plan to tackle the spread of coronavirus.

Both the EU and the UK are committed to agreeing a future partnership by the end of 2020 and are working to achieve this. The Government is working to ensure that UK patients can access the best and most innovative medicines, whatever the result of negotiations with the EU on our future relationship. It is in the interests of both the UK and the EU to agree a future partnership that keeps goods flowing, services being provided and business being done.

House of Commons – Written Answer, 25 March 2020

Chris Green (Bolton West): To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that all medical device businesses are re-certified so that they comply with the Medical Device Regulation before the May 2020 deadline.

Ms Nadine Dorries (answered on 25 March 2020): The new Medical Device Regulation (MDR), which will become United Kingdom law from 26 May 2020 as part of the European Union Withdrawal Act 2019, substantially strengthens the regulatory framework for medical devices and notified bodies and manufacturers are having to make significant changes to meet the enhanced requirements.

The Government recognises the importance of having competent notified bodies in place to ensure continuity of supply of products to the UK market. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with UK industry and notified bodies on an ongoing basis to ensure that they are prepared for the implementation of the MDR.

There are also transitional provisions in place which enable existing CE marked devices to remain valid for sale until the date of expiry of that certificate. This means in practice that all devices on the UK market do not require immediate re-certification.

The MHRA will publish further guidance on how we intend to support businesses who may struggle to obtain certification under the MDR and to ensure continuity of supply of medical devices to UK patients.

House of Commons – Written Answer, 25 March 2020

Lord Roberts of Llandudno (asked on 19 March 2020): To ask Her Majesty’s Government what assessment they have made of whether the COVID-19 pandemic is likely to result in any medicine shortages.

Lord Bethell (answered on 25 March 2020): The country is well prepared to deal with any impacts of COVID-19 and we have stockpiles of generic drugs, in the event of any supply issues or significant increases in demand.

The Department is working closely with 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.

The steps being taken to protect United Kingdom supplies in response to the COVID-19 outbreak were set out in the Department’s press statement issued on 11 February 2020. These steps include asking suppliers to carry out risk assessments of the potential impacts of COVID-19 on their business and to retain any existing stockpiles of medical supplies from our previous European Union exit work. The statement also outlines that there is no need for the public or NHS to stockpile as this could aggravate problems elsewhere in the supply chain if they emerge.

 

Full Coverage

European Commission draws up plans to postpone MDR implementation

Med-Tech News, 26 March 2020

The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.

The new regulation was due to come into force on 26th May this year but in light of the pandemic, and calls from trade bodies, the Commission has confirmed it is working on a proposal to postpone the application date.

The Commission said: “With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May, its deadline for entry into force. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the Coronavirus crisis.”

Trade association MedTech Europe, who called for the postponement of its implementation earlier this week, welcomed the Commission’s action, but said that a similar solution is need for In Vitro Diagnostic Regulation (IVDR) – which is due to come into force on 26 May 2022.

A statement from MedTech Europe read: “We welcome the announced intention of the European Commission to propose the postponement of the date of application for the Medical Devices Regulation by 12 months, and we also welcome the support that the European Parliament has expressed for this.

“Once adopted, this measure would enable healthcare stakeholders to maintain focus on fighting the COVID-19 pandemic while keeping healthcare systems running. Rest assured that our industry is putting all its efforts to deliver needed medical technologies to patients and healthcare professionals during these difficult weeks.

“For the In Vitro Diagnostic Regulation, we remain convinced that a similar solution is needed. Although this Regulation has a longer implementation time, diagnostic manufacturers and authorities alike must prepare for major changes and requirements to adapt to the new regulatory framework. Right now, their capacity is focused on the critical task of keeping diagnostic tests available, despite the challenges the pandemic is creating for their production and distribution. By providing the same solution for the in vitro diagnostics and medical devices sectors, the EU would be doing even more to keep health systems up running effectively in times of the COVID-19 pandemic.”

Medicine shortages: what’s going on?

Which?, Anna Studman, 25 March 2020

Paracetamol and ibuprofen are just some of the items that are increasingly hard to get hold of as people stock up on everyday essentials in the wake of the coronavirus crisis and UK government lockdown.

But even before the pandemic hit, there were issues with prescription medicine shortages in the UK.

We surveyed Which? members in December 2019 and found that one in four people had experienced problems getting hold of the medicines they needed because of stock shortages in the past year.

Pharmacy stocks have always been subject to fluctuations, but these appear to have become worse in the past six months, particularly, and the recent pressure on supplies due to people’s fears over coronavirus certainly hasn’t helped matters.

Coronavirus and paracetamol shortages

Paracetamol is the main form of relief available for the fever-like symptoms of COVID-19 if you’re self-isolating at home. It’s also an everyday household medicine that people are buying to prepare for self-isolation.

This increased demand has put stress on supplies – stocks are currently low or non-existent across pharmacies and supermarkets.

Painkillers such as paracetamol and ibuprofen are already subject to limits of how many you can buy in one go, but some stores are now putting even stricter limits in place in an attempt to regulate supply. Boots has now limited customers to just one paracetamol product.

But even so, a pharmacist we spoke to who works at a large Boots store said there were no paracetamol products in stock, and that they were on order but there was no promise of imminent delivery. We’ve been to several pharmacies and supermarkets and been greeted by empty shelves there too.

COVID-19 and increased global demand

Like hand sanitiser and other household essentials, paracetamol is increasingly hard to find. And there are some concerns about the scarcity of supply.

India, the world’s biggest supplier of generic drugs, recently introduced a limit on the export of medicines including paracetamol. The move came as factory shutdowns in China, attributed to the coronavirus lockdown, have fractured the supply chain (India gets most of its raw ingredients for medicines from China).

Will prices go up?

Drug wholesalers have passed on increased costs to high street retailers and pharmacies, but bigger chains can usually absorb these costs. Boots told us: ‘Customers can be reassured that the cost of their regular brands, including Boots own-brand Paracetamol, has not and will not go up.’

The Pharmaceutical Services Negotiating Committee (PSNC), a representative body for community pharmacists, said that it’s ‘keeping a close eye on generic medicines (including paracetamol) affected by recent price hikes and is making applications for price concessions [where pharmacies are reimbursed by the government for wholesale price hikes] in the usual way’.

UK government seeks to reassure consumers

Unsurprisingly, people are concerned about the shortages. We asked the Department of Health and Social Care (DHSC) for comment, and a spokesperson told us: ‘The country is well prepared to deal with any impacts of coronavirus and we have stockpiles of medicines such as paracetamol in the event of any supply issues or significant increases in demand.

‘We are working with suppliers of paracetamol to monitor and assess available supplies and demand, and will continue to do so. Suppliers have informed us that manufacture continues and deliveries are scheduled.’

The DHSC also said that the NHS has stockpiles of paracetamol reserved for use in hospitals.

What to do if you’re having problems getting hold of paracetamol

If you have a specific medical need for paracetamol and are struggling to find it in stores, speak to your GP or pharmacist to see if they can help you track it down and what options or alternatives are available.

Why do medicines shortages happen?

The current shortages of painkilling medication can be explained by the coronavirus impact: a toxic combination of massive increase in global demand, disruption to supply chains and people stocking up on things such as food, household products and medicines.

But what about the shortages of other medicines people were already experiencing?

A London GP told us their practice had faced a significant rise in workload because of daily medicine shortages: ‘In the past year, we’ve acquired three part-time pharmacists who are now “in-house” to share the load for finding alternatives to medicines in short supply.’

Another GP, based in Surrey, said shortages are affecting all sorts of medicines and they’re notified of new shortages almost daily, but with little advice on what to do about them.

It’s thought that a couple of different factors have led to the supply issues we’re seeing now. These are:

  • Manufacturing and distribution issues. If there’s an issue with a single ingredient or batch, this can affect the whole supply chain. There may then be a snowball effect as lots of people switch to an alternative, which is then in higher demand.
  • Pricing issues. Changes in wholesale prices, the drop in the value of the pound in recent years and what the NHS can afford to pay for some medicines can be another factor.
  • Parallel exports. Sometimes medicines on the market in the UK are bought by wholesalers and exported to another European Economic Area (EEA) country, which can also affect supply. It’s thought this may have become more attractive due to the drop in value of the pound.
  • Brexit. In a similar way to the COVID-19 impact, this may also have been a factor insofar as contingency planning and uncertainty about supplies could have exacerbated the situation.

The government has now banned parallel exports of some medicines which were experiencing shortages – including HRT treatments, some vaccines and adrenaline – in an attempt to make sure there’s enough for patients in the UK.

Responding to questions about increased demand for paracetamol due to coronavirus, the DHSC said: ‘Paracetamol is not on the list of products that can’t be parallel exported or hoarded, but we are keeping that list under review.’

Finding alternative medication

Pharmacists and GPs are constantly working to find substitutes for unavailable medicines.

Sometimes a medicine unavailable at one pharmacist will be stocked elsewhere or can be ordered in.

If your medicine is in low supply the pharmacist might dispense the prescription in stages – giving you some upfront and asking you to come back at a later date for the rest.

But a lot of the time, patients aren’t so lucky. One in five people we surveyed who faced a shortage had to take a break from their medicine until stock returned. One in four had substitute medication prescribed.

Getting used to a different formulation can create problems. One patient told us their substitute medication ‘had nasty side effects and caused more problems than it solved’.

What can patients do?

With the continuing spread of COVID-19 and global uncertainty, it’s now more important than ever to be responsible when buying medicine and only buy what you need.

That said, it’s worth anticipating when you might run out and ordering new supplies before this happens.

The PSNC advises patients to order any medicines that you need from your GP in good time (but no more than seven days before it’s due).

It also issued a reminder to only order medicines that you need. If you have unused medicines in your cupboard, use these first (remember to check the expiry date) and do not order extra medicines.

If you’re experiencing issues with any substitute medication you are prescribed, talk to your pharmacist.

India to set up $1.3bn pharma manufacturing fund, says report

European Pharmaceutical Review, Victoria Rees, 25 March 2020

Due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.

According to a new report, India will establish an almost 100-billion-rupee ($1.3 billion) fund to aid pharmaceutical companies in the manufacturing of active pharmaceutical ingredients (API).

Published in Bloomberg, the report highlights that the disruptions to the supply chain because of the COVID-19 coronavirus revealed the extent to which India relies on China for APIs and how easily medicine shortages could occur.

Reportedly, a government statement outlined that the funding will go towards infrastructure for drug manufacturing facilities and financial incentives of up to 20 percent incremental sales value over the next eight years.

As the outlet highlights, India imports almost 70 percent of its APIs from China, with many sourced from the Hubei province – the epicentre of the COVID-19 outbreak, leading to its decision to invest inwardly.

COVID-19 update: Eli Lilly assures security of insulin supply

European Pharmaceutical Review, Hannah Balfour, 25 March 2020

Having become aware of insulin shortages in pharmacies, the company has stated that its products are not backordered and should be available for delivery by wholesalers.

Eli Lilly has released an update about how the insulin supply chain is being affected by COVID-19. According to the company, they do not anticipate shortages and have set up resources to enable low- or no-income patients to access insulin during the coronavirus pandemic.

The company previously stated that it does not source any active pharmaceutical ingredients (APIs) for their approved medications from China. Therefore, it does not expect to be impacted by reduced manufacturing from the Asia Pacific market.

Lilly stated that it has a network of global manufacturing sites, at current, those producing insulin in Europe and the US are still operational, with increased precautions in place to protect the supply of medicine and the welfare of employees from COVID-19. The company say it is continually monitoring the situation for possible impact on the supply of their medicines.

According to the business, some US pharmacies have temporarily run out of stock of insulin products due to high demand. Lilly stated that, while some pharmacies have not had their orders fulfilled by wholesalers due to “manufacturer backorder”, they are not aware of any such problems and pharmacies should be able to secure orders for delivery in one or two days.

Lilly also advised that patients financially affected by COVID-19 can call the Lilly Diabetes Solution Center to access treatment options, including free insulin.

“COVID-19 is an unprecedented challenge for all of us, but Lilly has planned for such events,” said Mike Mason, president of Lilly Diabetes. “Our manufacturing facilities, supply chain and Lilly Diabetes Solution Center are designed to support those who rely on insulin. We are committed to providing a regular supply of safe insulin and our Solution Center can provide real insulin affordability assistance for people during this difficult time, including people whose jobs have gone away. If you need help, please call the Lilly Diabetes Solution Center.”

Diamorphine 5mg and 10mg supply update

Dispensing Doctors’ Association, Ailsa Colquhoun, 25 March 2020

Healthcare professionals are asked to plan for a permanent move to morphine sulphate injection as opioid of choice, where clinically appropriate, in place of diamorphine 5mg and 10mg.

Suppliers Wockhardt and Accord have indicated that full supply of these items are unlikely before Summer 2020. Manufacturers of diamorphine hydrochloride 30mg ,100mg, 500mg, which remain available, say they are unable to support an increase in demand on these strengths.

All healthcare professionals in primary care who prescribe, dispense or administer diamorphine hydrochloride injection 5mg and 10mg should:

  • identify a local lead within their organisation to manage the delivery of actions as advised in this document where possible
  • review and update guidelines and protocols, moving to morphine sulphate injection as opioid of choice, where clinically appropriate, in place of diamorphine 5mg and 10mg
  • identify and deliver required education and training to General Practice and community nursing teams to support the switch over to morphine;
  • ensure no new patients are started on diamorphine hydrochloride 5mg or 10mg injection
  • review patients currently receiving diamorphine 5mg or 10mg injection and manage the switch to an alternative opioid
  • not switch patients to higher strengths of diamorphine injection as there is insufficient stock to support increased use
  • consider morphine 10mg/ml injection as the first line opioid as supplies of alternative opioid agents are limited and these should be prescribed for patients where morphine is not clinically appropriate
  • place orders for morphine sulfate 10mg/1ml solution for injection ampoules (Ethypharm (Martindale) and Hameln) from major wholesalers.

View the alert.

Contractors make urgent plea to chancellor on wholesale bills

P3 Pharmacy, Pharmacy Network News, 25 March 2020

Community pharmacy contractors are warning the Government that they will be unable to keep providing vital medicines to patients unless they receive urgent funding assistance to help pay their wholesaler bills.

Amid an extraordinary period in which pharmacies throughout the UK have dispensed record numbers of scripts and contended with shortages and price fluctuations, many are in pressing financial straits.

Sutton contractor Reena Barai posted on social media today: “I’ve just had an email from my pharmaceutical wholesaler to say I’ve nearly reached my credit limit this month. We’ve run this pharmacy for 41 years and never had this situation.

“[Chancellor] Rishi Sunak, you’ve said you’ll do whatever it takes. If patients need access to meds, I need money to pay for them.”

Dorset contractor Mike Hewitson wrote: “We urgently need 10 Downing Street to put money into community pharmacies or we will run out of money to pay for drugs. Action needed now.”

Another contractor wrote: “This is exactly what we will all be facing before too long. Words are nice but those expensive drugs and extra hours don’t get paid for by words.”

Mark Lyonette, NPA chief executive told Pharmacy Network News this afternoon: “We have already appealed to the Government for immediate support to help pharmacies remain operational, both as frontline care providers and as businesses employing thousands of people.

“We’ve requested a number of emergency measures, including an advance payment scheme for NHS income. Many pharmacies are small businesses with existing cash-flow problems and COVID-19 is dramatically exacerbating this situation.  Above all, we need urgent, substantial new funding to keep pharmacies open.”

PSNC is currently in talks with Government on a number of COVID-19-related issues, including how contractors can be supported financially.

Coronavirus: harmonised standards for medical devices to respond to urgent needs

European Commission, 25 March 2020

Yesterday, the Commission adopted decisions on harmonised standards which will allow manufacturers to place on the market high performing devices to protect patients, health care professionals and citizens in general. The standards will facilitate a faster and less expensive conformity assessment procedure. The revised harmonised standards play a pivotal role in the current coronavirus pandemic because they relate to critical devices* such as:

  • medical face masks
  • surgical drapes, gowns and suits
  • washer-disinfectors
  • sterilisation

Stella Kyriakides, Commissioner for Health said: “We must not waste a second in our fight against the coronavirus. With the measures we adopt today, we speed up the entry of safe, essential medical equipment and devices such as masks, gowns and suits in the EU market. This equipment is fundamental for our health professionals – the brave and resilient women and men at the front line – to keep saving lives”.

Once implemented, the use of these standards will allow manufacturers of medical devices and other concerned economic operators, to comply with the health and safety requirements of the EU legislation, taking into account the most updated technical solutions. These standards, once referenced in the Official Journal of the European Union, grant conformity of devices with the requirements of the three Directives on medical devices.

The decision to adopt these harmonised standards for medical devices represents an additional measure taken by the Commission to respond to the coronavirus outbreak. Also upon the urgent request of the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), in cooperation with their members made available a number of European standards for certain medical devices and personal protective equipment.

Background

European standards are an essential pillar of a fully functioning internal market. They reduce costs, promote innovation, ensure interoperability between different devices and services, and help companies to access markets.

To support EU product legislation, the Commission can request the development of European harmonised standards to facilitate compliance by manufacturers of the relevant requirements. Once agreed and referenced in the Official Journal of the European Union, these harmonised standards become part of EU law and allow companies an easy and direct access to the internal market for their products, while ensuring a high degree of safety for users and consumers.

European legislation for medical devices also relies on harmonised standards. In particular, under the three current directives on medical devices, there are about 300 harmonised standards conferring presumption of conformity with the legal essential requirements. The Commission and the concerned European standardisation organisations (CEN and CENELEC) continuously work together to update and improve the set of harmonised standards available to economic operators in the EU. In such a common effort to face the coronavirus pandemic, the Commission, CEN and CENELEC have agreed to make a number of harmonised standards for important medical protective equipment like face masks and single-use gloves freely available to those companies that are willing to start producing these items.

Useful links

Dedicated Commission webpage on the EU’s response to the COVID-19 outbreak

Medical device

Media And Political Bulletin – 26 March 2020

From Factory to Pharmacy

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