News

Media And Political Bulletin – 06 April 2020

Media and Political Bulletin

06 April 2020

Media Summary

Virus delays put Brexit trade negotiations under threat

The Times, Stephen O’Brien, 05 April 2020

The Times reports that EU trade commissioner Phil Hogan said Britain will have to evaluate how the calendar for Brexit trade deal negotiations has changed, because the Covid-19 pandemic has reduced the already tight timeframe for talks.

The former Fine Gael minister, who is in his second European Commission term, said it was now certain that a comprehensive trade deal could not be concluded in time for Britain’s withdrawal from the union on December 31 this year.

He also fears that insufficient progress will be made on the individual sections of the withdrawal agreement that Britain and the EU had agreed to prioritise to facilitate that orderly exit.

UK medicines and medical devices regulator investigating 14 cases of fake or unlicensed COVID-19 medical products

MHRA, 04 April 2020

An increasing number of bogus medical products being sold through unauthorised websites claiming to treat or prevent COVID-19 are being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA). 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 9 domain names and social media accounts selling fake or unauthorised COVID-19 products. 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.

EU postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus pandemic

EU Today, Martin Banks, 04 April 2020

EU Today reports that the European Commission has adopted a plan to postpone by one year the date of application of the medical devices regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.

This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable.

Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now.”

Emergency legislation could empower pharmacists to supply controlled drugs without a prescription

Pharmacy Business, Pri Mandav, 03 April 2020

Pharmacy Business reports that the Home Office has been proposing emergency legislation in the wake of the coronavirus crisis which could allow pharmacists to supply some controlled drugs without needing a prescription. In a letter dated 1st April Home Secretary Priti Patel asked Chair of the Advisory Council on the Misuse of Drugs Owen Bowden-Jones to respond to the proposals by Friday.

The new legislation, if enforced, would allow pharmacists to supply drugs in Schedules 2 and 3 and Part 1 of Schedule 4 of the Misuse of Drugs Regulations 2001, provided the patient receives them as part of their ongoing treatment. It would not affect Schedule 1 drugs.

Patel wrote that the proposed measures would “ensure patients continue to have access to medicines critical for ongoing treatment, build resilience and help relieve pressure elsewhere in the health system.”

This was also reported in P3 Pharmacy.

 

 

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Virus delays put Brexit trade negotiations under threat

The Times, Stephen O’Brien, 05 April 2020

Britain will have to evaluate how the calendar for Brexit trade deal negotiations has changed because the Covid-19 pandemic has reduced the already tight timeframe for talks, according to Phil Hogan, the EU trade commissioner.

The former Fine Gael minister, who is in his second European Commission term, said it was now certain that a comprehensive trade deal could not be concluded in time for Britain’s withdrawal from the union on December 31 this year.

He also fears that insufficient progress will be made on the individual sections of the withdrawal agreement that Britain and the EU had agreed to prioritise to facilitate that orderly exit.

“I don’t believe it is possible to have major improvements made in the negotiation of any of the [priority] chapters in such a short space of time that will give answers to all of the issues that arise at the end of the year, so I think that the United Kingdom will have to reflect on that calendar reality,” said Hogan.

“In every member state, including the UK I suspect, it is all hands on deck for the public servants and civil servants to deal with the Covid-19 crisis, and there aren’t [enough] people who are able to apply themselves to these intensive negotiations that are required to be concluded in such a short space of time.”

Asked whether he would welcome a British application to extend the Brexit deadline to allow for more negotiation, the trade commissioner said: “It is a matter for the United Kingdom to make up its mind on that issue. I am not going to pre-empt any decision they might make.

“The European Union side is ready to engage in this timeline or indeed any other timeline in order to reach agreement so really, this is a political call that has to be made by the UK, and the EU doesn’t have any control over it.

“There’s nothing like face-to-face negotiations in order to make a deal, and of course [the virus] has closed [them] down and we won’t have those opportunities for the duration of the crisis.”

In terms of the EU response to the coronavirus, Hogan acknowledged there were differences between governments on how to treat the debt that member states would run up in tackling the pandemic, but said several financial instruments were already in place, including a €750bn lending stream from the European Central Bank.

“How we treat the debt that will arise from this particular crisis is the subject of discussion in the eurogroup next week,” said Hogan.

A blanket of austerity measures would not be part of the response, he stressed.

“I believe that an agreement as soon as possible on the budget of the EU for the next seven years would give us new instruments and new opportunities to be able to help member states to overcome this problem,” he said. “Not every member state has the financial firepower to be able to deal with this crisis economically or from a health point of view.”

The former Carlow-Kilkenny TD and keen Kilkenny hurling supporter said he was confining himself to Brussels “for the time being at least”, but planned to be “back in Ireland for the first round of the championship, whenever that might be”.

He said he had spoken last week to his colleague Michel Barnier, the lead EU trade negotiator and one of the first high-profile figures to contract Covid-19 in Europe. He said Barnier, 69, had taken part in meetings since recovering and would be back at work next week.

Hogan said the European Commission had moved swiftly to stop some member states taking “unilateral action” to retain certain medical equipment and supplies within their own borders, but also to stop excessive exports of ventilators, test kits and personal protection equipment.

“We addressed that by introducing within a matter of days an export authorisation [requirement] to prevent product from going out of the EU in any distortive way that would have an impact on the capacity of the health authorities to have sufficient material in hospitals and healthcare facilities to deal with the virus for our own people,” he said.

UK medicines and medical devices regulator investigating 14 cases of fake or unlicensed COVID-19 medical products

MHRA, 04 April 2020

An increasing number of bogus medical products being sold through unauthorised websites claiming to treat or prevent COVID-19 are being investigated by the Medicines and Healthcare products Regulatory Agency (MHRA).

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 9 domain names and social media accounts selling fake or unauthorised COVID-19 products.

Lynda Scammell, MHRA Enforcement Official said:

“Don’t be fooled by online offers for medical products to help prevent or treat COVID-19.

“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 your health.

“The risk of buying medicines and medical devices from unregulated websites are that you just don’t know what you will receive and could be putting your health at risk.

“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.

To stay safe when buying medicines and medical devices online, the MHRA advises that you purchase from a registered pharmacy – either from the premises or online. Registered online suppliers can be found here. If people suspect they have a dodgy medicine or medical device they can report if via our safety monitoring system – the Yellow Card Scheme.

The National Fraud Intelligence Bureau is also seeing reports from victims who have lost money when they have tried to purchase PPE or self-testing kits online, from fraudulent websites, that simply do not exist. If you think you have been a victim of fraud, please report it to Action Fraud or by calling 0300 123 2040.

EU postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus pandemic

EU Today, Martin Banks, 04 April 2020

The European Commission has adopted a plan to postpone by one year the date of application of the medical devices regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic.

This decision takes into account the unprecedented challenges of the coronavirus pandemic and the need for an increased availability of vitally important medical devices across the EU whilst continuing to ensure patient health and safety until the new legislation becomes applicable.

Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “Shortages or delays in getting key medical devices certified and on the market are not an option right now.

“The Commission is therefore taking a pragmatic approach and delaying the entry into application of new EU rules on medical devices, so we can have our medical industries pouring all their energy into what we need them to be doing: helping fight the pandemic. This shows once again that the European Union is leaving no stone unturned in our support to national public health systems in their hour of need.”

As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.

Today’s proposal therefore postpones, for exceptional reasons in the current context, the application of the Regulation by one year – until 26 May 2021.

Whilst the new Medical Devices Regulation is key to ensure patient safety and increase transparency on medical devices across the EU, the currently applicable rules will continue to guarantee the protection of public health.

In addition, the proposal also ensures that Member States and the Commission can address potential shortages of vitally important medical devices in the EU in a more effective manner through EU wide derogations.

The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.

The coronavirus pandemic and the associated public health crisis presents an unprecedented challenge to Member States and is a high burden for national authorities, health institutions and economic operators. The coronavirus crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. None of this could reasonably have been anticipated at the time of adoption of the Medical Devices Regulation.

Those extraordinary circumstances have a significant impact on various areas covered by the Medical Devices Regulation. It is therefore very likely that Member States, health institutions, economic operators and other relevant parties would not have been in a position to ensure its proper implementation and application from the stipulated date of application on 26 May 2020.

To safeguard an effective regulatory framework for medical devices, it is also necessary to postpone the date of repeal of the directive on active implantable medical devices and the directive on medical devices by one year.

This proposal will not affect the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.

Emergency legislation could empower pharmacists to supply controlled drugs without a prescription

Pharmacy Business, Pri Mandav, 03 April 2020

The Home Office has been proposing emergency legislation in the wake of the coronavirus crisis which could allow pharmacists to supply some controlled drugs without needing a prescription.

In a letter dated Wednesday (April 1) Home Secretary Priti Patel has asked Chair of the Advisory Council on the Misuse of Drugs (ACMD) Owen Bowden-Jones to respond to the proposals by Friday.

The new legislation, if enforced, would allow pharmacists to supply drugs in Schedules 2 and 3 and Part 1 of Schedule 4 of the Misuse of Drugs Regulations 2001, provided the patient receives them as part of their ongoing treatment. It would not affect Schedule 1 drugs.

Patel wrote that the proposed measures would “help secure access to controlled drugs within the healthcare system in a pandemic and where there is a serious risk to human health. They will ensure patients continue to have access to medicines critical for ongoing treatment, build resilience and help relieve pressure elsewhere in the health system.”

The letter said since there was “a significant risk of supply shortages” due to the impact of Covid-19 on the supply chain, the proposals would also include supply of controlled drugs under a Serious Shortage Protocol (SSP).

“Pharmacists would only supply under an SSP at their professional discretion and in cases where they deem it reasonable and appropriate for the patient and would refer any complex cases back to a prescriber,” the stated.

This was also reported in P3 Pharmacy.

Media And Political Bulletin – 06 April 2020

From Factory to Pharmacy

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