News

Media And Political Bulletin – 07 August 2018

Media and Political Bulletin

07 August 2018

Media Summary

Government’s medicines shortages group has not met since 2016

Chemist and Druggist, Grace Lewis, 6 August 2018

Chemist and Druggist reports that the Department for Health and Social Care’s Medicine Supply Chain Group, set up in 2009 to bring together pharmacy, manufacturing and wholesaler bodies, has not met since spring 2016.

Representatives from the Medicines and Healthcare products Regulatory Agency (MHRA), the Pharmaceutical Services Negotiating Committee (PSNC), the Royal Pharmaceutical Society (RPS), the Healthcare Distribution Association (HDA), the Association of the British Pharmaceutical Industry (ABPI) and the General Pharmaceutical Council (GPhC) – among others – have all attended previous meetings.

The article includes a statement from Martin Sawer, Executive Director of HDA, explaining why the meetings ceased: ‘The terms of reference of the group solely concern branded medicines supply issues – not generics supply – identified by the pharmacy bodies represented in the group.’

Brexit Guidance: MHRA Outlines What to Expect

Regulatory Focus, Zachary Brennan, 6 August 2018

The MHRA has released some technical guidance detailing what a Brexit implementation period means for the life sciences sector, once finalized as part of the Withdrawal Agreement.

During the implementation period, which will end in December 2020, pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, which will be recognized by the EU and vice versa, the MHRA has said.

But one of the setbacks is that for medicines, the UK will not have voting rights in EMA and EU committees during the implementation period, the MHRA highlights.

Read the full document here.

ABPI Response: MHRA guidance on Brexit Implementation

ABPI, Press Release, 6 August 2018

The ABPI has issued a press release responding to new technical guidance published by the MHRA.

Responding to the guidance, Dr Sheuli Porkess, Deputy Chief Scientific Officer for the ABPI said: ‘Pharmaceutical companies need as much clarity as possible so they can continue to supply medicines to patients as the UK leaves the EU…There are still some unanswered questions. We are clear that there needs to be an implementation period but whether there will be one is still subject to negotiation. The document also states that the future role of the MHRA, whose expertise is vital, is also still being discussed.’

UK FMD Working Group update

NPA, 6 August 2018

The NPA states that the UK Community Pharmacy FMD Working Group has said that the Falsified Medicines Directive (FMD) and Brexit uncertainties mean that all pharmacies need to carefully consider which systems they choose to verify the authenticity of the medicines they supply.

Chair of the working group, NPA Board member Raj Patel MBE, said: ‘Given continued Brexit uncertainties, we recommend that whatever system pharmacies choose, they ensure that termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository’.

Mr Patel continued: ‘With a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment. However, we are mandated to comply so we must proceed, albeit with caution.’

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Government’s medicines shortages group has not met since 2016

Chemist and Druggist, Grace Lewis, 6 August 2018

The government group set up to look into shortages across the medicines supply chain has not met since spring 2016, C+D has exclusively revealed.

The Department of Health and Social Care’s (DH) Medicines Supply Chain Group was set up in 2009 to bring together pharmacy, manufacturing and wholesaler bodies to “exchange information regarding medicine supply issues arising from parallel trade”.

Representatives from the Medicines and Healthcare products Regulatory Agency (MHRA), the Pharmaceutical Services Negotiating Committee (PSNC), the Royal Pharmaceutical Society (RPS), the Healthcare Distribution Association (HDA), the Association of the British Pharmaceutical Industry (ABPI) and the General Pharmaceutical Council (GPhC) – among others – have all attended previous meetings.

However, the group has not had any meetings in the past two years, a C+D investigation using a Freedom of Information (FOI) Act request has revealed.

The GPhC said it had not been part of the group since September 2016, while the RPS said it had not attended any meetings for “some time”, although it would “be happy” to attend future events if invited.

In 2013-14, the group met an average of more than four times a year to discuss ways to improve communication with pharmacists about medicines shortages, the use of buffer stocks, and how information about quotas could be made clearer.

Why did the meetings stop?

Explaining why the meetings ceased, the DH told C+D: “The vast majority of medicine shortages [we are] currently managing are due to manufacturing and regulatory problems, which fall outside the remit of the Supply Chain Group.”

“If new problems arise within the remit of the group, it will reconvene.”

HDA chief executive Martin Sawer added: “The terms of reference of the group solely concern branded medicines supply issues – not generics supply – identified by the pharmacy bodies represented in the group.”

No group dedicated to generic shortages

When asked by C+D whether the DH had set up a similar group tasked with looking into the ongoing generics shortages affecting pharmacies, it said: “There is a DH medicine team responsible for medicines shortages and its number one priority is to ensure that patients have access to safe and effective medicines.

“In order to address wider supply issues, the DH continues to meet extensively with individual trade associations, companies and NHS organisations on individual supply issues.”

PSNC also told C+D it has “been in constant dialogue with the DH about medicines shortages (branded or generic) that we receive reports on”.

DH chief commercial officer Steve Oldfield told a Public Accounts Committee hearing last month that he had “personally met with the five main wholesalers” in October 2017 to “gain some insight” on what led to last year’s generics supply and pricing issues.

Brexit Guidance: MHRA Outlines What to Expect

Regulatory Focus, Zachary Brennan, 6 August 2018

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Monday explained what pharmaceutical and medical device companies can expect during the period that the Brexit agreement is implemented.

During the implementation period, which will end in December 2020, pharmaceutical firms will be able to continue UK batch release testing and Qualified Person certification in the UK, which will be recognized by the EU and vice versa, MHRA said.

But one of the setbacks is that for medicines, the UK will not have voting rights in EMA and EU committees during the implementation period, MHRA said.

“Marketing authorisation holders and qualified persons for pharmacovigilance will continue to be able to be based in the UK and access EU markets. There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP),” the regulator added.

And UK-based companies will be able to apply for marketing authorisations via either the centralised or decentralised procedures.

Devices

For medical devices in the implementation period, the MHRA said that CE marking will continue to be used and recognized for both the UK and EU markets, and UK-based industry will not require an authorised representative established in the EU.

“UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets,” MHRA said.

The EU Medical Devices Regulation will fully apply from May 2020, and MHRA noted that this takes place during the implementation period so the government “will fully implement the legislation.”

The new EU regulation on in vitro diagnostics (IVDs) “will not apply until May 2022, which is outside of the implementation period. However, elements of both new devices regulations have applied directly in UK law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the UK market if they are in conformity with the new regulations, invoking all relevant requirements.”

MHRA added: “We cannot pre-judge the outcome of negotiations which will inform what the future arrangements will be, however, the UK has been central to agreeing the new legislation and we are supportive of its aims to strengthen the regulatory system and increase the transparency of information about products on the EU market.”

Clinical Trials

As far as the new Clinical Trials Regulation (CTR), the MHRA says it is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the implementation period.

“If the new regulation does not come into force during the implementation period, the government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty,” MHRA said.

In general, the MHRA also said that progress is being made to finalize the Withdrawal Agreement as a whole. “We will aim to agree this by October, alongside the framework for our future relationship with the EU.”

Falsified Medicines Directive

“UK will still be a Member State in February 2019 and will therefore implement the FMD Delegated Regulation in line with our existing obligations,” MHRA said. “When the UK exits the EU, the Withdrawal Act will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the FMD would continue to apply, unless specifically revoked.”

ABPI Response: MHRA guidance on Brexit Implementation

ABPI, Press Release, 6 August 2018

The MHRA has published technical guidance on what a Brexit implementation period means for the life sciences sector, once finalised as part of the Withdrawal Agreement.

In response, Dr Sheuli Porkess, Deputy Chief Scientific Officer for the ABPI said:

“Pharmaceutical companies need as much clarity as possible so they can continue to supply medicines to patients as the UK leaves the EU. Today’s guidance from Government is welcome, as is the reiteration of the UK’s preference for close cooperation with the EU across all aspects of medicines regulation.

“There are still some unanswered questions. We are clear that there needs to be an implementation period but whether there will be one is still subject to negotiation. The document also states that the future role of the MHRA, whose expertise is vital, is also still being discussed.

“The industry will continue to plan for all scenarios, including ‘no deal’. We believe that the best way to protect patients and public health is for the EU and UK to agree continued cooperation on the regulation of medicines.”

UK FMD Working Group update

NPA, 6 August 2018

The Falsified Medicines Directive (FMD) and Brexit uncertainties mean that all pharmacies need to carefully consider which systems they choose to verify the authenticity of the medicines they supply, according to the UK Community Pharmacy FMD Working Group.

Authentication of medicines under FMD will start from 9 February 2019. Arvato, part of the Bertelsmann group, has recently signed a contract with SecurMed UK to provide the UK FMD system. Community pharmacies should be able to start getting connected to the system from September this year. The UK system will connect to the central EU FMD hub.

Chair of the working group, NPA Board member Raj Patel MBE, said: “Given continued Brexit uncertainties, we recommend that whatever system pharmacies choose, they ensure that termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository”.

Continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. Access is likely to continue during the transition period, and if the UK government realises its aim of a close alignment on medicines policy within the BREXIT agreement, it will continue after 2020 too.

Meanwhile, the Department of Health and Social Care and MHRA have launched a consultation on some aspects of implementing FMD in the UK, which contains a section on sanctions for non-compliance.

Mr Patel continued: “With a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment. However, we are mandated to comply so we must proceed, albeit with caution.”

One of the key requirements of FMD is the ‘decommissioning’ of a medicinal product before a supply is made to a patient. IT solutions will be available which will include standalone FMD systems or FMD capability integrated into patient medication record (PMR) systems. The UK Community Pharmacy FMD Working Group (FMDWG) has published a list of FMD IT system suppliers for any pharmacists who have not yet started to prepare for FMD, to help them consider their options.

Media And Political Bulletin – 07 August 2018

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?