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HDA UK Media And Political Bulletin – 5 February 2018

Media and Political Bulletin

5 February 2018

Media Summary

19 wholesalers under MHRA ‘suspicion’, claims BBC

Chemist and Druggist, Grace Lewis, 2 February 2018

Chemist and Druggist reports on claims by the BBC that nineteen wholesalers are “under suspicion” for the diversion of prescription-only medicines onto the criminal market. BBC Radio 4’s File on 4 programme aimed to investigate the “extensive network of criminality involving businesses such as wholesale dealers and registered pharmacies” diverting POMs to be sold illegally online. One of the “weak link[s] in the chain is among wholesalers who trade in bulk”, the BBC has claimed. “Offenders have been buying from them, sometimes using fake licensing documentation.”

The publication also highlights the response to this investigation from Martin Sawer, Executive Director of the Healthcare Distribution Association (HDA) – which represents “less than 5%” of the “2,500 wholesale dealer” licences in the UK – who told C+D that “many of these [licences] are held by [organisations] whose main business is not wholesaling or distribution”.

All licence holders “are mandated to observe EU good distribution practice guidelines”, he added. “HDA members have rigorous checks in place to ensure we only supply medicines to those who have a legal right to dispense to patients and who are subject to strict professional regulation.” They also “conduct their own internal audits and inspections to ensure full compliance with the due diligence process”, Mr Sawer said.

UK medicines regulator looks to post-Brexit future with China links

Pharmaphorum, Andrew McConaghie, 2 February 2018

Pharmaphorum highlights that the head of the MHRA accompanied the Prime Minister’s delegation to Beijing last week. While there, Dr. Ian Hudson, chief executive of the MHRA, signed a new memorandum of understanding (MoU) with Chinese counterparts.

Dr. Hudson signed the agreement with the China Food and Drug Administration (CFDA), which oversees regulation for the country’s 1.39 billion citizens. The agreement pledges new areas of co-operation such as an exchange of learning from the UK’s Accelerated Access Review (AAR), the life science industry-focused strategy, and insights on how to regulate the trading of medicines online.

European Medicines Agency surveys pharmaceutical companies on preparedness for Brexit

The Pharmaceutical Journal, 2 February 2018

The Pharmaceutical Journal reports that the European Medicines Agency is surveying pharmaceutical companies on their preparedness for Brexit, in order to identify issues that could disrupt medicines supply and impact on human and animal health when the UK exits the European Union.

The survey is targeted at marketing authorisation holders of centrally authorised human and veterinary medicines that are located in the UK, or who have an important part of their site operations in the country. It asks about their plans for submitting transfers, notifications or variations to their marketing authorisations after Brexit.

The deadline for return of completed questionnaires to the EMA is 9 February 2018.

Parliamentary Coverage

Commons Tabled Written Questions – Department of Health and Social Care, 2 February 2018

Kevan Jones: To ask the Secretary of State for Health and Social Care, what assessment he has made of the robustness of the vertically integrated community pharmacy network and the medicines distributions chain and the effect on patients of the failure of one part of that network.

Kevan Jones: To ask the Secretary of State for Health and Social Care, what assessment he has made of the effect on competition and the availability of medicines across the community pharmacy network by the use of sole supplier agreements by branded manufacturers and wholesalers; and if he will make a statement.

Kevan Jones: To ask the Secretary of State for Health and Social Care, what assessment he has made of the effect on competition and the availability of medicines across the community pharmacy network of the operation of vertically integrated wholesaler and pharmacy businesses; and if he will make a statement.

 

Full Coverage

19 wholesalers under MHRA ‘suspicion’, claims BBC

Chemist and Druggist, Grace Lewis, 2 February 2018

 

Nineteen wholesalers are “under suspicion” for the diversion of prescription-only medicines (POMs) onto the criminal market, the BBC has claimed.

BBC Radio 4’s File on 4 programme – which aired on Tuesday (January 30) – aimed to investigate the “extensive network of criminality involving businesses such as wholesale dealers and registered pharmacies” diverting POMs to be sold illegally online, which the UK’s medicines watchdog revealed earlier in the day.

The Medicines and Healthcare products Regulatory Agency (MHRA) said that its latest crackdown – which leads on from its 2016 investigation into the “significant diversion of benzodiazepines and other hypnotics/anxiolytics” onto the black market – involves “businesses such as wholesale dealers and a small number of registered pharmacies” across the UK.

Following the MHRA’s confirmation of “more than 40 arrests” and the suspension of five pharmacists, the BBC – which claimed to have seen a full copy of the watchdog’s intelligence report – said 19 wholesalers are still “under suspicion as investigations into the criminal network continue”.

One of the “weak link[s] in the chain is among wholesalers who trade in bulk”, the BBC claimed. “Offenders have been buying from them, sometimes using fake licensing documentation.”

The BBC also claimed that 12 wholesale dealer licences have been handed in or terminated so far, as part of the MHRA’s investigation.

The MHRA would not confirm the figures to C+D and said it could not comment while investigations are ongoing.

HDA responds

Martin Sawer, chief executive of the Healthcare Distribution Association (HDA) – which represents “less than 5%” of the “2,500 wholesale dealer” licences in the UK – told C+D that “many of these [licences] are held by [organisations] whose main business is not wholesaling or distribution”.

All licence holders “are mandated to observe EU good distribution practice guidelines”, he stressed.

“HDA members have rigorous checks in place to ensure we only supply medicines to those who have a legal right to dispense to patients and who are subject to strict professional regulation.”

They also “conduct their own internal audits and inspections to ensure full compliance with the due diligence process”, Mr Sawer said.

“Huge spike in demand”

John Preston, head of offsite dispensing at Phoenix Healthcare Distribution, told the BBC Radio4 programme the wholesaler had reported a customer to the MHRA after seeing “a huge spike in demand” for an unnamed product.

Phoenix’s close monitoring of its distribution activities “quite regularly throw[s] up cause for concern”, Mr Preston said on the programme.

The BBC said the “bigger players in the legitimate wholesale market” are vigilant to suspicious activity.

UK medicines regulator looks to post-Brexit future with China links

Pharmaphorum, Andrew McConaghie, 2 February 2018

The head of the UK’s medicines regulator accompanied the Prime Minister’s delegation to Beijing this week, and signed a new memorandum of understanding (MoU) with Chinese counterparts.

Dr Ian Hudson, chief executive of the MHRA, signed the agreement with the China Food and Drug Administration (CFDA), which oversees regulation for the country’s 1.39 billion citizens.

The agreement pledges new areas of co-operation such as an exchange of learning from the UK’s Accelerated Access Review (AAR), the life science industry-focused strategy, and insights on how to regulate the trading of medicines online.

The visit to China was important for Prime Minister Theresa May, who wanted it to demonstrate the UK being globally minded and ‘open for business’ as it searches for a new post-Brexit identity.

This year will be hugely decisive regarding the terms of Brexit, which is set to begin with a two-year transition period in March 2019.

However massive uncertainty still hangs over the venture – not least in the UK life sciences sector, which is lobbying hard to stay as closely aligned with Europe’s EMA medicines regulator and other EU standards.

In the event of a ‘no deal’ or ‘hard’ Brexit, however, the MHRA may have to go it alone, and break away from the EMA’s centralised marketing authorisation.

The UK pharma and biotech sectors are certain this will mean the UK will be relegated in importance for product launches, with new medicines either launched later, or not at all, unless a deal with the EU can be struck.

There is speculation that the UK could align itself with other major regulatory blocs around the world, although the viability or desirability of these ideas has yet to be tested.

The MoU was signed in Beijing’s Great Hall of the People with both Prime Minister Theresa May and China’s Premier Li Keqiang present.

This new signing expands on a previous MoU signed in 2014 which focused on the exchange of safety information on medicines and medical devices to protect patients in the UK, China, and around the world.

Dr Ian Hudson, chief executive at the MHRA said: “China is a world leader in the market for raw materials for the pharmaceutical industry and closer collaboration with MHRA will support the promotion of innovation, good practice, and protect UK patients.

“We operate in a global environment and formalising our international relationships helps strengthen regulatory systems to protect public health worldwide.”

The MoU is also of interest to China, as it is looking to rapidly bring its regulatory framework up to speed with Europe and the US.

The CFDA last year announced it will formally join ICH GCP, the international regulatory standards agreement.

It is also changing its clinical trial approval system to one similar to the US FDA’s Investigative New Drug (IND) process – a move which could eventually see a huge shift in global clinical trials into China.

European Medicines Agency surveys pharmaceutical companies on preparedness for Brexit

The Pharmaceutical Journal, 2 February 2018

The European Medicines Agency (EMA) is surveying pharmaceutical companies on their preparedness for Brexit, in order to identify issues that could disrupt medicines supply and impact on human and animal health when the UK exits the European Union (EU).

The survey is targeted at marketing authorisation holders of centrally authorised human and veterinary medicines that are located in the UK, or who have an important part of their site operations in the country. It asks about their plans for submitting transfers, notifications or variations to their marketing authorisations after Brexit.

The EMA said information gathered in the survey will help identify companies with a need for concerted action to address medicines supply concerns, and help the EMA and the European Commission ensure they direct adequate resources to the areas where submissions will be made. Information from the survey will also be used to inform next steps in Brexit preparedness for the EMA, the European Commission and the European medicines regulatory network.

The EMA also hopes that the survey will prompt pharmaceutical companies to prepare for the regulatory steps required for their centrally authorised products to remain on the EU market after Brexit, in order to minimise disruption to medicines supply and avoid shortages.

The Brexit Health Alliance, which includes the NHS Confederation, NHS Providers, and the Academy of Medical Royal Colleges among its members, warned in January 2018 that the distribution of medicines could be disrupted if the UK and the EU reached ‘no deal’ over Brexit.

The deadline for return of completed questionnaires to the EMA is 9 February 2018.

HDA UK Media And Political Bulletin – 5 February 2018

From Factory to Pharmacy

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