HDA UK Media And Political Bulletin – 31 October 2017

Media and Political Bulletin

31 October 2017

Media Summary

Warnings of Brexit impact on medicines supply

P3 Pharmacy, 30 October 2017

P3 Pharmacy reports on the HDA’s submission to the Health Select Committee’s inquiry on Brexit. The article highlights the HDA’s concerns regarding price hikes on NHS medicines and an increase in red tape on imports which could have a serious effect on the post-Brexit UK medicines supply chain and put patient safety at risk. P3 Pharmacy reports that the HDA has called for both a transitional period during which the status quo is maintained and the formulation of a sustainable long-term approach.

 

BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 30 October 2017

Pharmacy Business reports that the British Generic Manufacturers Association has reassured community pharmacists who have struggled to source products in the wake of generic drug shortages that its members are working with the Department of Health to find solutions and ensure “any impact on patients is kept to an absolute minimum.”

When asked if he was aware of generic shortages at Bristol Labs and Dr. Reddy’s or any other of its members, BGMA director general Warwick Smith told Pharmacy Business: “A regulatory issue is currently limiting the supply of some medicines. The industry is working with the Department of Health to identify alternative sources of supply so that any impact on patients is kept to an absolute minimum”.

 

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Warnings of Brexit impact on medicines supply

P3 Pharmacy, 30 October 2017

Price hikes on NHS medicines and an increase in red tape on imports could have a serious effect on the post-Brexit UK medicines supply chain and put patient safety at risk, the Healthcare Distribution Association has said. The Association has called for both a transitional period during which the status quo is maintained and the formulation of a sustainable long-term approach.

The Association, which represents businesses that supply medicines, medical devices and healthcare services, was responding to the Health Select Committee’s Brexit inquiry.

Customs and tariffs

Answering the Committee’s question regarding the key considerations for companies, healthcare service and regulatory bodies, it outlined scenarios that could see changes to customs and tariffs affect the “timely and cost-effective supply of medicines to patients”, including prohibitive tariffs on imported medicines and significant increase in the administrative burden for imports before they reach the UK.

In addition, the loss of equivalence with EU legislation would make it difficult for manufacturers to bring products to the UK as quickly as happens currently, the HDA said, adding that “greater clarity on future regulatory and trading relations is required as soon as possible if patient safety is not to be put at risk.”

The HDA said: “The government must urgently agree not only a transitional arrangement with the EU for these issues, but a long-term and sustainable way forward that provides the medicines supply chain with the much-needed certainty that it requires to deliver the right medicine, in the right place at the right time for patients across the UK.”

Parallel imports

Leaving the common trademarks system and the free movement (or ‘parallel trade’) of medicines this allows– a state of affairs that could be permanent in the event of a ‘hard Brexit’ – is also likely to increase the risk of medicines shortages, the HDA said, and could lead to price hikes for NHS medicines.

To avoid these harmful effects, the government “must consider sector-by-sector deals on IP rights, agreeing to mutually recognise certain products, such as pharmaceuticals,” the HDA said.

Stresses on the supply chain post-Brexit could affect the UK’s ability to implement the Falsified Medicines Directive by the February 2019 target date, the HDA added.

BGMA: We are working with Department of Health to counter generic shortages

Pharmacy Business, Neil Trainis, 30 October 2017

The British Generic Manufacturers Association has reassured community pharmacists who have struggled to source products in the wake of generic drug shortages that its members are working with the Department of Health to find solutions and ensure “any impact on patients is kept to an absolute minimum.”

The PSNC said last week it was in “urgent” talks with the DoH over “price concessions and wider concerns” following reports that contractors were enduring a shortage of generic drugs from Bristol Laboratories and Dr. Reddy’s.

When asked if he was aware of generic shortages at Bristol Labs and Dr. Reddy’s or any other of its members, BGMA director general Warwick Smith (pictured) told Pharmacy Business: “A regulatory issue is currently limiting the supply of some medicines.

“The industry is working with the Department of Health to identify alternative sources of supply so that any impact on patients is kept to an absolute minimum.

“Due to the multi-source nature of the UK generics market, when occasional supply issues of this kind arise, other manufacturers are usually able to increase production to mitigate any potential supply shortfall. Our focus and priority is on quality and security of supply.”

Rajiv Shah, a director at Sigma Pharmaceuticals, told the Avicenna conference in northern Cyprus in 2015 that generic drug shortages were costing independent pharmacists in England £10 million a year.

Media and Political Bulletin

30 October 2017

HDA Submits Evidence to Health Select Committee’s Inquiry on Brexit

 

The Healthcare Distribution Association (HDA UK) welcomes the opportunity to respond to the Health Select Committee’s inquiry on ‘Brexit – medicines, medical devices and substances of human origin’. As the trade association that represents the companies responsible for distributing 92% of the medicines to the NHS, the Healthcare Distribution Association has been working closely with the MHRA and Department of Health on the implications of the UK leaving the European Union on the medicines supply chain.

 

In the Association’s submission to the inquiry, the HDA outlines its main concerns as the UK is preparing to leave the European Union. The Association therefore urges the UK government to consider the following key issues as it negotiates the country’s exit from the European block:

 

  • Guaranteeing the resilience of the medicines supply chain
  • Mitigating the potential for price rises to NHS medicines
  • Ensuring that patient safety is assured

The HDA highlights that any disruption to the cross-border flow of medicines will place patient safety at risk. Therefore, it is imperative that the  UK aligns  its  approach  to  medicines  regulation  as  much  as  feasibly  possible  to  mitigate  the  substantial risks  associated  with  leaving  the  current  European  regulatory  regime,  which ensures patient  safety across 28 countries.

 

In a further point raised in its submission, the HDA advocates for a transitional arrangement with the EU from March 2019 to address the issues of customs arrangements and tariffs; medicines licensing; release of medicines; access to labour; parallel trade and good distribution practice. This arrangement should focus on a long-term and sustainable way forward to ensure that the medicines supply chain gains the much-needed certainity it requires to continue to deliver the right medicines, in the right place, at the right time for patients across the UK.

 

Media Summary

Fears for patient safety as Brexit threatens free flow of medicines                                                         The Telegraph, Iain Withers, 29 October 2017

The Telegraph reports on the HDA’s warning that patient safety could be at risk as a result of supply problems and health risks stemming from the UK exiting the European Union. These concerns were expressed as part of the Association’s submission to the Health Select Committee’s inquiry on the impact of Brexit. The Telegraph quoted the HDA’s submission explaining that “disruption to the cross-border flow of medicines has the potential of placing patient safety at risk”. Similarly to Emma Walmsley, GSK chief executive, mentioned in the article, the Association calls for a transitional agreement with the EU to mitigate these issues.

 

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Fears for patient safety as Brexit threatens free flow of medicines                                                         The Telegraph, Iain Withers, 29 October 2017

Britain’s medicines bill could jump by £100m a year if pharmacies are not able to source cheaper drugs from the Continent after Brexit.

 

Pharmacists currently buy the bulk of their medicines from UK wholesalers, but look to suppliers in mainland Europe for a minority to make savings.

 

Now the Healthcare Distribution Association (HDA), an organisation representing firms that supply 92pc of the NHS’s medicines, has warned that failure to agree a smooth exit from the EU could jeopardise patients.

 

Its members include giant Alliance Healthcare, the sister company of high street pharmacy chain Boots.

 

In a submission to MPs on the health select committee, which is gathering evidence on the potential impact of Brexit, the HDA warned it could lead to supply problems and health risks.

 

The HDA said that “disruption to the cross-border flow of medicines has the potential of placing patient safety at risk”. It warns a disorderly Brexit could lead to customs controls and added 
administrative hurdles slowing the supply of medicines to patients.

 

The UK bought £26.4bn of drugs from overseas while exporting £25.1bn in 2015, the most recent year for which data is available, making it a net
 importer. Access to skilled labour was also a concern raised by the organisation.

 

It noted that across the healthcare sector – from research scientists, to pharmacists – highly qualified workers were often sourced from EU countries.

 

Ensuring that the UK maintained a parity of professional standards with EU nations after Brexit is crucial in
order to ensure that EU workers can still practise in the UK with ease, the HDA warned.

 

There were even risks that pharmaceutical manufacturers “may choose not to market their product in the UK at all” if faced with new, country-specific red tape, due to the associated costs and relatively small population compared to that covered by the broader European licensing regime.

 

Concerns have been growing in Britain’s healthcare industry in recent months at the lack of progress on Brexit.

 

Last week GSK, Britain’s biggest drug maker, warned it expected to start incurring costs from preparing for Brexit as early as this year, including on plans for duplicate medicine testing centres in the EU and preparing for separate drug licensing regimes.

 

Emma Walmsley, GSK chief executive, called for a transition period of “at least two years” to be finalised “as soon as possible”.

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

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