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HDA UK Media And Political Bulletin – 13 December 2017

Media and Political Bulletin

13 December 2017

The Business, Energy and Industrial Strategy Select committee has published a transcript of the oral evidence given to its inquiry on Brexit and the implications for UK business on 5 December. The session focused on the potential impact of Brexit on the pharmaceutical industry. The full transcript is available to view on the HDA website here.

A reminder to all members that the GIRP supply chain conference ‘Supply chain to value chain together adding value’ will be held at The Oakley Court, Windsor, 21-22 March 2018. More information on the registration details for this are available on the HDA website, to view these please click here.

Media Summary

“Safeguarding public health must be number one priority” for EU27 and UK Government in phase two of Brexit talks

ABPI, 12 December 2017

The ABPI highlights the findings of a new report it commissioned in conjunction with the BioIndustry Association. The new report titled ‘Public Health and Economic Implications of the United Kingdom Exiting the EU and the Single Market​’ shows that the public health implications of Brexit could become more severe if public health cooperation and trade relationships decline and would have a detrimental effect on patients across the European Union, the European Economic Area (EU27 / EEA) and in the UK.

In the event of Europe and the UK no longer cooperating as they do today on medicines and public health, key findings in the report show that:

  • ​The sharing of important drug safety information or information relating to adverse medical events could face a five-month delay.
  • Europe’s management of large-scale emerging public health concerns or crises – such as the Zika virus – could be at risk.
  • A potential for increased frequency of medicines shortages due to administrative burden, customs delays and tariff measures.

Pharma warning of Brexit impact to public-health emergencies

Financial Times, Sarah Neville, 13 December 2017

The Financial Times underlines the findings of the report from the ABPI and the BioIndustry Association which warns of the potential impact of Brexit on Europe’s capacity to respond to a continent-wide public-health emergency.

The associations have said that Europe’s ability to manage big public-health crises related to the use of medicines, such as the Zika virus, could be at risk if the UK were excluded from cross-EU incident management planning.

The report also notes that the EU’s incident management plan is used on average nine to 10 times a year and cites how, in 2015, the UK and the rest of Europe contributed their shared expertise to the global response to the Zika threat, and gave advice on scientific and regulatory issues related to research and development of medicines or vaccines against the virus.

Almost 70 concessionary drug prices still to be agreed for November

The Pharmaceutical Journal, 12 December 2017

The Pharmaceutical Journal reports that, while the PSNC had asked for an unprecedented 97 drugs to be granted concessionary prices in November, by the end of November, the Department of Health had agreed prices for only 38 of them.

The Pharmaceutical Services Negotiating Committee (PSNC) has responded to the Department of Health’s (DH) delayed proposed price concessions highlighting that they are threatening the cashflow of thousands of community pharmacies.

The government has now proposed prices for 52 of 67 outstanding medicines, and the PSNC has responded, but the DH will make the final decision on the price it will pay.

Parliamentary Coverage

House of Commons Tabled Written Question – Department of Health – 12 December

Jim Shannon (Strangford): To ask the Secretary of State for Health, what steps he plans to take to ensure the link between UK Drug Licensing continues to the European Medicines Agency after the UK leaves the EU to ensure that decisions by the two organisations are made to the same timetable?

Full Coverage

“Safeguarding public health must be number one priority” for EU27 and UK Government in phase two of Brexit talks

ABPI, 12 December 2017

To coincide with today’s House of Commons Health Select Committee on ‘Brexit: the regulation of medicines, medical devices and substances of human origin’, the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) have published new research on the public health implications of Brexit.

​Giving evidence to the committee today, Steve Bates, CEO of the BIA, will use the research to urge the Governments of the EU and the UK Government to “safeguard public health in the UK and Europe by making the regulation and supply of medicines the first priority in phase two of Brexit talks.”

The new report ‘Public Health and Economic Implications of the United Kingdom Exiting the EU and the Single Market​’ produced by OHE Consulting, shows that the public health implications of Brexit will become more severe if public health cooperation and trade relationships decline and will have a detrimental effect on patients across the European Union, the European Economic Area (EU27 / EEA) and in the UK.

In the event of Europe and the UK no longer cooperating as they do today on medicines and public health, key findings show:

​The sharing of important drug safety information or information relating to adverse medical events could face a five month delay.

Europe’s management of large-scale emerging public health concerns or crises – such as the Zika virus – could be at risk.

A potential for increased frequency of medicines shortages due to administrative burden, customs delays and tariff measures.

The research assesses the consequences arising from legal and regulatory changes associated with Brexit based on four scenarios[1] – from full EU/UK cooperation on public health and trade to no cooperation. In Brexit scenarios where the UK fails to negotiate continued participation in public health activities or a free trade agreement (FTA), medicines safety, incident and crisis response to public health threats and the medicines supply chain are all found to be detrimentally effected in Europe and the UK.

Speaking to the select committee, BIA CEO, Steve Bates will say:

“This report highlights to negotiators on both sides of the channel, the scale of the issue in safeguarding public health. With 82 million patient packs travelling between the UK and EU each month, it is vital that teams on both sides of the channel make patient safety a priority. The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks and industry needs a realistic transition period to ensure that the supply of lifesaving and life extending medicines to patients in the UK and across Europe is not affected.”

Mike Thompson, ABPI CEO, added:

“While a breakthrough on ‘sufficient progress’ is a significant step forwards – this momentum must now be carried forward to prioritising the issues that matter the most to people in the EU and the UK in the next round of talks.

This report highlights the very real consequence of failing to get this right for patients and the public and we will continue to work to mitigate these risks as the UK leaves the EU.

However, a swift cooperation agreement between the EU and the UK on medicines is the only way to ensure that there is no disruption to 500m patients accessing the best possible healthcare and getting the medicines they need. “

Analysis from the report highlights three significant public health concerns:

Medicines safety in the EU27 / EEA and the UK

Based on an analysis of communication between the European Medicines Agency (EMA) and non-EU authorities, the report finds that in scenarios where the UK’s expertise is lost from the current network, the detection of ‘signals’ – information relating to a possible causal relationship between an adverse event and a drug – could be delayed by up to five months and the publication of safety recommendations relating to these ‘signals’ could also be delayed by the same amount of time[2]. In 2016, 2,076 potential signals were reviewed by the EMA[3].

The report finds that the UK has detected the greatest number of signals of all EU27 / EEA countries since 2012[4]. In Brexit scenarios 2, 3 and 4, the UK’s expertise will no longer be directly and immediately available to the EU27 / EEA, nor the EU’s to the UK.

The report further demonstrates the strength of the UK’s role in reporting and evaluating the safety of medicines. Analysis shows that the UK hosts the highest number of centres for the conduct of pharmacoepidemiology studies[5] – studies that aim to monitor and improve the use of medicine on a population-wide basis.

The UK also hosts the highest number of post-authorisation safety studies (PASS) centres in the EU27 / EEA and also conducts half of all EU27/EEA PASS[6]. Following the regulatory approval of a medicine, PASS further monitor the safety and benefit-risk profile of a medicine and evaluate any risk-management plans in place.

Public health threat management activities in the UK and EU27 / EEA

The report identities that Europe’s management of large-scale emerging public health concerns or crises related to the use of medicines could be at risk. The report finds that in scenarios where the UK would be excluded from the EU Regulatory Network Incident Management Plan, delays in communication around crisis management or divergence in standards and procedures between the EU27 / EEA and the UK are likely to lead to delays in action. This incident management plan is found to be used on average 9-10 times a year[7]. Health authorities and regulators from outside the EU are not part of this communication network.

The report also finds that in Brexit scenarios where EU27 / EEA and UK collaboration does not take place, the timely availability of vaccines and the monitoring of the safety profile of medicines administered to large populations, in the event of a pandemic or continent-wide public health threat, could be at risk[8].

Case study: In 2015, when the spread of Zika virus infections raised worldwide concern, the Europe, including the UK, contributed their shared expertise to the global response to this threat and gave advice on scientific and regulatory matters regarding research and development of medicines or vaccines against the virus.

The EMA and competent authorities in Member States, which include the UK’s MHRA, also carried out an assessment of plasma-derived or urine-derived medicines and concluded that there is no increased risk of contamination with the Zika virus for patients who take these medicines.

This collaborative regulatory network delivered reassurance that even if plasma or urine came from donors who had contracted the Zika virus, there is no risk of the virus contaminating the final products and thus affecting the patients taking them[9].

Medicines supply in the UK and EU27 / EEA

The report finds that changes to trade and the medicines supply chain as a result of Brexit could contribute to an increased frequency of medicines shortages in the EU27 / EEA and the UK.  A recent survey by the European Federation of Pharmaceutical Industries and Associations has found that 45 million packs of medicine go from the UK to the EU27 / EEA each month – with over 37 million packs coming back the other way[10].

For the EU27 / EEA, the impact of the UK becoming a ‘third country’ would be felt the most on vaccines and advanced therapies that use human blood/plasma, as these products are disproportionately manufactured or imported via the UK[11]. These impacts are likely to be particularly acute during any implementation period where pharmaceutical companies have to duplicate or relocate batch release testing (a critical part of Good Manufacturing Practice (GMP) and a final safety check that pharmaceutical manufacturers must perform before a medicine is released for use).

The report also demonstrates risk relating to delays in the supply of medicines coming from outside the EU. The UK has the highest number of sites certified to import pharmaceuticals from ‘third countries’, ahead of Germany[12]. Currently, pharmaceutical products from ‘third countries’ certified at sites in the UK can be readily dispatched to the EU27/EEA freely through the single market and customs union.

The analysis concludes that in a Brexit scenario where the UK and the EU fail to reach a trade agreement on pharmaceuticals, medicines will be subject to tariff and non-tariff measures that could increase administrative burden, cause customs delays and increase costs.

Pharma warning of Brexit impact to public-health emergencies

Financial Times, Sarah Neville, 13 December 2017

UK pharma industry leaders have warned of the potential impact of Brexit on Europe’s capacity to respond to a continent-wide public-health emergency, as they step up their drive to ensure the sector’s interests are addressed when the next phase of negotiations begins.

The Association of the British Pharmaceutical Industry and the BioIndustry Association said that Europe’s ability to manage big public-health crises related to the use of medicines, such as the Zika virus, could be at risk if the UK were excluded from cross-EU incident management planning.

A report commissioned by the associations suggested that “delays in communication around crisis management or divergence in standards and procedures” between Europe and the UK “are likely to lead to delays in action”.

It noted that the EU’s incident management plan was used on average nine to 10 times a year and cited how, in 2015, the UK and the rest of Europe contributed their shared expertise to the global response to the Zika threat, and gave advice on scientific and regulatory issues related to research and development of medicines or vaccines against the virus.

Another striking finding in the research, carried out by OHE Consulting, was that if co-operation between the EU and the UK came to an end, there could be a delay of several months in sharing information about drug safety or adverse medical events.

The associations said that if the UK’s expertise were lost, “the detection of ‘signals’ — information relating to a possible causal relationship between an adverse event and a drug — could be delayed by up to five months, and the publication of safety recommendations relating to these ‘signals’ could also be delayed by the same amount of time”.

The report also highlighted the key role played by the UK in reporting and evaluating the safety of medicines on a population-wide basis, saying that the country hosted the highest number of centres for monitoring and scrutinising the safety and effectiveness of medicines of any European country.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, added: “A swift co-operation agreement between the EU and the UK on medicines is the only way to ensure that there is no disruption to 500m patients accessing the best possible healthcare and getting the medicines they need.”

The report also found that changes to trade and the medicines supply chain as a result of Brexit “could contribute to an increased frequency of medicines shortages in the EU27/EEA and the UK”.

It pointed to a recent survey by the European Federation of Pharmaceutical Industries and Associations that found that 45m packs of medicine went from the UK to the rest of Europe each month, with more than 37m packs coming back the other way.

The impact of any change would be felt most on vaccines and advanced therapies that use human blood or plasma, “as these products are disproportionately manufactured or imported via the UK”, it said.

Giving evidence to the Commons health select committee on Tuesday, Steve Bates, chief executive of the BioIndustry Association, said that the governments of the UK and the other 27 member states should “safeguard public health in the UK and Europe by making the regulation and supply of medicines the first priority in phase two of Brexit talks”.

Separately, following an appeal from the chemical and pharmaceutical industries to be allowed to remain within EU rules post-Brexit, Michael Gove, the environment secretary, told a Commons committee that a key regulatory standard, known as Reach, is “a single market measure so any company wanting to place products on the EU market after the UK’s exit will still have to follow Reach, whatever our future relationship with the EU”.

In his letter to the environmental audit committee, he added that Reach would continue to apply until Britain leaves the EU “and we are urging UK companies to still meet the final Reach registration deadline in 2018 to ensure they are compliant with regulatory requirements in the EU while we remain a member, and recognising that the EU Withdrawal Bill will bring Reach, with this registration requirement, into UK law”.

Almost 70 concessionary drug prices still to be agreed for November

The Pharmaceutical Journal, 12 December 2017

The PSNC had asked for an unprecedented 97 drugs to be granted concessionary (higher) prices in November, but by the end of November, the DH had agreed prices for only 38 of them.

The Pharmaceutical Services Negotiating Committee (PSNC) has responded to the Department of Health’s (DH) delayed proposed price concessions that are threatening the cashflow of thousands of community pharmacies.

The PSNC had asked for an unprecedented 97 drugs to be granted concessionary (higher) prices in November, but by the end of November, the DH had agreed prices for only 38 of them.

The government has now proposed prices for 52 of 67 outstanding medicines, and the PSNC has responded, but the DH will make the final decision on the price it will pay.

The PSNC said the delay in agreeing November’s price concessions has caused “massive concerns” for contractors who will need to pay for November supplies at the end of December, including many products bought at very high prices.

PSNC director of pharmacy funding, Mike Dent, said contractors were working hard to find medicines for patients, but they still did not know whether they would be fully reimbursed for the drugs they had provided.

Pharmaceutical Services Negotiating Committee (PSNC) director of pharmacy funding, Mike Dent, said PSNC was keen to see concessionary prices rolled over from month to month until new evidence suggested that the price had fallen

Analysis of prescribing data and concessionary prices by Oxford University’s Evidence-Based Medicine DataLab, estimates that an extra £56m was spent on concession-priced drugs in October 2017, putting the total increase in cost to the NHS from concession prices at £233m since April 2017.

The DataLab has also warned that concession prices were influencing the drug tariff price for products, with medicines increased in price under the concessionary scheme not falling back to their original drug tariff price when the concession ends.

Dent said the PSNC was keen to see concessionary prices rolled over from month to month until new evidence suggested that the price had fallen. The current system, where concessions applied only in the month where they are granted, left contractors “buying into a world of uncertainty”, he said.

Warwick Smith, Director General of the British Manufacturers Association (BGMA), said prices of some drugs had increased following “production issues that have impacted a small number of manufacturers”.

But he said a survey of BGMA members had shown that concessionary prices set for October were “on average 2.5 times the actual prices charged by manufacturers”.

Martin Sawer, executive director of the Healthcare Distribution Association (HDA), which represents drug wholesalers, agreed that there had been a worldwide shortage of generic drugs for regulatory and production reasons.

He suggested that the Medicines and Healthcare products Regulatory Agency (MHRA) should scrutinise the current generic drug supply system.

“Someone needs to look at the supply chain, because clearly, the existing system is not working,” he said.

Community Pharmacy Wales and Community Pharmacy Scotland both said pharmacies in their countries had also experienced a rise in generic drug prices.

In Scotland, community pharmacists will receive a one-off payment of 21% of their dispensing pool balancing payment for October 2017, to help with cashflow problems caused, in part, by an increase in drug prices.

A spokesperson for the Department of Health said it was still considering the outstanding concessions requests and that it had increased pharmacies’ advance payments twice in recent months.

HDA UK Media And Political Bulletin – 13 December 2017

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.

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