HDA UK Media And Political Bulletin – 14 December 2017

Media and Political Bulletin

14 December 2017

The BBC Radio 4 consumer affairs progamme ‘You and Yours’, reported on the current drugs shortages in the UK yesterday, the programme asked the HDA for comment and the association provided a statement. To listen to the coverage of drugs shortages on the programme, please click here. The clip starts at 34 minutes.

Media Summary

EU and UK life sciences industry issue joint policy document on Brexit

ABPI, 14 December 2017

 

The ABPI reports that eleven associations representing the European and British life science industry, including the ABPI, have today launched a joint policy document on the potential impact of the United Kingdom’s exit from the European Union. Setting out their priorities in advance of the European Council taking place on 14-15 December in Brussels, the sector has sent a clear message that the regulation, trade and supply of medicines must be a priority for the second phase of negotiations.

Among several key priorities, the joint paper sets out the following:

  • Patient access to medicines must be a primary consideration for phase two of the Article 50 negotiations.
  • Close cooperation in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the EU and the UK can continue to access medicines.
  • Trade between the UK and EU will ensure that medicines are able to continue to move between both regions, ensuring that both UK and EU patients can continue to access medicines.
  • Provided the UK remains in the single market or in a new legal arrangement with the EU based on consistency of regulatory frameworks, the EU and the UK IP systems should remain aligned in order to avoid uncertainties for industry.

 

Parliamentary Coverage

House of Commons – Tabled Written question – Department of Health, 13 December 2017

Ronnie Cowan MP: To ask the Secretary of State for Health, what discussions his Department has had on ensuring that decisions on the timetable for UK drug licensing remain linked to the timetable for decisions to be made the European Medicines Agency after the UK leaves the EU.

Full Coverage

EU and UK life sciences industry issue joint policy document on Brexit

ABPI, 14 December 2017

 

Eleven associations representing the European and British life science industry, including the Association of the British Pharmaceutical Industry (ABPI), have today launched a joint policy document on the potential impact of the United Kingdom’s exit from the European Union.

Today, the Association of the European Self-Medication Industry (AESGP), the ABPI, the BioIndustry Association (BIA), the British Generics Manufacturers Association (BGMA), European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), the European Association for Bioindustries (EuropaBio), Medicines for Europe, the Proprietary Association of Great Britain (PAGB) and Vaccines Europe, have called for medicines to be a priority in phase two of the Article 50 negotiations.

Setting out their priorities in advance of the European Council taking place on 14-15 December in Brussels, the sector has sent a clear message that the regulation, trade and supply of medicines must be a priority for the second phase of negotiations.

Whilst being encouraged by the breakthrough in phase one of the negotiations so that the second phase can now begin, the sector states that focusing on the framework for transitional arrangements and future relations with the UK must be a priority for negotiators.

The organisations are of the opinion that the agreement of transitional arrangements after March 2019 will be critical in ensuring there is minimal disruption to patients receiving medicines after the UK leaves the EU. Such a period will be essential in allowing companies to make the necessary changes to marketing authorisations and to their supply chains and ensure patients experience no disruption to their access to medicines. As such, negotiators should include access to medicines and the implications of Brexit for patients across the EU in the second phase of negotiations and be agreed in both the future agreement and in transitional arrangements.

The publication of this joint policy paper shows that the integrated nature of the supply chains for medicines across Europe, alongside a shared regulatory framework, means that patients in both the UK and EU need an early agreement on the future of medicines in phase second of the negotiations.

Among several key priorities, the joint paper sets out the following:

Patient access to medicines must be a primary consideration for phase two of the Article 50 negotiations.

Close cooperation in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the EU and the UK can continue to access medicines.

Trade between the UK and EU will ensure that medicines are able to continue to move between both regions, ensuring that both UK and EU patients can continue to access medicines.

Provided the UK remains in the single market or in a new legal arrangement with the EU based on consistency of regulatory frameworks, the EU and the UK IP systems should remain aligned in order to avoid uncertainties for industry.

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.

Media and Political Bulletin

12 December 2017

The Health Select Committee has published a transcript of the oral evidence given to its inquiry on Brexit on 5 December. The witnesses who appeared at this session include Martin Sawer, Executive Director of the HDA. The full transcript is available to view on the website here.

Media Summary

Brexit could hinder medicines supply to UK, MPs told

The Pharmaceutical Journal, Debbie Andalo, 8 December 2017

 

The Pharmaceutical Journal reports on the comments by UK drug distributors and those involved in the parallel importing of drugs, in which they highlighted to the parliamentary Health Select Committee that they want to see the UK remain in the customs union and the single market.

Martin Sawer, executive director of the Healthcare Distribution Association told MPs at an evidence session for the Health Select Committee’s inquiry on Brexit on 5 December that “we take the drugs supply chain for granted. I think we are invisible. It’s important to recognise that this supply chain is there. This [Brexit] jolt to it like this could throw a lot of cogs out of a very complicated machine.”

Chemical and pharma groups urge Gove to stick to EU regime

Financial Times, George Parker, Sarah Neville and Robert Wright, 11 December 2017

The Financial Times highlights that Britain’s chemicals and pharmaceuticals industries have called on the government to let them remain within EU rules at the time when some ministers have stepped up a campaign to break away from the bloc’s regulations.

In a letter to Michael Gove, the Chemical Industries Association urged the government “to do all it can to remain within or as close as possible” to the EU’s rule book for the sector, which exports about £50bn a year.

Steve Elliott, the chemicals association’s chief executive, said leaving the EU framework “would seriously bring into question 10 years of investment, as registrations and authorisations that permit access to the EU single market would suddenly become non-existent on exit day”.

The Association of the British Pharmaceutical Industry also said securing co-operation between the UK and EU on chemicals legislation and medicines regulation would be vital to ensuring there was no disruption for patients “and that 82m packs of medicines can move between the UK and EU every single month without delay”.

PSNC responds to Department of Health on list of concessionary drug prices for November

Pharmacy Business. Neil Trainis, 11 December 2017  

Pharmacy Business highlights the PSNC response to the Department of Health on its list of concessionary drug prices for November. The PSNC said on Friday that it had received a list of proposed concession prices for 52 of 67 outstanding requests for November amid growing concerns that pharmacists were being made to wait for prices for numerous medicines.

“DH’s action in delaying many November concessions has caused massive concerns for contractors as they will need to pay for November supplies at the end of December and this will include many lines purchased at very high prices,” the PSNC said.

PSNC receiving ‘unprecedented’ number of calls from pharmacies struggling with drugs shortages

Pharmacy Business, Neil Trainis, 7 December 2017

Pharmacy Business reports on a statement from Mike Dent, the director of pharmacy funding at the PSNC, in which he has said that the negotiating body is receiving an “unprecedented” number of calls from community pharmacies who are struggling to get hold of medicines.

The issue of drugs shortages was shunted back into the spotlight, after a story appeared in The Times on 7 December, claiming medicines have cost the NHS £180 million in six months. Drugs currently in short supply include those used to treat breast and prostate cancer, epilepsy, schizophrenia and bipolar disorder.

Martin Sawer, the executive director of the HDA, told the Times that his members “do not sit on stock, they make generics available to customers as soon as they get them.”

Yet wherever the source of the problem, shortages are getting worse as Mike Dent revealed.

“We are receiving unprecedented numbers of calls from community pharmacy teams who cannot get hold of certain medicines that patients need despite their best efforts; or who are having to pay prices many times more than the NHS reimbursement price. This has been going on for many months,” he said.

Drug shortages featured in national press

PSNC, 7 December 2017

The PSNC responded to The Times article on 7 December underlining that community pharmacy contractors and their teams will be all too aware of the current generic supply situation.

The Committee also noted that PSNC Committee Member and independent contractor Mark Burdon was quoted in The Times article referencing the difficult situation that pharmacy teams were being put in trying to explain the situation to patients whilst they were “scratching around” for crucial supplies.

Parliamentary Coverage

There is no parliamentary coverage today.

Full Coverage

Brexit could hinder medicines supply to UK, MPs told

The Pharmaceutical Journal, Debbie Andalo, 8 December 2017

Medicines could become more difficult to import into the UK post-Brexit, MP members of the House of Commons Health Select Committee were told on 5 December 2017.

UK drug distributors and those involved in the parallel importing of drugs told the committee that they wanted to see the UK remain in the customs union and the single market in any negotiated Brexit deal.

And they believed a transition period of between two to five years was needed to work out with the Medicines and Healthcare products Regulatory Agency (MHRA) how to protect the medicines supply chain after March 2019, the date the UK is scheduled to leave the European Union (EU).

Martin Sawer, executive director of the Healthcare Distribution Association, which represents businesses that supply medicines to the UK chain, told MPs: “We take the drugs supply chain for granted. I think we are invisible. It’s important to recognise that this supply chain is there. This [Brexit] jolt to it like this could throw a lot of cogs out of a very complicated machine.”

Inquiry into impact of Brexit

Sawyer was speaking at the committee’s ongoing inquiry into the impact of Brexit on the UK’s medicines supply chain (Brexit — medicines, medical devices and substances of human origin inquiry), which was announced in September.

MPs are looking at the logistics of the supply chains for medicines and medical devices, the current issues and the risks and opportunities that Brexit poses for the sector and patients.

Sawyer revealed that 90% of UK medicines are imported, and of that number 45% come from the EU. Businesses were unable to plan for uncertainty and needed at least two years after the UK leaves the EU in March 2019 to work out a new supply system with the MHRA and others.

Consequences for imports/exports

Richard Freudenberg, secretary-general of the British Association of European Pharmaceutical Distributors, which represents companies involved in the parallel importing of medicines, said the sector would be hard hit if the UK became part of World Trade Organization rules.

He told MPs: “My understanding in these circumstances would be that exports from the UK would cease… in licensing terms I think imports could continue with agreement.”

He said: “My understanding is that we would be able to trade with the rest of the world, but the medicines regulations would not be in place to bring those in line with trade laws.”

Sawyer pointed out that if the UK had a post-Brexit trade agreement with the US for example it would mean drugs would start to leave the UK because they were 50% cheaper than the cost of the same medicines in the US: “We have got to be really careful about doing trade deals with well-off countries because they could start sucking medicines out of the UK.”

First report

This is the second part of the inquiry the committee has held into the impact of Brexit on the health service. In April 2017, it published its findings on the effect leaving the EU would have on the UK’s health and social care sectors.

The government published its response to this report on 1 December 2017, saying that “all policy teams with the DH [Department of Health] have assessed the implications of the UK’s withdrawal from the EU on their area”, but that there were no plans to publish these assessments.

The DH also said it would submit evidence to the government-commissioned Migration Advisory Committee “to ensure that the staffing needs of health and social care are fully considered”.

Chemical and pharma groups urge Gove to stick to EU regime

Financial Times, George Parker, Sarah Neville and Robert Wright, 11 December 2017

Britain’s chemicals and pharmaceuticals industries have called on the government to let them remain within EU rules as Eurosceptic ministers step up a campaign to break away from the bloc’s regulations.

In a letter to Michael Gove, the cabinet’s champion of regulatory divergence, the Chemical Industries Association urged the government “to do all it can to remain within or as close as possible” to the EU’s rule book for the sector, which exports about £50bn a year.

The issue of regulatory divergence has moved centre stage in the Brexit debate since Friday’s divorce deal with Brussels, in which Theresa May, prime minister, agreed that Northern Ireland would not stray far from EU rules to ensure there would be no hard border with the Republic of Ireland.

That promise has cheered pro-business cabinet members but raised alarm in Eurosceptic circles, where the prospect of sweeping deregulation has been one of the main policy goals Brexiters have promoted in leaving the EU.

A split in the cabinet looms as it prepares to discuss Britain’s future relations with the EU this week. Mr Gove has the backing of defence secretary Gavin Williamson, along with foreign secretary Boris Johnson, trade secretary Liam Fox and Brexit secretary David Davis to push for a clean break.

Mr Williamson has told friends he is “definitely for divergence”, pitting him against a “hugger” cabinet faction led by chancellor Philip Hammond and home secretary Amber Rudd, who want to align Britain more closely to the EU.

While Mr Gove and his colleagues argue that Britain could achieve high standards of regulatory protection through a lighter-touch regime, business fears it could create new barriers to trade with the EU.

In the letter to Mr Gove, Steve Elliott, the chemicals association’s chief executive, said leaving the EU framework “would seriously bring into question 10 years of investment, as registrations and authorisations that permit access to the EU single market would suddenly become non-existent on exit day”.

Meanwhile, the Association of the British Pharmaceutical Industry said securing co-operation between the UK and EU on chemicals legislation and medicines regulation would be vital to ensuring there was no disruption for patients “and that 82m packs of medicines can move between the UK and EU every single month without delay”.

Referring to the EU regulation for the sector Mr Elliott said that although it was “far from perfect”, the bloc’s legislation was the best way of ensuring that “cars continue to run, planes continue to fly and medicines continue to work”.

But the European Chemicals Agency, which determines standard-setting for chemicals and single market access, comes under the framework of the European Court of Justice — a red line for Brexiters.

The EU has always resisted accepting the chemicals regulations of other countries as automatically equivalent to Reach, emphasising that it considers its own rules as the gold standard. In practice, without any formal agreements in trade deals, companies around the world often adopt the Reach standards as their default regulation in order to be able to sell into the EU.

Several countries, including China, Malaysia and South Korea, have amended their own chemicals regulation along similar principles to Reach, though without being formally recognised as equivalent.

Mr Gove’s department is consulting on a new independent body to uphold environmental standards in England after Brexit, but the chemicals sector could be forced to engage in costly duplication of registration of products in the UK and EU.

“We are working to ensure a smooth transition for the chemical industry as we leave the EU,” said a spokesman for the Department for Environment, Food and Rural Affairs.

“Our priority is to maintain an effective regulatory system for the management and control of chemicals to safeguard human health and the environment, respond to emerging risks and allow trade with the EU that is as frictionless as possible.”

The government has already been willing to fudge its Brexit “red lines” in other areas: it will ask for its aviation industry to be regulated by the EU after Brexit, in a move that will place it under the indirect jurisdiction of the European Court of Justice.

PSNC responds to Department of Health on list of concessionary drug prices for November

Pharmacy Business. Neil Trainis, 11 December 2017  

The PSNC has said it has responded to the Department of Health on its list of concessionary drug prices for November although pharmacy’s negotiator has yet to provide details around its response.

The PSNC said on Friday that it had received a list of proposed concession prices for 52 of 67 outstanding requests for November amid growing concerns that pharmacists were being made to wait for prices for numerous medicines.

“DH’s action in delaying many November concessions has caused massive concerns for contractors as they will need to pay for November supplies at the end of December and this will include many lines purchased at very high prices,” the PSNC said.

“In light of these extreme pressures and the high level of press interest in this area we are advising contractors of this latest news now. We will provide further details as soon as we can via our website and email news alerts.”

The DoH’s list of concessionary prices was released last week following pressure from the PSNC who said it was “pressing for confirmation of December concessions as soon as possible.”

The PSNC added: “We are also working to ensure that the DoH understands the problems and risks if pharmacies are not able to obtain medicines for patients in a timely manner, and pressing for better systems to address the impact of high price rises.”

PSNC receiving ‘unprecedented’ number of calls from pharmacies struggling with drugs shortages

Pharmacy Business, Neil Trainis, 7 December 2017

Mike Dent, the director of pharmacy funding at the PSNC, has said the negotiating body is receiving an “unprecedented” number of calls from community pharmacies who are struggling to get hold of medicines.

The issue of drugs shortages was shunted back into the spotlight, a story appearing in today’s Times claiming they have cost the NHS £180 million in six months. Drugs in short supply include those used to treat breast and prostate cancer, epilepsy, schizophrenia and bipolar disorder.

The paper revealed pharmacists struggled to obtain 97 drugs last month alone compared with 27 in April, with health officials forced to approve temporary price increases of up to 4,000% to ensure stocks of medicines are replenished.

The key players in the supply chain also appear to be engaging in finger-pointing and blame-shifting. Warwick Smith, the director-general of the British Generic Manufacturers Association, told the Times that wholesalers were artificially inflating prices, a claim rejected by the Healthcare Distribution Association (HDA) who in turn called for greater focus to be placed on smaller wholesalers.

Rajiv Shah, a director at Sigma, said during the Avicenna conference in Vietnam in October that his customers had informed him that wholesalers were deliberately stockpiling and hoarding medicines.

Those medicines, he alleged, would remain unavailable until concessionary prices were announced prompting wholesalers to start calling pharmacies telling them stocks were available. Shah did not reveal the identity of those wholesalers when contacted by Pharmacy Business.

Martin Sawer, the executive director of the HDA, told the Times that his members “do not sit on stock, they make generics available to customers as soon as they get them.”

Yet wherever the source of the problem, shortages are getting worse as Dent (pictured) revealed.

“We are receiving unprecedented numbers of calls from community pharmacy teams who cannot get hold of certain medicines that patients need despite their best efforts; or who are having to pay prices many times more than the NHS reimbursement price. This has been going on for many months,” he said.

“When we request price concessions, the Department of Health always makes its own inquiries following reports from us to validate the availability and prices around the country.”

The PSNC said it “continues to press urgently for a decision on the outstanding November price concession applications” and has “been assured by the Department of Health that this is a priority.”

Smith told Pharmacy Business: “There have been disruptions to the supply of a number of generic medicines due to production issues that have impacted a small number of manufacturers.

“Other generic medicines manufacturers have increased their production of the affected products or have entered or re-entered the market in them. The industry’s focus has rightly been on ensuring continuity of supply to the greatest extent possible in the interest of patients.

“Production changes such as this, however, inevitably incur additional costs and the prices of these products have increased. To reflect higher costs incurred by community pharmacists, the Department of Health sets so-called concessionary prices for these products based on surveys of actual selling prices in the market.

“A survey of our members shows that the concessionary price set of these products in October were on average 2½ times actual prices charged by manufacturers.”

Drug shortages featured in national press

PSNC, 7 December 2017

The front cover of this morning’s (Thursday 7th December) The Times featured an article raising concerns about patients not being able to get hold of vital medicines due to drug shortages.

The Times reports that cancer patients and people with severe mental illness are being particularly affected by the shortages, which have cost the NHS £180 million in the last six months due to substantial price increases. The article goes on to state that at least 100 drugs have been affected by supply problems, forcing health officials to approve temporary price rises of up to 4,000% to boost stocks.

Community pharmacy contractors and their teams will be all too aware of the current generic supply situation. PSNC Committee Member and independent contractor Mark Burdon is quoted in the article referencing the difficult situation that pharmacy teams were being put in trying to explain the situation to patients whilst they were “scratching around” for crucial supplies.

PSNC continues to press urgently for a decision on the outstanding November price concession applications and we have been assured by the Department of Health that this is a priority. We hope to receive a reply soon and well before November prescription pricing is finalised. As soon as any announcement is made we will inform pharmacies via our website and email news alerts.

The PSNC Dispensing and Supply Team has set up a specific email address for community pharmacy teams to contact us regarding the outstanding November price concessions: novemberconcessions@psnc.org.uk. Please use this address to submit any further relevant information about the impact the delay in granting the concessions is having on patients and pharmacies.

Mike Dent, Director of Pharmacy Funding at PSNC, said:

“We are receiving unprecedented numbers of calls from community pharmacy teams who cannot get hold of certain medicines that patients need despite their best efforts; or who are having to pay prices many times more than the NHS reimbursement price. This has been going on for many months. When we request price concessions, the Department of Health always makes its own inquiries following reports from us to validate the availability and prices around the country.”

In response to the series of articles published by The Times on medicine shortages, the HDA provided the following comment to the paper, part of which was reproduced in an article on Friday 8th December:

 

As the trade association representing the largest distributors of medicines on behalf of manufacturers and the NHS, the Healthcare Distribution Association (HDA) was dismayed by some of the broad inferences contained in your article of 8 December: “Patients hit by shortages of drugs as prices soar.  The medicines supply chain is a very complex, efficient and competitive ‘just-in-time’ integrated distribution network, on which patients and the NHS depend every single day.

 

To suggest that our members, whose stock will turnover in a matter of days, are somehow ‘playing the market’ is an insult to their professionalism and their legal obligation as wholesalers.  Let me lay out some facts not discussed in your piece. 

 

There are over 2,000 medicines wholesale licenses across the four countries of the United Kingdom; these licenses can apply to over 5,000 different premises or addresses. The HDA wholesalers own around 50 of these – 1% of the total.  We may handle and distribute over 90% of NHS medicines, but our members are not focused on storing a few generic medicines based on price, as many of these other businesses could be.  All holders of wholesale licenses have a legal obligation to “maintain a continuous supply” of medicines and, therefore, we do agree with your leader conclusion that “if some in the supply chain are milking the system that is disgraceful”, and that the government and regulators must “move swiftly to fix it”.

 

In the recent past, the HDA has proposed to government that a Patient Service Obligation be imposed on every type of medicines wholesaler, with the aim of guaranteeing patient supply. Maybe now is the time to urgently revisit this type of regulation?

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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