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HDA UK Media And Political Bulletin – 29 January 2018

Media and Political Bulletin

29 January 2018

Media Summary

EMA surveys pharma companies on their preparedness for Brexit

European Pharmaceutical Review, Zara Kassam, 26 January 2018

 

The European Pharmaceutical Review reports that the EMA is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

The EMA is consulting marketing authorisation holders of centrally authorised medicines that are located in the UK, or who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance(QPPV) or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of the UK’s withdrawal from the European Union (EU).

The aim of the survey is to identify those companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health, and secondly to help the Agency and the European Commission plan resources in the areas where these submissions will be processed.

 

Last year ‘worst ever’ for NHS medicines shortages – expert

Pharmaphorum, Richard Staines, 25 January 2018

 

Pharmaphorum highlights that last year was one of the worst years for medicines shortages for NHS patients, and that the situation is unlikely to improve, according to senior health service figure.

The Medicines for Europe conference heard that shortages of previously abundant generic drugs is an issue throughout the continent. A perfect storm of pricing pressures, increasing costs, and procurement policy is causing issues across the EU, with countries such as Portugal, Romania and Estonia being the worst hit.

Maggie Dolan, regional pharmacy procurement specialist at NHS Commercial Solutions, said the UK issues had been caused by an industry-led legal challenge to the health service’s procurement of drugs.

Dolan told the conference in London: “In the UK 2017 was the worst year we have ever had in terms of generic medicines shortages.”

 

 

Government has commissioned external analysis of Brexit impact on UK medicines supply chain, MPs told

The Pharmaceutical Journal, Debbie Andalo, 25 January 2018

 

The Pharmaceutical Journal reports that the government has commissioned an analysis by professional services consultants Ernst and Young (EY) into the impact of Brexit on the UK medicines supply chain. The results of the investigation, which will include talks with drug manufacturers who have already revealed they are spending millions of pounds preparing for the UK leaving the European Union (EU), may however, remain secret because the information could be commercially sensitive.

Details of the external scrutiny were revealed to the House of Commons health select committee at its continuing inquiry into the impact of Brexit on the UK’s medicines supply chain. Health and social care secretary Jeremy Hunt, appearing before the committee, impressed on MPs the importance of protecting the supply chain during the current Brexit negotiations.

 

Parliamentary Coverage

 

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Full Coverage

EMA surveys pharma companies on their preparedness for Brexit

European Pharmaceutical Review, Zara Kassam, 26 January 2018

 

The EMA is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health…

EMA surveys

The European Medicines Agency (EMA) is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

EMA is consulting marketing authorisation holders of centrally authorised medicines that are located in the United Kingdom (UK), or who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance(QPPV) or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of the UK’s withdrawal from the European Union (EU).

The aim of this survey is twofold. Firstly, to identify those companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health, and secondly to help the Agency and the European Commission plan resources in the areas where these submissions will be processed. Information from the survey will also be used to inform next steps in Brexit preparedness for EMA, the European Commissions and the European medicines regulatory network.

The survey is being sent directly to holders of a centralised marketing authorisation for human and veterinary medicines who are located in the UK, or who have an important part of their site operations in the country. The deadline for completion of the questionnaire is 9 February 2018.

The survey will also serve to stimulate those companies who have not yet taken any action to start planning for any regulatory steps required for their centrally authorised products to remain on the EU market post-Brexit in order to minimise disruption to medicines supply and avoid shortages.

Findings and recommendations from the survey will be shared with the European Commission and presented to EMA’s Management Board. A high-level summary of the overall results of the survey will be published on the EMA website.

Further surveys may be carried out by the EU national competent authorities in relation to nationally authorised products. Companies should check EMA’s dedicated webpage regularly for guidance on the consequences of Brexit.

Last year ‘worst ever’ for NHS medicines shortages – expert

Pharmaphorum, Richard Staines, 25 January 2018

Last year was one of the worst years for medicines shortages for NHS patients, and the situation is unlikely to improve, a senior health service figure has said.

The Medicines for Europe conference heard that shortages of previously abundant generic drugs is an issue throughout the continent.

A perfect storm of pricing pressures, increasing costs, and procurement policy is causing issues across the EU, with countries such as Portugal, Romania and Estonia the worst hit.

Maggie Dolan, regional pharmacy procurement specialist at NHS Commercial Solutions, said the UK issues had been caused by an industry-led legal challenge to the health service’s procurement of drugs.

The shortages are affecting products such as analgesics, anaesthetics and antibiotics which have been available for years.

Dolan told the conference in London: “In the UK 2017 was the worst year we have ever had in terms of generic medicines shortages.”

Dolan was unable to provide figures about the problem because the NHS is so busy fire-fighting the problem, but she said the shortages are occurring across different drug types.

Procurement had previously based around ensuring that at least three companies were included on tenders for drugs, a system that ensured that there are at least two other suppliers who could step in should shortages occur.

But since the legal challenge around two years ago, Dolan said NHS legal experts said the arrangements were not legal, giving rise to an increasing number of tenders with a single supplier.

She warned that there is no end in sight, as procurement laws prevent the NHS from managing supply of drugs across different contracts.

Dolan said: “What we have seen in 2017 and 2018 is we have more and more single responses to tenders for molecules in the generic space. That is proving very challenging.”

But it is not just procuring drugs that is causing problems – in some cases there are issues with supplies of ingredients that are having a knock-on effect on the supply of certain products.

These range from the unpredictable issues such as factories burning down, to an industry’s approach to manufacturing which is increasingly based around contracting out production to external suppliers.

Representatives of the generics and biosimilars industry at the conference said that the only way to solve the problems was through joint working to resolve the many issues that are causing the patchy supply of drugs.

Marc-Alexander Mahl, president of Medicines for Europe, which represents biosimilars and generics manufacturers, said regulations such as the falsified medicines directive and expensive anti-tamper safety features are driving up costs.

At the same time the rock-bottom prices demanded by government tenders in some countries mean it is not economical to supply drugs in those areas.

One of the most shocking examples is Romania, where according to Mahl generics firms have pulled around 2,000 drug products from the market because of the government’s aggressive pricing demands in tenders.

And Kristin Raudsepp, chair of a task force from European regulators created to tackle the issue, also called for joint working from regulators, industry and government to solve the problem.

Government has commissioned external analysis of Brexit impact on UK medicines supply chain, MPs told

The Pharmaceutical Journal, Debbie Andalo, 25 January 2018

The government has commissioned an analysis by professional services consultants Ernst and Young (EY) into the impact of Brexit on the UK medicines supply chain, MPs on the Health Select Committee were told on 23 January 2018.

The results of the investigation, which will include talks with drug manufacturers who have already revealed they are spending millions of pounds preparing for the UK leaving the European Union (EU), may however, remain secret because the information could be commercially sensitive, MPs were told.

Details of the external scrutiny were revealed to the House of Commons health select committee at its continuing inquiry into the impact of Brexit on the UK’s medicines supply chain.

Health and social care secretary Jeremy Hunt, appearing before the committee, impressed on MPs the importance of protecting the supply chain during the current Brexit negotiations.

He said: “We need to make sure that there is continuity for the supply chain … that will all be part of the different scenarios that we are preparing for.”

Hunt said he was confident about reaching a successful transition agreement with the EU, which would protect both the supply chain and UK patients’ access to drugs.

“It is uniquely damaging to both parties if we don’t come to an agreement … that gives me a lot of confidence that we will ultimately agree what needs to be agreed,” he said.

“It is an absolute priority to make sure that access to new drugs does not slow down as a result of Brexit,” he said.

“We are confident that we can avoid that. When it comes to importing drugs from overseas we are the customers. It would be against our national interest to make it harder to import life-saving drugs.”

Hunt was responding to concerns from MPs who were keen to discover whether the government had carried out any analysis into the risks that Brexit posed for the life sciences industry and for patients, and what measures had been put in place to minimise those risks.

They also asked about any government contingency plans for the possibility of a no-deal — especially if it happened at the last minute.

They wanted Hunt to spell out the impact of Brexit on the government’s life science strategy, the medicines supply chain and what it expected its future relationship to be with the European medicines safety watchdog, the European Medicines Agency.

Hunt reiterated the government’s position statement on medicines regulation post-Brexit.

He told MPs that negotiators were seeking a deal that offered regulatory alignment but “with a different legal structure under it.” He said: “That is the case that we will be making to the EU; that would be our most preferred outcome.”

He said that there was no “intellectual problem or incompatibility” to having “close regulatory alignment” in the long term post-Brexit: “The issue is the legal underpinning to that.”

But, he said, staying in the single market and in the customs union was not an option: “I don’t think that is compatible with what the British people voted for … But I think we can have close regulatory alignment and still be outside the single market. It’s entirely possible.”

Dr Ian Hudson, chief executive of the UK’s medicines safety watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) told MPs he was confident that the UK’s contribution to potentially ground-breaking clinical trials would continue post-Brexit.

Hudson explained that the country could still be involved in multi-national clinical trials regardless of the outcome of Brexit talks, provided it continued to observe agreed protocols and went through the necessary approval process.

“Our ability to run a multinational trial involving the UK doesn’t change,” he said.

“The mechanism for that approval may change but the ability to do it does not change.”

HDA UK Media And Political Bulletin – 29 January 2018

From Factory to Pharmacy

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