News

Media And Political Bulletin – 23 November 2018

Media and Political Bulletin

23 November 2018

Media Summary

GIRP Wholesale Brief

GIRP, Horst Matzer, 22 November 2018

The November edition of the GIRP’s monthly UK wholesale brief comes from KNAPP’s Director of Healthcare Services and highlights the fact that in less than three months, the Falsified Medicines Directive will go live.

The article also states that ‘it is not only new regulations which we at KNAPP see coming up on the horizon, it is also additional services which have been introduced to the Pharmaceutical Supply Chain. KNAPP’s “Pack to Patient” systems consist of automated systems facilitating the consolidation of all items ordered by a patient as well as labeling of these items with patient specific data, where the legislation allows for this service. We are very pleased to see our “Pack to Patient” systems successfully entering the supply chain and thus allowing our customers to provide additional services to pharmacy as well as to the patients.’

EU, UK ‘agree’ draft on post-Brexit ties

RFI, Toby Melville, 22 November 2018

The RFI reports that the EU and British negotiators have agreed in principle on a draft declaration for post-Brexit relations.

The article includes a section on drugs shortages, stating that ‘UK industries are on tenterhooks’ as the March 29 deadline draws closer. And that in August the UK government recommnended that pharmaceutical companies stockpile six months worth of medication to avert shortage post-Brexit.

The article includes a quotation from Martin Sawer, Executive Director of the HDA, who said that ‘the risk of a shortage of medical supplies to hospitals remains real and has yet to be addressed by the government.’

Lords ask Minister for clarity on access to medicine after Brexit

Pharma Times, Anna Smith, 23 November 2018

The Pharma Times reports on the fact that the House of Lords EU Home Affairs Sub-Committee has written to Matt Hancock asking for clarity on the government’s contingency preparations to ensure the UK has continued access to medicines and medical products in the event of a ‘no-deal’ Brexit.

The article states that there is still concern that a ‘no-deal’ Brexit may limit the availability of medicines in the UK and that there was little sign to date of potential delays on the border being addressed.

Read the letter here, which contains a quotation from Martin Sawer, Executive Director of the HDA, who said in an oral evidence session to the House of Commons last December that ‘given that the Healthcare Distribution Association estimates that 45% of all medicines in the UK are imported from the EU, disruption to this supply chain could be felt acutely in the UK.’

Faster access to groundbreaking medicines as major milestones reached in deal with pharmaceutical industry

ABPI, Press Release, 23 November 2018

The ABPI has released a press release which states that patients could have access to new, ground breaking medicines up to six months earlier and that the NHS across the UK is expected to save around £930 million on its medicine bill under a new scheme being finalised with the pharmaceutical industry.

The Government and the ABPI have reached a deal on the Heads of Agreement for a new voluntary scheme for Branded Medicines Pricing and Access, which is expected to come into effect from January 2019.

The press release states that the final details are still being finalised, but a major milestone has been reached in the discussions which would see the most transformative and best value medicines made available on the NHS more quickly through better horizon scanning, earlier commercial dialogue, and faster appraisals from The National Institute for Health and Care Excellence.

See this also reported in the Financial Times, which reports that the first details have emerged overnight of the UK government’s proposed new agreement with the pharmaceutical industry on how it will pay for branded medicines from next year.

CMA closes investigation into alleged anticompetitive generic drug pricing practices

The Pharmaceutical Journal, Carolyn Wickware, 23 November 2018

The Pharmaceutical Journal reports that, owing to a lack of sufficient evidence of lawbreaking, the Competition and Markets Authority has decided to close its investigation into anticompetitive generic drug pricing.

The investigation was launched on 13 October 2017 at the height of the crisis in the generics market that hit community pharmacy. When it launched, the CMA said in a statement that the investigation related ‘to alleged anticompetitive agreements and/or concerted practices in relation to generic pharmaceutical products’.

However, the investigation was closed on 14 November 2018 because the body concluded that continuing with the case ‘would not be the best use of the CMA’s resources’.

Brexit – no-deal contingency planning

Politico, 23 November 2018

Politico reports that ‘as Hancock scrambles to explain whether the government’s preparations to mitigate risks to drug supplies is up to scratch, the ABPI has provided some details on their estimates of the potential impacts of a no-deal Brexit — as well as some new examples of its member’s contingency planning.

The details include some numbers, for example, the fact that 45 million packs of drugs move from the UK to the EU every month, with 37 million moving the other way.

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 22 November 2018

Laura Smith, MP: To ask the Secretary of State for Health and Social Care, if he will make an assessment of the effect of the UK leaving the EU on the availability of Keppra for people with epilepsy.

Answered by Steve Brine: The United Kingdom’s position on medicines regulation remains clear. We want to retain a close working partnership with the European Union to ensure that medicines remain available to UK patients in a safe and timely manner. We have been clear that this involves us making sure our regulators continue to work together, as they do with regulators internationally. As the Prime Minister has said, we intend to to explore with the EU the terms on which the UK could remain part the European Medicines Agency.

Until we can be certain of the outcome of Brexit negotiations our duty as a responsible Government is to prepare for all eventualities, including ‘no deal’. On 23 August 2018, therefore, the Department wrote to all pharmaceutical companies that supply the United Kingdom with prescription only or pharmacy medicines from, or via, the European Union/European Economic Area, asking them to ensure they have a minimum of six weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019 in the event of a no-deal scenario.

Since then, we have received very good engagement from industry who share our aims of ensuring continuity of medicines supply for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a no-deal Brexit.

We understand that the medicine Keppra is important to many people in this country. However, the Department recognises that through its medicines supply contingency programme it is requesting sensitive commercial information from pharmaceutical companies. To reassure participating companies, we have committed to treating all information received confidentially, securely and to using it only for the purposes of the Department’s programme. That means not introducing information about a company, specific medicine or their supply routes into the public domain.

Dr Rosena Allin-Khan, MP: To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure the supply of statins after the UK leaves the EU.

Answered by Steve Brine: Until we can be certain of the outcome of Brexit negotiations our duty as a responsible government is to prepare for all eventualities, including ‘no deal’. On 23 August 2018, therefore, the Department wrote to all pharmaceutical companies that supply the United Kingdom with prescription only or pharmacy medicines from, or via, the European Union/European Economic Area, asking them to ensure they have a minimum of six weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 29 March 2019 in the event of a no-deal scenario.

Since then, we have received very good engagement from industry who share our aims of ensuring continuity of medicines supply for patients is maintained and able to cope with any potential delays at the border that may arise in the short term in the event of a no-deal Brexit.

We understand that statins are vitally important to many people in this country. However, the Department recognises that through its medicines supply contingency programme it is requesting sensitive commercial information from pharmaceutical companies. To reassure participating companies, we have committed to treating all information received confidentially, securely and to using it only for the purposes of the Department’s programme. That means not introducing information about a company, specific medicine or their supply routes into the public domain.

Bill Esterson, MP: To ask the Secretary of State for Health and Social Care, with reference to the European Medicines Verification Organisation’s report, NMVO’s Fee Models Status, published on 21 August 2018, what discussions his Department has had with the UK’s National Medicines Verification Organisation on reducing the entrance fees for small companies in line with those of other European countries.

Answered by Jackie Doyle-Price: SecurMed, the not-for-profit company set up by stakeholders in the United Kingdom medicines supply chain, is responsible for setting the fee model and level of fees as the UK’s National Medicines Verification Organisation (NMVO). In their supervisory capacity, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department’s aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way. As part of that role, the MHRA and the Department have been involved in discussions with SecurMed to challenge and seek to influence the pricing model to ensure that the UK’s fee structure is fair and proportionate.

The European Commission has confirmed that the fee model being used by SecurMed is in line with the majority of other member states NMVO’s across the European Union. It is based on the number of users and cost per connection where larger organisations, which are more likely to have multiple marketing authorisations, pay more. An annual fee waiver scheme exists for micro Marketing Authorisation Holders which is designed to support start-ups and help ensure there is not a barrier to market entry.

Full Coverage

GIRP Wholesale Brief

GIRP, Horst Matzer, 22 November 2018

In less than 3 months, an incredible piece of work carried out by GIRP will go live – the Falsified Medicine Directive as well as the GDP requirements will come into force and will be enacted by February 2019. Countless hours of support provided by GIRP to its members over the last months and years will assure a smooth start of this regulatory framework in the Pharmaceutical Supply Chain.

But it is not only new regulations which we at KNAPP see coming up on the horizon, it is also additional services which have been introduced to the Pharmaceutical Supply Chain. KNAPP’s “Pack to Patient” systems consist of automated systems facilitating the consolidation of all items ordered by a patient as well as labeling of these items with patient specific data, where the legislation allows for this service. We are very pleased to see our “Pack to Patient” systems successfully entering the supply chain and thus allowing our customers to provide additional services to pharmacy as well as to the patients.

For GIRP members and KNAPP customers, offering a variety of services is not only relevant but it is also essential to be able to provide services efficiently as well as consistently: in a nutshell, to maintain an extremely high service level while also monitoring the costs thereof. KNAPP’s Smart Services, a suite of key performance indicators constantly online and available at your fingertips, supports the monitoring of order processing as well as the monitoring of the warehouse logistics. Live data, benchmarks and trends easily displayed allow for a so far unparalleled operation in all aspects.

With your input, dear GIRP members, KNAPP was able to develop and provide systems featuring new services while also developing the tools – Smart Services – to master the increasing complexity of the operational aspect of the business.

Undoubtedly, the combination of well-established business partners, you, dear GIRP members and KNAPP on the other hand as well as a highly active and professional association, namely GIRP, assures success – on behalf of KNAPP, thank you all for your cooperation.

EU, UK ‘agree’ draft on post-Brexit ties

RFI, Toby Melville, 22 November 2018

European Union and British negotiators have agreed in principle on a draft declaration for post-Brexit relations, that is now to be sent to EU leaders for endorsement, according to European Council President Donald Tusk.

The two sides have also agreed a draft deal extending the transition period by one or two years beyond the end of 2020, a final sticking point of the divorce deal.

European Council President Donald Tusk said the EU executive, the European Commission, informed him it has agreed the political declaration on the future ties with Britain.

“I have just sent to EU27 a draft Political Declaration on the Future Relationship between EU and UK,” said Tusk, who represents the 27 remaining EU member countries.

The Commission President (Jean-Claude Juncker) has informed me that it has been agreed at negotiators’ level and agreed in principle at political level,” Tusk tweeted.

He said EU leaders still have to endorse the draft declaration, which is due to accompany a draft of agreed terms for Britain’s withdrawal from the bloc on March 29.

Austria’s key role

Shortly before a meeting with her Austrian counterpart – Sebastian Kurz – Theresa May described the latest development as, “the right deal for the UK that delivers on the referendum vote.”

Austria currently heads the EU presidency and so Kurz is set to play a key role when EU leaders meet at a summit in Brussels on Sunday to endorse both documents.

Speaking alongside May, Kurz expressed his country’s desire to maintain the unity of the EU, but warned that Spain needed reassurances about the status of the British island of Gibraltar.

Transition period extended

The other areas cover law enforcement, criminal justice, foreign policy, security and defence and wider areas of cooperation, according to the draft.

In an update of the withdrawal agreement, both sides have agreed to extend the post-Brexit transition period from December 31, 2020 “for up to one or two years.”

The transition period is designed to allow governments and businesses to adjust to a new relationship after more than four decades of close ties.

Following the announcement of the draft declaration, the British parliament said Prime Minister Theresa May will make an “emergency statement” to MPs on Thursday.

Downing Street said the prime minister was holding a teleconference with cabinet ministers about the deal.

Shortages feared

UK industries are on tenterhooks as the March 29 deadline draws closer. An extended transition period is likely to calm the nerves of the food and pharmaceutical industries.

In August the UK government recommnended that pharmaceutical companies stockpile six months worth of medication to avert shortage post-Brexit.

“The risk of a shortage of medical supplies to hospitals remains real and has yet to be addressed by the government,” Martin Sawer, Director of Healthcare Distribution Association, told RFI.

Food distribution companies are also making provisions to avert post-Brexit shortages by doubling the time food is stored before being distributed.

“Some companies are now storing food for twelve days instead of five, but they cannot store food for three months,” Tim Long, Vice President for Sales and Distribution at Tiger Soybeans, told RFI.

Lords ask Minister for clarity on access to medicine after Brexit

Pharma Times, Anna Smith, 23 November 2018

The House of Lords EU Home Affairs Sub-Committee has written to Matt Hancock MP, Secretary of State for Health and Social Care (DHSC), asking for clarity on the government’s contingency preparations to ensure the UK has continued access to medicines and medical products in the event of a ‘no deal’ Brexit.

There is still concern that a no deal Brexit may limit the availability of medicines in the UK and that there was little sign to date of potential delays on the border being addressed.

Despite pharmaceutical companies “doing everything in their power” to minimise disruption to the supply of medicines should the UK leave the EU under a ‘no-deal’ scenario, MPs have been told a deal is urgently needed to fully protect patients.

The Minister has been asked to clarify issues such as: “How confident are you that the contingency measures deployed as an immediate response to secure the supply of medicines and medical products can be sustained beyond the first six weeks after Brexit, should this be required?” and “What plans has the Government made to secure and prioritise airborne routes for medical products?”

The Government’s current guidance is to stockpile six weeks’ worth of medicines and medical products in the event of blockages at borders, however medicines with short shelf lives cannot be stockpiled and would have to be flown in.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (ABPI), recently reminded a commons select committee that there are medicines “which simply can’t be stockpiled due to temperature control, short shelf life or inability to travel,” stressing “that is why we urgently need a deal.”

Faster access to groundbreaking medicines as major milestones reached in deal with pharmaceutical industry

ABPI, Press Release, 23 November 2018

Cutting-edge and best value drugs will be fast-tracked through the approval process so patients can gain access up to six months earlier

Deal will also mean a more flexible and streamlined commercial process which will make UK more attractive to investors

Under the new Voluntary Scheme for Branded Medicines Pricing and Access, the NHS across the UK would save almost £1 billion on medicines next year which could be put back into NHS services.

Patients could have access to new, ground-breaking medicines up to six months earlier and the NHS across the UK is expected to save around £930 million on its medicine bill under a new scheme being finalised with the pharmaceutical industry.

The Government and the Association of the British Pharmaceutical Industry (ABPI) have reached a deal on the Heads of Agreement for a new voluntary scheme for Branded Medicines Pricing and Access, which is expected to come into effect from January 2019.

The final details are still being finalised, but a major milestone has been reached in the discussions which would see the most transformative and best value medicines made available on the NHS more quickly through better horizon scanning, earlier commercial dialogue, and faster appraisals from The National Institute for Health and Care Excellence (NICE).

Health Secretary Matt Hancock said:

“This new deal will be good for patients, good for the NHS and good for the UK life sciences industry. Cutting-edge and best value medicines will be fast-tracked and we will cut our medicines bill by £930 million next year following tough but constructive negotiations with the pharmaceutical industry – money we can redeploy into better NHS services, alongside the NHS Long Term Plan.

“The deal will also ensure the UK remains an attractive hub for research and investment so the next generation of ground-breaking treatments can be developed here with patients benefitting earlier.”

The terms in the Heads of Agreement set out how the 2019 Voluntary Scheme, once agreed in full, will benefit patients by ensuring the NHS gets the best value and most effective medicines into use more quickly by:

Faster NICE appraisals meaning that patients are likely to get access to new medicines up to six months earlier than today

More NICE technology appraisals than ever before so all new medicines are assessed by NICE, and the NHS is required to fund all those recommended for use

Smoother and faster introduction of transformative medicines through better horizon scanning and early engagement with companies to ensure clinicians and the NHS infrastructure are ready to use them more quickly

More commercial options to incentivise better value for the NHS

Health Minister Lord O’Shaughnessy said:

“The agreement is a vote of confidence for our world-leading life sciences sector, and shows the NHS is ready to embrace innovation so that patients get the best medicines earlier.

“Small and medium-sized business in particular will be better supported through greater commercial flexibility, helping SMEs to bring their innovative treatments into the NHS.

The agreement will also ensure the UK remains an attractive hub for our world-leading life sciences sector, a central part of the government’s Industrial Strategy.

Mike Thompson, Chief Executive of The Association of the British Pharmaceutical Industry, said:

“This agreement is a commitment by the Government and the NHS to work with us to support innovation for the benefit of patients. This means that people across the UK should see better and faster access to the most effective new medicines and vaccines.

“Under the scheme the NHS will have absolute certainty that the sales of branded medicines will not grow by more than two per cent in any of the next five years – or industry refunds the money.  This is a significant contribution by pharmaceutical companies to support the NHS.”

The scheme is designed to keep growth in the branded medicine bill predictable and affordable by:

Placing a 2% cap on the growth in sales of branded medicines to the NHS, with pharmaceutical companies repaying the NHS for spending above that limit – delivering expected savings of around £930 million in 2019.

Supporting smaller companies to innovate through payment exemptions and targeted case management through NHS England commercial discussions

Simplifying price controls: reducing unpredictability and complexity for companies and the NHS

Enabling faster and more flexible commercial discussions than ever before to get the best value and most effective new medicines into use as quickly as possible.

CMA closes investigation into alleged anticompetitive generic drug pricing practices

The Pharmaceutical Journal, Carolyn Wickware, 23 November 2018

Owing to a lack of sufficient evidence of lawbreaking, The Competition and Markets Authority has decided to close its investigation into anticompetitive generic drug pricing.

The Competition and Markets Authority (CMA) has closed an investigation into alleged anticompetitive generic drug pricing after concluding that the case was not a good use of its resources.

The CMA said the investigation had been looking into “suspected breaches of competition law” relating to a range of drugs.

However, the investigation was closed on 14 November 2018 because the body concluded that continuing with the case “would not be the best use of the CMA’s resources”.

The investigation had focused on potential breaches of the Competition Act 1998, but no details were released onwhich companies or organisations were under investigation.

The investigation was launched on 13 October 2017 at the height of the crisis in the generics market that hit community pharmacy. When it launched, the CMA said in a statement that the investigation related “to alleged anticompetitive agreements and/or concerted practices in relation to generic pharmaceutical products”.

The CMA added that it “had not reached a view on whether there is sufficient evidence of an infringement of competition law for it to issue a statement of objections to the parties under investigation”.

In a summary of its decision to close the investigation on 7 November 2018, the CMA said that although this case was now closed, two of the alleged anticompetitive agreements “in relation to generic pharmaceutical products” were being investigated further as two new cases.

The Pharmaceutical Journal previously revealed in July 2018 that the CMA had opened six new investigations into anticompetitive practices in the pharmaceutical sector at the height of the pricing crisis in the generics market. At the time, it was not clear whether the products involved were generics.

Brexit – no-deal contingency planning

Politico, 23 November 2018

And here‘s why it matters. As Hancock scrambles to explain whether the government’s preparations to mitigate risks to drug supplies is up to scratch, ABPI gave us some details on their estimates of the potential impacts of a no-deal Brexit — as well as some new examples of its member’s contingency planning.

BY THE NUMBERS:

£24.9 billion: The value of pharmaceutical products the U.K. exported in 2016. Half went to Germany, the Netherlands and France. Additionally, 54 percent of U.K. pharmaceutical imports come from Germany, Belgium and the Netherlands.

45 million packs: The volume of drugs that move from the U.K. to the EU every month, with 37 million packs moving the other way.

50 percent: An estimate of the proportion of the new medicines approved last year that require cold storage.

PREPARATION PLANS:

AstraZeneca has increased the number of finished medicines available to pharmacies and hospitals in both the U.K. and EU by 20 percent. It has spent £40 million preparing for a no-deal Brexit, including building labs in Sweden to duplicate product testing.

GSK is expanding re-testing and certification processes, updating packaging and leaflets and transferring U.K. marketing authorizations to an EU entity. It estimates the cost of planning at £70 million over the next two to three years, with ongoing additional costs of £50 million per year.

Ipsen has one U.K.-made drug that’s distributed to more than 80 territories worldwide. The company has changed distribution channels and boosted stocks in the U.K. and in the EU.

Lilly has moved lab testing for specific medicines from the U.K. to Spain, secured additional warehouse and cold-chain space to enable stockpiling and transferred marketing authorizations.

MSD, the European branch of Merck & Co, is supporting EU employees in getting settled status in the U.K. post Brexit. It’s also stockpiling medicines.

French pharma Sanofi is securing additional U.K. warehouse space for medicines and vaccines that require cold storage and also moving some manufacturing operations from the U.K. to EU27 countries.

Media And Political Bulletin – 23 November 2018

From Factory to Pharmacy

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