Media And Political Bulletin – 02 March 2020

Media and Political Bulletin

02 March 2020

Media Summary

FDA reports first coronavirus-related drug shortage

CNBC, Berkeley Lovelace Jr., 28 February 2020

CNBC reports that the FDA has said the pharmaceutical industry has reported the first shortage of a drug due to the COVID-19 outbreak. The FDA, which declined to identify the drug, said the shortage is related to a manufacturing site impacted by the outbreak in China.

“It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage,” the agency said in its notice.

The FDA also said it has been in touch with more than 180 manufacturers of human drugs since 24 January, asking them to evaluate their entire supply chain and other components manufactured in China.

10 things you should know about the English pharmacy contract update

C+D, Valeria Fiore, 28 February 2020

While the overall funding for community pharmacy is fixed at £2.592bn per year until 2024, the number of services offered by the sector will grow in 2020-21.

An update on the English community pharmacy contractual framework (CPCF) for 2019-20 to 2023-24, shared with contractors last week (February 23), offers more detail about some of the services first announced in the contract last year.

C+D gives their pick of the 10 key updates contractors need to get ready for.

 

Parliamentary Coverage

Medicines and Medical Devices Bill: overarching documents

Department of Health and Social Care, 28 February 2020

Further documents relating to the Medicines and Medical Devices Bill 2020 have been published:

  • The impact assessment evaluates the measures in the Medicines and Medical Devices Bill and gives an overarching assessment of the impact they will have.
  • The illustrative statutory instruments accompany the Delegated Powers Memorandum. These are illustrative examples of how the powers in the bill may be used, and are not final drafts for consultation.
  • The 10 factsheets provide additional information on key areas of the Medicines and Medical Devices Bill.

 

Full Coverage

FDA reports first coronavirus-related drug shortage

CNBC, Berkeley Lovelace Jr., 28 February 2020

The Food and Drug Administration said the pharmaceutical industry reported the first shortage of a drug due to the COVID-19 outbreak that has spread to 44 countries in a matter of weeks.

The FDA, which declined to identify the drug, said the shortage is related to a manufacturing site impacted by the outbreak in China.

“The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” the agency said in its notice dated Thursday. “It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage.”

The agency has been warning consumers that the impact to the medical supply chain would likely impact their own lives, including potential disruptions to prescription drugs or shortages of critical medical products in the United States. China, where the outbreak began in late December, is a large supplier of active pharmaceutical ingredients used to make several medicines.

China this week began reopening operations for a number of businesses, but travel restrictions that are still in place are likely to slow down production.

The FDA also said it has been in touch with more than 180 manufacturers of human drugs since Jan. 24. The agency is asking them to evaluate their entire supply chain and other components manufactured in China.

“Also, as part of our efforts, the FDA has identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China,” the agency said.

10 things you should know about the English pharmacy contract update

C+D, Valeria Fiore, 28 February 2020

While the overall funding for community pharmacy is fixed at £2.592bn per year until 2024, the number of services offered by the sector will grow in 2020-21.

An update on the English community pharmacy contractual framework (CPCF) for 2019-20 to 2023-24, shared with contractors last week (February 23), offers more detail about some of the services first announced in the contract last year.

Changes include the introduction of the NHS Discharge Medicines Service, which community pharmacies will be expected to provide a new essential service from July. As part of this, hospitals will be able to digitally refer patients to their pharmacy for guidance on newly prescribed medicines or updated prescriptions.

Pharmacies will continue to deliver the Community Pharmacist Consultation Service (CPCS), which will be expanded to include referrals from NHS 111 online in June, and from GP practices later this year.

The Pharmaceutical Services Negotiating Committee (PSNC) is still finalising the details of each service, in collaboration with NHS England and the Department of Health and Social Care (DH) and working towards an agreement on the payment contractors will receive in 2020-21.

Here is our pick of the 10 key updates contractors need to get ready for:

  • Hepatitis C testing service: This service will be nationally commissioned from April, and will ask pharmacies to refer patients found to have positive antibodies to a local treatment service. Although all pharmacies can offer this service, it will “generally only be of interest to those pharmacies offering a locally commissioned needle and syringe programme”, PSNC said in a Frequently Asked Questions document, published last week (February 23). Reimbursement fees and service specifications are still being defined.
  • CPCS referrals from NHS 111 online: From June, pharmacies could receive referrals for urgent medicines supply from NHS 111 online.
  • NHS Discharge Medicines Services: This new essential service is expected to be introduced from July. It will allow pharmacists to use their skills as medicines experts to offer guidance on newly prescribed medicines to patients recently discharged from hospital. Under the service, PSNC expects pharmacies to receive a fee for each referral they complete, but the amount is still being decided.
  • CPCS referrals from GP practices: This extension of the CPCS could be introduced as early as October, subject to the success of current pilots, and will see GP practices refer patients to pharmacies when appropriate.
  • Clinical pilots: A number of clinical services will be piloted over the coming financial year. These include a blood pressure testing service; a smoking cessation referral service; and a point of care testing for Streptococcus A in community pharmacy.
  • NHS travel vaccinations service: Subject to negotiations with NHS England and the DH, pharmacies could soon be offering four NHS travel vaccines: against polio, typhoid, hepatitis A and cholera. PSNC believes these vaccines, already provided by some GP practices, could be introduced by March 2021.
  • Transitional payments: These will increase from April and will be linked to each pharmacy’s dispensing volume. However, payments will reduce over the course of this financial year, as new services are introduced and funding is transferred to them. PSNC was unable to share details on the revised payment bands for 2020-21 at this stage, as these are currently being finalised with the DH.
  • Establishment payments: Contractors can expect to receive reduced establishment payments. These will be phased out by the end of 2020-21, as announced as part of the CPCF last year.
  • Reduced Medicines Use Reviews (MUR) budget: In 2020-21, NHS England will commission a maximum of 100 MURs per pharmacy and from July, when the new NHS Discharge Medicines Services is introduced, “70% of MURs will be targeted solely at high risk medicines”, the commissioning bodies, the DH and PSNC said in a letter to contractors. MURs will be decommissioned by April 2021.
  • Pharmacy Quality Scheme (PQS): Funding for this has been maintained at £75m but payments will be made to pharmacies depending on their 2019 prescription volume – a new aspect of the scheme. More details on this will be announced in “due course”, according to a PSNC briefing published last week (February 23).

Media and Political Bulletin

18 May 2018

Media Summary

Medicines won’t be available in the UK post-Brexit unless MHRA-EMA deadlock ends

Pharmacy Business, Neil Trainis, 17 May 2018

 

Pharmacy Business reports that Richard Freudenberg, the chief executive of the European Association of Euro-Pharmaceutical Companies (EAEPC), has warned that a significant number of drugs may no longer be available to patients in Britain from midnight on March 29 next year unless its medicines regulator registers those products for use in the UK.

The long-running medicines shortage within community pharmacy which has jeopardised the safety of patients and placed great strain on pharmacies could get much worse as soon as the UK leaves the European Union (EU) in 10 months’ time, with over 400 drug molecules currently centrally approved in Europe no longer available for distribution to patients in the UK post-Brexit.

All medicines manufactured in the UK after March 29, 2019 will be regarded as imports from a ‘third country,’ however it is thought that manufacturers that set up entities in the EU could continue operating under EMA regulations. Otherwise all products which are authorised in Europe and manufactured in the UK will no longer be valid for use in the latter.

 

Hard Brexit could ‘injure’ UK pharma, MPs warn

Pharmaphorum, Richard Staines, 17 May 2018

 

Pharmaphorum highlights the warning from MPs that a hard Brexit could ‘injure’ UK pharma. The Business, Energy and Industrial Strategy Committee in an in-depth report into the impact of Brexit on the pharmaceutical sector, made a series of recommendations that aim to minimise the impact of leaving the EU in March next year.

These influential MPs have warned a hard Brexit could “injure” the UK’s pharma industry, and the government must take action to remove barriers such as tariffs and burdensome regulation to ensure its continued success.

MPs from the committee said they had concerns about the impact of Brexit in several areas affecting the industry – tariffs and customs arrangements, regulatory alignment, transitional arrangements, and trade opportunities after leaving the EU.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Medicines won’t be available in the UK post-Brexit unless MHRA-EMA deadlock ends

Pharmacy Business, Neil Trainis, 17 May 2018

 

Richard Freudenberg, the chief executive of the European Association of Euro-Pharmaceutical Companies (EAEPC), has warned that a significant number of drugs may no longer be available to patients in Britain from midnight on March 29 next year unless its medicines regulator registers those products for use in the UK.

The long-running medicines shortage within community pharmacy which has jeopardised the safety of patients and placed great strain on pharmacies could get much worse as soon as the UK leaves the European Union (EU) in 10 months’ time, with over 400 drug molecules currently centrally approved in Europe no longer available for distribution to patients in the UK post-Brexit.

All medicines manufactured in the UK after March 29, 2019 will be regarded as imports from a ‘third country,’ however it is thought that manufacturers that set up entities in the EU could continue operating under EMA regulations. Otherwise all products which are authorised in Europe and manufactured in the UK will no longer be valid for use in the latter.

Freudenberg (pictured) urged the Medicines and Healthcare products Regulatory Agency (MHRA), who he said was passing responsibility for avoiding a potentially devastating shortage to the European Medicines Agency (EMA) amid an impasse between the two agencies, to register the products to allow patients in the UK to continue accessing them.

Speaking to Pharmacy Business at the British Association of European Pharmaceutical Distributors (BAEPD) conference in London yesterday, Freudenberg said: “Yes, (there is genuine cause for alarm). But I don’t think it’s been expressed in as stark terms as the EMA is now presenting it. They are saying ‘you’re a third country from midnight on the 29th March next year and therefore these products will go out of our jurisdiction’ as far as they are concerned.

“It’s up to the two national agencies to deal with that and the MHRA are not in that position. They are saying it’s the EMA. So we are in this political football situation.”

When asked what he thought can be done to avoid the shortage, he said: “Look, we are in May and this is going to happen in March, so it’s 10 months away. Something needs to happen soon. The MHRA, if they are going to act, then they need to register those products for use in the UK.

“There are only two routes by which a medicine can be authorised. There’s a national route which the MHRA handle and there’s a pan-European route which the European Medicines Agency handles. The products can’t be authorised by both routes, it’s one or the other.

“It’s normally in the discretion of the manufacturer himself, which route he does that. But in this case we’re looking at such a big issue that I think it’s up to the agencies to get (the medicines) out there and that human story about availability of product is key.”

Freudenberg added: “Four hundred molecules which the EMA authorise and manage, roughly that number, and we just have no sight at the moment about what’s going to happen.”

He revealed that a supply of drugs is in place to offset the impact of a major shortage, with manufacturers already looking to secure “excess warehousing provision,” although he warned that those were short-term measures only.

“What I can tell you is this, and I don’t want to reveal my source, but I know that excess warehousing provision is being sought by manufacturers in advance of next March so there’s sufficient supply already in place. Any product which has already been QP-released, released to the market by the qualified person and the manufacturers, prior to the deadline date can still be distributed in the UK,” Freudenberg said.

“So there is provision being made for some interim measures but it won’t last forever. And don’t forget either that we’ve got a PPRS (pharmaceutical price regulation scheme) coming up on January 1, so that’s going to affect the price of the medicines, so balancing the volume price matrix is going to be key at distributors’ considerations.”

When asked if community pharmacists should be concerned, he said: “Of course they should. I know Raj Patel from the (National Pharmacy Association who was elected president of the Pharmaceutical Group of the European Union in 2016), I know the CCA (Company Chemists’ Association), I’m in contact with those guys through the FMD (Falsified Medicines Directive) stuff and they are as aware of this as I am and are as concerned about it.”

 

Pharmacy Business has contacted the MHRA for a response.

 

 

Hard Brexit could ‘injure’ UK pharma, MPs warn

Pharmaphorum, Richard Staines, 17 May 2018

 

Influential MPs have warned a hard Brexit could “injure” the UK’s pharma industry, and the government must take action to remove barriers such as tariffs and burdensome regulation to ensure its continued success.

The Business, Energy and Industrial Strategy Committee in an in-depth report into the impact of Brexit on the pharmaceutical sector, made a series of recommendations that aim to minimise the impact of leaving the EU in March next year.

MPs from the committee said they had concerns about the impact of Brexit in several areas affecting the industry – tariffs and customs arrangements, regulatory alignment, transitional arrangements, and trade opportunities after leaving the EU.

There are worries as negotiators have made little significant progress around detailed arrangements for Brexit since March, and pharma is preparing for a situation where the UK leaves without an agreement in place.

On tariffs, the committee said that evidence it had gathered suggests that arrangements post-Brexit will not affect pharma as much as other industries.

Nevertheless the committee said it has “significant concerns that (Brexit) could injure the UK’s position as a manufacturing base, a global supply hub and as a manufacturer and a recipient of new and innovative medicines.”

The government must therefore draw up a trade agreement with the EU and other countries, covering all finished and component pharma products, which is not limited to those currently listed under World Trade Organisation (WTO) rules.

Also of concern are customs arrangements – MPs on the committee called for the EU border to be as “frictionless” as possible, and wants arrangements so short-life pharma products for emergency treatments and public health needs can be transferred across the border.

“Form of membership” with EMA

The committee was most concerned about how Brexit will affect drug regulation, saying that “what little benefits there may be of regulatory divergence would be greatly overshadowed by the costs and loss of markets and influence the UK would face”.

MPs said it makes “commercial sense” for the UK to remain aligned with standards in the EU, because of the significant amount of trade between the UK and EU and access it gives to drugs.

They called for a “form of membership” with the European Medicines Agency that maintains cooperation and does not require replication of manufacturing sites, testing or roles.

There should also be a small number of EMA staff retained in the UK after its headquarters leaves London for its new home in Amsterdam, to support cooperation with the national regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

Other worries are trade opportunities post-Brexit – the committee wants the UK to remain aligned with EU intellectual property standards to allow easy trade, and ensuring skills shortages that already exist in the sector are not worsened by allowing effective circulation of staff from around the world.

Finally the committee called for the government to clarify its approach to R&D after Brexit, and whether it will be part of a successor to the Horizon 2020 research collaboration project.

Media and Political Bulletin

17 May 2018

Media Summary

Life Sciences sector responds to BEIS Committee report on the impact of Brexit on the pharmaceutical sector

ABPI, 17 May 2018

 

The ABPI has responded to the report published by the Business, Energy and Industrial Strategy Select Committee which calls on the Government to secure a post-Brexit deal to protect patients and the UK’s pharmaceutical industry.

A joint statement by the Association of the British Pharmaceutical Industry (ABPI) and the UK BioIndustry Association (BIA) – whose chief executives, Mike Thompson and Steve Bates, provided evidence to the Committee – said:

“Every month, 45 million packs of medicine move from the UK to the EU, with 37 million moving the other way.

“Today’s Select Committee Report is right – a Brexit ‘no deal’ would significantly damage public health, patient access to medicines and the UK’s leading pharmaceutical sector. This must be avoided at all costs.

“Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.”

 

How Brexit could increase drug prices

Politico, Carmen Paun, 14 May 2018

 

Politico reports that drugmakers, regulators and patient groups remain very worried about what Britain’s exit from the EU will mean for the way medicines are approved on both sides and how that will affect drug supplies. One highly sensitive issue is how much medicines will cost after Brexit.

In terms of regulatory costs, it is still far from clear whether Britain will remain part of the bloc’s drug regulation system after the Brexit transition period (due to finish in December 2020), the publication continues.

Prime Minister Theresa May said in her Mansion House speech in March that she would like the U.K. to be an associate member of the European Medicines Agency, which assesses applications for marketing authorizations for new drugs. But that suggestion has so far received a cold shoulder in Brussels.

The article goes on to quote Martin Sawer, Executive Director of the Healthcare Distribution Association, who reiterates that if drugmakers have to follow new, parallel regulations in the U.K., this could increase the cost of medicines.

Parliamentary Coverage

House of Commons Business, Energy and Industrial Strategy Committee publishes report on the impact of Brexit on the pharmaceutical sector, 17 May 2018

The House of Commons, BEIS Select Committee has published its report following an inquiry into the impact of Brexit on the pharmaceutical sector. The report calls on the Government to secure a post-Brexit deal to protect patients and the UK’s pharmaceutical industry.

The recommendations from the committee include securing the closest possible regulatory alignment with the EU27 post-Brexit as well as ensuing minimum border friction.

To read the full report, please follow this link.

 

Full Coverage

Life Sciences sector responds to BEIS Committee report on the impact of Brexit on the pharmaceutical sector

ABPI, 17 May 2018

 

‘The impact of Brexit on the pharmaceutical sector’ makes several recommendations which industry welcomes. This includes the need to secure the closest possible regulatory alignment with the EU as well as minimum border friction. Patients are at risk of harm and the UK pharmaceutical sector could lose its status as a world leader, the report says.

The Committee also concluded that “what little benefits there may be from regulatory divergence, these would be greatly overshadowed by the costs and loss of markets and influence the UK would face.”

A joint statement by the Association of the British Pharmaceutical Industry (ABPI) and the UK BioIndustry Association (BIA) – whose chief executives, Mike Thompson and Steve Bates, provided evidence to the Committee – said:

“Every month, 45 million packs of medicine move from the UK to the EU, with 37 million moving the other way.

“Today’s Select Committee Report is right – a Brexit ‘no deal’ would significantly damage public health, patient access to medicines and the UK’s leading pharmaceutical sector. This must be avoided at all costs.

“Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.”

 

How Brexit could increase drug prices

Politico, Carmen Paun, 14 May 2018

 

When Health Secretary Jeremy Hunt wrote last month that there were “gilt-edged opportunities” for health from Brexit, he probably didn’t have drug companies charging more for medicines in mind.

Drugmakers, regulators and patient groups are busy worrying about what Britain’s exit from the EU will mean for the way medicines are approved on both sides and how that will affect drug supplies. One highly sensitive issue is how much medicines will cost after Brexit.

Any increase could hit the U.K.’s already stretched National Health Service, soaking up funds and forcing cutbacks elsewhere in the service. That would not sit well with the promises of Brexiteers to release money from the U.K.’s contributions to the EU budget to be spent on the NHS.

Manufacturers of branded drugs don’t think Brexit will impact drug prices, but other industry players are worried that Brexit will lead to increases.

Here’s how Brexit could hit the price of medicines:

Ending parallel imports from the EU

Licensed distributors can now buy cheaper medicines from one EU country and resell them for more in the U.K. The EU rules allowing them to do so are based on the principle of free movement of goods within the bloc’s single market.

Unless the U.K. and the EU find an agreement to maintain the flow of cheaper medicines through parallel imports into the U.K., the practice would stop with Brexit (assuming the U.K. rejects the so-called Norway option of continued single market membership).

That will potentially lead to less competition and higher prices, according to Richard Freudenberg, secretary-general of the British Association of European Pharmaceutical Distributors (BAEPD).

“Parallel imports are the only price competition Big Pharma has for on-patent drugs,” he said. Drugmakers can launch their new medicine in the U.K. at a certain price, but parallel importers compete with them by buying the same drugs cheaper in other European countries. This competition depresses the list prices drugmakers ask in the U.K.

According to the BAEPD’s submission to an inquiry by the House of Commons health committee, the list prices for drugs in the U.K. are currently at least 3 percent lower than they would be without the existence of parallel trade. “The impact for launch prices of medicines will be affected by an absence of parallel imports in the future,” said Freudenberg. Not everyone agrees.

“I don’t see it,” said Richard Torbett, executive director for commercial policy at ABPI, the British lobby defending the interests of branded drugs manufacturers. He said the competition is fiercer between two branded medicines that treat the same disease than between a medicine that is placed on the market directly by the manufacturer and the same one coming from parallel imports.

Torbett doesn’t see Brexit affecting drug prices, since the process of pricing a new branded medicine “is based around the value of a medicine rather than the cost of manufacturing,” he said.

Regulatory costs

With Brexit negotiators only now beginning to tackle questions about the U.K.’s future relationship with the EU in earnest, it is far from clear whether Britain will remain part of the bloc’s drug regulation system after the Brexit transition period (due to finish in December 2020).

British Prime Minister Theresa May said in her Mansion House speech in March that she would like the U.K. to be an associate member of the European Medicines Agency, which assesses applications for marketing authorizations for new drugs. But that suggestion has received a cold shoulder in Brussels.

If drugmakers have to follow new, parallel regulations in the U.K., this could increase the cost of medicines, said Martin Sawer, executive director at the Healthcare Distribution Association, which represents medicines and medical devices distributors.

For generic drug manufacturers, even if the U.K. were to remain within the EMA they will have to deal with an extra regulatory burden. That’s because many of these drugs are certified at the national level, not by the EMA. The legal and logistical changes they will need to undertake before Brexit are likely to have an impact on prices.

The U.K. drug agency handled many approvals of generic medicines through the so-called decentralized procedure by which an EU country approves a drug and others then recognize it as approved in their country as well. Generic manufacturers will now have to transfer the files held by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to other EU countries’ agencies.

“This takes time and costs money,” said Adrian van den Hoven, director general at Medicines for Europe, the EU generics pharma lobby.

Transferring the quality assurance system from the U.K. to the rest of the continent will also be a logistical and cost burden, he said. All medicines or active pharmaceutical ingredients on the EU market need to be released by a qualified person who can attest that they fulfil all regulatory requirements and standards.

One challenge is that many of the active ingredients imported into Europe first go to the U.K, where they are laboratory tested and then released EU-wide, Van den Hoven said.

Without an agreement, all of this would have to be done somewhere in the EU, meaning the need for new laboratories that would have to be certified within a tight timeframe, which could in turn have a major impact on the supply of some medicines into the EU, he said.

“This could lead to shortages and in a market based on supply and demand, a huge temporary impact on cost,” Van den Hoven said. In the long term, the money used to build new labs in the EU would be reflected in the medicine prices, he said.

Media and Political Bulletin

16 May 2018

Media Summary

FMD and Brexit risks medicine shortage, European pharmacy body warns

The Pharmaceutical Journal, 15 May 2018

 

The Pharmaceutical Journal reports that the Falsified Medicines Directive (FMD) and Brexit could contribute to an increased risk of medicines shortages in Europe, according to the European Industrial Pharmacists Group (EIPG).

The EIPG represents professional organisations of pharmacists employed in the pharmaceutical or allied industries in Europe, and has reviewed the implications for Qualified Persons of both the FMD and the impact of Brexit on pharmacists in their roles to ensure availability of efficacious medicinal products for patients.

The group noted that all actors in the pharmaceutical supply chain must adapt their quality systems in considerably short time frames for both the FMD and Brexit, and that this relies heavily on key individuals — in particular Qualified Persons, who are responsible for certifying batches of medicines prior to release, and Responsible Persons, who are responsible for ensuring a quality system is implemented and maintained at wholesale distributors of medicines.

 

Brexit: UK promises ‘significant’ White Paper

BBC, 16 May 2018

 

The BBC highlights the government announcement that it will shortly be producing a White Paper setting out its Brexit position in what will be its “most significant publication on the EU” since the 2016 referendum. It will include “detailed, ambitious and precise explanations of our positions”, Brexit Secretary David Davis told colleagues. Ministers have yet to settle a debate about managing post-Brexit customs.

Labour has said it was “deeply disturbing” that ministers “still cannot agree on the most fundamental Brexit issues”.

The paper will be published ahead of June’s key EU summit. Extending to more than 100 pages, it will involve reaching agreement with almost every government department.

 

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

FMD and Brexit risks medicine shortage, European pharmacy body warns

The Pharmaceutical Journal, 15 May 2018

 

The Falsified Medicines Directive (FMD) and Brexit could contribute to an increased risk of medicines shortages in Europe, a European pharmacy body has warned.

The European Industrial Pharmacists Group (EIPG), which represents professional organisations of pharmacists employed in the pharmaceutical or allied industries in Europe, reviewed the implications for Qualified Persons of both the FMD and the impact of Brexit on pharmacists in their roles to ensure availability of efficacious medicinal products for patients.

The group noted that all actors in the pharmaceutical supply chain must adapt their quality systems in considerably short time frames for both the FMD and Brexit, and that this relies heavily on key individuals — in particular Qualified Persons, who are responsible for certifying batches of medicines prior to release, and Responsible Persons, who are responsible for ensuring a quality system is implemented and maintained at wholesale distributors of medicines.

Claude Farrugia, president of the EIPG, said the FMD deadline “exacerbates the potential risk to the availability of medicines” because it coincides with Brexit. The UK is scheduled to leave the European Union (EU) on 29 March 2019, followed by the FMD launch on 9 February 2019.

On 29 January 2018, the Brexit Health Alliance, which aims to safeguard the interests of patients and the healthcare and research relied upon during Brexit negotiations, warned that medicines supplies could be disrupted when the UK leaves the EU, and called on negotiators to put patients first.

 

 

Brexit: UK promises ‘significant’ White Paper

BBC, 16 May 2018

 

The government says a White Paper setting out its Brexit position will be its “most significant publication on the EU” since the 2016 referendum.

It will include “detailed, ambitious and precise explanations of our positions”, Brexit Secretary David Davis told colleagues.

Ministers have yet to settle a debate about managing post-Brexit customs.

Labour said it was “deeply disturbing” that ministers “still cannot agree on the most fundamental Brexit issues”.

The paper will be published ahead of June’s key EU summit.

Extending to more than 100 pages, it will involve reaching agreement with almost every government department.

A cabinet source told the BBC it would “allow the UK to go and actually negotiate”.

BBC political editor Laura Kuenssberg said the Brexit Department had been pushing for the White Paper – a type of policy document – for some time, but was only able to secure agreement from Number 10 and the rest of the cabinet at a meeting earlier on Tuesday.

Many subjects, including aviation, financial services and fisheries are expected to feature.

In comments to the Cabinet made earlier that the government has just released, Mr Davis said the document “will communicate our ambition for the UK’s future relationship with the EU, in the context of our vision for the UK’s future role in the world”.

It will also set out “the reasoning behind our approach” and “what will change and what will feel different outside the EU”, he added.

Analysis by BBC political editor Laura Kuenssberg

Whether it’s aviation, medicines, the law, fishing, agriculture, the City, the list goes on and on, the Brexit department and other departments have got only a few weeks now to agree what to put into black and white.

For the Department for Exiting the EU that means a multi-faceted negotiation, not with the EU this time, but with departments right across Whitehall.

It also implies that by then, there will be agreement in cabinet over which model of customs to pursue. MPs have been briefed, sub-sub committees (yes, you read that right), have been formed, and the arguments have been shall we say, well-ventilated even in public.

On that, this morning apparently at cabinet the chief whip told off those ministers who had been expressing their views rather too freely, with several around the table urging the need for unity, accompanied by what one told me was “chuntering and eyerolling” from Boris Johnson.

There is no obvious way out of this unless the prime minster picks a public side. And remember it’s been the hallmark of her time in Number 10 to try to stay above the fray – a method her critics would say is failing to take decisions, but her supporters say is dealing with reality.

The UK is due to leave the EU in March 2019, but ministers have not yet agreed how to replace the current membership of the customs union, which allows for tariff-free trading between members.

Cabinet Office minister David Lidington told BBC Radio 4’s Today programme on Tuesday that the white paper would give “the most detailed account that we’ve so far given in government of how we see these negotiations concluding, the sort of, very ambitious, deep and special partnership with the European Union 27 that we want to see.

“Not just on trade but in terms of our continued co-operation on police matters, on judicial co-operation against crime, and on political and diplomatic co-operation in a world where many of the challenges from terrorism, from an aggressive Russia and so on that the other European countries face are ones we continue to face as well.”

Earlier the group of senior ministers on the Brexit sub-committee met to discuss the government’s two proposals – a customs partnership with the EU, and the use of technology to minimise border checks.

The partnership arrangement – which is believed to be Theresa May’s preferred option – has been strongly criticised by Brexiteers including Foreign Secretary Boris Johnson.

There is still no firm decision on which option to choose, but several cabinet ministers had acknowledged privately there could be an extension of the UK’s customs union membership to give time for a solution to be developed, Laura Kuenssberg added.

In February, the government published a Brexit White Paper after pressure from Labour.

Responding to news of the new publication, shadow Brexit minister Paul Blomfield said: “Ministers have finally agreed to publish a White Paper on the government’s negotiating position, but they still don’t know what it will say.”

Mr Blomfield said ministers had “wasted months arguing amongst themselves rather than negotiating in the national interest”.

Media and Political Bulletin

11 May 2018

Media Summary

Greater pharmacist involvement can improve medicines supply chain, report says

The Pharmaceutical Journal, Graham Clews, 9 May 2018

 

The Pharmaceutical Journal reports that pharmacists should be more involved in all stages of medicines’ supply to improve drugs’ availability and quality, according to a newly published report by the International Pharmaceutical Federation (FIP).

The report ‘Pharmacists in the supply chain: the role of the medicines expert in ensuring quality and availability’, published on 8 May 2018, concluded that investment in training and education are needed to strengthen pharmacists’ roles in supply chains. And it sets out the skills that pharmacists need to have in these areas.

“Pharmacists engaged, or interested in being engaged, in the supply chain may need special courses, which are not always provided by the basic curriculum,” said Ulf Janzon, co-chair of FIP’s working group on pharmacists in the supply chain.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Greater pharmacist involvement can improve medicines supply chain, report says

The Pharmaceutical Journal, Graham Clews, 9 May 2018

 

The International Pharmaceutical Federation has concluded that investment in training and education are needed if pharmacists are to strengthen their roles within the medicines supply chain.

Pharmacists should be more involved in all stages of medicines’ supply to improve drugs’ availability and quality, the International Pharmaceutical Federation (FIP) has said.

The report ‘Pharmacists in the supply chain: the role of the medicines expert in ensuring quality and availability’, published on 8 May 2018, concluded that investment in training and education are needed to strengthen pharmacists’ roles in supply chains. And it sets out the skills that pharmacists need to have in these areas.

“Pharmacists engaged, or interested in being engaged, in the supply chain may need special courses, which are not always provided by the basic curriculum,” said Ulf Janzon, co-chair of FIP’s working group on pharmacists in the supply chain.

“For example, these pharmacists often assume leadership roles, and so courses in leadership and management should be provided in addition to courses in logistics.”

The report looks at pharmacists’ roles in the drugs supply chain in high-, middle-, and low-income countries. And it finds that in some low-income countries, particularly in rural and remote areas, a shortage of pharmacists means that other healthcare personnel have taken on roles in pharmaceutical storage and distribution at the point of dealing with individual patients.

The report’s chapter on the UK says pharmacy education and training is “at a crossroads”, and that “the roles of the pharmacist within primary care in the UK are changing rapidly”.

It adds that “both the primary and secondary care sectors have been profoundly affected by regular medicines shortages within the medicines supply chain, negatively affecting patient care”.

Media and Political Bulletin

9 May 2018

Media Summary

Manufacturers: Generics supply issues sorted but prices still unstable

Chemist and Druggist, Grace Lewis, 8 May 2018

 

Chemist and Druggist reports that generics shortages have “pretty much” been rectified, but prices remain unstable, according to the British Generics Manufacturers Association (BGMA).

Last September, the Pharmaceutical Services Negotiating Committee (PSNC) announced it was in “urgent discussions” with the Department of Health and Social Care (DH) about the “catastrophic” effect of generics shortages on contractors’ cash flow.

Supply issues and price rises were initially triggered by the closure of a Bristol Laboratories manufacturing site in Luton, and a Dr Reddy’s site in India, following inspections by the European Medicines Agency (EMA) the previous month.

Speaking to Chemist and Druggist last month, BGMA director general Warwick Smith said up to 120 products had been affected by the regulatory action.

 

Invest in pharmacists to improve access to medicines, FIP urges

P3 Pharmacy, 8 May 2018

 

P3 Pharmacy highlights the findings of a new report which argues that pharmacists can play a critical role in tackling inefficiencies in the medicines supply chain that leave people in many countries without access to basic life-saving medicines – but that investment is needed to strengthen this aspect of their roles.

The report from the International Pharmaceutical Federation (FIP), Pharmacists in the supply chain: The role of the medicines expert in ensuring quality and availability, looks at the role pharmacists play in safeguarding the supply chain in low-, middle- and high-income countries.

 

 

Parliamentary Coverage

House of Commons – Tabled Written Questions, 8 May 2018

Ian Murray MP: To ask the Secretary of State for Health and Social Care if Brexit meant the UK leaves the European Medicines Agency, whether the Minister could assure the house that would not stop the regulation of new drugs in the UK and stop world class medicine companies from working in the UK.

 

Full Coverage

Manufacturers: Generics supply issues sorted but prices still unstable

Chemist and Druggist, Grace Lewis, 8 May 2018

 

Generics shortages have “pretty much” been rectified, but prices remain unstable, the British Generics Manufacturers Association (BGMA) has told C+D.

Last September, the Pharmaceutical Services Negotiating Committee (PSNC) announced it was in “urgent discussions” with the Department of Health and Social Care (DH) about the “catastrophic” effect of generics shortages on contractors’ cash flow.

Supply issues and price rises were initially triggered by the closure of a Bristol Laboratories manufacturing site in Luton, and a Dr Reddy’s site in India, following inspections by the European Medicines Agency (EMA) the previous month.

Speaking to C+D last month (April 25), BGMA director general Warwick Smith said up to 120 products had been affected by the regulatory action.

PSNC’s list of products on concession show those items that have been most affected since the two suppliers’ licences were suspended and have been subject to higher prices as a result, Mr Smith said.

However, “other manufacturers increased their production to fill the gap” in supply of those affected products, he added.

“My understanding is that there are [now] adequate supplies for all but maybe a couple of products…and the market has pretty much caught up to fill the gap,” he added.

However, the costs involved in increasing production means generics prices may “still be higher” than the prices listed in the DH’s monthly drug tariff, he said.

“There will obviously be a bit of time before prices stabilise,” Mr Smith stressed.

Further price hikes could happen

“We have the lowest prices in Europe and I think we have probably gone as low as we can,” Mr Smith said.

“That means when there are issues to deal with, there is not much wiggle room.”

Mr Smith said while “factors” such as “exchange rates post-Brexit” and the cost of implementing the Falsified Medicines Directive, will not disrupt the supply of generics, “it probably does mean there will be an increase in price”.

“I’m pretty comfortable that manufacturers will meet [demand],” he said, but “if we face that sort of perfect storm” created by these factors, “those prices have to go up”.

These costs will “inevitably” be passed through the supply chain, Mr Smith added.

 

Invest in pharmacists to improve access to medicines, FIP urges

P3 Pharmacy, 8 May 2018

 

A new report argues that pharmacists can play a critical role in tackling inefficiencies in the medicines supply chain that leave people in many countries without access to basic life-saving medicines – but that investment is needed to strengthen this aspect of their roles.

The report from the International Pharmaceutical Federation (FIP), Pharmacists in the supply chain: The role of the medicines expert in ensuring quality and availability, looks at the role pharmacists play in safeguarding the supply chain in low-, middle- and high-income countries.

Ulf Janzon, co-chair of the FIP working group on Pharmacists in the Supply Chain, said: “The report recognises different levels of maturity of supply systems that could be used as a basis for discussion, particularly in developing countries. It doesn’t aim to describe a single gold standard system, but rather, it seeks to highlight that all systems should ensure efficient supply of quality medicines.

”It also draws attention to the effect of globalisation on the supply chain, which is adding complexities to ensuring appropriate quantities of quality medicines.”

In order to help safeguard the global medicines supply chain, pharmacists require training in areas that many degree courses do not cover, the FIP says. Mr Janzon commented that this could include courses in leadership, management and logistics.

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

Apply to become a Member

Membership of the HDA guarantees your organisation:

  • Access to leading policy and industry forums of debate and discussion
  • Invitations to a range of networking industry events organised through the year, including an Annual Conference and a Business Day
  • Representation on HDA working parties, including the Members’ Liaison Group
  • A daily Political and Media Bulletin and HDA Newsletters
  • Access to HDA policy documents and all sections of the HDA website
  • Branding and marketing opportunities
Apply Now

Already a Member?