News

Media And Political Bulletin – 28 January 2019

Media and Political Bulletin

14 January 2019

Media Summary

Should pharmacies trade medicines between themselves?

Chemist and Druggist, Thomas Cox, 11 January 2019

 

Chemist and Druggist includes a comment from Martin Sawer, Executive Director of the HDA, about his views on PSNC’s suggestion that regulations should be relaxed to allow pharmacists to trade medicines after Brexit.

 

Martin Sawer said that the HDA would support the idea of pharmacies being able to trade between themselves, should medicines supply be impacted post-Brexit.

 

“Pharmacy-to-pharmacy trading is a good contingency [plan]. It means borrowing stock and paying it back – you return the same medicine when you get some more,” he said.

 

“These are sensible proposals that should reduce the time taken for alternatives to be provided to patients and make it easier for clinicians to deliver the appropriate treatment.”

 

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 11 January 2019

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what consultation his Department has undertaken on proposals for the introduction of Serious Shortage Protocols for medicines.

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what the timeframe is for the introduction of Serious Shortage Protocols for medicine.

 

Wayne David, MP: To ask the Secretary of State for Health and Social Care, what safeguards his Department has put in place to ensure that medical Serious Shortage Protocols do not pose risk to the well-being of patients.

 

Answered by Steve Brine: The Department engaged with a wide range of stakeholder representative bodies about the proposals and also conducted a written consultation. The Department received 47 responses to its written consultation including from industry, patients’, pharmacists’ and doctors’ representative bodies. The responses to the consultation were broadly supportive.

 

The Statutory Instrument is expected to be laid shortly and come into force before 29 March. Any serious shortage protocol would be developed with and signed off by clinicians. Only if clinicians deem it appropriate, an alternative quantity, strength, pharmaceutical form or medicine can be dispensed in line with the protocol.

 

A protocol is only one of the tools that can be used to manage shortages. The Department manages shortages in collaboration with manufacturers and suppliers, the National Health Service and the Medicines and Healthcare products Regulatory Agency and will continue to do so. A protocol would only be introduced in case of a serious shortage, if it would help manage the supply situation and if clinicians think it is appropriate, taking account of the risks to and well-being of patients and after discussion with the manufacturer and/or marketing authorisation holder.

Any serious shortage would be time limited and the protocol itself would indicate the period during which it has effect.

Full Coverage

Should pharmacies trade medicines between themselves?

Chemist and Druggist, Thomas Cox, 11 January 2019

 

As PSNC suggests regulations should be relaxed to allow pharmacies to trade medicines after Brexit, C+D asks three contractors – and the wholesaler body – for their views

 

With just 77 days until the UK’s exit from the European Union, and Prime Minister Theresa May yet to secure parliament backing for her Brexit deal, the Department of Health and Social Care (DH) has ramped up its contingency planning.

 

As part of a raft of proposals suggested by the Pharmaceutical Services Negotiating Committee (PSNC) last month to ensure continuity of medicines supply post-Brexit – whether a deal is secured or not – it has called for the DH to “relax the restrictions on pharmacy-to-pharmacy wholesale dealing without wholesaler dealer licenses”, to allow pharmacies “to trade stock between them at a local level”.

 

This would “allow medicines to reach those patients who most need them, without regulatory barriers”, PSNC says.

 

Pharmacists were able to trade medicines under certain circumstances without a wholesaler licence until 2012, when the Medicines and Healthcare products Regulatory Agency revoked the legislation.

 

So, would pharmacies welcome the opportunity to swap stock between them once again? C+D asks three contractors and the head of the wholesaler’s body – the Healthcare Distribution Association (HDA) – for their thoughts.

 

“We don’t need any more pressure at this time”

Michael Lennox, chief officer of Somerset local pharmaceutical committee, tells C+D that he “would welcome the opportunity for the regulations to allow us to better support patients”.

 

“If Brexit were to have an impact, then I think we would need to change the framework,” he says. “We don’t need any more pressure at the minute.”

 

“Things will get worse”

Alan Kurtz, owner of Fishers Pharmacy in south London, says: “I don’t see any reason why we shouldn’t be able to help one another in order to be able to help patients.”

 

Mr Kurtz explains that his pharmacy has been struggling with medicines shortages for “years”, which has been “very difficult”, and he has “no doubt things will get worse”.

 

“It worked well before”

Indira Panchal, owner of four pharmacies in Bedford, says while it is a “good time” for pharmacies to be able to trade medicines to help ease shortages, it is “short-sighted” that the change is only under consideration now.

 

Ms Panchal says owners of a single pharmacy would particularly benefit from PSNC’s proposal, as they are unlikely to have their own wholesaler’s license.

 

Wholesalers: “Good contingency planning”

 

HDA executive director Martin Sawer tells C+D that his organisation – which represents wholesalers – would also support the idea of pharmacies being able to trade between themselves, should medicines supply be impacted post-Brexit.

 

“Pharmacy-to-pharmacy trading is a good contingency [plan]. It means borrowing stock and paying it back – you return the same medicine when you get some more,” Mr Sawer explains.

 

“These are sensible proposals that should reduce the time taken for alternatives to be provided to patients and make it easier for clinicians to deliver the appropriate treatment.”

 

Serious shortage protocol

 

While PSNC continues to discuss the impact of Brexit with the DH via its Brexit forum, the DH expects to lay legislative changes for its “serious shortages protocol” before parliament this month.

 

The DH is seeking to amend the Human Medicines Regulations 2012 to enable pharmacists to dispense an alternative in accordance with the protocol, rather than the prescription, and without having to contact a GP, in the event of a serious medicines shortage.

 

The DH insists the regulations “will come into force before March, regardless of the situation with Brexit”, and told C+D it is still reviewing responses to its consultation.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Media and Political Bulletin

28 January 2019

Media Summary

Brexit: Novartis urges government to secure drug supplies ‘rapidly’

Pharmacy Business, Kiran Paul, 25 January 2019

Pharmacy Business reports that Novartis has called on Britain to ‘urgently guarantee’ the movement of drugs in the event of a chaotic Brexit, and said that it was stockpiling to maintain the delivery of the 120 million packs it exports to Britain from Europe each year.

The company said that the risk of Britain leaving the European Union, its biggest trading partner, without a deal had risen after Prime Minister Theresa May failed to get her deal through parliament.

The Guardian also reports on this, stating that Novartis is stockpiling amid concerns about the supply and safety of medicines. The article includes a statement from Martin Sawer, the HDA’s Executive Director, who said that patients might need to think about ensuring they had enough of their own stocks, although NHS bosses have warned this could itself lead to shortages.

Implementing the Falsified Medicines Directive

European Pharmaceutical Review, 25 January 2019

EPR highlights the fact that the Falsified Medicines Directive comes into force on the 9th February 2019. It states that currently, the final phase of the Falsified Medicines Directive is being rolled out, and companies are still looking to understand its impact, and how the balance of responsibility has shifted in the pharmaceutical supply chain. It is also important to investigate any short-term challenges that might be faced by key stakeholders of a business during the transition period, and the implications of the varying interpretations of the Directive by EU member states.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

Brexit: Novartis urges government to secure drug supplies ‘rapidly’

Pharmacy Business, Kiran Paul, 25 January 2019

Novartis called on Britain to urgently guarantee the movement of drugs in the event of a chaotic Brexit and said it was stockpiling to maintain the delivery of the 120 million packs it exports to Britain from Europe each year.

The Swiss company, one of the world’s biggest drugmakers, said the risk of Britain leaving the European Union, its biggest trading partner, without a deal had risen after Prime Minister Theresa May failed to get her deal through parliament last week.

“Given the complex nature of the supply chain, government needs to implement a comprehensive continuity plan rapidly,” Novartis said in a statement.

Britain is due to leave the EU on March 29, and with May still battling to get the accord she agreed with the rest of the bloc through parliament, businesses are having to spend millions of pounds to prepare for a “no-deal” exit.

The highly regulated drugs sector is one of the most vulnerable to a no-deal outcome due to its pan-European supply chains and need for regulatory oversight.

More than 2,600 drugs have some stage of manufacture in Britain and 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, industry figures show.

Britain has called for drugmakers to produce an additional six weeks of medicines to cope with potential supply disruption in the event of a no-deal Brexit – a target the industry has said would be challenging.

“It is vital that government makes minimising disruption to the medicines supply the highest priority as it prepares for a potential hard or disorderly Brexit and ensures cooperation over medicines regulation in this event,” Novartis said.

Novartis also urged Britain’s health service and pharmacists to stick to the government’s advice not to stockpile medicines, so the supply can be managed centrally and not risk shortages.

Britain’s biggest drugmaker GlaxoSmithKline has said it is increasing inventory, updating packaging, amending importation licences and securing warehousing to protect its supply chains before March 29.

It puts the cost of implementing such changes at £70 million over the next two to three years, with ongoing costs of around £50 million per year.

Drug firm Novartis fears no-deal Brexit could put patients at risk

The Guardian, Jasper Jolly, 25 January 2019

The Swiss pharmaceuticals company Novartis has said it is stockpiling drugs in the UK before a possible no-deal Brexit, which it warned would be “hugely impactful” for patients.

Firms across the economy are bracing for the possibility of the UK leaving the EU on 29 March without a deal after parliament resoundingly rejected Theresa May’s withdrawal agreement.

The Basel-based company said on Friday it imported 120m packs of medicines to the UK from the continent each year but suggested a no-deal Brexit would affect supplies.

“Following parliament’s vote, the risk of the UK exiting the EU without a deal is increased and this will be hugely impactful for patients, particularly around the supply and safety of medicines,” it said in a statement.

“We are building increased inventories across our portfolio of medicines in the UK.”

The French cosmetics company L’Oréal, owner of brands ranging from Lancôme to Maybelline, also revealed on Friday that it was stockpiling products in the UK in preparation for Brexit.

Novartis, the world’s fifth-biggest drugmaker by revenues, makes a large number of medicines ranging from treatments for cancer through to anti-inflammatories, including Voltarol, and the Ritalin drugs used to treat attention deficit hyperactivity disorder (ADHD). It is a major supplier to the NHS.

Novartis called for the government to “implement a comprehensive continuity plan rapidly” to ensure drugs continued to reach patients, with a particular focus on clarity of customs arrangements and minimising disruption at the border.

Pharmacists have been told that the NHS is preparing for the use of alternative transport routes and the prioritisation of medicines as part of Brexit contingency planning.

The head of the UK’s pharmaceutical association warned in October that stockpiling by companies would not be enough on its own to cope with leaving without a deal.

Martin Sawer, who leads the Healthcare Distribution Association, said patients might need to think about ensuring they had enough of their own stocks, although NHS bosses have warned this could itself lead to shortages.

Novartis urged NHS trusts and pharmacists to refrain from stockpiling medicines so supplies could be managed centrally. This would minimise “the risk of medicine shortages across the UK”, it said.

A spokesperson for the Department of Health and Social Care said: “We recognise the vital importance of the medicine supply chain as we exit the EU.

“The government has secured additional capacity on a variety of routes including ferries into and out of Poole, Portsmouth, Plymouth, Immingham and Felixstowe, where medicines will be prioritised.

“We have asked manufacturers to build up six weeks’ additional stocks of medicines and we are confident that, if everyone does what they should do, the supply of medicines will be uninterrupted in the event of exiting the EU without a deal.”

Novartis, which currently employs 1,500 people in the UK, also warned that regulatory divergence between the UK and the EU after Brexit would have “far-reaching implications for the way the life sciences sector operates and its ability to develop and deliver medicines for UK patients”.

Implementing the Falsified Medicines Directive

European Pharmaceutical Review, 25 January 2019

The pharmaceutical industry is one of the world’s largest, and is often being targeted by those looking to make money quickly. Counterfeit medication currently has sales ranging from €150 billion to €200 billion per year, and is regarded by some as the largest fraud market.

The EU is looking to implement a new legislation, called the Falsified Medicines Directive to make the process of buying and selling pharmaceutical products safer and easier.

The Falsified Medicines Directive comes into force on 9th February 2019, and aims to increase the security of the manufacturing process and delivery of medicines throughout Europe, providing greater protection for patients. The MHRA have also announced that should there be a ‘no-deal’ Brexit, it will consider a UK version of the EU law.

Many are currently arguing over the positives and limitations of this EU directive, looking at serialisation to combat counterfeit medicine, the falsification of medicine, and tampering that occurs in the pharmaceutical supply chain.

Currently, the final phase of the Falsified Medicines Directive is being rolled out, and companies are still looking to understand its impact, and how the balance of responsibility has shifted in the pharmaceutical supply chain. It is also important to investigate any short-term challenges that might be faced by key stakeholders of a business during the transition period, and the implications of the varying interpretations of the Directive by EU member states.

The Directive ensures more stringent measures throughout Europe, with the inclusion of more safety measures, the legalities of online pharmacies, and stricter rules regarding the producers of pharma ingredients. Despite the rulings affecting the EU from next month, experts are arguing that they should not be seen as a regulatory burden; but should be embraced.

Some companies are looking at the use of anti-tampering technology to ensure best practice and safety.

How Brexit will affect this legislation remains to be seen, with the terms of the exit dictating how British pharma firms can trade with and market their products to Member States and indeed the rest of the world.

However, the MHRA has recently stated that should there be a ‘no-deal’ Brexit, a UK version of the deal will probably be considered, ensuring a smooth transition.

Media And Political Bulletin – 28 January 2019

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?