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HDA Media And Political Bulletin – 2 November 2016

Brexit will make it harder to import medicines into the UK

31 October 2016, Pharmacy Business, Neil Trainis

 

The HDA has written an open letter to the Government and the Medicines and Healthcare Regulatory Agency (MHRA) explaining its fears that Brexit will make the parallel importation of drugs harder for UK-based distributors. If this happens then it could increase drug shortages in the UK and a rise in the cost of drugs for the NHS. The HDA also said it is concerned about the potential loss of pan-European legislation due to Brexit. They believe this could have a substantial impact on the ability of pharmaceutical manufacturers to import drugs into the UK.

 

HDA UK highlights impact of Brexit on medicines supply chain

31 October 2016, P3 Pharmacy

 

The HDA explained in an open letter to the Government and MHRA that Brexit could result in nationwide drug shortages and a rise in the cost of drugs for the NHS. They warn that the needs of the pharmaceutical sector need to be taken into account during Brexit negotiations. The HDA call on the government to consider the impact that a ‘Hard’ Brexit could have on the effective and safe distribution of drugs in the UK. They also warn that leaving the single market could result in a more complicated process for the import of vital drugs. The HAD further explains in the letter that the loss of pan- European legislation could affect patients and businesses as well as the wider healthcare workforce in the UK.

 

Understanding the weak spots in the supply chain

02 November 2016, Dispensing Doctors’ Association

 

Warwick Smith, the Director General of the British Generic Manufacturers’ Association & British Biosimilars Association recently spoke at the Dispensing Doctors Association (DDA) Annual Conference. In his presentation he explained to delegates that there are challenges on the horizon for the current supply chain, most notably that there is a rise in pharmaceutical ingredient manufacturers being based outside the UK, increasing the risk of supply interruptions. Another challenge is continuing downward pressure on NHS cost prices. The average price of a generic drug in the UK is approximately 3.5 times cheaper than the cost paid in Europe. This discrepancy in price means that the UK may end up with the tail end of the supply purely because the price the UK will pay is lower.

 

Impact assessment of cuts: ‘All spin, no substance’

01 November 2016, Chemist & Druggist, Grace Lewis

 

The impact assessment of the Government’s plan to cut community pharmacy funding was published on 20 October 2016. Pharmacy Voice Chief Executive, Rob Darracott, said the assessment rejected the idea that there would be a negative impact to closures, staffing levels or service reductions. He says that the assessment does not take into account these real risks to the pharmacy sector.

 

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Brexit will make it harder to import medicines into the UK

31 October 2016, Pharmacy Business, Neil Trainis

 

The Healthcare Distribution Association has written to the government to express its fears that Brexit will make it tougher for UK-based distributors to import medicines into the UK and could increase shortages of vital drugs to patients.

 

In a letter signed by HDA UK council members, which was also sent to the Medicines and Healthcare products Regulatory Agency, the Association warns the parallel importation of medicines will be made harder if the UK fails to remain in the European Union single market.

 

“We are writing to explain our view that the recent referendum vote to leave the European Union (EU) could have significant consequences for the NHS medicines supply chain in the UK, if certain key issues are not resolved during the Brexit negotiations,” the HDA say in the letter.

 

“Our principal concern regards the ability of our companies to parallel import medicines into the UK, thanks to the common trademarks system operated across the European Economic Area.

 

“If the British government is favouring a Brexit that will see the UK leave the EU Single Market and Customs Union, this could result in the loss of the common trademark regulations, meaning that UK-based medicine distributors would no longer be able to easily and swiftly import vital medicines from the rest of the EEA to service the varying needs of British patients and the NHS.

 

“There is a high probability that this could then result in an increased risk of medicines shortages in the UK and a rise in the cost of medicines for the NHS.

 

“In short, parallel imports of medicines into the UK provide both certainty of supply, when there is not enough UK stock (because of a sudden spike in demand), and incentivised purchasing competition which saves the NHS over £100 million per annum, on current estimates.”

 

The HDA also said it was concerned the loss of pan-European legislation as a result of Brexit will have a detrimental impact on the supply of medicines into the UK.

 

“It is clear that pan-European legislation and regulations have an important public health role in medicines supply, which our sector supports and depends on, including the supply resilience and economic efficiencies created by the scale of the EU market.

 

“Another aspect that could impact British patients and our businesses more generally, regards the medicines licensing regime that currently allows for the common licensing of medicines across the EEA.

 

“The loss of equivalence with these European rules could have substantial consequences on the ability of pharmaceutical manufacturers to bring their products to the UK as quickly as is currently the case.

 

“In fact, pharmaceutical manufacturers may choose not to market their product in the UK at all due to the associated costs and relatively small population compared to the area covered by the broader European licensing regime.”

 

The letter was signed by Steve Anderson (Phoenix Healthcare Distribution), Jeremy Main, (Alliance Healthcare), David Bound (Celesio UK), Anup Sodha (Lexon UK), Ian Brownlee (Mawdsleys), Steve Burns (Sangers) and Peter Surgenor (UnitedDrug Sangers).

 

HDA UK highlights impact of Brexit on medicines supply chain

31 October 2016, P3 Pharmacy

 

Brexit could result in nationwide medicines shortages and rising medicines prices for the NHS if the needs of the sector are not taken into account during negotiations, the Healthcare Distribution Association (HDA UK) has said. The HDA’s Council has published an open letter to the government officials involved in Brexit negotiations, calling for them to consider the impact that a ‘hard’ Brexit (in which the UK leaves the EU Single Market and Customs Union) could have on the safe and effective distribution of medicines.

 

The HDA represents the companies that deliver 92 per cent of NHS medicines. Its main concern, it says, “regards the ability of our companies to parallel import medicines into the UK”, which is currently facilitated by the common trademarks system that applies across the European Economic Area. Leaving the single market could mean that these common trademark regulations no longer apply in the UK, in which case the import of vital medicines would involve a longer, more complicated process.

 

The Council writes: “There is a high probability that this could then result in an increased risk of medicines shortages in the UK and a rise in the cost of medicines for the NHS.

 

“In short, parallel imports of medicines into the UK provide both certainty of supply, when there is not enough UK stock (because of a sudden spike in demand), and incentivised purchasing competition, which saves the NHS over £100m per annum, on current estimates).”

 

The Council also cites the potential loss of equivalence with the European medicines licensing regime as a factor that could affect patients and businesses, saying that manufacturers “may choose not to market their product in the UK at all due to the associated costs and relatively small population compared to the area covered by the broader European licensing regime.”

 

Finally, the authors voice their concerns about the impact of Brexit on the healthcare workforce: “The healthcare sector, from research scientists in pharmaceutical companies, to pharmacists in hospitals and the community, benefits from skilled workers from the EU”.

 

The letter concludes by saying that HDA UK “looks forward to working with the Government, regulators and supply chain partners to ensure that UK patients are not negatively affected by the vote to leave the European Union”.

 

Understanding the weak spots in the supply chain

02 November 2016, Dispensing Doctors’ Association

 

Competitiveness adds to the resilience of the UK supply chain but there are emerging “weak spots”, which “should worry us”, Warwick Smith, director general of the British Generic Manufacturers’ Association & British Biosimilars Association told the DDA 2016 Annual Conference.

 

In a presentation on the generic and biosimilar markets, Mr Smith told delegates that the supply chain currently fulfills 94.5 per cent of orders on time and in full. But, there are challenges on the horizon, notably, consolidation in the number of suppliers and relocation of active pharmaceutical ingredient manufacturers from Italy and Spain to India and China – increasing the risk of supply interruptions.

 

Another challenge is continuing downward pressure on NHS cost prices. Mr Smith explained that the average price paid for a basket of generics in mainland Europe is around 3.5 times higher than that paid by the UK. “If there is a supply shortage and Germany will pay three times more for a drug than the UK, the UK will only get the tail end of the supply,” he said.

 

In his presentation slides, Mr Smith charted generic medicine reimbursement costs compared to average pack cost and percentage changes during the four years from 2012 to 2016. He showed delegates that there is a growing gap between market and reimbursement prices, and said that the recently announced medical costs bill had “spooked the horses”. This bill introduces official powers to improve the transparency of margins within the supply chain, including at dispensary level.

 

Mr Smith also forecast that there will be changes in the way category A prices are set, which could see this group of drugs priced by market rather than book prices – and reduce in price over time. Category A drugs are defined as readily available and where the reimbursement price is calculated from a basket list of suppliers.

 

Looking at generics as a market, Mr Smith said that these drugs made medicines affordable, reducing NHS costs by more than £13 billion per annum, compared to originator product prices. This allowed many more patients to be treated for the same cost. A 1 per cent swing to generic saved the NHS in England £172 million, he said.

 

As for biosimilar molecules, he told delegates that there are seven currently available in the UK market – but that take up of this category of medicines by trusts was very variable. Over five years using biosimilars could save Euro 50-100 billion in the EU5 and the US as a result of the use of biosimiliars, but wider take up could encourage different methods to get drugs to patients, including hospital to patient supply.

 

Impact assessment of cuts: ‘All spin, no substance’

01 November 2016, Chemist & Druggist, Grace Lewis

 

Experts claim the government’s evaluation of what effect the £113 million cut to pharmacy funding will have on the sector is “flawed” and “illogical”.

The long-awaited impact assessment – which was first promised by former pharmacy minister Alistair Burt in February – was published last month (October 20) and claims to evaluate the “likely costs, benefits and impact” of the government’s plans to impose a 12% cut to the global sum in England from December.

 

However, having read the full document, Noel Wardle, partner at law firm Charles Russell Speechlys, said it was “all spin and no substance”.

 

“There is actually no assessment of the impact of these cuts on either patients or community pharmacy,” he told C+D last week (October 27).

 

The document states “there is no reliable way of estimating the number of pharmacies that may close as a result of [the cuts]”, which Mr Wardle said is indicative of how “deeply flawed” the assessment is.

 

“When the funding cuts were [first] announced last December, the pharmacy minister accepted that up to 3,000 pharmacies might close. If the figure of 3,000 has been bandied around, you might expect that to be featured in [the document] somewhere. It is not mentioned at all,” he stressed.

 

All about the costs

 

Pharmacy Voice chief executive Rob Darracott said pharmacists would be “disappointed” if they were expecting the impact assessment to measure the impact of the cuts on community pharmacy.

 

“It rejects the idea that there are any negative impacts to closures and staffing or service reductions, other than the costs,” he added.

 

When the document was published, Labour MP Jon Ashworth said “[the government’s] failure to release an impact assessment up until now is evidence that these cuts are driven entirely by cost and not by concerns about care.”

 

Mr Darracott said the assessment “ignores the number of real risks” to the sector, including the threat to pharmacy services, both locally commissioned and offered free-of-charge.

 

“The impact assessment also assumes that pharmacies will adapt to this challenge so that the impact is mitigated,” he added. “We have previously pointed out the inelasticity of the community pharmacy cost base and its direct relationship to the amount of NHS workload currently undertaken.”

 

Various justifcations

 

Mr Wardle said some of the variables used to calculate the possible impact on travel time and cost for patients as a result of pharmacy closures – using the scenarios of 100 and 1,000 pharmacy closures –  are “flawed” and “illogical”.

 

He also questioned the government’s “various” justifications of why the savings are being made.

 

“It doesn’t explain how the government has reached the figures it has,” Mr Wardle said.

 

“The document says the [cuts] are part of £22bn NHS efficiency savings – money the NHS no longer has,” he explained. “In another part of the document it suggests the money [saved from community pharmacy] will be used elsewhere in the NHS.

 

“Is this money the NHS has, or needs to recoup?” Mr Wardle asked.

 

“If you can’t assess the impact [of the cuts to pharmacy funding], I’m afraid you can’t go on and do it,” Mr Wardle concluded.

HDA Media And Political Bulletin – 2 November 2016

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.

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