News

Media And Political Bulletin – 17 January 2019

Media and Political Bulletin

17 January 2019

Media Summary

No-deal Brexit could lead to drug shortages and delayed operations

New Scientist, Clare Wilson, 15 January 2019

New Scientist reports that the possible impact of leaving the European Union without a deal on the country’s healthcare is only just becoming clear. A no-deal exit from the EU on 29 March would pose immediate problems for the supply of important drugs. About two-thirds of medicines used in the UK are imported from the EU. At the moment, 90 per cent of these come through the French port of Calais.

She also reports that Martin Sawer of the HDA believes it would be understandable if some people do start trying to stockpile, saying “I could understand people wanting to do that if they have a life-threatening condition.”

‘UK wants certainty’ on how Brexit will affect healthcare

Practice Business, no author, 17 January 2019

Practice Business reports that following the Prime Minister’s Brexit defeat on Tuesday, experts have been particularly outspoken regarding how the UK leaving the EU could impact healthcare.

The industry’s £70bn contribution to the national economy could be at risk following the deal defeat and, potentially, a ‘no deal’ Brexit – according to GlobalData.

Gavin Davidson, a pharma analyst at GlobalData, said: “The UK has always been at the forefront of pharmaceutical and biotechnical investment and development. For this position to be maintained, companies based in the UK want certainty on the outcome of Brexit and, with MPs now debating ‘what next’, the stakes couldn’t be higher.”

Brexit – Patients’ Rights at Risk

Politico, Helen Collis, 17 January 2019

Politico reports that for now, EU and U.K. patients enjoy the right to health care services not only in their own country but in other EU states, from emergency care on holiday to specialist surgery for patients with rare diseases — but that under a no-deal outcome much of that would change.

Helen Collis takes a look at the no-deal scenario when it comes to health care and drug availability.

Fighting counterfeiting within the supply chain

European Pharmaceutical Manufacturer, Stanley Chia, 17 January 2019

European Pharmaceutical Manufacturer report that current estimations of the worldwide cost of counterfeit drugs are in the range of $75 billion. As a result, governments across the world are stepping up their efforts to combat this illegal trade.

From February 2019, the Falsified Medicines Directive will come into force across the EU and require all prescription medicines to come with a security feature enabling hospitals, pharmacies or healthcare providers to verify their authenticity.

Drug dilemma of a no-deal Brexit

Pharmacy Business, Kiran Paul, 16 January 2019

Pharmacy Business reports that following Prime Minister Theresa May’s defeat on Tuesday, no one really knows about the potential impact of a no-deal Brexit.  With barriers to trade coming back, at least in the short term, things could turn very serious for those who rely on medication.

Medicines prices, licensing of medicinal products, safety protocols and health sector workforce are all expected to bear the brunt of the departure without a divorce deal. The current assumptions warn of potential border delays for up to six months. Officials are talking to drug companies about creating a six-week ‘buffer stock’ on top of the three months they already have in place. Britain will also waive the need for EU firms to re-test their drugs under new rules.

Brexit: No-deal outcome would put UK medicine supply at risk, German pharma industry warns

The Independent, no author, 16 January 2019

The Independent reports that German chemical and pharmaceutical firms have warned that Theresa May’s government must avoid a hard Brexit in order to safeguard the supply of medicines to the UK.

After Theresa May’s Brexit deal was rejected on Tuesday, VCI said in a statement that Utz Tillmann, Managing Director of VCI, “deplores the rejection of the Brexit agreement by the British Parliament”. He added: “A collapse of supply chains would cause damage far beyond our industry. Therefore, specific transitional solutions are essential to at least somewhat ease the most detrimental impacts. In particular, this is about supplies of medicines in the UK.”

Pharma calls for ‘no deal’ preparation after Brexit deal rejected

pharmaphorum, Richard Staines, 16 January 2019

pharmaphorum reports that pharma has called for politicians to take action to ensure patient safety in the event of a ‘no deal’ situation, after the UK parliament’s historic decision to reject prime minister Theresa May’s Brexit deal.

EFPIA is calling negotiators to take a series of actions that need to be taken to protect patients, outlined in the article. Director General Nathalie Moll said: “Now is the time for policy makers in the UK and the EU to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit.

The full list of actions has been published on the EFPIA website.

PharmaTimes and European Pharmaceutical Review also report on EFPIA’s comments.

Pharmacy sector ‘deploying all necessary resources’ to prevent Brexit medicines shortages, as government deal voted down

The Pharmaceutical Journal, Julia Robinson, 16 January 2019

The Pharmaceutical Journal reports that following the historic parliamentary defeat of the government’s Brexit withdrawal agreement, the Pharmaceutical Services Negotiating Committee (PSNC) has said it is “deploying all necessary resources” to ensure patients do not run short of medicines when the UK leaves the EU.

Speaking after the government defeat on 15 January 2019 — and with less than three months until the agreed Brexit date of 29 March 2019 — Simon Dukes, Chief Executive of the PSNC, said pharmacy negotiators would continue to work with the Department of Health and Social Care (DHSC) to plan for all potential scenarios, including a no-deal Brexit.

The Falsified Medicines Directive: steps to compliance

European Pharmaceutical Review, no author, 16 January 2019

European Pharmaceutical Review reports that the Falsified Medicines Directive (FMD) 2011/62/EU, comes into full force on the 9th February 2019. Organisations that have not yet become compliant must now act fast to ensure they do not fall foul of the regulation.

The MHRA have also confirmed that should there be a ‘no-deal’ Brexit, it will consider a UK-only version of the EU law.

Christian Taylor, Serialisation Business Consultant at Zetes, provides a plan for becoming FMD compliant.

 

Parliamentary Coverage

House of Commons Question

Anne Marie Morris (Newton Abbot): To ask the Secretary of State for Health and Social Care, for what reason his Department held a public consultation for only three weeks on changes to the Human Medicines Regulation 2012 in relation to supply and the UK’s withdrawal from the EU.

Jackie Doyle-Price: The Medicines and Healthcare products Regulatory Agency (MHRA) ran a four-week public consultation on changes to the Human Medicines Regulations 2012 in preparation for the United Kingdom’s withdrawal from the European Union in the event of a ‘no deal’, from 4 October to 1 November 2018.

Preparations to ensure the UK will be ready for EU exit in all scenarios, including a potential ‘no deal’ outcome, requires contingency legislation to be made before 29 March 2019 to allow for an orderly exit. There was no statutory obligation to consult on these changes, but the MHRA applied the principles of best practice and consulted stakeholders publicly for as long as was feasible. This public consultation followed informal consultation with industry and the third sector on the proposed changes.

Full Coverage

No-deal Brexit could lead to drug shortages and delayed operations

New Scientist, Clare Wilson, 15 January 2019

As UK politicians prepare to vote on Prime Minister Theresa May’s Brexit deal tonight, the possible impact of leaving the European Union without a deal on the country’s healthcare is only just becoming clear. At worst, pharmacies could run out of certain drugs, and hospitals may have to delay operations, scans and other procedures.

A no-deal exit from the EU on 29 March would pose immediate problems for the supply of important drugs. About two-thirds of medicines used in the UK are imported from the EU. At the moment, 90 per cent of these come through the French port of Calais. “You have got all your eggs in one basket,” says Mike Thompson at the Association of the British Pharmaceutical Industry.

The fear is that, if new customs checks are introduced after March, even small delays at the border could lead to long queues of lorries building up at ports, delaying delivery of medical products to pharmacies and hospitals. The UK government has said it will not impose extra checks on the UK side, but the European Commission has said if there is a no-deal Brexit, it will impose extra customs controls.

“It’s fine for luxury cars to be sitting at a border for two to three days, but it’s not acceptable for drugs,” says Niall Dixon of the NHS Confederation, an umbrella group of health bodies. “People need these medicines. We can’t play games with this stuff.”

To reduce the health risks of a no-deal Brexit, the UK government is putting in place a range of emergency measures to protect medical supplies. These include ordering firms to stockpile drugs, and opening new ferry and air trade routes. The government also plans to provide pharmacists with emergency powers to give patients different medicines from the ones they were prescribed, if stocks run low.

Essential medicines

But medics warn that these steps may be insufficient to avoid shortages of essential drugs. “Anything that a patient is taking for a long-term condition, they worry about,” says Ash Soni, president of the Royal Pharmaceutical Society.

All medicines that are used in the UK have a manufacturer that holds stock in UK warehouses. Manufacturers tend to hold between one and six months’ worth of medicines in these warehouses. In August 2018, the government told firms to build up an extra six weeks’ worth of stock. It is also setting up refrigerated warehouse space for medicines that need to be kept cold, such as insulin and vaccines. “What we don’t know is, is six weeks sufficient?” says Soni.

It is impossible to say for certain which medicines are most vulnerable to supply disruptions, but interruption of many long-term medications could be life threatening. If someone ran out of a treatment to lower blood pressure, for instance, they could have a stroke. Being unable to get hold of medicine after an organ transplant could lead to rejection by the immune system.

Insulin is a particular concern. People with type 1 diabetes may need to inject it several times a day, and can die without it. And unlike with some medicines, if pharmacists have to switch people onto a different form of insulin because their usual brand has run out, there could be side effects such as blood sugar swings, says Pav Kalsi of patient group Diabetes UK. “It’s a very anxious time for patients who are uncertain about their access to insulin, which keeps them alive.”

Cancer treatments

An inquiry by the Parliamentary Health and Social Care Committee has identified other vulnerabilities, such as radioisotope compounds, which are used in scans to diagnose cancer and heart disease, and also to treat cancer.

These compounds cannot be stockpiled as their radioactivity quickly decays after manufacture. The most commonly used one, called technetium-99m, is made from a compound that is a by-product of some European nuclear reactors and has a half-life of about three days. The government has asked suppliers to have plans to air freight their products if necessary.

In December 2018, hospitals, pharmacies and patients were told not to stockpile any medicines themselves, as this could create shortages. Health secretary Matt Hancock wrote to family doctors saying there was no need to prescribe longer courses of medication than normal.

Hancock has also warned pharmacies that their medicine-ordering patterns would be monitored and any over-ordering would be investigated and followed up, although it is unclear how this would be done or what sanctions might be taken. “There’s no precedent,” says Soni.

A Department of Health and Social Care press officer told New Scientist: “If we see evidence of over-ordering it would depend on the case and the scenario. We would need to look into it.”

Stockpile warning

Soni says that while people shouldn’t try to build up extra supplies of their medicines, they should order repeat prescriptions before they run too low on supplies. “Continue to do what you do normally, but don’t leave it until you’re about to run out,” he says.

It would be understandable if some people do start trying to stockpile, says Martin Sawer of the Healthcare Distribution Association, which represents pharmaceutical wholesalers. “I could understand people wanting to do that if they have a life-threatening condition.”

As well as problems for the UK, border restrictions could also affect the supply of medicines made in the UK that are exported to Europe. While 37 million packs of medicines come into the UK from the EU each month, the UK sends 45 million packs the other way.

Of particular concern is a treatment for breast and prostate cancer that is only made in the UK. This drug has a highly complex manufacturing process, and it would take more than three years to build a factory capable of making it elsewhere.

A no-deal Brexit could also make it harder for people from the UK to access healthcare when they are in EU countries and vice versa, says Dixon.

‘UK wants certainty’ on how Brexit will affect healthcare

Practice Business, no author, 17 January 2019

A GlobalData analyst has commented on how he believes Brexit could affect healthcare in the UK at large.

Following the Prime Minister’s Brexit defeat on Tuesday, experts have been particularly outspoken regarding how the UK leaving the EU could impact healthcare.

The industry’s £70bn contribution to the national economy could be at risk following the deal defeat and, potentially, a ‘no deal’ Brexit – according to GlobalData.

Gavin Davidson, a pharma analyst at GlobalData, has offered his view on how Brexit could impact the UK healthcare industry’s contribution to the UK economy:

“Throughout 2018, the global biopharma industry’s opinion of the UK as an attractive place to base research and manufacturing has steadily eroded and last night’s vote will have done nothing to improve this sentiment with the looming possibility of a no-deal Brexit.

‘‘In a series of quarterly surveys (Q1-Q3), GlobalData asked key respondents from the US, UK, and EU healthcare markets, whether or not they thought that the UK will remain an attractive place to do central business.

“In all markets, decreases in ‘yes’ answers were observed; however in the UK and EU markets, confidence has collapsed with abysmal rates of 17% and 19% respectively after Q3.

“The UK has always been at the forefront of pharmaceutical and biotechnical investment and development. For this position to be maintained, companies based in the UK want certainty on the outcome of Brexit and, with MPs now debating ‘what next’, the stakes couldn’t be higher.

“The healthcare industry’s £70bn ($88.5bn) per annum contribution to the UK economy is at risk if the country ends up with a no-deal Brexit, an outcome that the EU has now escalated its planning for.”

Brexit – Patients’ Rights at Risk

Politico, Helen Collis, 17 January 2019

It’s groundhog day in British politics after Prime Minister Theresa May survived a no-confidence vote Wednesday night, meaning there’s still a government in place but no Brexit deal. For now, EU and U.K. patients enjoy the right to health care services not only in their own country but in other EU states, from emergency care on holiday to specialist surgery for patients with rare diseases — but under a no-deal outcome much of that would change. I took a look at the no-deal scenario when it comes to health care and drug availability. [Ed.’s note: It makes for rather uncomfortable reading for those of us living abroad.]

Ireland’s drugs ‘watchlist’: Taoiseach Leo Varadkar said the government has identified 24 drugs at critical risk of shortage in the event of no-deal Brexit, reported The Times. Health Minister Simon Harris was quick to warn patients not to try and stockpile their own meds.

Device availability warning: The medical device industry’s Brussels lobby said the threat of a no-deal Brexit represents an “extremely urgent” situation for Europe, with 30-40 percent of medical technologies approved by a U.K.-based notified body. “Consequently there is a concrete risk that such products would stop being distributed immediately putting both patients and hospitals into a very critical situation,” MedTech Europe said in a statement.

Fighting counterfeiting within the supply chain

European Pharmaceutical Manufacturer, Stanley Chia, 17 January 2019

Pharmaceutical supply chains are increasingly complex and highly regulated. The whole industry is facing huge pressure to perform and as a result, having an agile and robust supplier base is becoming more and more essential. The number of counterfeit drugs and product recalls as well as sophisticated cybercrime attacks are also highlighting the need for supply chains to be transparent and collaborate closely.

Illegal activity

According to the Pharmaceutical Security Institute, the number of worldwide counterfeit drug incidents increased from 196 in 2002, to 2,108 in 2012 to 3,509 in 2017. Current estimations of the worldwide cost of counterfeit drugs are in the range of $75 billion. As a result, governments across the world are stepping up their efforts to combat this illegal trade. From February 2019, the Falsified Medicines Directive will come into force across the EU and require all prescription medicines to come with a security feature enabling hospitals, pharmacies or healthcare providers to verify their authenticity. In the US, the FDA’s Drug Supply Chain Security Act outlines requirements to develop and enhance drug supply chain security by 2023. These developments are good news for pharma companies as they try to manage product quality and security.

Another key challenge is managing product recalls when or if they happen. The US Recall Index, a measure of publicly announced recalls across a variety of industry sectors in America, showed a sizeable jump for pharma in 2017. Over the whole year, 325 products were recalled, compared to 289 in 2016. When a recall happens, manufacturers must communicate clearly and swiftly with the entire supply chain, from wholesalers to pharmacies—and even patients in some cases—and collect the faulty items.

Finally, pharma companies are regularly being targeted by cyber-criminals. Whether intellectual property, private patient health data or commercially sensitive information, there is huge scope for fraudsters to obtain valuable data and so pharma companies are on high alert to mitigate the risk and protect their customers.

In the light of these varying challenges, collaboration is becoming more and more important. Pharma supply chain relationships need to be healthy so that information can be passed up and down the chain effectively and all partners can see the full picture and plan ahead more accurately. This applies both in terms of supply and demand but also when things go wrong.

Knowledge is power

The only way to fulfil these responsibilities is to have an agile, efficient and highly-optimised supply chain and an in-depth and up-to-date knowledge of all your suppliers. As with all industries, the more a business knows about its supply chain, the greater its ability to mitigate against risk. However, within pharmaceuticals, this is amplified as the stakes are so high and no one can afford to have a weak link. With increasing pressure for companies to maintain comprehensive records on their suppliers, the need for enhanced vendor master management has never been more urgent or relevant.

If pharma businesses perform these essential checks at this stage of the process, they can then have confidence that no matter what challenges get thrown their way their suppliers will be responsive and robust enough to survive.

Solid data

It is important that pharma companies use statistical and financial data as evidence to inform their decisions about suppliers. They need to know if suppliers are at risk of becoming insolvent, or are involved with financial crime or politically sensitive situations. When agreeing to a new contract, businesses should first check the trading status of a supplier and be certain they are compliant and registered with all the appropriate authorities. They should ask for comprehensive company details, bank account data and information about registered signatories to help build a clearer picture of a potential supplier. It is important to cross reference this information against sanction, watch and law enforcement lists to help identify those who have connections with financial crime. Running a credit score check can also help minimise problems down the line as having a network of suppliers with a low-risk credit rating will increase the likelihood of being paid on time, while also ensuring the companies you are dealing with are financially sound.

Because this is a huge task and requires teams to trawl through vast quantities of data in various different jurisdictions, it makes sense to use integrated and up-to-the-minute digital solutions, such as the recently launched Mastercard Track, to help with the process.

All of these checks and balances will become even more vital as the pharma industry expands into emerging markets. As it establishes new supply chains with unknown, overseas suppliers, having a detailed insight and knowledge of your supplier will be a linchpin of the supply chain process.

Drug dilemma of a no-deal Brexit

Pharmacy Business, Kiran Paul, 16 January 2019

Britain is due to leave the European Union in 10 weeks’ time but it still has no clear way out of the bloc, raising the prospect of no transition period to smooth the shock for the world’s fifth-biggest economy.

Prime Minister Theresa May suffered a major defeat on Tuesday (15 January) when a huge majority of lawmakers – many of them from her own Conservative Party – rejected her Brexit plan.

As Britain is the first to leave the bloc, no one really knows about the potential impact of a no-deal Brexit.

With barriers to trade coming back, at least in the short term, things could turn very serious for those who rely on medication.

Medicines prices, licensing of medicinal products, safety protocols and health sector workforce are all expected to bear the brunt of the departure without a divorce deal.

The current assumptions warn of potential border delays for up to six months.

Officials are talking to drug companies about creating a six-week ‘buffer stock’ on top of the three months they already have in place.

This should help cover any short-term disruptions at the border. However, the industry has said that the target will be challenging.

Britain will also waive the need for EU firms to re-test their drugs under new rules.

The EU’s drugs regulator, the European Medicines Agency (EMA), said last August that it and national regulators had set up a task force to minimise supply disruptions arising over the next two years.

Emergency powers to community pharmacists

As part of its contingency plans, the government has proposed emergency powers for pharmacists to ration drugs in the event of a no-deal Brexit.

The major proposal concerns with invoking a ‘serious shortage protocol’, allowing pharmacists to swap drugs, reduce quantity or change dosage, overruling GP prescriptions.

Pharmacists are however asked to refrain from stockpiling additional medicines beyond their business as usual stock levels.

The latest guidance issued by the Department of Health and Social Care mandates Chief and Responsible Pharmacists to ensure this.

Pharmacy bodies have suggested several other measures to lessen the impact of a no-deal Brexit.

These include relaxing the restrictions on pharmacy-to-pharmacy wholesale dealing without wholesaler dealers licenses.

The flexibility to share medicines with each another if one or more pharmacies run short of a particular line was available to pharmacies until a few years ago.

Pharmacists ask the government to reintroduce this provision to better manage medicine supplies.

Brexit: No-deal outcome would put UK medicine supply at risk, German pharma industry warns

The Independent, no author, 16 January 2019

Theresa May’s government must avoid a hard Brexit in order to safeguard the supply of medicines to the UK, German chemical and pharmaceutical firms have warned.

The UK was one of the largest buyers of German medicines last year but trade in pharmaceuticals between the two nations collapsed 10 per cent to €16bn from €17.7bn in 2017, according to VCI, the industry body for German drug manufacturers.

After Ms May’s Brexit deal was emphatically rejected on Tuesday in the worst Commons defeat ever suffered by a UK Prime Minister, VCI warned transitional arrangements were needed to avoid the worst consequences for drug supplies.

“A disorderly Brexit would create such a complex situation that it is impossible for companies to prepare for all eventualities,” said Utz Tillmann, Managing Director of VCI.

In a statement, VCI said Mr Tillmann “deplores the rejection of the Brexit agreement by the British Parliament”.

He added: “A collapse of supply chains would cause damage far beyond our industry. Therefore, specific transitional solutions are essential to at least somewhat ease the most detrimental impacts.

“In particular, this is about supplies of medicines in the UK.”

Uncertainty around regulation after Brexit was the primary reason that UK-Germany trade in medicines and chemicals dropped in recent months, VCI said.

The drop-off in trade has occurred in both directions. German pharmaceutical companies may have imported fewer UK drugs and instead signed contracts with other suppliers in Europe to replace British products in preparation for Brexit, according to VCI.

The cost of customs alone is estimated to be €200m per year and VCI expects even greater burdens in the event that UK and EU rules begin to diverge.

A no-deal Brexit would also have significant consequences for the UK’s chemicals industry, according to the trade body.

“In the event of a disorderly Brexit, chemical substances that were registered in the UK for distribution in the EU could be no longer simply sold in the European Union – with significant consequences for the supply chains,” Mr Tillmann said.

He called on the EU Commission to prevent this by temporarily recognising registrations by companies headquartered in the UK.

The warning is the latest to underline the far-reaching consequences of a disorderly Brexit beyond Britain’s borders.

On Tuesday, research from the Organisation for Economic Co-operation and Development (OECD) predicted that Danish food imports including bacon and butter could drop by almost a quarter if the UK crashes out of the EU.

That would cut Danish GDP by as much as 1.3 per cent, the OECD said.

Pharma calls for ‘no deal’ preparation after Brexit deal rejected

pharmaphorum, Richard Staines, 16 January 2019

Pharma has called for politicians to take action to ensure patient safety in the event of a ‘no deal’ situation, after the UK parliament’s historic decision to reject prime minister Theresa May’s Brexit deal last night.

May now faces a confidence vote in the House of Commons that could lead to a general election if she loses out.

But amid the political chaos European pharma is calling for action to ensure patients across the EU and UK receive their medications in the case of the increasingly likely ‘no deal’ situation when Brexit happens in March.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) said there is a “very real, tangible, and immediate” threat to patient safety and public health in the UK and Europe because of a “disorderly” Brexit.

Director General Nathalie Moll said: “Now is the time for policy makers in the UK and the EU to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit.

“In particular from disruption to the supply of medicines including from transport delays at the border and where the development, manufacture, packaging, safety testing and regulation of the medicine no longer benefits from mutual recognition.”

EFPIA is calling negotiators to take a series of actions that need to be taken to protect patients.

These include allowing the EU to recognise UK-based drug quality testing, at least until it can be transferred to the EU.

Other measures include fast track lanes or priority routes for medicines into ports and airports, and allowing paperwork and regulatory checks to be completed away from the physical border.

The European Air Safety Authority should recognise certificates issued in the UK to ensure that planes can continue to fly, EFPIA added.

Active pharmaceutical ingredients, and raw materials for medicines could also be exempted from border checks to ensure manufacturing continues with limited disruption, EFPIA added.

The full list of actions has been published on the EFPIA website.

Speaking on behalf of UK pharma, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry (APBI), said: “The focus of pharmaceutical companies is on making sure that medicines and vaccines get to patients whatever the Brexit outcome. This includes stockpiling and duplicating manufacturing processes here and in Europe. We continue to work as closely as possible with Government on no deal planning.

“But we reiterate that ‘no deal’ would prove to be extremely challenging. With time running out we hope Parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019.”

Pharma comments on Brexit withdrawal rejection

PharmaTimes, Anna Smith, 16 January 2019

Pharmaceutical groups have weighed in on the UK parliament’s rejection of the Brexit withdrawal agreement.

Commenting on the decision made by UK parliament to vote down Prime Minister Theresa May’s Brexit withdrawal agreement, the European Federation of Pharmaceutical Industries and Associations (EFPIA) urged negotiators to agree on certain actions that it says need to be taken in order to protect patients.

“With the prospect of the UK leaving the EU in a disorderly manner on March 30, 2019, without a deal, there are very real, tangible and immediate threats to patient safety and public health in both the UK and across Europe.”

It also recommended the development of measures to recognise UK-based testing until it can be transferred to the EU.

In addition, the industry group called for continued UK participation in key data-sharing platforms that protect public health and drug safety in Europe, in addition to discussions between relevant authorities and the sector to formulate contingency plans such as creating fast track lanes or priority routes for drugs through ports and airports.

Also commenting on the deal’s demise, Mike Thompson, chief executive of the ABPI, said: “We reiterate that ‘no deal’ would prove to be extremely challenging. With time running out we hope Parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019.”

The news comes shortly after the UK government warned that access at UK ports could be significantly reduced for up to six months if the country leaves the EU without an exit agreement. Previously, the UK’s Department of Health and Social Care asked drugmakers to stockpile at least six weeks’ worth of medicines to ensure that drug access was not interrupted for NHS patients in the case of a no-deal Brexit.

Gavin Davidson, Pharma Analyst at GlobalData, offered his view on how Brexit could impact the UK healthcare industry’s contribution to the UK economy:

“Throughout 2018, the global biopharma industry’s opinion of the UK as an attractive place to base research and manufacturing has steadily eroded and last night’s vote will have done nothing to improve this sentiment with the looming possibility of a ‘No Deal Brexit’.

‘‘In a series of quarterly surveys (Q1-Q3), GlobalData asked key respondents from the US, UK, and EU healthcare markets, whether or not they thought that the UK will remain an attractive place to do central business. In all markets, decreases in ‘yes’ answers were observed; however in the UK and EU markets, confidence has collapsed with abysmal rates of 17% and 19% respectively after Q3.”

“The UK has always been at the forefront of pharmaceutical and biotechnical investment and development. For this position to be maintained, companies based in the UK want certainty on the outcome of Brexit and with MPs now debating ‘what next’, the stakes couldn’t be higher with the healthcare industries’ £70 billion ($88.5 billion) per annum contribution to the UK economy at risk if the country ends up with a no deal Brexit, an outcome that the EU has now escalated its planning for.”

Pharma industry ‘call for action’ following Brexit vote

European Pharmaceutical Review, Nikki Withers, 16 January 2019

The pharma industry has called for the government to act to ensure that patients receive their medications in the case of a ‘no deal’ situation on 30 March 2019.

Yesterday, Prime Minister Theresa May’s Brexit deal was rejected by 230 votes, the biggest government defeat in history. The vote comes at the end of five days of debate over the plan. MPs voted by 432 votes to 202 to reject the deal, which sets out the terms of Britain’s exit from the EU on 29 March.

Commenting on the result, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said that there is a “very real, tangible and immediate” threat to patient safety and public health in both the UK and across Europe.

“Now is the time for policy makers in the UK and the EU to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit,” said EFPIA Director General Nathalie Moll. “In particular from disruption to the supply of medicines including from transport delays at the border and where the development, manufacture, packaging, safety testing and regulation of the medicine no longer benefits from mutual recognition.”

The EFPIA is calling on negotiators to agree on a series of actions that need to be taken to protect patients.

These include introducing measures that will continue to recognise UK-based testing, at least until it can be transferred to the EU.

Other measures include enabling the continued UK participation in key data sharing and putting fast track lanes or priority routes for medicines into ports and airports.

Medicines and clinical trial materials should be temporarily exempted from any new customs and borders checks and the European Air Safety Authority (EASA) should recognise certificates issued in the UK to ensure that planes can continue to fly.

The EFPIA also suggests active pharmaceutical ingredients (API) and raw materials for medicines should be exempt from border checks to ensure manufacturing of medicines continues with limited disruption.

Mike Thompson, chief executive of the ABPI, adds: “The focus of pharmaceutical companies is on making sure that medicines and vaccines get to patients whatever the Brexit outcome. This includes stockpiling and duplicating manufacturing processes here and in Europe. We continue to work as closely as possible with Government on no deal planning.

“But we reiterate that ‘no deal’ would prove to be extremely challenging. With time running out we hope Parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019.”

Pharmacy sector ‘deploying all necessary resources’ to prevent Brexit medicines shortages, as government deal voted down

The Pharmaceutical Journal, Julia Robinson, 16 January 2019

The Pharmaceutical Services Negotiating Committee is working to minimise the impact on community pharmacies in the event of a no-deal Brexit, while the European Federation of Pharmaceutical Industries and Associations is calling on negotiators to agree on a series of actions to protect patients.

Following the historic parliamentary defeat of the government’s Brexit withdrawal agreement, the Pharmaceutical Services Negotiating Committee (PSNC) has said it is “deploying all necessary resources” to ensure patients do not run short of medicines when the UK leaves the EU.

Speaking after the government defeat on 15 January 2019 — and with less than three months until the agreed Brexit date of 29 March 2019 — Simon Dukes, Chief Executive of the PSNC, said pharmacy negotiators would continue to work with the Department of Health and Social Care (DHSC) to plan for all potential scenarios, including a no-deal Brexit.

“Given the ongoing uncertainty, this work is now more critical than ever and the PSNC will be deploying all necessary resources to it,” he said.

“Our focus will remain on contingency planning with the DHSC to ensure that patients can continue to access the medicines they need, when they need them, and that the impact on community pharmacies is minimised.”

Dukes also revealed that government Brexit planning had delayed negotiations on community pharmacy funding and the future role of the sector.

“This is not an exclusive problem to pharmacy but we are concerned that this delay is now likely to continue,” he said.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, said that “with time running out, we hope parliament will come together and quickly find a solution to the stalemate and reassure patients that medicines will not be disrupted come March 2019”.

He reiterated that a no-deal Brexit would prove “extremely challenging” and the focus of pharmaceutical companies was on making sure that medicines and vaccines got to patients whatever the Brexit outcome.

“This includes stockpiling and duplicating manufacturing processes here and in Europe. We continue to work as closely as possible with government on no deal planning,” he said.

Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said: “Now is the time for policymakers in the UK and the EU to put politics aside and put measures in place to prevent patients being harmed by the consequences of Brexit, “in particular from disruption to the supply of medicines, including from transport delays at the border, and where the development, manufacture, packaging, safety testing and regulation of the medicine no longer benefits from mutual recognition.”

The EFPIA is calling on negotiators to agree on a series of actions that need to be taken to protect patients, including discussions between relevant authorities and the sector to coordinate contingency plans, such as putting fast-track lanes or priority routes for medicines into ports and airports and exploring the possibility of exempting active pharmaceutical ingredients and raw materials for medicines from border checks to ensure manufacturing of medicines continues with limited disruption.

The government has asked drugs manufacturers to maintain a rolling six-week stockpile of medicines for six months in the event of a no-deal Brexit.

In addition, GPs and community pharmacies were told not to stockpile additional medicines beyond their business as usual stock levels. The DHSC also said there was “no need” for clinicians to write longer NHS prescriptions and that the public should be discouraged from stockpiling.

Chaand Nagpaul, council chair of the British Medical Association (BMA), said that with less than 75 days to go before the UK is due to leave the EU, it was now “crucial” that a second referendum is held to decide the final outcome of Brexit.

“The BMA has been clear about the danger Brexit poses to the NHS, its workforce, patients and the nation’s health. Leaving the EU will result in poorer care for patients, reduced availability of drugs and medical supplies, and a diminished workforce,” he said.

The Falsified Medicines Directive: steps to compliance

European Pharmaceutical Review, no author, 16 January 2019

The Falsified Medicines Directive (FMD) 2011/62/EU, comes into full force on the 9th February 2019.

This directive aims to increase the security of the manufacturing process and delivery of medicines throughout Europe, providing greater protection for patients. Organisations that have not yet become compliant must now act fast to ensure they do not fall foul of the regulation.

The MHRA have also confirmed that should there be a ‘no-deal’ Brexit, it will consider a UK-only version of the EU law.

So, what can be done to make sure FMD compliance projects are completed in time and that the chosen solutions are robust enough to guarantee immediate compliance? Christian Taylor, Serialisation Business Consultant at Zetes, provides his plan to becoming FMD compliant.

Review existing processes

With the legalisation fast approaching, there is more urgency to find suitable solutions. However, as FMD compliance needs to be built into day-to-day operations, it requires a careful and considered process review.

Organisations should proactively be looking to implement solutions that create minimum disruption to current working processes, drive efficiencies and are simple to use every day. Operational team engagement in the plan is needed if businesses are to achieve full compliance and effective delivery. This, along with a well-managed implementation, that is supported by solid training and open communications, will also result in a rapid launch.

Frame projects

Organisations not only need to focus on making sure they have compliance ahead of the 9th February, but they also need to ensure that any FMD solutions that are implemented are built on flexible foundations. This flexibility will arm them with the ability to encompass broader roadmap principles such as automation for decommissioning, returns, consolidation and aggregation or adding a visibility layer for reporting and insight beyond the audit trail.

Examining the flexibility that an FMD solution can provide will allow businesses to think big, start small, scale fast and have a platform for growth in the future.

Furthermore, Good Distribution Practice (GDP) requires the capturing and storing of batch-level information. Whereas, FMD requires organisations to capture and share item level serialised data. Businesses, therefore, need to identify datasets, sources and recipients. This will be vital in ensuring future scalability, including the ability to consolidate, aggregate products and data and share this information in real time to enable other parties to mass decommission if needed.

Consider technology

Technology can play a key role in error reduction. The choice of technology is largely based on the volume throughput and the environment for capturing data. Large scale operations need to weigh up the value of manual scanning against semi-automated and fully automated options to ensure high accuracy for higher throughput volumes. Smaller scale operations may be able to get by with basic handheld devices but they must have operational procedures and process controls in place that are robust enough to ensure accuracy.

Regardless of its size, an organisation should try to avoid serialisation systems that are heavily reliant on a specific hardware or software. Such restraints could restrict its ability to take advantage of any new processes or technology without having to re-implement a whole new project further down the line.

The combination of people and technology

The successful deployment of an FMD solution requires the buy-in of not only compliance teams and the IT department but businesses should also consider wider operational teams and those using the solution day-to-day. It’s vital that any solution fits within the business environment.

Operational staff should also be made aware of the implications of FMD, however, organisations shouldn’t find themselves in a situation where an employee on the warehouse floor is making decisions that affect the legal standing of the business. Instead, it should ensure that users are armed with the most appropriate technology that helps with compliance.

Add value to the business

Typically, compliance is viewed as a business pain and something that is unlikely to create direct value. By implementing a solution that can optimise supply chains, update data flows, break down operational silos and enable tighter internal and external collaboration, substantial value will be unlocked.

Additionally, adding automation and digitising messages to complement the physical flow of the supply chain, will not only increase efficiency and reduce errors but also provide greater actionable insight to optimise the future process, while providing early alerts of any potential risks.

Media And Political Bulletin – 17 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

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