This month Brigadier Pinching shares a surprisingly palatable civil service coffee with the Department of Health’s NHS/big pharma relationship expert, Naima Khondkar.

I love Elephant and Castle. If you are in any doubt about where you are, just outside the station, there is large sculpture of... an elephant and a castle. Oxford Circus, King’s Cross and Cockfosters have clearly missed out on a neat trick. Anyway, I digress, for I was in central London on important business – to chat with Naima about how the private and public sector could make their marriage work. Having spent six years in curious governmental buildings, this was my territory. Bring on the future!

Hi Naima, what’s your story?

At the Department of Health I work in the Medicines, Pharmacy and Industry Group. The head is Giles Denham and he has a number of teams which sit under him. One looks after the pricing environment – which is very topical right now because of the negotiations – while the pharmacy team takes care of community and pharmacy issues. Another concentrates on prescription policy, and I’m in the industry sponsorship team.

How do you guys roll?

We’re almost account managers for the pharmaceutical industry, within government, and also the first port of call on health policy issues concerning research-based pharma companies, including global outfits that have locations in the UK. There’s a very high-level of strategic engagement, driven by the Ministerial Industry Strategy Group, which combines global heads of pharma, from as far afield as Japan and America, and ministers from health, business, the treasury and UKTI (UK Trade and Investment). The discussions are a great way to highlight how government policy can help partnerships. Our minister, Earl Howe, is a particularly engaging contributor, while ‘No 10’ frequently sends along a representative, indicating how serious the Government is about forming cohesive inter-sector partnerships.

How has the concept of joint working progressed?

Over the last few years we have carefully considered how to fundamentally improve the relationship between industry and the NHS, and a lot of this consideration has been carried out in conjunction with colleagues at the ABPI. There is still a lot of mistrust on both sides, however, and that is one of the greatest challenges reform needs to overcome. The NHS has the perception of pharma as being a big bad wolf, just above the arms and tobacco industries in terms of popularity! For some reason people have a big problem with the pharmaceutical industry making any kind of money. Sometimes I think the level of suspicion is unjustified, but then again, I don’t think pharma do themselves many favours sometimes. It’s important to be open and honest about these things! Equally, the NHS can sometimes be over-sensitive – they don’t like to be told by other people how to do their job.

What needs to change?

There needs to be a shift in how people on both sides view one another and they must learn to wipe the slate clean. Bad relationships can date back to minor incidents that happened 25 years ago, when a young, naive rep went into a meeting with a box of doughnuts to help flog a new product. Something as trivial as this may have resulted in a door being shut. Whereas now NHS representatives need to re-engage, open doors and think about the broader benefits of working together with the pharmaceutical industry towards joint goals. It’s really important that both sides build allegiances and forget past animosities. Ultimately this will benefit everyone.

Do the ‘different’ motivations of the public and private sector make gelling difficult?

There is an incorrect perception that, because pharma makes money, someone else has lost. We must remember that if people have their lives extended due to better treatment then NHS, industry and wider society has won. Recently Helen Bevan, NHS Director for Transformation, said both industries have been very target driven in the last 15 years and, consequently, the humanity factor has eroded. Healthcare professionals on the frontline have been too busy with waiting lists and reductions, while sales reps have been under enormous pressure to shift products and been too focussed on sales. Patient cases have become about performance measurement rather than health outcome, or quality of experience. Clearly there needs to be a radical change in priorities.

What can big pharma do to engender trust?

Their approach can be ill-informed sometimes. Often they think they know the NHS, but actually they need to fully appreciate the complexities of what is an ever-evolving beast. Companies need to consider who they make responsible to forge vital connections and forming sustainable relationships. They regularly send an under-qualified person, who might have the enthusiasm, but not the authority. With joint working one of the big issues has been compliance and, often, the pharma representative at the table can’t actually make a decision about whether a company can work in a certain way. This is one of the areas we are really trying to help with.

How should they alter their approach?

If pharma goes in simply looking for a market share increase, they’ll get figured out straight away. Representatives of the big companies need to prove that they genuinely want to improve a health economy or health outcome, before profits. These are the aspects that make the whole system better, and ultimately everyone wins. The CCGs want more people appropriately treated and that means less hospital admissions and, in turn, more financial resources will be available for commissioning. In this respect pharma needs to look at the bigger picture. Remember, every service that the NHS uses is a business – from nurses to bed sheets – but because of the fractious history, the NHS is suspicious about pharma making money. When they do engage the NHS needs to feel like pharma is an integrated and credible part of the solution, as opposed to a procured service. It’s a fine balancing act.

What are the priorities when it comes to galvanising joint working?

Since joint working was outlined as part of NHS reform we have been keen to establish how it can be improved. A policy working group in 2007 carried out some market research and they came up with some recommendations. The two major areas of focus, on our side, were the issuing of guidance – clear definitions of how the NHS works - and the language that should be used. This is a refreshingly concise 11 page document. We also addressed the practical side by combining with the ABPI to launch the, ‘Joint Working tool kit’. It’s an interactive quick-start guide, which includes exactly what the NHS’s definition of joint working is, essential templates and a versatile project management tool. Above all, it avoids jargon and allows people to understand what is required straight away. This has been endorsed by NICE, the NHS Alliance and Confederation among others. We will be looking again at how we can update these documents and make them more practical in the ‘new world’ and also partnering with industry [through the ABPI] and the NHS to review and revitalise both these tools.

Are you optimistic about fruitful partnerships?

Joint working will continue to be an important focus and a part of my day job. QiPP came and went, so we had to hold fire for a while, but now Innovation Health and Wealth (IHW) has provided a restructure, we are pretty sure of what is happening; six months ago we sat down and established that the shift of power is moving to CCGs. Now individual CCGs. Director of Partnerships, Ivan Ellul is particularly keen on localised, dynamic relationships and Mike Farrar is also a champion. Ian Carruthers is the NHS England lead for IHW and is also keen to encourage this type of engagement.

Do you feel that the tide is turning already?

I’m resolutely positive about changes within the NHS. I’ve had heated discussions with clinicians and pharma about joint working, because a lot of them see it as more rhetoric. Some companies, however, are hugely proactive and want to be pioneers of change. GSK are a good example. They’ve shifted their entire salesforce to encourage new ways of working with NHS counterparts. Their leader, Andrew Witty, is passionate about successfully transforming approaches and he’s someone you can believe in, because GSK have freed up patents, conformed to the ‘alltrials’ ideology and shared data. This has filtered down to the way they engage with the NHS and the company have been very smart, as they realise it’s about increasing the whole market. If a healthcare pathway improves it will produce better diagnosis, and better diagnosis means more appropriate and timely use of medicines.

Well said, thanks Naima!

Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

The UK medical professions have worked together to develop a strategy to address the national obesity crisis – the worst in Europe.

Two thirds of adults in the UK are now overweight and a quarter are clinically obese, the Academy of Medical Royal Colleges (AoMRC) has warned.

Professional training, weight management services, nutritional education and changes to the built environment are among the measures it recommends.

Obesity is a strong risk factor for diabetes, heart disease, musculoskeletal disorders and mental health problems.

The UK’s national health services should collectively invest £100m in weight management services modelled on the existing smoking cessation services, the AoMRC argues.

These should range from early intervention to bariatric surgery, with QOF incentives for GPs to refer patients to the relevant services.

Healthcare professionals should seek to “make every contact count” in influencing patient behaviour.

While most of the recommendations are related to patient lifestyles and the “obesogenic environment”, many medicines can impact on weight management – and vice versa.

While some measures, such as a ban on the advertising of junk food to children, are unlikely to be adopted by the Government, the prioritising of the obesity crisis within the NHS will influence many aspects of medical care.

Linda Hindle, Chairman of the Dietitians in Obesity Management group, said: “Obesity in the UK is an absolute epidemic, there is no question that the recommendations in this report are essential.”

The ABPI has raised concerns around the public’s general knowledge on the cost and value of medicines in the UK after a survey highlighted a series of misunderstandings.

The survey showed that the majority of respondents thought new medicines cost less than £10m to research and develop and more than a third believed drugs take up a large proportion of the NHS budget.

Stephen Whitehead, ABPI Chief Executive, said it was vital the public understands the facts of medicines and how they compare to the economic and health benefits they provide.

More than 1000 people were interviewed as part of the survey commissioned by the trade body. It revealed that 59% seriously underestimated the cost of R&D efforts with new products generally costing £1bn and taking 12 years to create.

Also, 35% of respondents indicated a belief that the NHS spends a fifth of its budget on medicines. Whereas in reality, the ABPI said, that only 9.7% was spent on drugs last year – a fall from 12.5% in 1999.

More than three-quarters of respondents (77%) indicated that more should be spent on medicines.

Stephen Whitehead said the survey highlighted some concerning outcomes. “To create new treatments in the UK, the pharmaceutical industry undertakes huge risk and investment and is still able to provide the NHS with amongst the lowest priced medicines in Europe,” he said. “These medicines are the bedrock of the NHS, and have saved and changed the lives of millions of people.”

The Chief Executive added that serious health problems such as HIV, diabetes and heart disease are now “manageable conditions” due to the effect of medicines and that treatments become cheaper in time due to generics entering the market.

“As well providing real value, we also contribute billions annually to the UK economy and provide 67,000 jobs.”

The ABPI said it will now increase its efforts to educate people about the facts of medicines in the UK.

The DH and the ABPI aim to achieve a new pricing system for branded medicines that reduces bureaucracy whilst being affordable, sustaining and responsive to the future needs of the NHS.

A joint statement from the two said that negotiations to replace the existing Pharmaceutical Price Regulation Scheme (PPRS) will begin next month and will include value-based pricing (VBP).

The two insist they are “committed” to reaching a new agreement that gives “patients better access to the most effective medicines”.

The new pricing scheme will cover the majority of branded drugs which will enter the market before 2014. It will operate under a similar but “evolved framework” to the existing PPRS.

However, the Government and the ABPI believe it is “important” for the new arrangement to provide “stability and predictability in the new framework” to ensure the NHS and the pharmaceutical industry manage financial and investment plans.

The statement said it is “vitally important” to continue the supply of innovative treatments to NHS patients and the ABPI “welcomes” value-based pricing alongside a renewed PPRS to “support this goal”.

Therefore, the statement said, VBP will be introduced in a “planned and progressive way” to focus on new medicines entering the market from 1 January 2014.

The Government aims to ensure the assessment of new medication is conducted as fully and early as possible for pharmaceutical companies to “predict well in advance” how products will “fare”.

The updated PPRS will also include a “statutory scheme” for companies that choose not to participate in the voluntary agreement.

Selling medicines in today’s marketplace should be built on partnership principles. ABPI CEO Stephen Whitehead talks exclusively to Pharmaceutical Field about the importance of NHS/industry partnerships.

Back in 2009, Chris Brinsmead – then President of the ABPI – told Pharmaceutical Field that the future role of the pharma field force would be to facilitate partnerships between the NHS and industry. Three years later and the partnership agenda is slowly inching forward. Progress has been made, but adoption of a more collaborative approach across the country has been variable. As ever, there are early adopters, and those that wait. Last month, Pf led with an ABPI announcement that predicted the NHS and industry would ‘become partners within 3-5 years’. Why not now, came the familiar cry? Why not, indeed. The ABPI seems determined to address this.

This month, Pf spoke exclusively to Stephen Whitehead as he approached the first anniversary of his tenure as CEO at the ABPI. It is clear that, in challenging times for the UK industry as it battles to ensure that patients gain access to life-changing medical innovations, partnership sits at the heart of the ABPI agenda.

“There is a currently a big commitment to move the joint working agenda forward,” says Stephen. “Strategically, over the past 15 years there has been the emergence of many different influences on prescribing – NICE, local commissioning and local formularies are obvious examples. The industry now has to work with a wide variety of stakeholders to demonstrate the value of its medicines. And traditional sales representatives have to work with many different and more complex audiences than they used to when they were purely detailing. Increasingly, I think joint working is the vehicle best suited to satisfy these varying demands.”

Innovation Health and Wealth
The environment for a more collaborative approach is certainly improving. The Innovation Health and Wealth review last December reiterated the need for greater partnership working to help accelerate the adoption and diffusion of innovation in the UK. Crucially, it said that the NHS needed to be ‘open for business’ on partnership. As such, advocates from both parties are working hard to raise the profile (and the benefits) of the approach. But resistance and misunderstandings around joint working remain.

“One of the problems is that there are variable definitions and understandings of what joint working is,” says Stephen. “In simple terms, joint working is a partnership approach focused on solving a patient-driven issue. The industry has disease expertise, it knows how to manage conditions and has developed medicines in those areas. Joint working is about bringing that expertise together with the providers and focusing on patient outcomes. And often we can find cost savings in delivering those outcomes as well.”

Importantly, says Stephen, joint working is not sponsorship. “This is not about industry paying for something. Historically we have funded a lot of things and sometimes there is a real benefit to us bringing money to the table. But this is about changing that perception. Partnership is where two parties, with different strengths and weaknesses, come together to focus on a shared goal. In this case, that has to be patient care.

“The fundamental issue is about recognising the value of innovation and its implications for a pathway of care. By working together to find out how these medicines can be used appropriately, we can save money in the system, we can prevent unnecessary and costly hospitalisation and we can improve patient care.”

Medicines in the middle
In recent years, discussion has focused on whether UK pharma companies should reconsider their product-centric approach to customer engagement, and concentrate instead on developing services with the NHS. The caveat being that a specific medicine would form the core part of any service. But joint working is not an exact science. There is no one-size-fits-all solution – it’s simply about working together to establish the most appropriate approach in a given disease area. “It’s about products and services,” says Stephen. “Some of our members do offer services. But the way I look at joint working is that there is always a medicine in the middle of it – because that’s what we discover, develop and sell. In today’s environment, the only way that the value of that medicine can be truly realised is through joint working that reengineers the pathway of care.”

At present, most joint working initiatives are being built around new innovations – and are being used to redesign services and improve the care pathway. A good example of this is in the field of anticoagulants, where a number of new brands are coming to market. “The new class of drugs have gone through NICE have been recommended and should therefore be utilised,” says Stephen. “Old warfarin clinics should now be closing as patients move onto the new drugs. But to achieve that, and to free up the funds to be able to use the new innovations, we need to take other measures. And you can only do that, in my view, through joint working.

“It is my passionate belief that in most cases, innovative medicines will save money in the system – in the short, medium and long term. We simply need to work together to deliver it.”

Implications for pharma sales
The implications for pharmaceutical sales professionals are significant. While joint working is not always appropriate – aspects such as disease area or where a particular product is along its lifecycle are key factors in whether the approach is applicable – adopting a partnership approach most certainly is. “Joint working is a natural evolution of partnership principles,” says Stephen. “Industry engagement has changed from being a simple seller/buyer transaction, into seeking to work in partnership with customers to ensure the NHS properly maximises the value of medicines. The UK has a low price and a slow uptake of medicine – and as a consequence, the UK system is not as efficient as it could be. It would be more efficient if it adopted innovation more quickly. And if it did, we would certainly have better patient outcomes.

“Joint working is best used when you want to coax the system into innovation. It is not always the most appropriate approach. But whatever you have in your medicine chest, partnership is always applicable. In today’s marketplace, how you approach selling that medicine should always be built upon partnership principles.”

The NHS is placing too much emphasis on ‘breakthrough drugs’ rather than on diverse and incremental innovation, according to the ABPI.

An updated report on pharmaceutical innovation commissioned by the UK trade association warns that by focusing on unique medical solutions, the NHS risks narrowing the scope of medicines.

ABPI Chief Executive Stephen Whitehead (pictured), launching the report, commented: “I fear for the future of UK medical research.”

The Many Faces of Innovation was commissioned by the ABPI from the Office of Healthcare Economics, updating a 2005 report commissioned by EFPIA.

As well as providing new case studies, the updated report places pharmaceutical innovation in the context of the UK health economy of 2012.

The report attacks the dichotomy between ‘breakthrough’ and ‘me-too’ products, arguing that innovation can be incremental – especially where ‘stratified’ medicine is concerned.

In addition, innovation has several dimensions: it could bring “advances in health gains”, “cost savings in health services” or “advances in patients’ and/or carers’ convenience”.

Finally, medical research benefits from multiple companies tackling the same problem – so it’s not helpful for there to be only one ‘winner’.

The report implicitly criticises NICE for assuming that each medical problem has one ‘best’ solution and that ‘value’ has a single metric.

The forthcoming medicine pricing negotiations will mark a watershed for the industry, Whitehead said: “If we minimise the reward for innovation in the UK, then our manufacturers will go abroad. Our industry, our economy, and our healthcare system will suffer – UK patients will suffer.”

Baxter International has recalled 300,000 doses of its flu vaccine Preflucel after a considerably high number of side effects were reported.

Most of the vaccines were distributed in Ireland and Scotland, where reports of side effects included tiredness, muscle pain and headache, which are typically associated with flu jabs.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement on its website saying: “The vaccine should no longer be used and any remaining stock should be returned to the original supplier for credit. No further Preflucel of any batch should be administered at this time.”

Baxter commented that the recall was precautionary and that those who have received the jab do not need to be re-vaccinated.

What level of medical device failure is acceptable? Brad Abbey argues that the industry needs to arm itself against the threat of litigation – not with lawyers, but with the right kind of evidence.

I was somewhat taken aback by a letter in the British Medical Journal last December, where under the unlikely-sounding title ‘FDA is gold standard of review’, Mark B. Leahy, president and CEO of the US Medical Device Manufacturers Association, while singing the praises of the industry, said that a recent study of FDA-approved medical devices from the past 5 years showed that fewer than 1% had been recalled.

Most recalls, he said, were due to manufacturing and design problems in a post-marketing setting. This was in response to an article that had been highly critical of the safety surveillance of medical devices in the US and the low hurdles that have to be jumped to get a device approved (seemingly true on both sides of the Atlantic).

I am a generalist in the healthcare industry, mainly involved with medicines, but to say I was surprised by that figure is an understatement. I realise that the number of car recalls may be higher – but with a surgically implanted device, the owner cannot check it in at the service centre and pick it up at the end of the day.

I know that MHRA gives daily warnings about medical devices, from wheelchairs to drug-eluting stents; but given that the level of adverse event risk that is acceptable to the public for a medicine is somewhere between 1 in 10,000 and 1 in 100,000, the 1% risk seems difficult to accept.

A lead article in the May 2011 BMJ, by Peter Wilmshurst of STARFlex fame, opened with the comment that the regulation of medical devices is (in his opinion) unsatisfactory, unscientific and in need of a major overhaul. Pretty damning stuff.

 

Duty of care

The registration of medicines requires data on the safety, efficacy and quality of products, and the numbers of patients needed to demonstrate an acceptable risk/benefit profile can be dauntingly high. The same level of scrutiny does not happen in Europe for medical devices, where a single approval can trigger cross-community acceptance.

With the increasing complexity of devices and the high levels of patient expectation, it is hardly surprising that when seemingly good devices go wrong the patients want compensation – and, where there is a suitable arena, for punishment to be meted out.

In the US, where many complex medical devices are developed and initially marketed, the ‘learned intermediary’ doctrine has been used by healthcare product manufacturers in recent times to protect themselves in the event of something going wrong. This doctrine, used in the US legal system, states that the manufacturer of a product has fulfilled their duty of care when they provide all the necessary information to a ‘learned intermediary’, who then interacts with the consumer.

This doctrine has been used primarily by pharmaceutical and medical device manufacturers in defence against tort suits. In a majority of American states, the courts have accepted this as a liability shield for pharmaceutical companies.

However, drug and medical device manufacturers sustained an unexpected blow in August 2008 in Rimbert v Eli Lilly and Company: in a federal court decision, for the first time, there was a rejection of the learned intermediary doctrine in its entirety. The decision rejected the notion that the manufacturers of drugs and medical devices do not have to make the patient fully aware of the risks associated with them and that this can be delegated to the prescriber.

The idea underlying the ‘learned intermediary’ doctrine is that the prescriber, who has expert knowledge and skill, should make the decision about risk. But changes in the consumer environment whereby prescription products can be advertised directly to potential patients have rendered this justification obsolete, and so it was predictable that for medical devices – some of them traditionally never coming ‘into the hands’ of the patient – the risk scenario would be influenced by the lesser amount of risk/benefit information needed before approval for marketing. While the doctrine has not been used in Europe, the risk information relating to devices is lagging behind that for medicines.

In order to be vigilant about the risks of medical devices, companies will be best served by surveillance systems that monitor the risk/benefit profile of products from the moment they are first evaluated (even if that takes place in animal models). This is not always easy.

A letter in the BMJ (in the same issue as Leahy’s letter) from a Welsh group of doctors highlights the problems of post-marketing surveillance for medical instruments, and in particular the use of single-use devices for tonsillectomy from 2001 in the wake of the variant Creuzfeldt-Jakob disease that followed the ‘mad cow’ scare of the 1990s.

Widespread adverse events were associated with these non-reusable instruments despite their CE marking, and they were deemed not fit for purpose. The case for reform of medical device regulation therefore seems a given.

 

Hip or lame?

In the meantime it seems that the visible portion of the iceberg of device regulation-related problems is giving rise to a stream of litigation that could possibly become a tide. Recent Medtech Business news reports have followed the fate of orthopaedic company DePuy and its ASR hip replacement.

Hip replacement is one of the clinical successes of the marriage between orthopaedic surgeons and the medical device industry, and it was estimated (before this year’s NHS rationing) that about 70,000 patients were undergoing total hip replacement each year in the UK.

I remember metal-on-metal hip replacements from the 1970s (I have one in a drawer at home that came to me as a result of its breaking), and they became popular again in the 1990s. However, the most recent generation have not fared so well, with higher than expected rates of failure and concerns about excessive levels of metal ions (cobalt and chromium) in the blood of patients.

According to 2010 data from the National Joint Registry of England and Wales, the DePuy ASR Hip Resurfacing System has a revision rate of 12% at 5 years after surgery and the DePuy ASR XL Acetabular System has a revision rate of 13%.

That means that during the first 5 years after a hip replacement with the DePuy ASR hip, at least 1 in 8 patients will experience hip failure requiring painful and expensive revision surgery. With more than 90,000 DePuy ASR hips in patients worldwide, over 11,000 people could require additional surgery due to the defective design of this implant and DePuy’s failure to remove it from the market earlier.

One of the questions that remains unanswered was whether there were potential conflicts of interest between the supplier and the healthcare professionals who developed and were involved in promoting these devices. The key issue in litigants’ minds is that the device did not perform as well as such a device might be expected to, and it seems that the device’s registration in the US was obtained without clinical trials to prove its long-term safety and efficacy. In a litigious society such as the US, where someone must pay for any mistake, the supplier appears to have suffered with the rolling of heads and the decision to remove the offending brand from the market.

Don’t get the idea that this case is a one-off: the recent history of medical devices suggests that arrivals on the market may sometimes be premature, as real risks may not have become apparent. Whether this is related to inappropriate endorsements from the medical profession is difficult to judge, but there are known examples of high-level payments to medical inventors who ‘sell’ their developments to industry and subsequently endorse them.

On the other hand, everyone is aware of what happened to Peter Wilmshurst when he took the opposite stance against a device manufacturer: there was a serious attempt to punish his critical views (which seemed to be well founded) and personally break him through the English court system.

 

Evidence is strength

Litigation against medical device companies is nothing new. However, in an age when people with problems can readily find lawyers willing to take on their problems, and some lawyers (particularly in the US) go looking for people who did not even know they had problems, access to litigation seems to be easier – and it is oiled by the possibility of compensation (which may be deserved when devices turn out to be inadequate or unsafe).

A Google search for the term ‘medical device litigation’ returned 640,000 hits; most of the leading ones were to do with lawyers offering their services in the pursuit of such litigation, or training sessions for lawyers who want to become involved in such cases, or training for companies who want to avoid them. I don’t believe a wake-up call about the risks of being sued is necessary, but what is well worth thinking about is the possible root causes of the current danger, which can ruin a company that believed it had a good product.

The message I am offering is consistent. The products of the healthcare industry must be subject to close and continuous scrutiny for their risk/benefit profile, and this should be done prior to marketing and continue in a structured manner post-marketing. NICE advisory policy on the best devices to use is still in its early stages.

There seems to be a raft of opinion supporting the idea that the regulation of medical devices (in Europe, and probably also in the US) needs to be overhauled to eliminate the placing of devices on the market with inadequate safety and efficacy monitoring.

Rather than finding ways of avoiding expenditure during a product’s development and launch by minimising the collection of such data, companies need to embrace the need for resilient data sets and continual risk/benefit signal monitoring. The competent authorities will wake up to this need, and those with effective systems in place will withstand the culture change best.

Brad Abbey is an industry observer, or the pen-name of an industry observer. The views expressed in this article are those of Brad Abbey, and do not necessarily reflect the views of Medtech Business.

The ABPI has backed proposals from the MHRA to repeal part of the Medicines Act which allows pharmacists to trade overseas without the need for a wholesalers licence.

Pharmacists can currently sell medicines intended for UK patients at an inflated rate to customers abroad and could potentially lead to a shortage for patients and the NHS.

Stephen Whitehead, CEO of the ABPI, says the current practice is “not acceptable” and the repeal of the legislation “is a good first step” for patients and the health service.

The proposal is expected to be approved and implemented in 2012.

The new legislation would mean that pharmacies will only be permitted to trade when there is a necessary public health need, when small quantities are required, the order is infrequent and deals are non-profit.

The UK has some of the lowest medicine prices in Europe. This has resulted, the ABPI says, in “flowing out of the UK” and having a direct effect on supplies.

“The ABPI welcomes the MHRA proposal to end the trading of medicines by pharmacies that do not have a wholesale dealers licence, except in exceptional circumstances to meet a public health need,” said Mr Whitehead.

“To fully address this challenge it is now essential that pharmacies who serve NHS patients directly need to separate wholesaling activities from pharmacy dispensing activities.

“The ABPI looks forward to taking an active role in solving the on-going challenges.”