In the UK joint working is being encouraged to develop innovative services and propagate best practice. But in France, new legislation is placing significant barriers between pharma and its clients. Jérôme Guermonprez explains the implications for market access strategies in the country.

Across Europe pharmaceutical companies have been looking to underpin market access strategies with strong links to healthcare professionals. And while most pharmaceutical companies admit there are significant national differences that demand specific market access strategies, there has been a push, where possible, to leverage expertise, messaging and strategy to drive economies of scale.

Many organisations are now actively embarking upon innovative, cooperative working with regional decision-making bodies – such as the Clinical Commissioning Groups (CCG) in the UK; whilst doctors and pharmacists are increasingly involved in research projects, from clinical research to patient care, patient outcomes and procedures. Indeed, the UK’s amended Health and Social Care Bill strongly encourages pharmaceutical research, innovation and the use of scientific evidence in decision-making.

In France, the forthcoming radical overhaul of the drug regulatory system will significantly change relations between pharmaceutical companies, healthcare professionals, patient associations and physician associations. The “Reforme du Medicament” legislation aims to crack down on health practitioner conflicts of interest, restructure the country’s drug regulator and tighten the process for licensing drugs and for monitoring their effects once in use.

The proposed bill creates compliance requirements that far outstrip the UK anti-bribery laws and includes a number of significant changes which will directly affect the way pharmaceutical companies interact with opinion leaders across the French health service.

To minimise the risk of conflict of interest, the new legislation mirrors the US Sunshine Act by requiring pharmaceutical companies to disclose all financial relationships with healthcare professionals, patient associations and scientific experts.

With an emphasis on patient safety, the bill also requires far more detailed information and discussions about indications – from the provision of a helpline number on every drug packet to enable patients to report problems, to the creation of a government watch list of drugs under review.

It also demands pharmaceutical companies no longer undertake direct physician training but instead provide the funding for training to the government, which will then oversee independent training programmes.

 

Restricted access

Critically, from a market access perspective, the bill will prohibit individual medical representative visits to physicians within a hospital; visits must be collective to avoid any one-to-one relationships and ensure discussions are open and transparent.

The impact of this legislation – which is currently being discussed and should be passed by the French government by the end of 2011 – will be significant for pharmaceutical market access policies and demand companies gain new insight into key opinion leaders (KOL).

Under this new model, the industry will have to be incredibly careful about the type of relationships that are put in place with stakeholders; indeed, at least one pharmaceutical company has already announced it will no longer pay physicians directly in the future or invest directly in physician grants to avoid any regulatory compliance issues.

Furthermore, with many physicians likely to back away from any interaction with the pharmaceutical industry, at least in the short term, patient and physician associations will have a far greater role to play. Pharmaceutical companies will have to rapidly assess the way these associations and individual physicians respond to the new legislation and amend market access strategies accordingly.

 

Regional structure

This new challenge comes at a time when pharmaceutical companies are still adjusting to the major overhaul of the French healthcare system – which has seen the creation of 26 Regional Health Authorities (RHA).

While drug reimbursement is still set nationally as in the UK, since 2009, each region has found the responsibility to adapt national objectives to local or regional health and demographic problematic. Over the past year, each region has had to sign multiple year contracts between the  state and the region to deploy the health strategy.

As in the UK, over the past two years, pharmaceutical companies have realigned resources to create a regional approach based on a key account management (KAM) model. The regional structure has significantly broadened the number of stakeholders involved in decision-making, both financial and medical.

Furthermore, each RHA has a different demographic breakdown and health issues, creating very diverse goals for each region. This change has required a far greater insight into decision-makers and regional objectives; it has also demanded pharmaceutical companies use the KAM approach and strong CRM tools to drive synergies between teams at local, regional and national level.

Pharmaceutical companies in both France and the UK are now actively seeking in-depth insight into the KOLs within new regional structures. Information from the structure of the new organisations, including the multiple drug, technical and price commissions, to identifying specific members, roles and drivers is proving key to create the right regional messaging.

And with this regional, KAM-based model still in its infancy in France, pharmaceutical companies face a tough challenge to ensure the implications of the new medical reform legislation are incorporated.

Messaging, for example, must now be amended to include product safety, as well as quality and efficacy; while companies must ensure information is up to date to ensure changes in physician attitude to the pharmaceutical industry as a result of the new regulations are flagged to remove the chance of inappropriate or unwanted contact. CRM tools will also be essential to coordinate group visits to physicians to avoid any chance of the forbidden one-to-one interaction.

As in the US following the introduction of the Physician Payment Sunshine Act in 2009, pharmaceutical companies will also need help to meet their obligations to declare all activity with physicians.

 

What next?

It is tough to predict how the health service in France will respond to the new legislation over the next 12 months. For pharmaceutical companies there is no doubt that direct physician contact will decline and organisations will have to refocus efforts towards the increasingly influential patient associations and physician associations.

But for those organisations operating across Europe, the changes must demand very different approaches towards health service co-operation. As the UK market looks to drive service innovation and close ties with practitioners at every level, counterparts in France are being compelled to be transparent and improve patient safety. The concept of the global, or even pan–European, market access strategy looks ever less practical.

Jérôme Guermonprez is the Vice President and General Manager, France, Cegedim Relationship Management.

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.

Merck Serono has launched its easypod Connect, which monitors injection data collected by the easypod auto-injector in patients receiving growth hormones, in Europe.

The medical software is designed to display patients’ injection history from the easypod electronic auto-injector on a secured online database.

Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono, said: “easypod Connect is a new approach enabling health care providers to monitor patients' adherence to growth hormone treatment, with the goal of better understanding its impact on treatment outcomes and more objectively adapting the treatment regimen to a single patient.”

easypod Connect provides healthcare professionals with reports and data from the patient’s injection history, which both monitors and analyses patients treatment adherence.

The easypod Connect Observational Study (ECOS) has already been in use since its launch at the end of 2010, offering the additional functionality to combine and manage injection patient records with growth and/or clinical outcome data.

Thomas Bols, Vice President of Corporate Health Policy and Market Access at Merck Serono, said: “By monitoring injections and thereby adherence to growth hormone, easypod Connect gives health care providers important information to consider when making decisions for their patients to improve treatment outcomes.”

easypod Connect has already been launched in Canada and Australia. The medical device has not been submitted for use in the US.

Boston Scientific has launched the first iPad app to help healthcare professionals educate patients and carers about cardiovascular diseases and their treatment.

CardioTeach, available free of charge, provides an overview of normal heart function and the therapy options for atrial and ventricular arrhythmias, coronary artery disease, heart failure, heart rhythm disorders and peripheral vascular disease.

The app’s accessible content and graphics (see picture) help the clinician to explain specific conditions and procedures used to treat them, helping patients and their families to make informed choices.

Healthcare providers can also use CardioTeach to mark up anatomical illustrations with cardiac devices, add notes to a page or attach graphics to an e-mail for the patient or carer.

The patient can receive personalised cardiovascular education anywhere, helping them to make decisions and understand compliance and adherence requirements.

“Most medical device apps are designed to educate physicians on a specific product or therapy, said Leslie Saxon, Chief of Cardiovascular Medicine at the University of Southern California. “CardioTeach is unique because it lets clinicians better educate patients about their overall heart and vascular health and available treatment options.”

He added that CardioTeach gives patients “something they can reference after they leave my office and when thinking about or explaining what went on during the office visit,” as well as helping patients and their families “educate themselves prior to and between visits.”

Kenneth Stein, Boston Scientific’s Chief Medical Officer for Cardiac Rhythm Management, commented: “A recent study shows that one in five physicians use a tablet computer in their practice. Creating an app that enables healthcare professionals to use this technology to enhance communication with patients and caregivers is a logical extension of our efforts to empower patients with information about Boston Scientific’s therapies.”

Based in Massachusetts, USA, Boston Scientific is a global supplier of interventional medical devices.

A new website from UK-based infection control specialist Bioquell Healthcare aims to help hospital staff defeat healthcare-associated infections (HCAIs).

Focusing on ‘superbugs’ (drug-resistant germs), www.bugstoppers.co.uk adopts the style of the Crimestoppers campaign to profile the ‘bugs’ as individual villains.

Aimed at healthcare professionals and ancillary staff, the website provides accessible information on lethal pathogens such as C. difficile, MRSA and norovirus.

Each bug profile includes a microscopic image, a cartoon character image, a short description and some key facts, as well as a link to a detailed scientific profile of the pathogen on the Bioquell website.

The website is divided into three sections: ‘Bad bacteria’, ‘Villainous viruses’ and ‘Fearsome fungi’. Its first ‘Bug of the month’ is C. difficile, still a major threat to many hospital patients in the UK.

Less familiar bugs revealed on the website include anthrax and smallpox, as well as new resistant-gene superbugs such as NDM-1.

Bioquell has also produced a set of Bug Trump cards for use in infection control team training, as well as related posters and desktop tools.

James Salkeld, Head of Bioquell, said: “Our new website and supporting Bug Stoppers campaign has been developed with healthcare professionals to provide their colleagues with tools that can help to build a greater appreciation of the risks of HCAIs and improve practices that aid in its prevention.”

Based in Andover, Hampshire, Bioquell specialises in hydrogen peroxide vapour (HPV) bio-decontamination technology for healthcare environments.

The application of a bio-decontamination programme, including the use of hydrogen peroxide vapour (HPV), by Gloucestershire Hospitals has reduced the incidence of Clostridium difficile infection.

In three years, the Trust’s infection control programme – which includes the use of cohort wards and antibiotic control as well as UK company Bioquell’s HPV technology – has achieved a 65% reduction in C. difficile infection rates (from 771 cases to 267).

C. difficile (pictured) is the leading cause of hospital-acquired diarrhoeal disease in the UK, and its control is a major target for healthcare professionals.

Over the three-year period, 2,763 areas were decontaminated using HPV within the hospital. HPV can eradicate all biological contamination, providing a clean environment for patient re-admission.

C. difficile endospores are usually resistant to decontamination and can survive for months on hard surfaces, creating a reservoir of infection. The HPV process ensures complete surface sterilisation, breaking down endospores,

Deputy Nursing Director Paul Garrett commented: “HPV technology has played an important part in helping to reduce C. diff infection as part of an overall bundle of interventions. The Bioquell system has now been successfully integrated into the daily operations of our hospitals.”

Based in Hampshire, Bioquell is a leading supplier of bio-decontamination equipment and services, including its unique HPV technology.

Oxford, a division of patient lift provider Joerns Healthcare, has launched an online Sling Selector to help healthcare professionals select the best sling option for patients.

The online tool takes account of patient specifics, the transfer task, the safe working load and the lift to be deployed.

The Oxford Sling Selector (pictured) was demonstrated at the National Back Exchange (NBE) Conference and Exhibition 2011 in Hinckley.

The tool comes with an on-screen guide to answer any queries that arise during the selection process. It provides detailed sling information and has an account history to track patient sling usage.

Tom Bulpitt, Marketing Manager for Joerns Healthcare, said: “Selecting the most appropriate sling is crucial since it ensures a safe, dignified and comfortable patient transfer while reducing the risks associated with manual handling.

“The Oxford Sling Selector will be of particular help to those clinicians less familiar with sling equipment such as junior or trainee occupational therapists, physiotherapists and back care advisors.”

During the NBE conference Joerns demonstrated the educational tool on its exhibition stand in the main hall and during an in-depth training workshop.

The Oxford Sling Selector is free to access by all professionals and can be located at its own dedicated website or via the Resources section on the main Joerns UK website.

Oxford is an established supplier of patient handling and rehabilitation products and a division of Joerns Healthcare, an international brand with offices in the UK, the US, Canada and the Netherlands.

The revised Health and Social Care Bill remains contentious, but appears likely to pass into legislation. Simone Carron-Peters of Frost & Sullivan analyses its probable impact on the UK healthcare market.

The Government’s contentious Health and Social Care Bill has raised many concerns among the various stakeholders. The eight-week NHS listening exercise conducted by the NHS Future Forum has resulted in the proposal of multiple changes to the Bill, whose passage towards legislation is summarised in Figure 1 below.

This article evaluates the planned NHS reforms for impact on the health system and the life science industry.

Overview of the Bill

The Health and Social Care Bill proposes to create an independent NHS Board, promote patient choice and reduce NHS administration costs.
Its key focus areas are:

• To establish an independent NHS Board to allocate resources and provide commissioning guidance.
• To increase GPs’ powers to commission services on behalf of their patients.
• To strengthen the role of the Care Quality Commission.
• To develop Monitor, the body that currently regulates NHS Foundation Trusts, into an economic regulator to oversee aspects of access and competition in the NHS.
• To reduce the number of health bodies, including abolishing PCTs and SHAs, in order to help the Government cut NHS administration costs by one-third.

More power (and money) to the GPs

In its initial form, the reform aimed to improve the quality of service delivery by devolving NHS commissioning powers and responsibility into the hands of GPs. The GP consortia would receive budgetary allocations from the new NHS Commissioning Board, which would be responsible for managing and allocating about £80 billion of the health budget. The consortia would, in turn, devolve the funds to the various practices under them.

The new GP consortia would replace the 302 PCTs in England, which would be abolished by 2013. All NHS trusts were set to become Foundation Trusts by April 2014. It was anticipated that the consortia would require significant assistance, including support from the private sector, in exercising these new commissioning functions.

Medical organisations and NHS trusts were immediately sceptical about the implementation of this reform, saying that the changes could have negative effects on NHS services. Some trusts argued that it is risky to reduce the central grip on commissioning at a time where urgent savings are being made. Others agreed that GPs are well positioned to make decisions on the use of resources for their patients.

The BMA: a critical response

The reform plans have also not gone down well with the British Medical Association (BMA), who expressed concerns about the level of responsibility being bestowed on GPs. One of the BMA’s major concerns was the lack of clarity in the Bill with regard to the roles that the GP consortia would be expected to perform. The BMA also believes that it is important to ensure the funding for GP practices remains distinct from other budgets, as it would cause significant complications if GP consortia were to be made responsible for amalgamated budgets that included the management of standard GP contracts.

Currently there are about 177 GP ‘pathfinders’ (pilot groups of GPs testing the system’s concepts and functions) who are taking the lead in implementing the new commissioning roles.

In May 2011, the BMA’s Health Policy and Research unit conducted a national survey of GP opinion that received a response rate of 39%. The survey findings revealed an alarming 55.8% of the respondents citing NHS reforms as a reason for their intention to retire in the next two years. That figure was composed of 59.4% of the 688 principal or contracted GPs, 41.1% of the 30 employed salaried GPs and 35.8% of the 39 freelance GPs who participated in the survey.

The survey also asked GPs how confident they were that the GP commissioning consortia would be appropriately skilled and supported. 65.6% were ‘not confident’ that the consortia would be appropriately skilled, while only 15.8% were ‘confident’ that they would be. In addition, 70.9% of the respondents stated that they were ‘not confident’ that the consortia would be supported, while just 10.2% were ‘confident’ that they would be.

Amendments to the Bill

Based on the recommendations of the NHS Future Forum, the Health Secretary announced changes to the Health and Social Care Bill in June 2011. The Bill is due for its third reading on the 6th and 7th September 2011.

The role and functions of GP consortia are now better-defined. The consortia – now called Clinical Commissioning Groups (CCGs) – would be required to publish details on their constitution and how the allocated budgets have been used. They would also be required to follow guidelines from, and be accountable, to the NHS Commissioning Board. GPs are also bestowed with a responsibility to promote research and innovation.

The plan for all NHS trusts to become Foundation Trusts by April 2014 has been amended. NHS trusts would become Foundation Trusts by 2016, based on their clinical readiness for transition. They would be given the liberty to make use of private health treatments, and would compete among themselves for patients.

The role of the National Institute for Health and Clinical Effectiveness (NICE) would increasingly focus on giving authoritative advice to clinicians on when and how the most effective treatments can best be used, and also on the development of quality standards for the NHS to aim for in the treatment of certain conditions.

Value-based pricing (VBP) would replace the Pharmaceutical Price Regulation Scheme (PPRS), which has existed since 1957. The purpose of VBP is to improve NHS patients’ and clinicians’ access to effective and innovative drugs and medical technologies by ensuring they are available at a price that reflects their value, based on an assessment of the outcomes they can achieve.

Impact assessment of the health reforms

The implementation of the Health and Social Care Bill will witness an increase in private sector and voluntary involvement in the delivery of healthcare. GP commissioning will allow the use of private healthcare for NHS patients. Healthcare vendors and providers can capitalise on this shift by offering products and services best suited to patients’ needs in order to influence GP commissioning.

The aim of value-based pricing is not to achieve the lowest price possible, but to encourage the development of new therapies and promote innovation. The principle of linking the price of innovations to their value has already received support from a broad range of stakeholders.

The priorities of the health reforms are ambitious; if instituted, they will have far-reaching effects on the way the British public accesses the health system. It will also affect the role of the private sector in the UK healthcare system, increasing opportunities for private providers of both clinical and support services to become involved in providing healthcare to NHS patients.

According to the Government’s calculations, the reforms will bring about a huge cost saving for the NHS. However, negative consequences such as redundancy for administrative staff in the health authorities will pose a huge socio-economic threat.

How will the savings affect the prospects for innovative medical technologies? The adoption of such products has always been necessary for medical professionals, predominantly because new technology aims to provide healthcare at a quicker rate – minimally invasive technologies being a major example. The Government has vowed to ensure the system delivers effective and appropriate healthcare to all who need it. Moreover, GPs have a greater understanding of patients’ needs than the managers or PCTs who at present make funding decisions. Thus the demand for innovative devices will arise regardless of the allocated NHS budgets.

One of the main objectives of the reforms is to put patients and public first by implementing a ‘no decision about me without me’ policy. National standards and independent inspection will continue to assure patients that all NHS-funded services are safe and of a high quality. Patients will have much more information about individual services and their performance, enabling them to choose the services that best meet their needs.

The reforms will ensure that services are easier to access and more responsive. Shorter patient waiting times, one-stop clinics for diagnostics, and increased provision of healthcare in patients’ homes are some examples of services that are likely to develop in response to new incentives. Patients will be able to gain access to healthcare in new ways that are more flexible. This is likely to mean more services delivered in local communities, such as urgent, preventative and rehabilitative care, thus helping to avoid unnecessary hospital admissions. Better information will help patients to understand and make the best use of the options available.

The reforms will also support services to become more integrated. Improved information systems will play a key role, enabling healthcare providers to exchange clinical data more easily and so gain a complete view of the patient’s condition. Increasingly, there will be opportunities for patients to influence the pattern of services within their locality. Local practices will have incentives to provide locally-based health improvement and health protection services. Patients will be in a better position to manage their own health.

Financial goals

The Government is confident that the health reforms will allow it to save billions. Figures from the Impact Assessment published alongside the Health and Social Care Bill earlier this year claim that the structural reforms to the NHS will save £5 billion per year, though this is a gross rather than net figure. The Bill promises to reduce NHS administrative costs while promoting patient choice. However, time alone will tell whether these reforms prove to be economic.

 

Simone Carron-Peters is a Research Analyst for growth consultants Frost & Sullivan.

The EMA’s approval system of comparing new drugs with placebos instead of against existing alternatives is flawed, according to a new report.

Written by the London School of Economics (LSE), the report argues that pharmaceutical companies should prove how their drugs differ with comparators to gain European approval, to guarantee that only the best drugs are funded.

The document suggests this will ease healthcare resources around the world, ensuring that only the most beneficial and safest drugs reach patients.

Researchers from the LSE said: “Comparative efficacy evidence should have a formal role in drug licensing decisions.”

They said that open dialogue between regulators, drugmakers and government agencies would “achieve better congruence between licensing and reimbursement requirements”.

As it currently stands, the EMA only requires significant comparison against a placebo rather than an existing therapy.

The researchers argued that the current method does not allow healthcare professionals to determine the health values of the new drug, resulting in “the widespread use of potentially less efficacious and unsafe drugs”, they warn.

“With this success comes an equally important additional need – to develop a systematic approach to evaluate the risks and benefits of these new therapies in the context of existing alternatives.”

A leading healthcare professional has criticised how the Government’s £200 million Cancer Drugs Fund is being spent.

Audrey Paterson, Director of Professional Policy at the Society and College of Radiographers, says that more money should be spent on improving radiotherapy than on chemotherapy drugs.

She said that if just “a fraction” of the £200 million fund was allocated to the development of radiotherapy “the impact would be immense”.

Professor Paterson was speaking after the NHS report, Radiotherapy Dataset Annual Report 2009/2010, found a poorer uptake of the treatment among cancer patients located in parts of the Midlands and the north.

Previous surveys have revealed that a number of cancer patients would chose chemotherapy drugs over radiotherapy due to fears of the nature of the treatment.

But radiographers have pointed towards new techniques which mean the therapy is safer and more effective than ever before.

Members of the Society and College of Radiographers believe the treatment has been overlooked in favour of chemotherapy, which may only prolong life by a matter of months but has received a higher amount of press and political attention.

“The Government must ensure that radiotherapy, which cures more people than chemotherapy, receives sufficient funding so that we can close the north-south divide which currently exists,” said Professor Paterson.

By investing £40 million in new equipment the Professor says it would make “a sizeable dent” in reducing the amount of deaths each year and “give people better quality of life”.

“What I would not want to do is set up a competition between chemotherapy and radiotherapy, because both have their place,” she added.

“I think there are strong arguments for saying that amount of money could be better spent elsewhere in terms of the long term fight against cancer.”

Paul Burstow, Care Services Minister, said that radiotherapy is one of the “key treatments” for cancer and that uptake will “undoubtedly contribute to saving lives”.

“Our cancer strategy sets out how we plan to improve cancer outcomes and save an extra 5,000 lives every year by 2014/15. It is backed by more than £750million of funding over four years, which includes additional funding for radiotherapy.”