Sir Andrew Witty, Chief Executive of GlaxoSmithKline (GSK), has been asked by the Government to find ways of strengthening the partnerships between universities and the private sector.

The man recently described in the BMJ as “the acceptable face of big pharma” will conduct a review and suggest practical means of ensuring that more discoveries made by academic researchers bring commercial benefits.

Witty’s review seeks a new model for industry-academic partnerships (across a range of industries) as funding for the Technology Strategy Board (TSB) continues to be cut back.

The role of Local Enterprise Partnerships, which lack the funding and powers of the now-abolished Regional Development Agencies, is one aspect of local partnership that Witty will consider.

Another is the effectiveness of universities in training scientists and other skilled professionals to take up roles in industry.

According to the Government, Witty will “identify where we have world-leading capabilities in our research base that can underpin the sectors and technologies of the industrial strategy”.

“A strong relationship between businesses and universities can provide real growth opportunities in local areas,” said University and Science Minister David Willetts. “By forging links and sharing best practice, an efficient and practical partnership will help to boost the economy, benefiting both businesses and institutions.”

The relationship between industry and academia is already changing. The number of ‘spin-out’ companies formed by university researchers increased from 2,457 in 2010 to 3,118 in 2011; but cuts in the TSB’s budget have reduced the number of formal ‘knowledge transfer partnerships’ between universities and companies.

Sir Andrew Witty commented: “It is vitally important that the world-leading capabilities in our universities and research base are at the heart of both the industrial strategy and local growth strategies that recognise and build on areas of local strength.”

New research shows that SME growth provides the best prospect for economic recovery in the UK. But, as private equity firm ECI notes, finding the cash to reach out to global partners and markets can be a critical hurdle.

With continued pressure on governments across the Western world to reduce their expenditure, together with sustained macro-economic uncertainty and a tightening of bank funding, times are not necessarily easy for the average healthcare company – which often relies on the public purse for reimbursement and debt funding for growth. One might therefore expect the short-term outlook for growth to be somewhat muted, despite the backdrop of positive longer-term demographic drivers of demand.

Hence it is interesting that a recent survey of UK SME businesses by ECI Partners, a UK-based midmarket private equity firm, has found executives to be generally positive about growth prospects over the next 12 months, with 74% of respondents anticipating headcount growth and 60% expecting double-digit turnover growth.

The results met with a warm response from the Government, with Mark Prisk, Minister of State for Business and Enterprise, saying: “It’s good news that despite a tough few months, nearly three-quarters of the SMEs surveyed by ECI are looking to recruit over the next year and half expect to see substantial profit growth in that period. Up and down the country, it is Britain’s SMEs that are driving our economic recovery.”

Reaching out

This year, the survey conducted each summer by ECI Partners gained responses from a total of 246 chief executives from UK growth companies from a range of sectors with turnover between £10m and £200m. The results paint a positive picture against the gloomy economic backdrop of the Eurozone crisis and sluggish UK economy, and suggest that there remains growth potential amongst SME businesses – which account for around a third of UK private sector employment.

Steve Tudge, a Managing Director of ECI, commented: “Despite the barriers to growth, which are principally cited as a weaker macro-environment and funding constraints, we continue to be optimistic about the prospects for good mid-market companies.”

Executives see the key growth drivers to be increasing international sales – with Europe and the USA remaining the dominant international markets, though India and China are becoming more important – and organic growth through investment in sales and marketing and new product development. Over 40% of companies are also planning to increase their use of overseas suppliers to improve their margins.

Internal cash flows are viewed as the most likely source of funding for this growth, though around half of respondents say they are likely to seek bank debt within the next 12 months (despite continued complaints about its cost and due diligence requirements) and around 40% are also likely to look at private equity backing. Fewer than 10% of companies see the public markets as accessible, perhaps reflecting the recent volatility and liquidity issues associated with the AIM market.

Healthcare respondents are less bullish about high growth than their peers in other sectors, and are noticeably less positive about growth than they were last year. This no doubt reflects, in part, the political uncertainty surrounding the current UK healthcare reforms and the public sector spending constraints that are impacting on the health and social care sectors.

Despite this, companies remain more confident of raising growth financing – and of raising it from private equity firms, with over 50% saying that was a likely consideration over the next year.

Financing growth

What does all this mean for SME healthcare businesses in the UK? The sector certainly faces challenges in responding to Government spending cuts, which are tending to put pressure on margins if not always on volumes.

However, opportunities for growth remain amidst these challenges, particularly for companies who are able and willing to venture beyond the UK in order to seek new customers and cheaper suppliers.

Of course, this internationalisation can put a strain on smaller businesses, which may lack the scale to fully support an international infrastructure. Private equity groups with experience and expertise in this process can potentially offer support to management teams in this position – whether by making introductions, sharing best practice or simply financing the required infrastructure.

There are significant sums of capital available for investment from the UK private equity industry, and there remains an appetite to invest in market-leading healthcare businesses. Thus private equity should be considered seriously as an option by management teams in the healthcare industry who are looking to fund growth to help their companies succeed in the current economic environment.

ECI is a private equity group that has been investing in mid-market growth businesses for over 35 years. It invests across sectors, with a focus on UK and Irish companies. Healthcare companies in its current portfolio include a primary care provider (Harmoni), assisted living specialists (Premier Bathrooms, DLP) and medical software companies (Clinisys, Ascribe).

The NHS Technology Adoption Centre (NTAC) has launched a new online system to help NHS and private health providers adopt proven medical technologies more quickly and effectively.

The new Generic Adoption Process (GAP) provides a detailed roadmap of the adoption process and access to the tools and resources needed.

GAP builds on the experience of NTAC’s Technology Implementation Projects over the past four years in improving the diffusion of proven medical technologies across the NHS.

Users of the GAP website are encouraged to navigate through each of its sections in order, thereby building relevant knowledge – however, they are free to navigate between sections as they wish.

The site is designed for use by health providers at all stages of the technology implementation process.

Sally Chisholm, CEO of NTAC, commented: “GAP has been tested by a number of key stakeholders from the NHS and industry. We believe this is a vital tool which will help drive widespread adoption of proven technologies, as GAP can provide unrivalled knowledge and information to those who do not choose to directly engage with NTAC on an implementation project, for example.

“The idea for GAP came from our recognition that there is a clear need for something which can equip clinicians, managers and other key stakeholders crucial to service development with the tools and resources they need to be able to drive change and innovation throughout the NHS.”

NTAC takes the view that the NHS often fails to adopt innovative medical technologies whose clinical and economic value is proven due to a lack of well-resourced and coordinated adoption pathways.

GAP is available at http://www.ntac.nhs.uk/GAP/GAP_Home.aspx

 

Takeda Pharmaceutical Company has created several new positions as part of its “Transformation into a New Takeda”, restructuring the company’s business operations.

The new roles include Chief Medical and Scientific Officer (CMSO) and Chief Commercial Officer (CCO).

The CMSO is set to replace the existing post of Chief Scientific Officer, to be filled by board member Dr Tadataka Yamada, a medical doctor and scientist with strong experience in pharmaceutical R&D.

The CCO will be responsible for the company’s global sales structure, replacing existing positions in International Operations in the US, Europe and North Asia.

Takeda’s Chief Executive Dr Frank Morich will claim this position, who will lead sales strategies in the US, EU and key emerging markets.

The restructuring of the company is said to relect Takeda’s recent acquisition of Nycomed, which the firm described as “another significant step towards globalisation”.

Takeda fully acquired Nycomed in October in a cash deal worth €9.6 million.

The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”

West Midlands home care specialist Salts Healthcare has acquired Healthlink, a Dispensing Appliance Contractor (DAC) covering Sussex, Hampshire, Kent and Surrey.

The acquisition will enable Salts to make its UK customer service network fully national, increasing its number of care centres to 17.

Sussex-based Healthlink has been run for 30 years by its founder and owner Liz Box, who is due to retire.

Family-owned Salts Healthcare, established over 300 years ago, specialises in stoma and continence care products.

The company’s home delivery service, Salts Medilink, provides specialist nurses and rapid prescription delivery via a network of customer care centres.

According to Peter Salt, Salts Healthcare’s Managing Director, the company “provides a vital service to ostomy and continence patients throughout the UK”. He added: “That passion to provide the very best service is found across the Healthlink team, and it’s that same quality of care and professional principles that attracted us.”

“This is a new chapter for both me and the company, and I’m delighted that my work will be continued with the same passion by Salts Healthcare,” said Liz Box. “As a family-owned firm, I know that Salts will look after my company, my staff and most importantly the patients.”

For Salts Healthcare, the last year has seen new product launches, significant export growth and the acquisition of UCI Healthcare.

Philip Salt, CEO, (pictured above with Liz Box and Peter Salt), commented: “Our early history shows we were originally metal workers who progressed to surgical instruments. This adaptation was borne out of our home-made but specialist skills and the desire to innovate. The same principles apply now, especially in a global economy with pressures for cheaper products coming from across the world.”

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.

A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.

The EMA is under investigation by the European Anti-Fraud Office (OLAF) over alleged conflicts of interest.

The investigation was raised by Michèle Rivasi, a French Member of the European Parliament, who claims independent oversight by the EMA is impossible due to the majority of its budget coming from pharma.

OLAF told The Independent the investigation opened in July, but “for reasons of judicial secrecy", could not give any further details.

It’s believed the inquiry relates to the Servier’s controversial diabetes drug Mediator. The medication was withdrawn from the European market in 2009, ten years after concerns were first raised the treatment may be responsible for fatal heart problems.

Mediator was on the market for more than three decades and was used as a weight loss drug taken by an estimated 5 million people in France alone, plus countless more in Italy and Spain. It is estimated the drug caused up to 2,000 deaths during its time on the market before it was withdrawn.

The fallout from the scandal saw the French regulator, the Health Products Safety Agency, overhauled and its chief executive resign after an official report found it had “failed in its duties”.

The EMA was formed back in 1995 to provide a collective voice on drug regulation systems in the EU. The Agency has been attempting to its transparency with a series of new working principles and said in October it had “strengthened the rules on how it handles potential conflicts of interest of its staff and experts" after criticism by the Budgetry Control Committee.

A spokesman for the Agency said it was aware of the inquiry but had yet to see any allegations. “We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything,” he said.

John Wilkinson (pictured), Chief Executive of Eucomed, has received a special Career award from the International Vascular and Endovascular Course (IVEC) in Milan.

The award recognises the medtech industry’s contribution to the development of vascular and endovascular surgery.

IVEC Chairman Giorgio Biasi presented the award to John Wilkinson to “honour the excellence of a distinguished scientist and eminent colleague who has contributed enormously in promoting, divulging and spreading culture, development and achievements in the field of vascular and endovascular techniques.”

Following the award presentation, Wilkinson gave the Edmondo Malan Lecture on ‘Development and Achievements in Endovascular Procedures as a Result of a Continuous and Ingenious Co-operation between Physicians and Industry’.

He discussed the long history of collaborative working between clinicians and industry over 200 years, with ideas from doctors and surgeons being developed by companies, culminating in such revolutionary devices as the drug-eluting stent.

Wilkinson also emphasised the need for innovation to be built on a platform of ethical interaction and transparency, and for industry to support education and training in the delivery of new therapies.

Finally, he drew attention to the demographic and economic challenges facing Europe’s health systems, and called for a collaborative approach between all stakeholders to support innovative solutions to these urgent problems.

Eucomed is the leading European medical technology industry association. It represents 4,500 designers, manufacturers and suppliers of medical technologies.