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.

Medical device outsourcing company Vention Medical has acquired ATEK Medical Group, a leader in medical device assembly, packaging and injection moulding.

Dan Croteau, CEO of Vention Medical, said, “Our partnership with the ATEK Medical Group management team will allow Vention to provide an enhanced customer experience. Like Vention, ATEK Medical Group aspires to continually satisfy customers through intense focus on services that improve quality, innovation, and cost.”

The acquisition will incur a variety of combined capabilities and services, including product design and development, innovative component technologies, along with the manufacturing space of 175,000 square feet at its Costa Rica campus.

ATEK recently opened a second facility in Grand Rapids, Michigan, to support customer demands in the US.

Chris Oleksy, President of ATEK Medical, and Tom Houdeshell of ATEK Plastics, said that Vention’s experience and capabilities in design, components and assembly makes Vention “a very appealing partner for us”.

Vention Medical specialises in components and services used in interventional and minimally-invasive products, including medical balloons, advanced extrusions and heat shrink tubing, clean room injection moulding, assembly and packaging services.

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.

Merck saw revenues increase by 3.8% to €2.5 billion and net profit rise 7.5% to €227 million in the third quarter after solid performances by its pharmaceuticals and Millipore divisions.

Revenues at Merck Serono increased 5.4% to €1.4bn after increased global sales of Rebif and Erbitux (pictured) whilst its Millipore division saw revenue reach €588 million compared to €559 million the same period a year ago.

Karl-Ludwig Kley, Chairman of the Executive Board of Merck KGaA, says the results leave the Group “well positioned as we head into the end of the year”.

Its Executive Board now forecasts annual Group revenues between €10-10.2 billion and the debt resulting from the 2010 acquisition of Millipore to decrease at an “excellent pace”.

Administration expenses were down 2.7% to €124 million with other operating expenses and income also declining slightly by 1.3%. R&D costs increased to €371 million in Q3 due to a combination of late-stage clinical trials and the strong Swiss franc.

Earnings before interest and tax were also down 8.4% with underlying core operating result – which excludes Merck Serono and Millipore – decreasing by 21.5% of revenues as a result of the weakening of the Performance Materials division, the Group claimed.

Generic organic revenue growth in Merck Serono increased nearly 9% after its multiple sclerosis treatment Rebif recorded global sales of €426 million and the cancer treatment Erbitux earned € 218 million, primarily as a result of growth in emerging markets.

“The Merck Group produced solid third-quarter revenue growth in a difficult environment, driven mainly by good performances from the Merck Serono and Merck Millipore divisions,” said Karl-Ludwig Kley. “We are making progress in driving our change agenda forward and we will provide important updates on this endeavour in the first half of 2012.”

Sanofi has appointed David Meeker as CEO of Genzyme to incorporate its Rare Disease and Multiple Sclerosis franchises.

He will join the company’s Group Management Committee, reporting to Sanofi’s CEO, Christopher Viehbacher.

He said that David’s “medical and business experience will be essential to move Genzyme’s broad portfolio of products forward and deliver much-needed therapies to patients”.

Mr Meeker joined Genzyme in 1994 as medical director to work on the company’s Cystic Fibrosis Gene Therapy programme. He has since held various positions at the company, including President of Global Rare Disease Business, and was promoted to Chief Operating Officer in 2009.

Sanofi is a global healthcare provider, which develops and distributes therapeutic solutions in diabetes care, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health.

A medical device that helps to prevent wrong-route injections has won the Medical and Life Sciences Award at the first ever Made in Wales Awards in Cardiff.

The Hall Lock system (pictured) from Flexicare Medical, developed in partnership with clinicians at Cardiff University, is a series of connectors designed to reduce the risk of potentially lethal misconnections.

The system was developed in response to the increasing number of fatalities due to wrong-route injections of intravenous drugs and anaesthetics.

The cross-sectional shapes of the Hall Lock connectors are not compatible with each other or with a standard luer connector, presenting a mechanical obstacle to misconnection.

Hash Poormand, Flexicare’s Business Development Director, commented: “The Hall Lock System is a truly Welsh idea inspired by Cardiff University Hospital and designed by Flexicare in Wales.

“We are proud to be at the forefront of shaping the future of patient safety. This award recognises that innovation can be taken from concept to market with all the expertise required right in the heart of Wales.”

In a keynote speech at the Made in Wales Awards, Cheryl Gillan, Secretary of State for Wales, said: “The innovation recognised at the awards today is inspiring and I want to congratulate each and every winner: they are first-class examples of how Wales can contribute to new technologies and private sector growth.

“SMEs in Wales have a critical role to play in supporting the economy in Wales and I am clear that the UK Government is here to provide support to help companies succeed.”

Based in Mountain Ash, Flexicare Medical manufactures medical devices across a range of product areas including anaesthesia, critical care, breathing systems, suction, resuscitation, continence care and colostomy.

Eli Lilly’s diabetes injection Bydureon, exenatide prolonged release suspension, has been preliminarily recommended by NICE.

The draft guidance recommends the injection as part of a triple and duel therapy regimens for type II diabetics when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE says the Institute is “pleased” to recommend another treatment option for people with the condition.

The injection improves glycaemic control by lowering the rise in blood sugar from eating and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors are contraindicated or not tolerated.

NICE says that treatment with the injection for both triple and dual therapy regimen should only be continued if a beneficial metabolic response has been proven.

Final guidance is likely to be published in February 2012.

Eli Lilly expects the drug’s increasing approval to create jobs at its US manufacturing facility in West Chester.

Bydureon was approved by the European Commission to treat type 2 diabetes in June 2011.

Precision Engineered Products (PEP) has acquired Boston Endo-Surgical Technologies (BE-ST), a specialist in the development of spinal and orthopaedic surgical instruments.

BE-ST provides a firm pipeline of technologies to strengthen PEP’s spinal surgery portfolio.

Alan Huffenus, CEO of PEP, said that the acquisition of BE-ST will continue the company’s “strategy of expanding our offering of highest technology medical devices that extend people’s lifespan and improve outcomes of surgical procedures”.

Massachusetts-based PEP is a manufacturer of surgical instruments including surgical stapling devices, endoscopic and laparoscopic devices and drug delivery systems.

European medtech industry association Eucomed will launch a conference pre-vetting system in early 2012 to assess all third-party educational conferences and congresses sponsored by its members.

The new system is the first of its kind in the healthcare industry, because its assessments will be binding.

The independent Eucomed Compliance Panel will assess educational events for compliance with the association’s Code of Ethical Business Practice in relation to such factors as scientific content, location and venue.

Each outcome will be made publicly available via a dedicated website, and relevant stakeholders will be notified.

The Eucomed Code allows member companies to sponsor third-party educational events such as medical congresses, seminars and training courses, subject to restrictions. Until now, members had to establish their compliance independently. The new system will apply a uniform compliance determination process to all Eucomed members.

“The conference pre-vetting system is a unique initiative in the healthcare sector,” said John McLoughlin, Chairman of the Compliance Panel. “It will be supervised solely by our Panel, which is a completely independent body. Eucomed members are required to follow the assessments.

“If a conference receives a negative assessment, Eucomed members may not sponsor either the conference or individual healthcare professionals who wish to attend the conference.”

John Wilkinson, Eucomed’s Chief Executive, added that the new system “is not only necessary for our members in their day-to-day activities but is also key to increasing the consistency and transparency of industry behaviour.”

Eucomed intends to give key stakeholders an opportunity to comment on the assessment criteria.

The pre-vetting system will begin as a pilot and be reviewed 6–12 months after its launch. It will be the sole responsibility of the Compliance Panel.

Eucomed represents 22,500 designers, manufacturers and suppliers of medical technologies in Europe.

Bolton-based medical consumables company Vernacare has emphasised the importance of teamwork and partnership for their development of the world’s first pulp wash bowl, which won a Queen’s Award for Enterprise 2011.

The Vernacare wash bowl (pictured) is used by hospitals in more than 270 NHS Trusts and across the globe for patient care, wound and continence care, hand washing and surface cleaning.

In a study reported in the BMJ, Vernacare’s wash bowls were among a package of measures that led to a 50% fall in cases of C. difficile at Salford Royal NHS Foundation Trust over 12 months.

Karen Haslam, Chief Executive of Vernacare (pictured, left), praised the company’s team and the clinicians who had helped them to develop and trial the product. “We developed our single-use wash bowl in response to customer demand,” she said. “Nurses told us they were concerned that re-using plastic wash bowls without properly cleaning and drying was a significant infection risk.

Vernacare’s previous pulp products were permeable to warm soapy water, she added. “This was a major challenge that took our in-house team two years of painstaking research and trial and error to overcome.”

Heather Dakin, Senior Nurse Infection Control at Colchester Hospital, said of the product: “Nursing staff found that they had more time for patient care and didn’t have to worry about decontaminating plastic bowls. They also found that wards looked much tidier as the pulp can be stacked on racking provided by Vernacare rather than hanging from lockers or beds collecting dust.”

Vernacare provides single-use pulp products for patient waste management and a macerator for disposal. The products are used in over 90% of UK hospitals and more than 50 countries.

The photo shows Karen Haslam and Maria Sinfield of Royal Bolton Hospital with the Queen’s Award.