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.

Despite huge investments into CRM systems some pharma companies still struggle to get all of their staff to embrace and fully interact with them. Pf’s Iain Bate explores why, and what the future holds for technology in the industry.

There’s no doubt that technological developments have changed the way we live and work from year to year – maybe even from month to month in the 21st Century. But has the world of healthcare been travelling in the slow lane of the intergalactic highway?

The potential that technology offers to pharma, and the general world of healthcare, is enormous. But is the pharmaceutical industry, and its staff in particular, using it to maximise the returns of billion-dollar investments?

It would seem that technology is the ‘buzz word’ on the lips of a few of healthcare’s major players at present. The DH recently invited people to nominate their favourite health-related mobile phone ‘app’ – be it for keeping fit, to locate a hospital or chemist, or helping to manage an illness. Creative minds were also asked to design their own health app with a panel of DH judges deciding on their favourite from the most popular entries.

Health Secretary Andrew Lansley says it’s the Government’s intention to give people better access to information using modern technology and the exercise is a “unique opportunity for the NHS and those who develop apps to not only showcase their work, but to bring to life new ideas and realise true innovation in healthcare”.

As part of the DH’s technology revolution, patients may also soon be offered online consultations with their GPs using programmes such as Skype. Clearly the Government is embracing the convenience technology offers to patients, but are other sectors in healthcare as interested? It would seem there is still some way to go.

 

In two minds

Pf ’s 2010/11 annual Company Perception, Motivation and Satisfaction Survey suggests that not all respondents are completely convinced by the power of technology in the workplace. Although the Survey – which relates to 2010 and the early part of this year – found that nearly 90% of respondents have access to a CRM system, only 43% find time to use it in the field and more than a fifth of people fail to accurately record post-call reports with important clients.

Questions have to be asked as to why, despite multimillion pound investment and training by pharma companies, there remains a percentage of staff that still ignore the power and potential of the technology at their finger tips.

Results from the Survey reveal there’s no difference in uptake by key account managers, primary and secondary care representatives, those in primary care roles only, firstline sales managers and secondline sales managers and the use of CRM technology between differing age groups – although surprisingly 10% of respondents in these positions with less than two years of experience said they did not have a CRM system, compared to just 5% more experienced colleagues.

The launch of the iPad in March 2010 promised to revolutionise the way sales representatives, and those in similar roles, use CRM systems in the field. However, nearly three-quarters (70%) of respondents from the Survey are still presently sent out with laptops containing their customer-relationship systems.

When quizzed on what they’d change about the hardware which houses their system, the majority of respondents said that their CRM was too awkward to carry, with poor running systems an issue and that batteries ran out too quickly. Apple claims its second-generation iPad now enjoys ten hours of use away from a plug socket in the field.

Yet the switch to the latest convenient tablet devices may not necessarily be about high levels of investment, it may be down to maximising value for money as Paul Shawah, Vice President, Multi Channel Strategy, Veeva Systems explains. “I would say the life cycle of devices within the industry is generally about three years, sometimes a little bit longer,” he said. “When a company invests in new technology they typically depreciate that over that period, so they don’t want to replace it in the field for that time to maximise their investment.

“However, with the introduction of game changing technology like the iPad, this has changed. We see a number of our pharmaceutical customers are justifying the business case to move to the iPad even before their tablets are fully depreciated. This speaks to the business benefit that pharma expects to achieve from the iPad and the related applications only available on that device.”

A convenient shield

Despite technology eliminating mundane process in the workplace and offering the potential to assist employees and improve their efficiency at work, it has historically been used as a shield to mask poor performance and abused as a means to waste company time – a recent online survey by AOL found that nearly half of Americans (44.7%) rank surfing the web as their primary activity during the two hours they ‘waste’ each day at work.

But it would seem that a high number of respondents do value the opportunities CRM offers. Almost two-thirds (64%) said they always enter correctly the amount of customer sales they make into their CRM. But 21% admitted they fail to always report face-to-face meetings with clients. More surprisingly, over a fifth of participants said they do not always record the number of products they had sold to clients.

The lack of honest accuracy is surprising considering the amount of time spent using CRM systems each day. A third said they spend between one and two hours a day on their system with a fifth spending three hours or more on their CRM. During their time using the management system, more than half (55%) said that call reporting was the most useful feature.

Although respondents were less impressed with the KAM abilities of their software with only 19% believing it to be the most useful facility. When questioned about what they would change given the chance, 45% said they wanted an improved database, over a quarter (28%) called for their system to be overall more useful, and 18% said they would prefer their CRM to be easier to use.

 

The next level

But what of the future of CRM systems? Will they be easier to use and have improved customer databases? David Round, General Manager, UK, Cegedim Relationship Management, says the regular interaction we now have with technology means we’ve all come to expect the latest developments.

“End users are significantly more ‘technology-savvy’ than their counterparts of even five years ago,” he explained. “If anything, the challenge for companies is to ensure that they provide their end users with the types of technology that they use as consumers. It’s also important to focus on the usability of your software to ensure maximum use. Technology companies – and pharma – must work together to develop a better understanding of the interaction, to ensure it meets users’ needs in the field.”

One main reason that users have become more ‘savvy’ is down to the use and interaction with social media. Whether at home or at work, websites such as Twitter, Facebook, LinkedIn and most recently Google+ have driven an increased use of various forms of technology – especially on devices such as smartphones or tablet devices which reps are calling for in the field.

Pharma companies, both in the US and UK, have flirted with the idea of fully embracing the power social media harnesses, but at present are restricted by the PMCPA’s Code of Practice and by the FDA – who has again delayed the publication of its guidance.

The FDA says it is “difficult to provide a timeframe... due to the extensive work and review process, or ‘Good Guidance Practices’, which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic”.

Although the FDA may be unsure on how to direct healthcare companies, David Round believes the introduction, both professionally and personally, of social media has had an impact on staff and their expectations.

“For the modern professional person, much of their everyday life is conducted online – for example on shopping, utilities, insurance or booking a holiday – and many users then want the same level of capability from the tools they use in their job,” he added.

Dan Goldsmith, General Manager, Veeva Europe, agrees there has been a significant shift in the way we operate and interact due to our experiences online through tagged posts or hash-tagged searches. But although the 800 million users on Facebook – more than half which ‘log-on’ every day – and 175 million people on Twitter have no problem saying hello to friends, pharma finds it more difficult reaching out to people.

“Social media create a new avenue for healthcare dialogue and will only continue to pervade our lives,” said Dan. “Consequently, I believe that pharma faces two challenges. The first is to decide how to participate in the online dialogue with stakeholders and then to create those interactions through the channels we’re all familiar with, such as Facebook and Twitter.

“The second is to figure out how to leverage the model of social dialogue internally to support stronger collaboration and more focused communication among employees. Already, we see some companies taking advantage of the latest social business tools to connect employees with one another and to access and share information in real time.”

Clearly CRM solution providers understand the potential modern technology and social media platforms offer to companies. Whether pharma and its workforce get fully up to speed on the intergalactic highway sooner or later remains to be seen.

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.

Lundbeck has appointed Jens Peter Balling and Iman Barilero as vice presidents in its R&D organisation.

The new appointments follow Lundbeck’s recent consolidation of its R&D activities into one organisation, creating a new unit.

Peter Balling (pictured, right) has been appointed as Vice President of the new unit, which will focus on regulatory product support, patient safety and quality assurance of clinical research.

Barilero (pictured, below) will be responsible for increasing Lundbeck's strategic efforts to build and maintain constructive cooperation and dialogue with national and international regulatory authorities.

Anders Gersel Pedersen, Executive Vice President of R&D at Lundbeck, said: “The regulatory and safety areas are an increasingly important prerequisite for this. The creation of one new unit and the increased focus on the other gives us a strong position in these areas.”

Peter Balling joined Lundbeck in 2006 as divisional director of global pharmacovigilance, previously working at Novo Nordisk and Nycomed.

Barilero began work for Lundbeck in 2007, when she served divisional director of regulatory development, strategy and policy, with previous experience at Hoffmann-La Roche and Johnson & Johnson.

Search for careers at Lundbeck.

An antitrust investigation into the contractual arrangements between Johnson & Johnson and the generic branches of Novartis has been opened by the European Commission.

The probe will analyse whether the agreement may have hindered the entry to market of generic versions of Fentanyl in The Netherlands.

Joaquín Almunia, Vice President of the Commission, who is in charge of competition policy, says that any such deals are a “restriction of competition that the Commission will not tolerate”.

If the Commission does find any irregularities, it would potentially represent a breach of EU antitrust rules, in particular Article 101 – which bans practices that restrict competition.

The European Commission says it pays “particularly close attention” to practices in the pharmaceutical industry after a previous inquiry showed that ‘originator’ companies may be paying generic manufacturers to delay the entry of cheaper generics on to the market.

“I regard this sector as a priority in terms of enforcement of competition rules given its importance for consumers and for governments' finances,” said Mr Almunia.

“Pharmaceutical companies are already rewarded for their innovation efforts by the patents they are granted.”

The duration of the investigation depends on a number of factors, the EC says, including the complexity of each case, the extent of co-operation and the exercise of the rights of defence.

Fentanyl is a strong pain killer for chronic pain.

Roche has appointed Dr Harsukh Parmar as Head of Translational and Experimental Medicine (TM) of its Inflammation Discovery and Translational Area (DTA).

Dr Parmar will be responsible for the strategy and implementation of early clinical progress in Inflammation as well as collaborating with Discovery and Clinical Development to ensure high quality of compounds used throughout drug production.

Dr Jacques Banchereau, Head of the Inflammation and Virology Discovery and Translational Areas, said that Harsukh is recognised as “an expert in respiratory, inflammation, immunology and oncology, and possesses the right combination of experience for this pivotal position”.

Dr Parmar joins Roche from AstraZeneca in the UK, where he worked as Early Development Director, Vice President and Global Head of Early Clinical Development in the Respiratory and Inflammation Therapeutic Area. He also previously served at Roche as Global Clinical Science Leader and Director in Oncology, Immunology, Virology and Transplantation.

“Having previously worked for Roche and recognising the rich heritage of innovation that has come from the pharma business in small molecules and biologics, I was excited to rejoin a company that has been a leader in many of its respective fields,” said Dr Parmar.

Lundbeck has appointed a trio of new Vice Presidents in Supply Operations and Engineering.

Kristian Sibilitz, Christian Houborg and Lene Andersen have all been promoted after impressing as divisional directors.

Lars Bang, Senior Vice President, Supply Operations and Engineering at Lundbeck, says the new VPs have all been “excellent ambassadors” during their time with the company.

Mr Sibilitz, who served as the personal assistant to Lars Bang from 2007 to 2009, has been appointed Vice President, Logistics, Christian Houborg is the new Vice President, Service & Technical Operations & Lean, and Lene Anderson will take the role of Vice President, Quality Supply Operations.

The FDA has approved MediPurpose’s new range of foam wound care products, MediPlus, containing antibacterial silver.

The products are indicated for use on chronic and traumatic wounds, including ulcers (arterial, diabetic and venous), pressure soles, donor sites, surgical incisions/excisions, and first and second degree burns.

The dressings use antibacterial silver control to provide an effective barrier to bacterial penetration.

Michael Riddle, Vice President of Wound Care at MediPurpose, said: “Our ability to provide cost effective wound care solutions is an integral part of MediPurpose’s value proposition. We can now supply a range of antibacterial dressings at prices that will allow healthcare professionals to offer these beneficial products to a larger population of patients.”

The company also launched its new Foam Ag, Comfort Foam Ag and Super Foam Ag dressings, part of the MediPlus range.

The products are expected to be available in the fourth quarter in the US.

Sucampo Pharmaceuticals has made leadership changes within its research and development (R&D) group after its Senior Vice President stepped down.

Dr Gayle Dolecek has changed to a part-time employee at the company and will now become and Executive Advisor with Dr Peter Lichtlen (pictured) and Taryn R. Joswick sharing the responsibilities.

Chairman, CSO and CEO, Dr Ryuji Ueno, says he is confident that changes “will bring the company’s performance to a new level”.

Currently, Dr Lichtlen works as Senior Medical Officer and Vice President of European Operations, of Sucampo AG and Ms Joswick fulfils the role of Senior Medical Officer and Vice President of European Operations, of Sucampo AG, both subsidiaries of Sucampo.

Dr Lichtlen only joined the company back in July 2011. Ms Joswick joined the company as a research assistant in 2001 and has held the roles of Vice President, Clinical Development, having been named Director, Clinical Development, in 2006.

Lundbeck has appointed Marie-Laure Pochon as its new Executive Vice President of Commercial Operations and slim lined its Executive Management Group in the process.

The new EVP has joined the Group after “realising high growth” as the Chief Executive of Lundbeck France and the Regional Vice President for France, Belgium, UK, Spain, Italy, Turkey & Germany.

Ulf Wiinberg, President and CEO, says he is “very pleased that Marie-Laure Pochon is joining Lundbeck’s Executive Management Group, where she can contribute with her strong commercial experience from a long career in the pharmaceutical industry”.

The company says it will “execute on many new opportunities” to implement its strategy and secure long-term growth and will reduce its Executive Management from six to four members in order to do so.

Peter Høngaard Andersen will now exit the Executive Management, but continue as part of Lundbeck’s corporate management team as Senior Vice President, External Scientific Relations & Patents.

Lars Bang will also leave the Group, but continue his role as Senior Vice President, Supply Operations & Engineering, leading Lundbeck’s global supply chain.

As a result, Anders Götzsche, Executive Vice President, CFO, Anders Gersel Pedersen, Executive Vice President, R&D, plus Ulf Wiinberg and Marie-Laure Pochon, now complete the Group.