Improving regulatory compliance in the wake of global legislation around anti-corruption has emerged as one of pharma’s key challenges for 2012.

A 2011 Cap Gemini report on impending change within life sciences showed that only addressing ‘fragmented business processes’ and a ‘lack of access to business critical data’ rank higher as the most critical issues for the sector.

But despite widespread recognition of the importance of business transparency in all interactions with customers, a recent study shows that 44% of pharma companies are still using manual paper-based systems to record promotional spend with HCPs.

The survey, European Trends in Aggregate Spend, Transparency and Disclosure, conducted in December 2011 by Cegedim Relationship Management, shows that life science companies are making real progress in their attempts to become more compliant. 94% of respondents report that their company enforces corporate standards for spending on HCPs, and over half (54%) indicate that their company already has a project team in place to address compliance issues.

But, despite 64% believing that the implementation of a unique spend data reporting and disclosure solution is an ‘absolute requirement’, a high number of European companies are using traditional methodology to record activity.

“Europe is at a pivotal moment as it approaches an enforcement model increasingly similar to the US,” explained Bill Buzzeo (pictured), Vice President of Global Compliance Solutions at Cegedim Relationship Management. “Companies are making essential strides at self-enforcement, but according to the 2011 survey, most respondents are reliant on inefficient manual and Excel spreadsheet reporting mechanisms.”

Faced with managing relationships within an already complicated customer jigsaw, medical sales professionals can ill afford the administrative burden of paper-based systems in the modern era.

The increased focus on transparency and disclosure follows the global development and enforcement of regulation and guidance to counter bribery and corruption across business sectors. The US Foreign Corrupt Practices Act and the UK Bribery Act impose criminal charges on companies that breach the law, and have already led to some high-profile casualties in the life science sector. In 2011, Johnson & Johnson were fined $70 million after admitting that the company bribed doctors in Europe and paid kickbacks to win contracts and sell drugs and artificial joints. Integrated technology company Siemens paid $1.3 billion following a bribery case that scarred its medical division, following violations in its healthcare unit.

With further, hard-hitting legislation expected in other parts of Europe this year, companies are being forced to assess their ability to achieve better transparency of aggregate HCP payment data – which in turn is having major implications for the industry’s sales and marketing strategies. Companies in Europe must not only track a complex matrix of marketing and promotional spending, but also keep track of, and uphold, each country’s unique reporting standards.

The Cegedim Relationship Management survey concludes that the US model of operational compliance serves as “the handwriting on the wall”, but warns that European organisations, uncertain as to how to approach transparency in the future, must act quickly to ensure they avoid paying a much higher price.

The UK industry has worked hard in recent years to improve its reputation with customers, and the issue of building trust with HCPs remains a high priority for companies. Medical sales professionals will continue to play a prominent role in achieving this.

The UK pharmaceutical market is expected to experience growth of just 0.4% until 2015, a new report says.

Research and Markets’ The Pharmaceutical Market: UK predicts growth of less than one per cent in real terms due to the effects of the recession, cuts in public spending and NHS savings targets.

The report says that tighter healthcare spending could have a negative impact on the market with the NHS having less capital to spend on new or expensive drugs.

The NHS has been challenged with making a total of £20 billion in annual efficiency and productivity savings by 2014.

However, despite these cost-cutting measures, the UK Government has released additional funding through its Cancer Drugs Fund – which came into force in April 2011.

The report notes the impact of value-based pricing (VBP) in order to promote innovation and ensure better access for patients to new medicines when it is introduced in 2013.

A VBP system will be implemented for new active substances introduced from 1 January 2014 onwards. Existing medicines could be included in the system, but generics are expected to be excluded from the scheme.

As it would not be feasible to carry out a VBP assessment for each new medicine entering the market, the report says, interim arrangements are expected to run alongside the new scheme – which is likely to resemble the existing PPRS, the report predicts.

The introduction of the Government’s Patent Box is expected to generate growth in the industry, the report says. GSK has already confirmed it will invest more than £500m when the programme is introduced, which will lead to the creation of around 1,000 new jobs.

Despite the modest growth expected in the UK pharmaceutical market, the outlook is still brighter than the European counterpart. In a similar report, the European pharmaceuticals market had total revenues of $213.9 billion in 2010 – representing a compound annual growth rate of 4.6% from 2006 to 2010.

But the market is forecast to decelerate by a compound annual growth rate of 3.2% between 2010 and 2015, the report anticipates. This will result in the market value being approximately $250.3 billion by the end of 2015.

Pfizer, the report says, will lead the European pharmaceutical markets, with a market share of 6.7%.

The Chief Executive of biopharmaceutical company UCB, Roch Doliveux, has been appointed the Chairman of the Governing Board of the Innovative Medicines Initiative (IMI).

Mr Doliveux, who has been involved with the IMI since it was formed and a member of the Governing Board since May 2010, will oversee the Initiative’s projects and €600m budget.

Michel Goldman, Executive Director of IMI, says the group will “greatly benefit” from the appointment of Mr Doliveux.

The IMI is a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA). It aims to improve the environment for European pharma companies by engaging with industrial and academic experts.

Currently, it funds around 30 projects offering information on drug safety and efficacy, knowledge management, and education and training.

It is the world’s largest public-private partnership in health R&D, funded through a €1bn contribution from the European Union and a further €1bn from member companies of the EFPIA.

“The biopharmaceutical industry has reached an inflection point where public-private partnerships, bringing academic and industry knowledge together, are paving the way to better respond to new healthcare needs and bring safer, more efficacious and cost-effective treatments to patients,” said Mr Doliveux.

“EFPIA considers IMI as a key instrument to implement the new business models which will ensure the sustainability of pharmaceutical industry and increase the wellbeing of patients across Europe.”