Compliance — position paper

Why can Clinical evaluation be an Anti-Corruption Weapon?

The importance of Compliance within Clinical Evaluation

Recently, the healthcare system has been attempting to »clean-up its act« and much attention is being brought to corruption and bribery. Medical Device and Pharmaceutical organizations are being targeted by anti-corruption and anti-bribery officials, followed closely by Global Policy reinforcements (European laws, Bribery Act, Sunshine Act…). Serious investigations have already hit major and smaller businesses, forcing Life Science companies to establish global guidelines and standards to monitor their interactions with healthcare professionals.

London conference

During the last International Medical Device Industry Compliance Conference held in London, the topic of corruption was discussed. In fact, corruption is still very widely spread in the industry and many CEO’s have demonstrated their techniques to best comply with the regulations in place —internal auditing, risk assessment program, compliance departments…

A KPI framework was presented by David Wysocky, Director at PwC, which demonstrated the importance of R&D in compliance and stated that »informative/accurate KPIs can only be obtained through a combination of policies, processes, data and support«.

Denise Botticelli, VP, Associate General Counsel & Secretary at Edwards explained the importance of an »on-going operation cycle of transparency«. This very explicit cycle begins with clinical evaluation (thanks to monitoring, data and updates); this demonstrates the importance of clinical evaluation as it represents the basis for a transparency cycle.

ClinSearch’s point of view

Relationship with healthcare professional

In order to develop a new product, the help, advice and knowledge of healthcare professionals is essential. However, this relationship must be purely professional, corruption and bribery free and is now strictly regulated. A good relationship must be put in place between the two parties meaning: a scientific, rational, objective and documented relationship. It must be mutually beneficial while still respecting the rules of compliance.

Clinical evaluation: the legitimate reason to collaborate between industrials and Health Care Professionals

The question is: how can manufacturers comply with these requirements?

The answer lies in Clinical Evaluation. Innovation and product development is an act of validation; it promotes company value and healthcare technology. It should bring value to the manufacturer, the distributor and the healthcare professional who worked on the project at each step.

A thorough and detailed analysis can under no circumstances be corrupt. When manufacturers are in relations with physicians and distributors, everything must be documented and transparent. Clinical evaluations allow to have documented research thus proving the quality and performance of the innovation and its compliance. Outsourcing this research to compliance committed companies further allows lowering the risk of internal corruption.

Be ahead

Your company’s reputation is at stake; anti-corruption and anti-bribery officials are looking deeper into these matters especially in the United States. Clinical Research is still just emerging as a tool and a weapon against corruption; it is still poorly used as it should. Major companies have now started to acknowledge this and are looking into increasing their level of clinical research. Compliance departments are developed; »external« companies are used for their professional know-how and to avoid corruption (outsourcing lowers the risk of civil and/or criminal prosecutions on your company). Be amongst the first to follow this trend and demonstrate the values of your product and company.

How to increase sales?

The best way to ally market growth and compliance is to develop innovative technology or products with healthcare professionals (HCPs). Clinical evaluation is still not commonly used throughout the industry to validate and promote the efficiency of an innovation or product. However, it is undoubtedly the best way to demonstrate the benefits brought by your innovation. Clinical evaluation should be your first marketing decision. There is no alternative to enter the market durably.

It is important to make a clear cut between marketing and clinical evaluation. Clinical evaluation MUST NOT be corrupted for marketing purposes. However, a well performed clinical evaluation is always useful for marketing purposes: clinical evaluation demonstrates the performance and safety of the product thanks to the use of data.

The best marketing tool for a medical product is a proven security and performance