The quest for transparency in the relationships between life sciences companies and healthcare professionals has become a global movement, as companies are beset by a multitude of obligations designed to make public their interactions with their customers. Effectively managing those obligations while concurrently ensuring compliance with the growing body of international transparency requirements and anti-corruption legislation is a significant challenge to the continued growth and success of life sciences companies.
For a number of years, pharmaceutical companies doing business in the United States have dealt with a host of states that impose limits and reporting obligations on interactions with healthcare professionals. Device companies were brought into the fray more recently when several states expanded the applicability of their laws. However, the past two years have seen the rise of transparency challenges throughout the world. Two countries, France and Slovakia, have enacted laws similar to the US Sunshine Act. In other countries, reform is taking place through industry codes enacted by the relevant industry association. Pharmaceutical industry codes including reporting requirements have been enacted in a number of countries, including, significantly, the Netherlands, the United Kingdom, Japan, and Australia. The transparency trend has not affected the medical device industry as much yet, as medical device industry associations have yet to impose reporting requirements in their codes.
It is widely anticipated that numerous countries will join this growing trend. The key question for the life sciences industry is whether reporting requirements will be imposed through governmental action or voluntary industry self-regulation. Although a self-regulatory solution would likely be more consistent and efficient than a plethora of disparate legislative obligations, in either case it is imperative for life sciences companies to monitor which approach is adopted in individual countries and regions.
Another transparency challenge facing the life sciences industry is the burgeoning body of anti-corruption laws. Although these laws are distinct from the transparency codes and laws, in no small part because violations can lead to criminal penalties, anti-corruption laws relate to transparency requirements in two ways: 1) both are aimed at rooting out corruption and reducing the cost of doing business; and 2) the increase in transparency reporting can provide ammunition to prosecutors in seeking indictments.
The purpose of this post is not to explore these global challenges; rather, it is to introduce these issues to our loyal readers and outline how we will be addressing them going forward. We envision periodic posts about these types of global compliance issues –for example, we may highlight the transparency requirements in Australia’s pharmaceutical industry code; or discuss the United Kingdom’s Bribery Act; or analyze Eucomed’s White Paper on transparency issues. Unfortunately for companies in the life sciences industry, the possibilities for topics that we can cover is endless. We intend to do our best to span the globe and keep you informed about the latest news and trends in this evolving area, and we welcome your feedback about how you may dealing with these challenges.