As global health care providers (HCPs) focus on transparency to deliver quality care, it has become more complex than simply targeting high-level care. A recent study by international consulting firm, Deloitte Consulting LLP, generated interesting results for global life sciences organizations. U.S. pharmaceutical companies have experience dealing with transparency regulations for some time.
However, new or pending European regulations pose even more challenges for international pharmaceutical organizations. For example, France passed new disclosure laws in 2011 that reinforce the prediction that more than 70 percent of pharmaceutical revenue will come from countries with HCP transparency regulations by 2015.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) issued industry codes, which affect HCPs and HCOs, while focusing on global transparency. The Deloitte study summarizes findings and offers guidance for life sciences organizations, with suggestions to successfully address worldwide HCP issues.
The future of global HCPs involves meeting the EFPIA disclosure code requirements and obligations. This code also covers research-based pharmaceutical organizations, and those pharmaceutical companies performing research and development for specific segments of the market.
HCAs and pharmaceutical companies offering treatment medications are subject to this code. The code states that interactions between HCAs and these pharmaceutical organizations have a “profound and positive influence on the quality of patient treatment and the value of future research.”
The code understands that the HCA and pharmaceutical industry partnership is “critical” to society’s expectations and successful patient treatment regimens. Transparency is a primary focus of the EFPIA code.
Pharmaceutical and life sciences companies must focus on transparency issues in operations, marketing and research. Global transparency is undergoing an evolution and resurgence, as witnessed by the U.S. Sunshine Act (February 2013) and the French Sunshine Act (June 2013), for health care organizations.
As the path to transparency twists and turns, the EFPIA and other organizations offer a roadmap to success for HCAs and pharmaceutical companies. The guidelines of the EFPIA and global Sunshine Acts offer the guidelines necessary to achieve transparency objectives.
U.S. and global pharmaceutical organizations face compliance regulations that are challenging, all of which target transparency. The scope and diversity of these regulations create risks of scrutiny that force organizations to carefully execute their missions. These organizations need to hold tight to their focus on goals, objectives and risk management.
Deloitte Study Results
This study examined various global transparency laws affecting HCPs and others. Their research included the U.S., U.K., France, Slovakia, The Netherlands, Japan, Australia and the European continent.
The results provide a window to the future of global transparency regulations for HCPs and pharmaceuticals. The survey lists the regulatory body that developed and/or published the guidelines along with the scope of the regulations. Research confirms that some features are laws while others are industry codes.
For example, Europe adopted the EFPIA industry code, which covers individual HCPs and HCP organizations, such as hospitals and pharmaceutical companies. Conversely, the French government established a law with broad coverage, including physicians, hospitals, students, media and software developers. The similar objectives generated different processes and approaches within the same continent.
Life Science Organization Concerns
While HCPs around the world face transparency issues, life science companies are concerned with increasing scrutiny. The industry has more questions than answers about the future. Common questions include the following regarding solutions and data collection.
- Will governments and countries pass more laws or adopt further regulations in the coming years? When might this happen—and where?
- What are proper responses and action plans? Should they develop global solutions or await individual countries to suggest alternatives?
- How can life sciences organizations ensure that collected HCP data is accurate? Which person or persons in organizations should be responsible for data collection?
- Should the industry and/or individual companies learn what other organizations are doing to comply with global transparency laws/regulations?
The Economist Intelligence Unit predicts that by 2015, over 70 percent of pharmaceutical sales will be made in countries with transparency regulations and industry codes. Projections like this identify global transparency guidelines for HCOs as a primary focus of the world community, even with country-to-country regulation differences.
Since U.S. pharmaceutical companies have dealt with federal and state transparency regulations for years, they may have a deeper understanding of effective methods to comply with these global developments. However, the worldwide community of HCPs and pharmaceutical organizations must address their country’s specific laws or codes.
At the heart of the matter is the credibility of captured data to accurately measure the impact of these global regulations. The continuing integrity of data collection is critical to the future success of these global transparency initiatives.
To learn more about global transparency trends in life sciences, join us at CBI's 5th Annual Global Transparency conference taking place April 15-16, 2015 in London, England.
(Image courtesy of Ali T via Flickr)