IFPMA code of conduct discusses research motivations and data disclosure

03-Sep-2012 - Last updated on 04-Sep-2012 at 14:13 GMT

The IFPMA pharma wants members that sponsor clinical trials to do so only if the research develops knowledge and benefits patients.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) – which represents sponsors and their local industry groups - made the declaration in a Code of Practice guide published earlier this week.

Point seven of the organisation’s principles states that clinical research must be “conducted with the intent to develop knowledge that will benefit patients and advance science and medicine”

An IFPMA spokesman told in-Pharmatechnologist.com that: "The guiding principles in the IFPMA Code of Practice are fundamentals on which the research-based pharmaceutical industry operates. This particular principle underscores that the focus of our research is patient-centric and we conduct research and development to improve peoples`health around the world by addressing their needs."

He added that: "This principle also supports article 9.2 of the IFPMA Code of Practice, which states that 'all human subject research must have a legitimate scientific purpose. Human subject research, including clinical trials and observational studies, must not be disguised promotion."

Transparency

The IFPMA code also discusses clinical trial data disclosure, which is an issue that made the headlines last month after the European Medicines Agency (EMA) asked sponsors and CROs for input on plans to set up a publically accessible database of study results.

In an article in the PLOS Journal the agency wrote that raw clinical trial data should not be kept secret for commercial reasons. It also called for the development of “rules of engagement for sharing raw data, with the same standards applying to all clinical trial data on medicines, regardless of the type of sponsor.”

The IFPMA appears to agree that in general disclosing clinical trial information has potential benefits for patients. However, unlike the EMA, the industry group stresses the importance of protecting company intellectual property (IP) in its guidance.

“It is recognized that there are important public health benefits associated with making clinical trial information more publicly available to healthcare practitioners, patients, and others.

“Such disclosure, however, must maintain protection for individual privacy, intellectual property and contract rights, as well as conform to legislation and current national practices in patent law.”