What is in this article?:
Taking a pharmaceutical meeting outside the U.S. can get complicated as you have to consider the meeting's host country's rules around payments to healthcare providers, as well as those of the HCPs' home countries. This article offers a country-by-country snapshot of HCP-related rules and codes, and tips on other things to consider when planning a meeting for HCPs outside of the U.S.
Regs Around the World
As government spending on healthcare continues to grow around the world, expectations are that more countries will develop healthcare provider aggregate spend and reporting requirements for pharmaceutical companies. In fact, in a recent survey at a pharmaceutical industry conference, attendees agreed that every country in the world will have some sort of reporting requirements within three to five years. Burberry detailed the status of regulations for a number of countries around the world:
Australia: The land down under has enacted an industry code of conduct, but it is only mandated if the company is a member of the Medicines Australia association, and it only covers spending related to prescription products. The code says that companies must publicly list on their Web sites the health consumer organizations to which they provide financial support and/or significant direct or indirect non-financial support.
Denmark: The Danish Pharmacy Act, which applies to pharmaceutical companies, covers products that are distributed or sold through pharmacies. Pharmaceutical companies have to disclose the name, address, civil registration number, and period of association of any doctors and dentists they work with. The Danish Medicines Agency may require further disclosure about the nature and extent of the relationship, and the total remuneration involved.
France: The Reinforcement of the Safety of Medicinal and Health Products law, often referred to as “Le Sunshine Act,” passed in 2011, but the final decree is still pending as government and industry continue discussing the details, such as threshold amounts for reporting. The law requires all pharma and medical device companies to disclose all of their financial relationships and agreements with physicians, experts, healthcare firms, patients’ associations, and specialized media. Another thing that’s still up in the air is the reporting timeframe. Burberry said that it initially required companies to report every 15 days: “Good luck with getting reps to do this,” he joked.
Slovakia: The Act on Medical Aid No. 362/2011 requires all pharmaceutical companies to report on advertising andexpenses and non-financial benefits (direct and indirect) to HCPs to the Ministry of Health by January 31 for the previous year. The Ministry of Health then publishes the data on its Web site.
India: Increasingly important in terms of the number of clinical trials conducted there and the rapid growth in its physician population, India has the voluntary Code of Marketing Practices for the Indian Pharmaceutical Industry. Only members of the association are required to comply. It requires companies to maintain a record of what they spend on promotional, scientific, and professional meetings, congresses, conferences, and symposia.
Japan: The Japanese Pharmaceutical Manufacturers Association has a code that is only mandatory for its members and only applies to pharma companies. The JPMA code, which was enacted in 2011 and requires companies to begin reporting in 2013, requires that its members have a transparency policy in place and that they publicly disclose clinical and non-clinical payments to HCPs and medical institutions. The Japanese Medical Device Association is expected to demand something similar of its members in 2013.
The Netherlands: In the Netherlands, pharmaceutical companies have to report all service agreements and related financial transactions related to nonclinical activities such as consulting,fees, and advisory board activity, to a central agency. Currently this is a code that was defined by industry and associations, with some input from the government. Enacted in 2012, the first reports are due in 2013.
The United Kingdom: The Association of the British Pharmaceutical Industry code, enacted in 2012, involves self-reporting on a public Web site of pharma spend on nonclinical activities. For the first year, 2013, reporting can be done anonymously, and the code currently applies just to pharmaceutical companies. “Everyone was going to use the U.K. as an example if they enacted a law,” Burberry said, “but France beat them to it.”
Estonia: The Medicines Act, which applies only to pharmaceutical companies, requires them to report (on paper) any nonclinical HCP spend of more than 6.48 euros to the Ministry of Health.
Germany, Ireland, and Hungary all have laws requiring companies to make direct and indirect financial support to patient associations public, while Turkey, the Philippines, and Thailand are considering some sort of transparency legislation.