Transparency Updates Around the Globe

MediSpend experts recently presented a webinar focused on the ever-evolving life science transparency regulations around the world. They discussed the newly released Connecticut pharmaceutical sales representative disclosure report, along with recent transparency updates in Denmark and India. The presentation concluded with the status of requirements in Italy and the United Kingdom.

Connecticut

Public Act 23-171 was signed and became effective on October 1, 2023.  ​As part of the Act, pharmaceutical manufacturers that employ pharmaceutical sales representatives must register with the Connecticut Department of Consumer Protection. Beginning October 1, 2023, no pharmaceutical manufacturer may have sales representatives acting on their behalf without registering with the department. Registrations will expire annually on June 30^th and must be renewed each year. As part of the renewal process, companies must submit disclosures that include:

• The aggregate number of contacts the pharmaceutical sales representative had with prescribing practitioners

• The specialty of each of those prescribing practitioners and pharmacists
• Whether any product samples, materials, or gifts of any value were provided to either a prescribing practitioner, their staff, or a pharmacist​
• An aggregate report of all free samples provided, by drug name and strength

The Connecticut Department of Consumer Protection published a disclosure template on its website; however, little guidance was provided for completing the template. As a result, companies must make some internal assumptions and business decisions regarding their processes for disclosure. One key assumption is what classifies as a “gift” for disclosure purposes. After speaking with numerous life science companies, MediSpend found that most companies plan on including promotional materials, entertainment, meal expenses, and educational materials such as journal articles provided by representatives in their disclosures. The consensus is that anything related to a contract for consulting, speaking, or other bona fide services, including research, is not reportable.

Regarding the samples report, companies have stated they plan to use the current wholesale acquisition cost (WAC) price of the drug at the end of the reporting calendar year. Additionally, since the Connecticut report requires information about the sales representative interactions and the information reported varies from the data required for CMS Open Payments reporting, federal preemption would not apply.

Denmark

In January 2024, the Danish Medicines Agency clarified a company’s duty to inform certain healthcare professionals (HCPs) of their requirement to disclose financial payments. ​If a professional receives payment from a pharmaceutical or medical device company for participating in professional activities abroad or international congresses and conferences in Denmark, they must report the financial support to the Danish Medicines Agency. Covered companies have a duty to inform the HCPs they provide financial support to. The Danish Medicines Agency encourages this to be done in writing.

There is also an expanded list of covered HCPs, which varies depending on whether the company providing the support is a pharmaceutical or medical device company. For more information regarding Denmark’s financial reporting obligations, see Financial Support.

India

The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) was released in March 2024 by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals. The UCPMP includes transparency requirements for CME events and free samples.

Regarding CME, the UCPMP states that all pharmaceutical companies should share the details of such events conducted by them, including the expenditures incurred, on their website. These details may be subject to independent, random or risk-based audits.​

Additionally, when providing free samples, each company should maintain records such as product name, doctor name, the quantity of samples given, date of supply and the monetary value of samples. The total monetary value of samples distributed should not exceed two percent of the company’s annual domestic sales.​ Specific guidance or requirements on data collection have not been released.

Finally, a self-declaration by the executive head of the company regarding compliance with the UCPMP must be made within two months of the end of each financial year. For more information, the UCPMP can be found here.

To stay up to date on industry knowledge, subscribe to MediSpend Perspectives for insights from MediSpend experts. The MediSpend Advisory Services team is led by a team of experienced attorneys and compliance professionals to assist life science companies with the development and implementation of policies and procedures that facilitate compliance with global healthcare laws, regulations and codes of conduct.