Best practices for pharma support of patient organizations in the EU

The support of patient organizations by pharmaceutical companies is common practice. In 2022, pharmaceutical companies paid around 110 million euros to support various patient organizations in the EU, Norway, Switzerland, and the UK. In recent weeks, patient organization sponsorship have again received critical media coverage, raising questions over the laws surrounding pharmaceutical sponsorship. In addition to significant legal risks, supporting patient organizations may also affect a pharmaceutical company’s reputation. Below we summarize some best practices that pharmaceutical companies supporting patient organizations should consider as they assess their compliance policies in Europe.

Supporting patient organizations financially is common and has a valid purpose. However, there are certain European anti-bribery and corruption laws, drug advertisement regulations, and tax laws that may be implicated by this practice.

When supporting patient organizations financially, the following are considered best practices:

1. Clearly distinguish between mere altruistic donations/grants and sponsorships. Legal requirements and tax implications depend on whether you provide unilateral support in the form of an altruistic donation/grant to be used for a specific or various projects, or a bilateral form of support, such as a sponsorship, which is also in the sponsor’s interest. Therefore, make sure that you qualify your payments to patient organizations as one of these types and document this qualification accordingly.
2. Perform due diligence on the patient organization and the collector. A careful assessment of the patient organization should be carried out to ensure that the organization is legitimate and its funds are used in accordance with the purpose of the financial support. In addition, the relationship between the sponsor, the patient organization, and third parties should be assessed for conflicts of interest. For example, such a conflict may arise if the collector of the financial contribution within the patient organization is a decision-maker with regards to the procurement of medicines or works in the public health industry or in public service.
3. Purpose of your financial contribution. The sponsoring of patient organizations must be done for the purpose of supporting health care, research, or education, and must not provide an incentive to recommend and/or prescribe, purchase, supply, sell, or administer specific medicinal products. Financial support to individual members of an organization is generally not permitted.
4. Ensure transparency and documentation. Sponsors should ensure that all financial contributions are documented and kept on record. In addition, the purpose and terms under which the financial contribution is made must be documented. Thorough documentation also needs to be maintained in view of a potential tax audit. Furthermore, the specific transparency requirements of pharmaceutical self-regulation must be considered.
5. Ensure the independence of the patient organization. Sponsors cannot attempt to take control over the content or activities of patient organizations.

Pharmaceutical companies are well advised to review their compliance policies and to perform refresher trainings for their employees to ensure that all relevant laws and regulations are followed.

Authored by Désirée Maier, Arne Thiermann, and Hubertus Weber.