Pharmaceutical marketing. How to ensure compliance?

Navigating marketing strategies in the pharmaceutical industry is not an easy task. It is a strictly regulated and ever-changing market that has also established self-governance bodies, such as the EFPIA, to ensure high ethical standards in the field. Although similar cannons are applied across the European Union (EU), every country might interpret some concepts differently or have additional requirements which add even more complexity to the mix. In practice, it means that in order to ensure compliance, all promotional materials and marketing strategies have to be evaluated for each particular market individually so any potential issues and risks can be identified and prevented.

To ensure compliance, a pharmaceutical company must think in a much broader sense than simply using marketing materials approved internally. Any interaction by the pharmaceutical industry with healthcare professionals, healthcare organizations, patient organizations or the general public must comply with legal requirements and the applicable codes of practice.

There are many subtle differences between the countries in how particular interactions may be conducted or must be disclosed. Different interpretations exist on what is considered a pharmaceutical marketing activity or a promotional material, as well as how pharmaceutical marketing campaigns can be run and what must be taken into account when planning interactions with healthcare professionals.

Moreover, new channels for communication and advertising constantly emerge and are being used for pharmaceutical marketing. As regulators take time to establish specific guidance, these new channels are less regulated and carry more risks.

Building a trustworthy brand takes a long time, but it can be tarnished in a day. A minor misstep can become a reputational crisis. Therefore, compliance with ethical standards should be at the heart of every pharmaceutical activity, and its importance should be understood by all employees of a pharmaceutical company.

So how do you stay compliant? One of the essential elements for success is cross-functional collaboration. Engagement with a medical and regulatory partner early in the development of brand plans and marketing strategies helps assess associated risks in a timely manner. It also ensures that these marketing plans will not be later deemed inviable. When it comes to fleshing out your campaign, your regulatory compliance partner can help ensure that ideas are presented in a fair and balanced manner and that resources are not wasted on avenues which would result in non-approvable materials. Understanding these details in advance leads to a more efficient development and review process.

About Insuvia. Insuvia is a regulatory affairs and pharmacovigilance services provider. We partner with biotech and pharmaceutical companies to ensure regulatory and safety compliance during the commercialization of their products. With direct local presence in more than 50 markets we are perfectly positioned to assure compliance with local country-specific regulations and pharmaceutical marketing codes. Our regulatory experts provide clear and constructive feedback on each promotional material. We indicate associated risks and potential solutions to overcome them. Our aim is to ensure that the result is both compliant, as well as effective and appealing to the target audience. Check our services for pharmaceutical marketing compliance or contact us now, for more information.