Pharmaceutical companies depend on a well-planned promotional campaign to support the launch of their products. With the cost of pre-, during and post-launch estimated at up to $830 million[1], it is imperative that companies carefully manage the promotion of their products while adhering to global and local guidelines.
Industry bodies, including the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and the European Federation of Pharmaceutical Industries (EFPIA), have established codes of practice for the ethical promotion of prescription medicines[2],[3]. In addition, Art. 98 of Directive 2001/83/EC, marketing authorization holders (MAHs) establishes requirements with regards to product promotion[4].
There is also local legislation that companies must understand and adhere to when launching a product. For companies unfamiliar with those local requirements, it can often be a difficult path to manage.
During a recent presentation, we explored the complexities faced by US pharmaceutical companies launching their first product in Europe, particularly if they don’t have a local affiliate or partner. Specifically, we explored the promotional requirements of three major European markets: Germany, France and the United Kingdom.
Preparing promotional activities
Before planning their promotional activities, we advise companies to put in place processes to manage their promotional material internally. This should start with a global team to act as first filter for promotional and non-promotional materials before these are rolled out to local affiliates. It is then important to carry out a medical and regulatory review of all promotional materials and then carefully assess the requirements for each market.
In France, Germany and the UK companies will need to have a local responsible person or signatory for promotional material, depending on the local legislation.
France requires companies to have a responsible pharmacist to handle the responsibilities for promotional materials, in particular the scientific validity of the information, as well as regulatory activities, pharmacovigilance, and quality assurance[5]. Germany requires companies to have an information officer, who also handles promotional material responsibilities, among others.
In the UK, the ABPI Code of Practice for the Pharmaceutical Industry requires an appropriately qualified signatory, who must certify that the promotional material is in accordance with requirements of the relevant regulation and the code, is not inconsistent with the marketing authorization and the summary of product characteristics and is a fair and truthful presentation of the facts about the medicine[6].
Submission to the authorities
Other differences concern the submission of the materials to the health authorities. In France, the “exploitant” must follow specific annual slots published by the local health authorities to submit their promotional material and will need to wait for feedback from the health authorities before they can disseminate and use the promotional material5.
In Germany there is no requirement to submit the promotional materials to the health authorities. However, it requires internal approval and sign off by the information officer.
And in the UK, submission only applies to newly authorized products, and on a case-by-case basis, generally for products subject to additional monitoring that undergo a vetting procedure by the Medicines and Healthcare products Regulatory Agency (MHRA). In that case, the MHRA will issue a letter requesting a review of the promotional material6.
One other notable difference is that, because the UK is no longer part of the EU, companies must perform a local procedure for the registration of their product with the MHRA, which could affect launch of a product[7].
Planning the promotional strategy
Given the important role that promotional materials play in a product’s success, it is advisable that companies carefully consider their communication needs and strategies. Even before Committee for Medicinal Products for Human Use (CHMP) or MHRA approval, companies can begin a disease awareness campaign, or non-promotional communication, focusing on the disease pathology.
Once the CHMP and MHRA approval process is underway, they ideally should be starting to work on the final SmPC, or product information, and begin their review of promotional materials based on that SmPC. This is an opportunity to focus on the sales representative materials and promotional materials, assessing and validating the claims against core global documentation. This step will help companies to save time validating material at the local level.
Another important step we recommend is to prioritize countries for product launch. This will allow MAHs to pre-empt country-specific requirements and allow for the time involved. For example, our experience shows that it can take a month to establish an information officer in Germany, while getting a responsible pharmacist in place in France can take three to four months. Early preparation can help companies ensure they meet health authority timelines and avoid costly delays to their product launch.
Industry questions and concerns
One question raised at the end of the presentation concerned whether it is necessary to have global and local standard operating procedures (SOPs) in place to detail the promotional material review process. Since local regulations differ quite significantly in terms of roles and responsibilities of those involved in the process, it is not only recommended to do so, but, in many countries, it is mandatory to describe these activities. In some countries global SOPs may be sufficient, with an appendix or working instructions for the country, while in others both local SOPs and working instructions are mandatory.
For example, the UK’s PMCPA guidelines state: “It is important for companies to have policies and standard operating procedures (SOPs) to communicate corporate standards, expectations and behavior. These might be a mixture of global, regional and local SOPs. Company documents should support compliance, ensure consistency, manage risk and provide a platform for continuous improvement. It should be clear and apparent to all staff which requirements are relevant to their role. These policies and SOPs are minimum requirements which should be adapted to fit the arrangements at a particular company6.”
The most widely asked questions centered on social media, and, specifically, managing social media activities according to strict local requirements. In France, the specific time slots for submission can make it difficult for companies to have quick social media communication and stay in compliance. Managing these complexities requires proper knowledge of the local requirements and careful communications planning on a case-by-case basis.
About the author:
Audrey Athlani Jorno, is Associate Director, Development Consulting & Scientific Affairs and International Service Lead for Ad Promotion, PharmaLex. She has more than 10 years of experience in Promotional Materials and Healthcare compliance activities for a wide range of products. She has a Doctor of Pharmacy with a Master’s Degree in Regulatory Affairs.
Disclaimer: This blog is intended to communicate PharmaLex’s capabilities which are backed by the author’s expertise. However, PharmaLex France and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this blog and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the blog may contain certain marketing statements and does not constitute legal advice.
[1] First-in-class and follow-on launch cost analysis, Health Advances, March 2020. https://healthadvances.com/application/files/5216/9341/5243/health_advances_launch_costs_spend_wisely.pdf#:~:text=Launching%20a%20drug%20is%20a,where%20and%20how%20they%20invest
[2] Code of Practice, IFPMA. https://www.ifpma.org/wp-content/uploads/2018/09/2023_IFPMA-Code-Interactive.pdf
[3] EFPIA Code of Practice. https://www.efpia.eu/media/fg2n40ks/efpia-code.pdf
[4] Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2001L0083:20121116:EN:PDF
[5] Public health code, Regulatory part (Articles R1110-1 to R6441-2), Section 1: General provisions (Articles R5122-1 to R5122-2-1). https://www.legifrance.gouv.fr/codes/article_lc/LEGIARTI000025787782?init=true&page=1&query=R5122-2&searchField=ALL&tab_selection=all
[6] Code of Practice for the Pharmaceutical Industry 2021, Prescription Medicines Code of Practice Authority. https://www.pmcpa.org.uk/media/3406/2021-abpi-code-of-practice.pdf
[7] Apply for a licence to market a medicine in the UK, Gov.UK. https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk
