ABPI Code of Practice
It is important to understand that pharmaceutical companies are regulated by strict guidelines and regulations. The pharmaceutical industry is self-regulated under an international, regional and national code of conduct.
In the UK, most companies must comply with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice, which is updated every few years. The current version of the ABPI Code of Practice is the 2019 version.
The extent to which a company must comply with the ABPI Code varies across the industry because:
- Most pharmaceutical companies are signatories to the Code and so must agree to comply with it. These companies tend to be the most cautious, resulting in long waits between email communication and confirmation of projects as legal teams rigorously go through each agreement.
- Smaller companies, such as biotech or start-up companies, are often not signatories to the Code, but instead use it as guidance. Smaller companies tend to be more reactive but will still require legal documents to be signed before work can go ahead.
In the latest version of the ABPI code, clause 27 on page 38 relates to relationships with patient organisations. It is important to note that this section does not provide in-depth guidance on all forms of patient group and industry interaction.
In general, it is fair to say that the legal teams within pharmaceutical companies tend to be very conservative in their interpretation of the code. Their aim is to mitigate risk to the company, and interactions with patient groups (and specifically patients) have traditionally been viewed as having the potential to be risky, as the company may be perceived as trying to influence the patients to use their products. Though this attitude is understandable, it may be frustrating and counterproductive as it limits the potential for fruitful collaborations with the development of proper safeguards to ensure independence.
In the last few years, more companies are becoming increasingly aware of the benefits of such collaborations and encouraging them. This is helping to reduce the conservative interpretation of the code, and Findacure is keen to support these more progressive approaches within industry. As each company will operate in different ways, it may be useful for your own patient organisation to draw up some guidelines on what kind of interaction and rules you would like to put in place to be prepared when companies approach you with different requests.
The ultimate goal of the ABPI code is to protect patients, however it is a code developed for the industry, not specifically the patient. It is therefore important not to let the ABPI code act as a barrier to working with industry.
|Quote from Stephen Whitehead, ABPI Chief Executive:
“The ABPI believes that it is absolutely appropriate for the pharmaceutical industry to work with patient groups. These relationships help inform the drug development process and help to create a better understanding of how medicines support better outcomes for patients.”
In addition to the ABPI code of practice, there are various other guidelines and industry groups that can help facilitate the interactions between industry and patient groups.
BioIndustry Association (BIA)
The BIA is a trade association for innovative life sciences companies in the UK. The BIA represent biotech companies, which are typically smaller companies than pharmaceutical companies, conducting early stage research. The BIA is separate from the ABPI, which represents pharmaceutical companies. The BIA’s goal is to promote a global hub for biotech companies to operate in the UK and promote fair access to medicines. Members of the BIA include start-ups, life sciences companies, innovative companies, and small pharmaceutical companies.
The BIA has three principles of engagement between industry and patient groups:
- Integrity: Both parties should always act honestly and with integrity.
- Independence: Patient groups should maintain their independence from the company involved and should be able to direct interactions and partnerships as they wish. A company should never tell a charity what to do.
- Transparency: Patient groups should be entirely open about their collaborations with industry.
EURORDIS Charter for Clinical Trials in Rare Diseases
EURORDIS is a unique non-profit alliance of 932 rare disease patient organisations from 73 countries that work together to improve the lives of those living with rare diseases in Europe.
The EURORDIS Charter for Collaboration in Clinical Research in Rare Diseases was created to improve the quality of rare disease clinical research and enhance the transparency and effectiveness of dialogue between industry and patient groups.