As the ABPI's Public Affairs Manager Tim Windle departs the Association for pastures new, Tim reflects upon the issue of pharmaceutical industry and charity sector collaboration.
For the past two years I have been responsible for running the Patient Organisation Forum at the ABPI. Now, as I am about to depart for a new opportunity in the charity sector, I wanted to share my reflections on the debate around collaboration between the charity sector and pharmaceutical companies and the issues advocates face in trying to increase patient involvement in research. I believe that all of the problems experienced in trying to collaborate between charities and pharmaceutical companies come down to a lack of understanding between the parties. Until the drivers and objectives of each party are understood by all others, it is unlikely that collaboration and patient involvement will increase.
These reflections build on the ABPI and National Voices guide on collaboration, which outlines some of the broad principles that charities and pharmaceutical companies should follow when considering collaboration. The Association of Medical Research Charities has a similar guide.
As with any private company, pharmaceutical companies are ultimately accountable to their owners or shareholders. This contrasts with patients and charities whose accountability is to patients and the public. This can lead to confusion, since while companies work to improve patient outcomes and can speak openly about the importance of patient centricity, they are still profit making and need to reinvest into research for future medicines. Pharmaceutical companies have to consider where they place their investments. They are unlikely to engage in activities which are not financially sustainable even if it is for the benefit of patients. For example, there is little incentive for companies to apply for licenses for new indications for off-patent medicines when the money could be invested in new medicines in development instead.
Collaboration must benefit all sides
Corporate social responsibility and collaboration should be considered completely separate. Proposals or projects requiring significant funding from pharmaceutical companies must be able to articulate the benefit to the individual company. For example, a popular idea is a fund that multiple companies pay into which can be used to support charity research activities or patient involvement in research. This can be difficult for any company to pay into as the Code requires transparency about what company money is used for and stipulating and agreeing specific activities may not be possible across multiple companies. Additionally, companies may be reluctant to pay into funds where they cannot guarantee that funding they put in will be used to benefit the patient populations they focus on and in fact may well focus on competing treatments and benefit competing companies.
Patient involvement as an end in itself
There is an assumption that the case for greater patient involvement is established; patient involvement can be seen as an end in itself without understanding and articulating the benefits of greater patient involvement. It is worth noting that even within a company there may be divergent views on the value of engaging with patients in the research and development of medicines. There is a case to be made for all parties to jointly define the benefits of patient involvement so that advocates are better enabled to shift perceptions. In particular, evidence of stronger evidence from clinical trials or faster medicines development from patient involvement would be compelling.
The Code of Practice
Neither the ABPI Code of Practice nor the law prohibit the involvement of patients at any stage of the medicines development process. The ABPI Code and EU law prohibit the advertising of prescription only medicines to members of the public. Companies take these rules very seriously. Often company policies take a more stringent and cautious view than that which is set out by law or the Code of Practice and each individual company will have their own definition of the extent of patient engagement they support. Companies will balance the benefit of patient engagement against the risk of being considered to be promoting a medicine directly to the public. Some will decide this is not worth the risk.
This is not designed to be a comprehensive list, I could write another blog on patient understanding and expectations of involvement, but I hope you find it an interesting contribution to a debate that if resolved will almost certainly result in an improvement to patient outcomes.