Regulate, don’t strangulate
pharmafile | January 6, 2014 | Feature | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | ABPI, code of practise, low, myeloma
As many of you will know, work is now under way to revise the ABPI Code. Not before time I say. I have no doubt at all that poor behaviour on all sides at some point in the distant, murky past was likely to have been the major driver for having such a code, but I think and hope the world has moved on.
Changes in the environment have been so significant, particularly over the last few years, it may mean that much of the current code is not be fit for purpose. Every day, we at Myeloma UK – and many other stakeholders – work tirelessly to remove the barriers that are standing in the way of progress. So why would we support such inappropriate barriers being placed there in the first place?
Background
The ABPI Code of Practice prohibits pharmaceutical companies from undertaking or sponsoring any activity deemed to promote prescription-only medicines to the public.
In 2006, a new clause concerning relationships with patient advocacy groups was introduced. Whilst companies are permitted to work with such groups, their involvement must be made clear and the requirements for arrangements of meetings are the same as those for health professionals (clause 23).
Specifically, companies must make public at a national or European level, by means of information on their website or annual report, a list of all patient organisations to which they provide financial and/or other support.
This must include a description of the nature of the support given, and there must be a written agreement with every organisation setting out exactly the terms of the relationship and the funding of every significant activity or ongoing relationship. Specifically, clause 23.1 requires companies to respect the independence of patient organisations.
I don’t know for sure, but my hunch is that until the advent of NICE, the industry’s relationship with patient groups largely went under the radar. However, a succession of high-profile media stories around NICE decisions and the accusation from some critics that patient groups were no more than a front for industry, very likely led to the inclusion of the new clause in 2006. The Code was needed to challenge accusations like these.
Since then, the scrutiny bestowed upon the relationship between industry and patient groups has been pretty intense, and, at times, prohibitive. I have no doubt it has led to a number of missed opportunities for collaborative working for the benefit of both patients and the NHS.
Case for change
Nobody can argue with the principles and aims of the Code and the need for both parties to operate in a transparent and ethical manner with the best interests of patients at the centre of any relationship.
However, it appears to me that the original intention and spirit of the Code has been lost along the way. These days, industry and patient groups are so paranoid about it that any type of useful relationship is almost rendered impossible.
We recently invited a company to a reception we were holding to update our donors and supporters on our progress. I was shocked when I received a lengthy email back asking 20 questions about what type of food and drink would be available, how much would people be consuming, who would be there, who would be speaking, what information would be available and so on.
Increasingly I am also hearing stories from event organisers having to deny patients and the public access to exhibit halls and from attending certain conferences purely because industry will be present. Patient experts are also often prohibited from taking part in steering groups or advisory committees if they or the organisation they represent has any involvement with industry. This cannot go on.
What’s more, over the last few years, the UK environment has changed dramatically: NHS reforms in England have created several new stakeholder groups and the growing role of HTA and value-based assessment has put a greater focus on factors beyond clinical practice and cost-effectiveness.
Additionally, the advent of patient and public involvement in NHS services and the enhanced role of patient organisations are creating new opportunities for patient voices to be heard, while rapid advances in the role of social and digital media are changing the way we all communicate, think and work.
As a result, for both industry and patient groups, the time seems right to review the Code to ensure that it is actually regulating rather than strangulating behaviour.
Does it cover everything?
A quick read of the Code will tell you that it does not cover every aspect of the potential relationships and collaborations between industry and patient groups.
With the role of some research charities and/or patient organisations, like Myeloma UK, evolving from a primary emphasis on grant funding to a driving force that is advancing scientific development and leading cutting-edge, patient-centred research, the potential for research collaborations between industry and patient groups is greater than ever before.
These types of relationships are much more likely to involve larger amounts of funding and may involve highly complex areas such as intellectual property. For example, Myeloma UK has several strategic research relationships with industry both in the pre-clinical and clinical settings. I don’t recall in any of these discussions or negotiations any reference to the Code.
However, when I recently requested a very small amount of funding from a company we work with to attend the American Society of Hematology meeting in December, I was stunned by the complexity and pain it caused them even to discuss it. You have probably guessed already that I didn’t get the funding.
Consistent interpretation?
One of the major issues with the Code as it is currently has been its interpretation by both industry and patient groups. As a consequence, there has been a huge amount of conservatism and caution which may not have been justified.
This may be, in part, due to the sometimes vague language in which the Code has been written or, as several companies have suggested to me, a way in which the ABPI ‘keeps control’ over what we do.
Whatever the reasons for this, there is no doubt that it has contributed to feelings of suffocation and the sense that not doing anything is better than doing something that may infringe the Code. These are factors that the revisions needs to tackle.
A valid relationship?
Patient groups which have the best interests of patients and families at heart should usually have an appropriately strong working relationship with industry. Why wouldn’t they? Industry plays such an important role in delivering better outcomes that not working with it seems to be a significant missed opportunity.
Many patient groups I am in touch with feel that the relationship shouldn’t need to be justified at all, that they know ‘perfectly well’ how to behave and that they would expect a company to know ‘how to behave too’.
However, others felt it extremely important to have some ‘rules of engagement’ or a ‘framework of principles’ to work within – this was especially true of individuals from groups representing less-common diseases or those new to working with industry.
Patients have for years paid the price for stakeholder silo-working and thinking, and have suffered as a result of an environment that has allowed stakeholders with vested interests and agendas to pursue these without the appropriate barriers and obstacles.
The consequence of this is that we are often required to fit round pegs in square holes for patients to benefit from new medicines. This world is changing and it is broadly recognised that the huge issues and challenges facing all stakeholders are best addressed by finding solutions that work and are fair for all.
The big challenge in revising the Code is to create a framework that ensures best practice but also gives industry and patient groups the freedom to work closely together and to support, not inhibit, the development of creative and meaningful initiatives and relationships that will tackle the challenges.
The revised Code needs to be enabling rather than prohibitive: and the ABPI needs to take this opportunity to make it so.
Eric Low is chief executive of Myeloma UK
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