8 Jun, 12 | by BMJ
Recently, at a joint ABPI/BMJ conference, the Ethical Standards in Health and Life Sciences Group (ESHLSG) published the latest in a series of collaborative documents: Clinical Trials Transparency-Principles and Facts. The conference was excellent, and there were many difficult questions asked around the transparency issue—and rightfully so, as it is difficult to understand why medical research data isn’t more transparent.
But before I go into details, I’d like to start by looking at the wider picture. My industry is responsible for 90% of the medicines available to patients; we have developed medicines that have saved and improved millions of lives; researched and developed the medicines that underpin the NHS—without these medicines the modern NHS would be unaffordable. This is all so often forgotten.
We all want to see greater transparency; pharma is a global industry of hundreds of companies worth hundreds of billions of pounds, and change on this scale takes time. We have already come a long way, and under our code of practice the industry’s standards are already the highest in medical research, so it is right that we are expected to lead the way. The work we are involved in now is taking the whole research sector further in the right direction. We recognise that we have some way to go, but the best way to get there is to work together with those who lead and work in the healthcare sector; with those professionals who dedicate their lives to helping patients.
The principles, like the recent joint working collaborations dos and don’ts guide, is a joint piece of work by industry, academia, and other senior representatives from the healthcare sector such as the Royal Colleges. Transparency in medical research is important to more than just my industry, so the work of the ESHLSG seeks to raise awareness of good practice principles not just for commercial trials but across the whole research community, putting voluntary and regulatory agreements in place to support disclosure.
The ESHLSG will address some key issues over the coming months, such as industry supported medical education, and the transparency of relationships between industry and HCPs. As things stand, the NHS does not—and cannot—fund the continued education of healthcare professionals (HCPs). It is the industry that funds this education. This understandably raises moral questions, but the fact is that HCPs need to understand new medicines and how they work, and no one will know more about a new medicine than the researchers who just spent 12 years developing it. So how do we answer the moral questions? That is still open to debate, and that is why the ESHLSG medical education report will be based on the results of a survey of HCPs—they are the key stakeholders here, so we are asking them for their opinions. We need to ensure our relationship with them is as ethical and transparent as possible, and we are working with them to discuss how we can make sure this happens.
After that, the next step for the ESHLSG will be to look more broadly at joint working collaborations—if the future of medicine is personalised and stratified, then it will be more important than ever before for medical researchers to work closely with the NHS and HCPs. So we have to resolve the ethical concerns, and we need to continue to address the issues which impact on the relationship between industry and HCPs; that is why ABPI is committed to being a partner in the ESHLSG. But again we must remember that this is crucial for the entire research community, not just pharma. We are keen to continuously work to improve practice across the research community, and we can only do that by working with other sectors such as academia.
I welcome close scrutiny, and it is the very nature of modern science to question everything, but instead of criticising my industry for things that happened in the past, we should look at where we are today, and how we can continue to improve. Industry has made great strides in recent years, and the wider research community recognises the need to improve too. The purpose of the ESHLSG is very straightforward: improve ethical standards in the wider healthcare and life science sectors. That is what the group is trying to do, and my industry is a willing and active partner in this work.
Stephen Whitehead, chief executive, The Association of the British Pharmaceutical Industry.
Conflict of interest:
Chief executive of the ABPI, a pharmaceutical trade body