Q&A with TOPRA's first president on the organisation's 40th anniversary

Posted on 13/11/2018

Brian JamesTo mark 40 years since the British Institute of Regulatory Affairs Constitution was signed – the birth of what is now known as TOPRA – we speak to Brian James, the first president of TOPRA, for his views on how the profession and the professional body have evolved.

In November 1978 the British Institute of Regulatory Affairs (BIRA) Constitution was signed, which marked the starting point for a professional body offering a whole range of networking and educational activities that have contributed to the development of the regulatory profession today. As the profession of regulatory affairs progressed and regulation became more complex, BIRA followed suit and evolved into a global entity. TOPRA was established in 2004, and came out of 25 years of regulatory professional organisations: BIRA the and the European Society of Regulatory Affairs (ESRA). 

Brian James, a PhD graduate in organic chemistry, started his working life at the pharmaceutical company Beechams. After a few years, a position came up in the regulatory department and so he began his career in regulatory affairs in 1978. He was there to see the profession and the global regulatory affairs professional body grow to what is now TOPRA, the largest professional body for regulatory affairs professionals in Europe and one with a steadily growing global membership base. Dr James has been a longstanding member and supporter of BIRA and TOPRA. He was the chair of BIRA from 2003–2004 and was the first President of TOPRA in 2004. 

How has regulatory affairs evolved in the past 40 years?

"Regulatory affairs has certainly become more complex over the years as new technologies have evolved, and the need to ensure that these provide appropriate levels of safety, efficacy, and, of course, quality of the new medicines, medical devices, and drug-device combinations. The introduction of the paediatric medicine regulations, which is in itself a laudable initiative, has added significantly to the cost and timeline for drug development. In addition, governments have realised that they often do not have the necessary expertise or manpower in-house to deal with the demand from industry and their citizens for rapid approval of applications and marketing of novel products. So consequently, they have increasingly got together to share resources and to accept approvals from other regulatory agencies. The introduction of the fourth (national) requirement for cost-effectiveness assessments has added an additional and potentially political hurdle to the introduction of novel and more expensive treatments. “Cost-effectiveness” is a somewhat qualitative measure, which can be interpreted in a number of ways."

You were a pioneer in the regulation of medical devices. How was this sector changed in the past decade?

"Medical device legislation was, until the introduction of the European Medical Devices and In-vitro Diagnostic Directives, much lighter in touch and rarely enforced in many countries. When I joined the medical device industry, the development of the device directives was still a work in progress. I joined a team of European medical device industry experts, who met regularly with the European Commission to develop the regulations. This was a period of successful partnership between industry and regulators, which resulted in what was, at the time, a pragmatic and practical solution to controlling thousands of diverse devices, both powered and non-powered. These ranged in complexity from those that would be life threatening if they failed to those that bore minimal risk if misused.

The pharmaceutical professionals, at both the European and national level, and within the pharmaceutical industry itself, were not really familiar at that time with the differences between medicines and machines, and particularly the implications of combining a medicine with a delivery system. This has now changed with the pharmaceutical oversight of delivery devices, which often incorporate complex mechanical, electrical circuitry and software programmes. 

TOPRA recognised this need and I was asked to start a device working group to help educate members about medical devices. This has expanded over the years and we now have an extensive medical device educational element within the TOPRA education programme."

Visit TOPRA.org/history for more on TOPRA's first 40 years 

What are some major milestones for TOPRA?

"I think the most significant milestone for TOPRA was its formation. This visionary approach at that time, when use of the mutual recognition system at the EMEA [European Medicines Evaluation Agency] was only attracting a handful of applications, recognised that the pharmaceutical and medical devices industries were truly global in nature, and there was a need to develop a highly skilled professional organisation to navigate the emerging increase in global regulation, and which would indeed be global in its outlook.

The second milestone is the incredible teaching and training programmes introduced over the years, particularly the introductory courses held in the UK and Continental Europe. This undoubtedly contributes very positively to the development of regulatory professionals and supplements in-house training programmes.

The third corporate milestone is the way TOPRA has worked towards getting recognition of regulatory affairs as a recognised profession in its own right, as equally prestigious as other recognised professions societies."

You retired from the profession in 2014. Where do you see regulatory affairs heading in the next 10 years?

"Well, undoubtedly there will be more regulation. Regulatory professionals must be visible and a vigorous part of this debate – trying to ensure that new regulations are both practical and pragmatic, and are really relevant to modern industry. Undoubtedly vigilance and risk assessment will increase in importance – and the need for industry to respond to early indicators of potential safety or effectiveness issues will be essential." 

What do you see as immediate challenges for the profession and what are the solutions?

"In light of changing regulations, I would refer to the wise words given to me when I joined the board of one of the companies I worked for during my career. The Chief Executive was very clear in his brief to me, which was essentially: “If I wanted someone who would just read the regulations and tell me to comply, I would have hired a monkey. What I want you to do is to anticipate and tell me how to meet the regulations in the most sensible, cost- and time-efficient manner.” In other words do not forget to think outside the box. I think this advice is still pertinent today.

When I started in the profession it was possible to discuss potential issues and barriers with the regulators, and to discuss the science. In these days of multinational committees, this is becoming more and more difficult as the regulators do not want to be seen to be offering unfair advantages to one company over others. The need to seek opportunities to present rational scientific arguments with regulators and company and industry colleagues is still vital in my view."

What was your proudest achievement during your presidency of TOPRA?

"Undoubtedly the launch of TOPRA, where we held a joint launch meeting hosted by the European Commission in Brussels and the European Medicines Agency in London. This cemented TOPRA as a partner to both organisations, which continues to this day."

Any particular memorable incident you could share with us during your association with TOPRA?

"I always enjoyed the Annual Symposium. There were many social activities, which are recalled with great affection many years after they occurred. But perhaps the one that sticks out in my memory was the conference in Stratford-on-Avon, where I was Chair of the organising committee. This took place at the height of the Animal Liberation militant action, when bombs had been placed under scientists' cars. One of our speakers was considered to be at risk and had to tell Scotland Yard of his movements. We had to meet the police before the symposium, and precautions were put in place to ensure delegates were kept safe. The police assured us that they would keep an eye on us over the duration conference. The first morning of the conference dawned, and I was approached by a number of delegates to say that their cars had been broken into overnight and their radios stolen.

Also, the symposium in York is where Margaret, my wife, and I first got together."

Looking at TOPRA today, what do you think about where we have got to?

"TOPRA is now well established as a world-class organisation for the regulatory affairs professionals. It is well respected by regulatory agencies not just across Europe but around the world. The links that TOPRA has developed over the years with senior regulatory figures in both government and industry are to be applauded. But equally significant is the way that the original ethos of BIRA as a self-help, member participation society has been retained throughout the years. Without many hours of voluntary effort from its members, the small number of excellent office staff would not be able to function effectively. TOPRA continues to educate members of our profession on current hot topics, and this will continue. Industry and regulators continue to recognise the importance of TOPRA and to provide top quality speakers when asked. This is no mean achievement and should not be underestimated. 

Long may TOPRA continue to thrive, and here’s to the next 40 years!"