Expert insight

Five Questions to …. Dr. Lembit Rägo

21 January 2020
  • Lembit Rägo

This year IFPMA is hosting its 10th Asia Regulatory Conference (ARC2020) in Kuala Lumpur. The Council for International Organizations of Medical Sciences (CIOMS) is represented in the conference Advisory Board by Dr Lembit Rägo, its Secretary General. IFPMA sat down with Dr Rägo to discuss CIOMS’s activities, future of the biopharmaceutical industry and the future role of ARC.

CIOMS’s mission is to advance public health through guidance on health research including ethics, medical product development and safety. What is the impact of Regulatory System Strengthening on the work of CIOMS, and what is CIOMS doing in this area?

Regulatory systems strengthening consists of a huge variety of activities. As a big picture, it involves combined administrative and scientific efforts in the area of medicines and medical devices to better protect public health. This also involves the need for continuous improvement of the technical knowledge of regulators. CIOMS is issuing guidance documents that are complementary to those of other parties, such as The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and WHO, in three major technical areas: clinical research ethics, product development and pharmacovigilance. CIOMS is in official relations with WHO, and since 2016 it is an ICH observer. Several CIOMS pharmacovigilance guidelines have served as a basis of ICH guidelines.

CIOMS has also had a long-standing collaboration with ICH focusing on specific areas supporting the implementation of MedDRA. From 2002 to 2019, CIOMS Working Groups (WG) prepared more than 100 MedDRA Standardized Queries (SMQs). The work on MedDRA implementation aspects is continuing with a new CIOMS WG on MedDRA Labelling Groupings (MLGs). Another major CIOMS document, issued in collaboration with WHO, are the 2016 International Ethical Guidelines for Health-related Research Involving Humans. In collaboration with WHO regional offices, these have been translated into all UN languages. The CIOMS Guide to Active Safety Surveillance (2017) and the CIOMS Guide to Vaccine Safety Communication (2019) complement WHO work in the area of vaccines. At present, CIOMS is finalizing the report of its Drug Induced Liver Injury (DILI) Working Group (WG). New CIOMS WGs are dealing with patient involvement in drug development and safe use, and with assessing benefit-risk balance for medicinal products.

IFPMA is committed to ensuring that the biopharmaceutical industry contributes with innovative solutions and can effectively support regulatory framework strengthening initiatives worldwide. Where do you see the biopharmaceutical industry playing a more active role and how can the ARC contribute to that?

The biopharmaceutical industry is very important for creating innovative, more effective and safe medicines to prevent and treat diseases and alleviate suffering. The industry is one of the major parties affected by regulatory frameworks, and thus it has very knowledgeable regulatory experts and, allow me to say that, sometimes more knowledgeable than chronically resource-constrained regulators. Thus, involving the best brains from the industry when creating new guidelines would help a lot. Industry experts can also provide feedback about how the regulatory frameworks are functioning and can thus, contribute to the creation of more transparent and efficient frameworks.  Perhaps there are ways of getting more reflections from the industry about what works well and what does not in regulatory systems. It is laudable that in several regions both regulators and the industry have started to work more with patients. Perhaps it is time to think how to get patients more involved in ARC meetings. In CIOMS, we are very eagerly awaiting the results of our Working Group that, with the participation of patients, regulators and industry, looks at how better to constructively involve patients during the whole life-cycle of medicines – from the early stages of development until their retirement from the market.

Reliance is one of the major themes for ARC 2020. Geographically, where do you see reliance having greater impact in optimizing regulatory systems and what are some of the opportunities for implementing national regulatory authorities?

I have to declare conflict of interest upfront. I am a passionate supporter of pragmatic and rational regulatory reliance practices! The future of regulation is a lot more in effective collaborative regulatory networks based on different forms of reliance, rather than individual regulators doing everything. Although, reliance practices can help in all geographical locations. However, well-designed and transparent reliance practices are especially useful for small and medium-sized regulators. But even the “big fish” can do better when there is an efficient use of reliance practices. Very few, if any, can be equally good in all regulatory activities relating to all types of regulated products. On the other hand, even very small agencies can be “world class” in some selected activity or product class. The rest they could cover by making use of effective cooperation and well-designed reliance procedures. I believe that the future of regulatory systems is with more reliance and collaboration – a smart regulation enabling even the small regulators to be trusted and be reliable “world class” players.

Looking ahead, what are some of the challenges faced by national regulatory authorities globally and can emerging technologies and digitalization play a role in addressing (or adding to) these challenges?

One of the major challenges is that in many countries regulators are still seen as part of the problem rather than part of the solution. Another challenge, at least in some locations, is lack of innovative vision for the future and lack of political support to improve regulatory systems. For these, emerging technologies and digitalization are likely not helping. I also see education of regulators as a big challenge, and in this area emerging technologies and accessible online training courses could be put to better use than they are today. Emerging technologies and digitalization can already offer more opportunities than we are actually able (or willing?) to use. Technologies and digitalization have enabled the creation of paperless authorities. This means that in principle experts are able to work online on the same topics/dossiers globally, no matter where they are actually located.

What would you like to see coming out of the 2020 ARC and what discussions would you like to see in the next ARC 2022?

The best would be if somebody goes home from this conference and makes a change to improve existing practices. For example, improving an existing reliance practice or initiating a new one.

In the next ARC, it would be great to see more patient involvement and discussions about collaboration and reliance. And considering the new concept of WHO-listed authorities, it would be great to have an overview of regulatory bench-marking in the region.


  • Lembit Rägo