Has a Regulatory Putsch Been Overlooked in the Distractions of Summer?


Applied Clinical Trials

Summer is traditionally the period of vacation and distraction - and when people are distracted and vacationing, they don't always give their customary attention to what is going on back at the office. Certainly that is the case of this columnist, who has only just noticed the announcement of what looks like a very interesting development in international drug regulation, tucked away inconspicuously in a press release issued last month.

The press release comes from the International Conference on Harmonisation (ICH), that worthy body which has, for the last two decades and more, laboured diligently at simplifying drug regulation across national boundaries. The announcement is that ICH has "agreed on new principles of governance". The significance of this development is that it presages a downgrading of industry influence in what has, until now, been very largely a joint operation between industry and regulatory authorities.

The new principles of governance "better define the roles of regulators and industry parties within ICH", says the announcement. But it is more than a better definition. It looks, in effect, more like a putsch. "In circumstances when regulators and industry may not have the same interests or priorities with respect to a particular harmonisation activity, the new principles allow ICH to proceed with a proposed topic for harmonisation provided it is supported by the three ICH regulatory parties, irrespective of whether or not this topic is supported by the industry parties", the release states.

This is a real departure from the long-established practice in this unique international forum. As its own official history records, "the birth of ICH took place at a meeting in April 1990, hosted by the European Federation of Pharmaceutical Industries and Association in Brussels", when "representatives of the regulatory agencies and industry associations of Europe, Japan and the US met". The impetus came from the industry, which "found it necessary to duplicate many time-consuming and expensive test procedures, in order to market new products internationally", according to ICH itself: "The urgent need to rationalise and harmonise regulation was impelled by concerns over rising costs of health care, escalation of the cost of R&D and the need to meet the public expectation that there should be a minimum of delay in making safe and efficacious new treatments available to patients in need."

The results, as most readers of ACT will know all too well, included the development of tripartite ICH guidelines on safety, quality and efficacy topics, as well as progress on the Medical Dictionary for Regulatory Activities, the Common Technical Document, and electronic standards. These achievements are widely and rightly regarded as a success story - and ICH itself highlights the key contribution of "the process of scientific consensus developed between industry and regulatory experts".

The July press release emphasises that "ICH will continue to be consensus driven". And in order to "remain at the cutting-edge of scientific and technical developments in the pharmaceutical area", it will be essential to maintain "the continued close cooperation between regulatory and pharmaceutical industry experts that has been instrumental in providing the best scientific and technical input in the development of ICH products".

ICH also downplays the significance of the new governance principles, arguing that it is really just a question of more of the same. "This action will highlight ICH’s longstanding premise that the regulators have the ultimate responsibility in ensuring the protection of public health", it says, pointing out also that the changes have been agreed by "the six official ICH parties" - including, that is, the industry associations representing Europe, the USA and Japan.

But what are the cases where "regulators and industry may not have the same interests or priorities with respect to a particular harmonisation activity", and how serious have they been, to occasion this shift in governance? Late with the news, this columnist has turned only now to ICH for enlightenment. But it is August, and no-one is answering the phone at ICH. I am not alone in having been distracted and vacationing!


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