Ninth annual meeting of International Regulatory Cooperation for Herbal Medicine

8-10 November 2016, New Delhi, India

Excellencies, distinguished participants, ladies and gentlemen,

A very good morning to you.

I would like to thank the Government of India and the Ministry of AYUSH for inviting me to address the Ninth annual meeting of International Regulatory Cooperation for Herbal Medicines. It is a great pleasure to be here today and to have the opportunity to engage with you on a subject that has such wide-ranging significance in people’s lives.

Indeed, traditional medicine has been a part of health and wellbeing in the South-East Asia Region for many centuries, from Vedic India through to the present. As those of you who have travelled from afar would also know, traditional medicine has long-standing historical and cultural roots elsewhere, including in Europe, the Americas, Africa, the Middle-East and the Pacific.

But beyond its cultural resonance, traditional medicine is often perceived as a safe and affordable option in contrast to the potentially burdensome costs of standard health care treatments and procedures. Where coverage may be incomplete or out-of-pocket expenditures high, traditional medicine is a reliable go-to for many.

When traditional medicine services are integrated with existing health systems, kept safe through effective regulation and made easily accessible and affordable, they can enhance a health care system’s performance. Moreover, they can do so in a way that promotes health-seeking behaviour and reinforces positive health care experiences.

As public health practitioners and advocates, it is of critical importance that we understand this. As outlined in the WHO traditional medicine strategy adopted in May 2014 at the 67th World Health Assembly, we must harness the contribution of traditional medicine to health, wellness and people-centred care. At the same time we must promote the safe and effective use of traditional medicine by regulating, researching and integrating traditional medicine products and practitioners with national health systems.

The interlocking nature of these aims is self-evident: Safety is fundamental to the provision of any treatment or procedure, including when we use herbal and traditional medicines alone or combined with other medicines. Effective regulatory systems are therefore crucial to ensure and maintain the safe use of herbal and traditional medicines.

Nonetheless, setting and enforcing comprehensive standards and regulations for traditional medicine products remains a significant challenge in most countries. Overcoming these challenges and improving regulatory systems is vital for a number of reasons.

First, traditional medicines are now being produced on an industrial scale, meaning effective quality assurance and control practices must be in place to ensure a consistent and reliable product. Regulators and manufacturers need to work together to strengthen the specific quality assurance practices unique to traditional medicine products.

Second, traditional medicine products are no longer restricted to local markets, but are entering regional and global supply chains. Regulatory harmonization and collaboration across the globe is crucial to maintain and enforce appropriate standards of quality.

And third, as with any lucrative trade, large profits may attract unscrupulous producers that attempt to exploit the traditional medicine market, which is typically less regulated than others. Regulators must protect the public from adulterated, fake or poor quality traditional medicine products that can be harmful and may cause lasting injury or death.

Drafting and implementing effective policies depends not only on the technical capacity of regulators, but also on their ability to communicate, collaborate and rely on competent regulators in other countries and regions. It is for this reason that this meeting is of such critical importance. It is also for this reason that your mission – to “protect and promote public health and safety through improved regulation for herbal medicines” – is commendable and should be adopted by all countries.

In saying this, I note that only four countries in the South-East Asia Region are members of IRCH. Nevertheless, I do hope that more countries will adopt good regulatory practices that have been developed by your network, and that they also consider becoming members in future. After all, strengthening Member States’ regulatory systems for herbal and traditional medicines is consistent with WHO’s aims, and we are most pleased to work with you on this. Of late a number of importance initiatives have occurred within the Region.

During October 2015 WHO organized a Region-wide meeting in DPR Korea where we discussed how to monitor and evaluate the performance of traditional medicine systems. At this meeting Member States highlighted the importance of strengthening regulatory systems for traditional medicine products, particularly with regards to developing national adverse event reporting systems.

As a result, in 2016 WHO initiated documentation of country case studies on pharmacovigilance systems for traditional medicine products in India and Thailand. In addition, in August WHO organized a follow-up technical consultation to establish indicators that will help monitor traditional medicine system performance.

It is anticipated that this meeting will help inform these ongoing initiatives and will help enhance international regulatory cooperation for herbal medicine. I look forward to the action points that emerge from this meeting and again reiterate WHO’s commitment to support you in your efforts to promote safe and effective use of traditional medicines.

I wish you success in your deliberations and a very pleasant stay here in Delhi.

Thank you for your kind attention.