What can be done to speed up access to new medicines for patients and improve quality, safety, and efficacy of medicines in Asia
The 2015 Asia Regulatory Conference (ARC) on February 4-5 in Chinese Taipei brought together over 250 stakeholders from regulatory, pharmaceutical, academic, civil society, international and non-governmental organisations, including policy experts from Asia. They met on the understanding that no single state, regulatory authority or company within the pharmaceutical industry can meet current regulatory challenges alone. Cooperation, coordination, and convergence on priority issues are important to ensure a pragmatic, effective, and rapid response to facilitate access to new medicines. The conference’s goal was to discuss how to advance best practices for regulatory review and submission in Asia, ultimately expediting access to medicines for patients across the region.
This blog summarizes keynote remarks made by former chair of ARC 2013, A/Professor John C.W. Lim, Deputy Director of Medical Services (Industry & Research Matters) Ministry of Health, Singapore, and current Executive Director of the Centre of Regulatory Excellence, Duke-NUS Singapore, on ‘regulatory convergence and cooperation to improve public health’. Professor Lim is uniquely placed to bear witness to the path traveled since 2013 and today’s challenges.
1. Science-based regulatory decisions enhance collaboration and priorities
To keep up with the rapid advancements in science and technology, today it is all the more essential to ground our regulatory pathways on sound science. Consequently, it is only sensible that collaboration increases among regulatory authorities, industry, and academia – working together to address the challenges presented by this fast changing environment. Regulatory frameworks must be based on sensible decisions and sound understanding, and require making judicious judgments by prioritizing which scientific advances are the most relevant and applicable to specific settings. Professor Lim applauded the move since 2013 towards practical convergence over ideal harmonization. But for the future, given the limited resources facing countries in the region, he emphasized that “we also need to tackle which are the priority issues that we need to converge on”.
2. Addressing capacity gaps is a challenge across the board
A review conducted by Centre of Regulatory Excellence at Duke-NUS at the end of 2014, showed a strong desire by key regulatory stakeholders to see the capacity and capabilities of national regulators built up further and move towards greater convergence in the Association of Southeast Asian Nations (ASEAN) and South East Asia. Interestingly, “we found out that industry’s own regulatory affairs professionals in the region also needed capacity development, including scientific capabilities needed to address the rapid growth of the biomedical sector in Asia” said Professor Lim. Finally, because of the increasing activities involving companies, organizations, clinical trials, and biomedical research in Asia, there is a need for greater regulatory leadership. Without effectively addressing these gaps, the full potential of the many biomedical initiatives in Asia will not be achieved in the years ahead.
3. Boldness to challenge old regulatory paradigms
Professor Lim called for more boldness in challenging old paradigms and promoting innovation in both drug development and regulation. This includes developing sound regulatory approaches to manage benefit-risk, health technology assessment, and dynamically monitor as well as prioritize scientific advances and their impact. He added that it was “highly commendable how things have moved on with two good complementary approaches: good review practices being developed by the World Health Organization (WHO) and regulators, and good submission guidelines developed by industry is in itself an example of how convergence and stakeholder cooperation have advanced and continue to advance”. This is clearly mirrored in the region as the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee works with WHO on the review aspect, whereas Asia Partnership Conference of Pharmaceutical Associations (APAC) serves as the representative of industry on submission guidelines. Instead of working in isolation and at cross purposes, they share expertise and demonstrate how regulatory stakeholders can build on their expertise and strengths towards convergence, coordination, and communication to address capacity issues in a rational and complementary manner.
4. A healthy dose of pragmatism to achieve tangible outcomes
The last priority exposed in Professor Lim’s remarks is “the need to support our aspirations with a healthy dose of pragmatism and reality”. He noted that gatherings like the ARC enable regulatory stakeholders to gain a better understanding of the many issues different players have to deal with. These include ongoing public health challenges, ethical issues, commercial realities as well as public and political pressures. However, he drew the audience attention to the fact that understanding and shared commitments alone are not very useful unless they are translated into finding practical approaches and meet tangible outcomes that address significant regulatory issues.
Parting thoughts – making a genuine difference to the quality of regulation in Asia
Today, all the various regulatory stakeholders, including national agencies, industry associations, international organisations and regional groups, show a commitment to regulatory excellence, which Professor Lim believes is key to effectively meet the range of regulatory challenges unfolding around us. This involves professional development through:
- targeted education initiatives;
- greater transparency;
- collaboration for consistent monitoring and follow-up;
- advancing best practices for regulatory reviews and submissions.
Regulatory excellence will help ensure regulatory authorities and industry has the necessary legitimacy, credibility, and moral standing to carry out their responsibilities. The more so as all these stakeholders are under greater scrutiny from the public and governments, and need to meet increasingly high expectations from civil society and patients.
Professor Lim concluded his remarks by stressing the importance of keeping the momentum going and the dialogue open with all key stakeholders. As he put it, “all stakeholders in the region have a shared goal: to make a genuine difference to the quality of regulation in Asia”.