Speech by Minister of State for Health, Dr Amy Khor, at the opening ceremony of the DIA-IFPMA Asia Regulatory Conference 2013, 28 Jan 2013

Dr Ling Su, President, DIA Board of Directors

Mr Toshiaki Miyoshi, Managing Director, Japan Pharmaceutical Manufacturers Association (JPMA), Japan

Dr Arun Mishra and Associate Professor John Lim, Chairpersons, Asia Regulatory Conference 2013

Distinguished Guests and Participants

Good morning. It gives me great pleasure to join you at this Asia Regulatory Conference 2013, with the theme “Regulatory Convergence and Cooperation to Improve Access and Quality”. I am happy that Singapore is hosting this year’s meeting and I’d like to wish a warm welcome to all especially our overseas guests. I do hope that you will have some time to enjoy the sights, sounds and cuisine here.

2. This is the second Asia Regulatory Conference to be co-organised by the Drug Information Association (DIA) and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) following a successful first meeting in Seoul in 2011. This conference offers an excellent platform for key stakeholders from health authorities, pharmaceutical companies and academia to exchange views and identify specific areas to enhance patient access to new and improved medicines.

3. I’m sure that the discussions on “Regulatory Convergence and Cooperation to Improve Access and Quality” at this conference will spur greater collaboration among industry players and regulators. Such partnerships will not only ensure more effective and efficient drug development, provide early access to safe and high quality products to markets, but will also ensure more effective surveillance of medicines already in the market.

Asia’s role in drug development

4. Asia has experienced very fast growth in global drug development activities, encouraged by various initiatives and incentives from the countries in this region. The Singapore Government has provided wide-ranging financial incentives and infrastructure support to grow local drug development activities. We have committed $16.1 billion Singapore dollars to support research, innovation and enterprise activities from 2011 to 2015. Of this, $3.7 billion has been earmarked for enhancing existing biomedical R&D infrastructure, integrating multi-disciplinary research and translating basic science into tangible outcomes.

5. Many multi-national pharmaceutical corporations and global contract research organizations are now operating in Asia, and drug development is expanding and advancing rapidly. The region’s diversity, and its wide spectrum of demographic and socio-economic settings, allow for drugs to be developed for diseases present in both developed and developing countries.

6. With the world’s two most populous countries in the region, Asia is a crucible for ongoing and future drug development. The presence of a ready pool of skilled healthcare professionals in the region and the adoption of the Good Clinical Practice guidelines developed by the International Committee on Harmonisation (ICH) by many Asian countries helps to ensure that the standards of drug development activities in Asia are globally comparable and acceptable. Based on both commercial considerations and speed-to-market, Asia now plays an ascendant role in global drug development programs and cannot be ignored in the planning of global drug development strategies.

Asia’s role in regulatory convergence

7. Over the course of the past few decades, the world has seen a significant change in disease demographics. While the benefits of biomedical research and innovation are reflected in the successes we have witnessed in the treatment of many debilitating diseases resulting in increased life expectancy, some communicable diseases like tuberculosis have re-emerged with strains that are resistant to conventional treatments. Since the turn of the century, emerging infectious diseases like SARS have also forced our healthcare systems to maintain a good balance in managing communicable and non-communicable diseases. In addition, chronic conditions continue to be a major health challenge in developed and developing countries.

8. Countries like Japan, Korea and Singapore face the increasing challenge of appropriately managing the healthcare needs of a rapidly ageing population and the rising incidence of chronic diseases. In this context, it is important to look at more public-private partnerships to ensure better utilisation of resources to meet national healthcare needs, as well as to create the right environment for ongoing life science innovation.

9. In Singapore, the Health Sciences Authority, or HSA, is participating in the “NEW Drug development paradIGmS programme”, or NEWDIGS for short. The HSA will explore scientific criteria for new and potentially expedited ways of regulatory review for new medicines to benefit defined patient groups. The NEWDIGS project is done in collaboration with the Massachusetts Institute of Technology’s Centre for Biomedical Innovation, to study and develop an adaptive licensing approach. This approach involves a series of iterative phases of data gathering and regulatory evaluation. By segmenting the regulatory process into phases, certain patients will be able to benefit from a specific drug earlier in the process than through the conventional drug development and approval approach.

10. For such novel processes to be studied and eventually adopted, there needs to be a convergence of regulatory requirements to enhance the efficiency and robustness of regulatory processes in companies and government agencies. I understand that across the region, active efforts are underway to promote harmonisation and sharing of best practices. I applaud and support such activities. With convergence of standards and avoidance of duplication of efforts, the lag-time for market entry of critical and safe medicines can potentially be shortened. Co-operation amongst international and regional regulators, industry and other stakeholders is necessary to facilitate this process of convergence.

Pharmacovigilance and Risk Management

11. At the same time, regulatory convergence activities leading to earlier patient access to medicines must be balanced with a robust post-market surveillance system to monitor the benefit-risk profile of these products over their life-cycles. A strong and effective post-market surveillance and vigilance system is critical to our regulatory systems. Over the past few decades, there have been a series of high-profile incidents around the world in which widely used medicines were found to cause harm, such as sibutramine for lowering obesity. These had resulted in suspension or restriction of use for these products, or even complete withdrawal from the market in some cases. Such experiences emphasise the importance of ongoing post-market vigilance activities and finding ways to step up trans-national collaboration to strengthen these efforts.

12. Such incidences have sparked a paradigm shift in vigilance activities from spontaneous reporting to active surveillance. We have also seen the increased customisation of risk management plans to mitigate potential risks associated with medicinal products. A life-cycle approach to product safety is now regarded as the cornerstone of effective product vigilance. This means greater anticipation of issues during pre-market product evaluation and more active assessment of the benefit-risk profiles of products during their marketed lifespan. In Singapore, we have taken advantage of our small geographical size and harnessed our good IT infrastructure to link patients’ electronic health records together in a national system. With this linkage, active surveillance can be more effectively conducted through the mining of available data and problems associated with particular drug use can be arrested at an early stage. A recent example of the value of this linkage was HSA’s prompt detection of the serious skin reactions suspected to be associated with the osteoporosis drug, strontium ranelate. This enabled HSA to take prompt regulatory actions to mitigate the risks when the drug is used.

13. In addition to conventional pharmacovigilance, innovative approaches related to personalised and stratified medicine have the potential to reduce adverse drug reactions in specific patient groups. Being able to predict in a reliable way, who will benefit most or who is less likely to suffer a particular adverse reaction could have an enormous impact on the way medicines are prescribed. This can also produce valuable data to help minimise the risk of exposure and adverse events in the wider population. This can subsequently translate into substantial savings in overall healthcare costs.

14. To strengthen the regulatory scientific basis for personalised and stratified medicines, the Vigilance Branch of the Health Products Regulation Group in HSA has been building up its capacity in pharmacogenetics. The aim is to put in place an innovative surveillance network that will be able to capture relevant genetic information associated with serious adverse drug reactions. Two ongoing projects using pharmacogenetics to relate certain drugs to serious skin rashes and drug induced liver injury are currently being studied in Singapore. The aim is ultimately to translate the findings into regulatory recommendations and implement clinical approaches to identify individuals who may be pre-disposed to certain serious adverse drug reactions. This will enable them to avoid consuming inappropriate medicines and prevent the occurrence of related adverse drug reactions. HSA is now working with our public sector hospital clusters on the implementation details of this initiative.

Risk of Counterfeits

15. While regulatory frameworks are in place to ensure access to safe medicines, countries in Asia are also concerned about unscrupulous individuals and syndicates aiming to profiteer from selling counterfeit health products. These products, which end up penetrating supply chains may not only be ineffective but may also contain dangerous substances that increase the risk of adverse events, thus endangering the lives of innocent patients. Concerted efforts to eliminate counterfeit medicine continue to be undertaken by drug regulators and law enforcement authorities around the world. One well-known initiative supported by WHO and INTERPOL is Operation Pangea¹. However, both counterfeit and adulterated drugs continue to pose a considerable challenge. To safeguard public safety and health, regulators and industry need to work together in more coordinated and collaborative networks to prevent the manufacturing and distribution of counterfeit and sub-standard products.

16. In this globalised world, public health cannot be effectively achieved in silos. National regulatory agencies, industry and key partners in academia must work collaboratively to strengthen regulatory systems so that there is faster access to improved and affordable medicines. This must happen in tandem with more effective initiatives and programmes to safeguard the health and well-being of our populations.

Conclusion

17. Let me end by congratulating the organisers for successfully putting together this year’s Asia Regulatory Conference. I trust that you will have a fruitful time sharing experiences, best practices and ideas.

18. May you have a productive and successful conference, and a memorable experience from your time in Singapore.

19. Thank you.

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¹ Operation Pangea is an international collaboration targeting the illegal online sale of counterfeit and unlicensed medicines through raising public awareness of the associated health risks. Ops Pangea is co-ordinated by INTERPOL, the World Customs Organization (WCO), the Permanent Forum of International Pharmaceutical crime (PFIPC), the Heads of Medicines Agencies Working Group of Enforcement Officers (HMA WGEO), the pharmaceutical industry and the electronic payments industry. This is the fifth year of the global operation.