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04 Nov 2003
By Dr Balaji Sadasivan
Venue: The Shangri La Hotel
It is a pleasure for me to join all of you this evening.
I am happy to note that after more than three decades, SAPI remains a strong and cohesive association playing an important role in the development of the local pharmaceutical industry.
The theme of this evening's colloquium - the value of innovative medicine - is timely as we are living in a truly remarkable era of science and medicine. Innovative medicines that are the results of laboratory breakthroughs and cutting edge technology are making growing contributions to the health of our population.
The Singapore Government recognizes the value that innovative medicine brings. As such, we have adopted a multi-pronged approach to enhance the development of innovative medicine in, as well as its entry into, Singapore, and yet safeguard the long term affordability of our healthcare system. Let me highlight some of these initiatives to set the stage for your colloquium.
Development of Biomedical Sciences in Singapore
As you all know, the Biomedical Sciences industry is being developed as the fourth pillar of Singapore's economy. The supporting infrastructure and the growth of R&D and regulatory sciences will continue to provide a strong impetus for the development and entry of innovative medicine in Singapore.
To promote the Biomedical Sciences sector, strategic plans have been developed from an inter-ministerial and inter-sector perspective. This encompasses education, R&D, industry development and healthcare. Underscoring the government's commitment to develop biomedical research activities, a research fund of S$1 billion has been allocated to attract world-class industry players to invest in R&D in Singapore. The Biomedical Research Council (BMRC) was established in 2000 to oversee and coordinate public sector biomedical sciences R&D activities. The BMRC recently launched four different categories of grants to support and stimulate biomedical research in the public sector. We are already seeing an escalation of R&D activities in our public sector health institutions. These developments provide an ideal opportunity for pharmaceutical companies to establish a significant R&D capability based in Singapore.
The Economic Development Board is actively promoting Singapore as an integrated, strategic and global bio-science hub of choice. Significant progress towards this goal has already been achieved. With a pharmaceutical plant investment of approximately S$3 billion, Singapore is probably the most dynamic and innovative biomedical hub in Asia outside of Japan. Activities now include growing a basic research and development hub; the manufacture of Active Pharmaceutical Ingredients (API), medicines and parenteral biotech proteins; and the escalation of clinical trials, particularly early phase trials.
With our politically stable environment, a strong ethical business and government culture, and a skilled and hardworking population, the pharmaceutical industry can look forward to the future in Singapore with confidence.
Efficient drug regulation
In the area of drug regulation, we know that timelines are critical to the industry when introducing innovative medicines to the market.
The Health Sciences Authority's mandate is to protect and promote public health by helping to make safe and effective medical treatments as accessible and as quickly available as possible, but without compromising safety, efficacy and quality. It will not unnecessarily duplicate, the evaluation work completed by other drug regulatory agencies, especially its benchmark agencies . Such duplication must lead to higher cost to consumers. The public sector now has a cut red tape committee. They are searching for red tape to cut in order to make Singapore more efficient and competitive. If you see any red tape, let me know and I will send this committee in to investigate and destroy any wasteful red-tape.
HSA has embarked on strengthening its alliances with various strategic international regulatory agencies through the signing of Memoranda of Understanding or MOUs. In the present era of globalisation, more and more innovative medicines will move freely across lowered market barriers. Establishing strategic alliances with regulatory counterparts will help develop direct communication channels that speed up information exchange of regulatory information. This will facilitate the approval of innovative medicines as well as enhance post-marketing monitoring safety programmes. In addition to the MOU that was signed with Australia in 2002, HSA has recently, in September this year, signed an MOU with the State Food and Drug Administration of China. A working group between the US FDA and HSA, established under the US-Singapore Free Trade Agreement, is now also exploring opportunities for regulatory collaboration.
Facilitation of Clinical Trials
As you would also be aware, HSA is working with stakeholders, such as the public sector hospital clusters and the EDB, to further enhance the regulatory infrastructure and facilitate the running of clinical drug trials in Singapore. Expeditious approval of clinical trials is being balanced with the maintenance of high standards of safety, ethics and quality.
Intellectual property and data protection
You are all aware that the development of new innovative medicines is a long and often uncertain process. Some sources cite the costs for developing a new drug at around US$800 million and even then, the odds of it becoming a successful blockbuster are remote.
To safeguard a reasonable return on investments, Singapore has committed itself to strengthening our intellectual property protection laws. We have been ranked as having the best intellectual property rights protection in Asia since 1997. The Intellectual Property Office of Singapore (IPOS), launched in 2001. aims to provide the infrastructure, platform and environment for greater creation, protection and exploitation of intellectual property.
Cost containment issues
While innovative medicines hold great promise as we move towards more individualized and effective treatment, this has to be balanced with the reality of the high acquisition costs of these medicines. These may result in effective medicines being beyond the reach of many of the patients who most need them.
Therefore, while we are serious about ensuring meaningful and strong patent protection to encourage the development of innovative medicines, we must also promote a culture of medical practice in our institutions in which lower cost and effective generic alternatives are prescribed as and when appropriate.
Conclusion
In conclusion, I wish to say that we all have a shared interest in the development of innovative medicines. All of us stand to benefit from these products, both in terms of the economic benefits of a dynamic biomedical sciences environment and the improved health of our population. We stand at the point where the new technology and developments, over the last two decades, are ready to yield breakthrough treatments. We need to work together to make sure that we sustain and further promote a conducive environment in Singapore to encourage and sustain such medical progress.
I wish you a fruitful discussion, this evening, on the value of innovative medicines.
Thank you.