AN INTRODUCTION TO THE LIFE SCIENCES LEGISLATIVE LANDSCAPE IN SINGAPORE AND A LOOK AT SOME RECENT LEGISLATIVE DEVELOPMENTS

INTRODUCTION

The Life Sciences industry has for some years been lauded as a key industry for Singapore’s economy. The Singapore government is fully committed to nurturing and cultivating this industry, by investing in and developing several critical infrastructures for the Life Sciences industry.

The Government has made funds and investment available through the National Research Foundation as well as Bio*One Capital. There is also infrastructure for research and development, led by the Agency for Science, Technology and Research (A*Star), which houses 7 research institutes under its Biomedical Research Council. Singapore has also provided for physical infrastructure, with the building of the Biopolis and Fusionopolis research hubs, as well as the Tuas Biomedical Parks, which houses manufacturing facilities for pharmaceutical and other biomedical products.

Besides the above initiatives, the Singapore government has also strengthened the regulatory infrastructure of the Life Sciences industry by (a) consolidating and reorganising several previously existing regulatory agencies, such as the Health Sciences Authority (“the HSA”), and (b) imbuing them with specific functions of regulating the Life Sciences industry.

In tandem with the regulatory infrastructure, Singapore has established a legislative infrastructure to ensure that Singapore is kept at the forefront of the race to become the biomedical hub in Asia. In this article, we will look at the key elements of this legislative infrastructure. We will also look in particular at the Health Products Act 2007 and the recent amendments to the Infectious Diseases Act.

I. STRONG IP REGIME

The first key element of Singapore’s legislative infrastructure is the presence of a strong regime that recognises and protects intellectual property in Singapore. Many products in the Life Sciences industry are borne out of countless hours of painstaking research and development, generating intellectual property rights that form the foundation of product development. Without an adequate and robust intellectual property legislative regime in place, there is little incentive for innovation.

Singapore has taken significant steps in strengthening its intellectual property regime. This can be seen from the fact that Singapore:

(a) is a member of major IP-related conventions and organisations such as the World Intellectual Property Organisation, the Paris Convention, the Berne Convention, the Madrid Protocol, the Budapest Treaty and the Patent Co-operation Treaty.

(b) Singapore has fully complied with the WTO’s TRIPS Agreement.

(c) has a one-stop government agency known as the Intellectual Property Office of Singapore (“IPOS”) that provides the infrastructure, platform and environment for the creation, protection and exploitation of IP rights in Singapore. IPOS also provides professional qualifications for patent agents in Singapore.

(d) has a strong and independent judiciary with specialist IP judges that facilitate the enforcement of IP.

(e) has consistently promoted a high level of awareness and appreciation of IP rights among the business and research communities through on-going educational programmes.

II. USE OF ETHICAL GUIDELINES

A second key feature of Singapore’s life sciences legislative infrastructure is its approach to the ethical challenges facing the life sciences industry.

Unlike many other technological industries, the Life Sciences industry is constantly confronted with ethical issues. A case in point was in 1997 when scientists unveiled Dolly, the first successfully cloned animal. There was much debate generated at that time on whether cloning was morally acceptable and currently, issues concerning stem cell research can prove deeply polemic.

Due to the cutting edge research generated by the Life Sciences industry involving research on humans and animas, issues of ethically accepted behaviour and research are grappled with not only by industry practitioners but also society at large.

Life Sciences research constantly challenges the frontier of what is ethically accepted in society. To assist the Singapore government in navigating the constantly evolving ethical issues, the Bioethics Advisory Committee (BAC) was set up in 2000. Since then, the BAC has released five reports, examining critical ethical issues such as human cloning, stem cell research, research involving humans, human tissue and human genetics as well as the use of personal information in research.

These guidelines, whilst not having the force of law, provide a framework that enables businesses, researchers and scientists alike to be aware of the ethical issues and to know where the Singapore government’s position on certain matters may be. It also allows the Singapore government to be more adept at regulating the ethical issues faced by the life sciences industry through guidelines rather than legislation. If thought fit, the Singapore government would also promulgate some of the guidelines as legislation, as can be seen below.

III. LEGISLATION

A third key feature is the use of existing legislation and the promulgation of new legislation to meet the challenges in regulating the life sciences industry.

Existing Legislation

In Singapore, there are five main pieces of legislation that relate to the regulation of pharmaceutical and other related products:

(a) Medicines Act;
(b) Medicines (Advertisement and Sale) Act;
(c) Misuse of Drugs Regulations;
(d) Poisons Act; and
(e) Sale of Drugs Act.

In addition, subsidiary legislation is also promulgated under the existing legislation to regulate specific areas or aspects of the life sciences industry. For example, the Medical (Clinical Trial) Regulations provide for the mechanisms that have to be followed for a clinical trial to be conducted in Singapore, although this set of regulations is only applicable for pharmaceutical products.

However, it became gradually apparent that the existing legislation was inadequate to address some of the issues facing the Life Sciences industry, and new legislation would have to be enacted in order to address such specific concerns, e.g. the use of medical devices and cosmetics and whether human cloning or stem cell research, the subject of much ethical debate, should be allowed.

The Human Cloning and Other Prohibited Practices Act 2004 (“the HCOPP Act”) was passed in 2004 to address some of the gaps in the existing legislation. The HCOPP Act attempts to address and strike a balance between the view that human cloning was abhorrent and should be prohibited, whilst allowing some forms of cloning, such as therapeutic cloning, so as to enable stem cell research into diseases. It also specifically prohibits the placing of a human embryo clone in the body of a human or animal and certain other practices associated with reproductive technology. The HCOPP Act was drafted based on recommendations made by the BAC, and shows that where necessary, the Singapore government would be prepared to pass legislation to regulate the Life Sciences industry, especially on critical issues.

Other more recent pieces of legislation, such as the Health Products Act 2007, and the amendments to the Infectious Diseases Act, would be looked at in more detail next.

IV. RECENT DEVELOPMENTS

A. Health Products Act 2007

Key features of the Health Products Act

The Health Products Act (“the HPA”) came into effect in 2007. It is meant to eventually act as an omnibus Act to regulate all types of health products, including pharmaceutical products, for use in humans in Singapore.

Purpose of the HPA

There has been a gradual recognition that health products are no longer confined to the traditional form of pharmaceuticals or drugs. With the development of modern technology, therapeutic products would also include non-pharmaceutical products such as medical devices, cosmetics, traditional Chinese medicines, and even health supplements, all of which can be used for health purposes.

There was thus a need for legislation to regulate such products, beyond the traditional framework of pharmaceuticals. The HPA was introduced with a broad-based approach to “regulate the manufacture, import, supply, presentation and advertisement of health products and of active ingredients used in the manufacture of health products and provide for matters connected therewith.”

Relationship between HPA and existing legislation

Under the HPA, a health product is essentially any substance, preparation or device for use by humans solely or principally for a health-related purpose, and that falls within any of the categories of health products specified in the First Schedule. “Health-related purpose” is also defined in the HPA.

As products currently legislated under the Medicines Act are intended to be eventually brought within the HPA, the HPA also provides that where any product is designated as a type of health product under the HPA, the Minister may declare that the provisions of the Medicines Act shall cease to apply to that type of product.

Key Provisions of the HPA

The key provisions of the HPA are:

a) the setting up of a system of registration for health products according to the categories specified in the First Schedule;
b) the requirement of obtaining licences for the manufacture, import and supply of health products;
c) the regulation of advertisements of health products;
d) the prohibitions against the supply of adulterated, counterfeit or unwholesome health products and/or health products that have been tampered with; and
e) the setting out of certain presumptions and evidentiary matters for the enforcement of the HSA

Categories currently established

As of May 2008, only medical devices and cosmetic products are specified in the First Schedule. There is also specific subsidiary legislation pertaining to medical devices and cosmetics, i.e. the Health Products (Medical Devices) Regulations 2007 (the Medical Devices Regulations) (“Medical Devices Regulations”) and the Health Products (Cosmetics Products – ASEAN Cosmetics Directive) 2007 (“Cosmetics Regulations”).

Medical Devices Regulations

Before the enactment of the HPA, there was no specific legislation of medical devices, save for subsidiary legislation pertaining to contact lenses and condoms under the Medicines Act, and irradiating medical devices under the Radiation Protection Act. These products continue to be regulated under the existing regime. The HSA also established a system of voluntary registration and medical devices guidelines for these specific devices.

For all other medical devices, the Medical Devices Regulations places a statutory obligation on the manufacturer, importer or wholesaler of a medical device to keep proper records of, and make available for inspection by the HSA:

any supply made by him of the medical device; and
every complaint received by him pertaining to the medical device.

In addition, the Medical Devices Regulations sets out steps to be taken by the manufacturer, importer or wholesaler in the reporting of any occurrence that reveals any defect in the medical device or any occurrence that concerns any adverse effect arising from the use of the medical device. The Medical Devices Regulations also stipulates that the HSA must be notified before carrying out any recall of a medical device.

Cosmetics Regulations

As its name suggests, the Regulations are part of an ASEAN-wide initiative to harmonise the regulation of cosmetic products across all ASEAN countries.

The Cosmetics Regulations puts in place a regime of notification whereby a person responsible for placing a cosmetic product in the market shall not begin or continue the supply of that cosmetic product unless prior notification to do so has been submitted to the Authority.

There are also provisions legislating against the use of certain substances listed in Part I of the Third Schedule in the cosmetic product, provisions on the labelling and advertisement of cosmetic products. In addition, the person responsible for placing a cosmetic product in the market shall have the duty to maintain records of supply and have a duty to report defects and adverse effects to the Authority.

Comments on the HPA

Flexibility

The HPA is generally a very adaptable piece of legislation. Whilst the definition of what constitutes a “health product” is defined within the HPA, the definition of each health product category is defined within the First Schedule instead of within the HPA. This ensures that changes can be promulgated quickly as there is no need to constantly revise or amend the HPA, and thus position Singapore to be better adept at navigating the fast changing landscape in the life sciences industry.

Another feature of the flexibility of the HPA can be seen from the Minister having the powers to determine the provisions of the HPA which apply to each specified category of health products. For example, the requirements of Parts III and IV of the HPA (pertaining to the Manufacture, Import and Supply of health products) do not apply to medical devices for the present moment. As for cosmetic products, Parts VI and VII (pertaining to Licenses and Registration requirements), and other specified sections of the HPA, do not apply to cosmetic products. This gives considerable scope in determining the extent to which certain categories of health products need to be regulated.

Potential confusion with existing regime

However, some possible confusion with the existing legislative regime may be present. For the present moment, at least, legislation relating to the regulation of health products under the existing regime continues to be in force. For example, legislation relating to contact lenses and radiation-emitting devices do not appear to have been repealed, and continue to apply. This may give rise to conflicting regulations of health products under the existing regime and the HPA. As the HPA is an omnibus Act, it is anticipated that the legislation in this field will gradually be tidied up as Singapore moves to bring all other types of health products into the HPA.

Clinical trials

Thirdly, the Second Schedule sets out a list of matters for which further subsidiary legislation may be enacted, including those for clinical trials. Despite bringing the regulation of medical devices under the HPA, there does not appear to be any subsidiary legislation relating to clinical trials of medical devices at the moment. This lacuna between clinical trials for medical products and medical devices appears to still exist.

Given that the Medicines Act is a rather dated piece of legislation (it was enacted first in 1975), the introduction of the HPA is certainly a timely one. It is anticipated that Singapore will continue to refine the HPA in the years to come, slowly replacing the Medicines Act.

B. The Infectious Diseases Act

Singapore recently introduced a Bill to amend its Infectious Diseases Act (“IDA”) and the amendments were passed in the 1st quarter of 2008. The amended IDA will come into force very soon.

Key Features of the amendments to the Infectious Diseases Act

Infectious diseases know no territorial limits. The outbreak of SARS in Singapore in 2003 taught the whole nation a significant lesson in disease management. Although the SARS virus was brought into Singapore by someone who had visited another country, Singapore found itself at the mercy of a virus that eventually took away 33 lives. Singapore has, in the recent years, had to deal with other similarly infectious diseases such as the Avian Flu, and the Hand Foot and Mouth Disease (HFMD).

With a view to enhancing the public health safety and ensure that Singapore can respond quickly to imminent threats of infectious diseases, recent amendments were introduced to the IDA.

The main aim of the amendments is to provide the Ministry of Health (MOH) with the necessary powers to reduce or restrict social interactions through “social distancing” measures. As the Minister of Health, Mr Khaw Boon Wan, stated in his parliamentary speech on 22 April 2008: “[the social distancing measure] is a technical term and it just means prohibiting mass gathering - in order to slow the spread of the disease in the community. For instance, schools can be closed. Cinemas and shopping centres may have to be closed too. This will buy us valuable time until an effective vaccine becomes available. Social distancing will also reduce the peak of the pandemic, in other words, reduce the maximum number of casualties, thus minimising the burden on our hospitals and healthcare institutions.”

Declaration of a Public Health Emergency

The new Section 17A of the IDA authorizes the Minister of Health to declare a public health emergency if he is satisfied that “an outbreak or an imminent outbreak of an infectious disease poses a substantial risk for significant deaths and disabilities in Singapore.”

Once such a declaration has been made, the Minister may take measures to declare restricted zones and restrict the movement or attendance of persons at these restricted zones. The Act gives powers to the police to enforce compliance within the restricted zones.

As such a declaration is draconian and the effects wide ranging, the IDA specifies that such a declaration will expire in 14 days, unless further extended. It also gives Parliament the opportunity to annul such a declaration if the Minister cannot justify such a declaration.

New research areas

To prevent the spread of infectious disease and to ensure that significant and relevant medical remedies are found swiftly, the amendments to the IDA empowers the Director to acquire information or existing samples from patients, or order a doctor to obtain, with consent, additional samples from patients under his care. Such information will then be used to facilitate national public health research. To protect medical confidentiality, the IDA provides that the information and samples will be provided on an anonymous basis.

Amendments to HIV/AIDS legislation

The other significant amendments made to IDA concerns the control of the spread of HIV in Singapore. The new amendments impose certain obligations on a person who knows he has, or has reason to believe that he has or has been exposed to a significant risk of contracting AIDS or HIV, when such person engages in any sexual activity with another person.

Some comments on the amendments to IDA

Timely amendments

It is anticipated that as global travel becomes more and more prevalent, infectious diseases will continue to rise. Singapore’s disease management so far since the SARS outbreak had significantly improved. As a case in point, the authorities had issued orders to some child care centers in Singapore to close for a certain number of days to curb the rise of HFMD among young children. Whilst the effect of such closure may not possibly be scientifically assessed, it would appear that Singapore has taken steps to avoid the mass epidemic that had struck certain provinces in China where many have lost their lives to the disease. Further, the additional powers for social distancing under the amended Infectious Diseases Act may facilitate the research and development of suitable vaccines or drugs to combat any series infectious epidemics.

Privacy of patients

One area of concern, however, is the need to strike a balance between the extent to which the Government should go to protect the public health of its citizens and the need to protect the privacy of patients. As stated above, the new amendments allow the Director of Medical Services to take residual (left-over) samples blood or body samples from healthcare institutes. Such a move begs the question of who owns these samples in the first place – the healthcare institutes or the patient itself? Should there have been an opt-out clause to allow the patients to make a determination? These issues continue to remain unanswered.

CONCLUSION

Singapore’s approach to developing the legislative infrastructure for the life sciences industry shows that it is aware of the need to strike the right balance between trying to encourage its growth and to make Singapore an attractive destination for life sciences work, whilst legislating to ensure that the life industry is properly regulated. With the life sciences facing a myriad of constantly evolving issues, it would be interesting to see how the Singapore government continues to strike this balance.

Joanna and Benjamin are part of Drew & Napier LLC’s Life Sciences business group, which is a multi-disciplinary practice group providing intellectual property, regulatory, corporate/commercial and dispute resolution perspectives and solutions to the life sciences industry.

Joanna Koh
Director (Intellectual Property)
T: +65 6531 2516
E: joanna.koh@drewnapier.com

Benjamin Gaw
Senior Associate (Intellectual Property)
T: +65 6531 2393
E: benjamin.gaw@drewnapier.com

The contents of this update are only intended to provide general information on the subject covered. Nothing in this publication should be treated as specific professional legal advice concerning any particular business, operational or other situations with which you might be faced. Drew & Napier LLC accepts no liability for, and does not guarantee the accuracy of, the information contained in this publication, and does not accept any liability for any loss or damage arising from any reliance thereon.