Health Products Act 2007.

Medicines Act 1975.

Medicines (Advertisement and Sale) Act 1955.

Poisons Act 1938.

Sale of Drugs Act 1914.

The Medicines Act and Health Products Act (and any related subsidiary legislation).

The Singapore Code of Advertising Practice (SCAP).

Guidelines issued by the HSA in relation to the advertising of or supply of health or medicinal products.

The SMA Ethical Code.

The SMC Ethical Code.

The SAPI Code of Conduct.

Direct subsidies from the government.

Medisave, a compulsory individual medical savings account scheme, where all working Singaporeans and their employers contribute part of the employee's monthly wages into the account, to save for the employee's future medical needs.

MediShield Life, a low-cost basic health insurance plan for all Singapore citizens and permanent residents, which helps to pay for large hospital bills and selected costly outpatient treatments.

Medifund, a medical endowment fund set up by the government for needy Singaporean patients, who cannot afford to pay their medical bills despite using the first three tiers of health care funding.

Community Health Assist Scheme.

Interim Disability Assistance Programme for the Elderly.

Medication Assistance Fund.

Health care professionals should place the health and welfare of patients above any financial or commercial gain.

The pharmaceutical industry should invest in research and development, to develop of new and improved treatment options for the benefit of patients and should market these treatment options ethically.

The marketing practices of the pharmaceutical industry (including in relation to promotions, gifts, symposiums or congresses, sponsorship and the supply of samples).

Consultancy arrangements between the pharmaceutical industry and health care professionals.

Integrating supply chain management across the public health care sector, to achieve better economies of scale and greater negotiating leverage.

Adopting value-based pricing, to negotiate drug prices to levels commensurate with the benefits.

Ensuring appropriate use of drugs (for example, encouraging the use of generic drugs where possible due to cost efficiency).

Prescription only medicines (POMs). POMs can only be supplied by a doctor or dentist or a pharmacist at a retail pharmacy according to a prescription by a doctor or a dentist. The advertising or sales promotion of POMs to the general public is not allowed (Therapeutic Products Advertisement Guidance).

Pharmacy only medicines (P-medicines) or General Sales List (GSL). P-medicines can be supplied by or under the supervision of a pharmacist without a prescription. GSL medicines can be purchased from any retailer. P-medicines must prominently display an advisory or warning statement (for example, statements advising consumers to read the information leaflet or product insert) and appropriate statements advising consumers to consult their healthcare professionals on the use of the medicine or if symptoms persist, and specific advisories based on what is required of that specific drug. For both P-medicines and GSL medicines, recommendations relating to the use of the product must be consistent with the HSA's approved indications.

Obtain an in-principle approval for the CPM product listing before making an application for a licence from the HAS.

Comply with the HAS's Good Distribution Practice (GDP) standard.

Offer of a gift or prize to promote sales of a medicinal product.

Use of the word "free" or "complimentary".

Use of a money-back guarantee.

Offer of a medicinal product free-of-charge with the purchase of a non-medicinal product.

Distribution of samples of Chinese proprietary medicines, traditional medicines, or homeopathic medicines.

After the expiry date stated on the label on the container or packaging of the medicinal product.

If the medicinal product is harmful, unsafe or non-conforming in terms of strength, quality or purity with the medicinal product's specification registered with the HSA or with the manufacturer's specification (for a medicinal product not registered with the HSA).

If the medicinal product contains the following toxic heavy metals exceeding the following amounts: arsenic (five parts per million (ppm)), cadmium (0.3 ppm), lead (10 ppm) and mercury (0.5 ppm).

Are naturally present in the ingredients of the medicines.

Fall within the exceptions set out in the Second Schedule to the Prohibition of Sale Order.

Supply to a person for the purposes of them supplying it again to some other person.

Supply to a person as a commercial sample in the normal course of a lawful trade.

Supply to a government department or statutory body which requires the health product for the purposes of public service or use in connection with the exercise of statutory power.

Supply to a person or institution concerned with scientific education or research which requires the health product for the purpose of education or research.

Supply to a person who requires the health product for the purpose of enabling them to comply with any requirements made by, or pursuant to, any written law with respect to the medical treatment of individuals employed by that person in any business or trade carried out by that person.

Supply to a person to use the health product, other than by way of administration to one or more individuals, for the purpose of the person's business or trade.

Supply by export to a party outside of Singapore.

Provide and maintain, or ensure the provision and maintenance of, staff, premises, equipment and facilities necessary for:

Show that the therapeutic product is imported/intended for the purposes highlighted in section 5(1)(b) of the Health Products Regulations 2016.

comply with the GDP for importers set out on the HAS's website.

Make their application in the form and manner specified on the HSA's website.

The applicant must obtain the HSA's prior approval for each consignment of the therapeutic product.

The amount of product must not exceed the approved quantity.

An application for approval must be made in the form specified on the HSA's website.

Asia Pacific Accreditation Cooperation for Testing, Calibration, Medical, Inspection, Proficiency Testing Providers, and Certification of Quality Management System, Environmental Management System, Energy Management System, Food Safety Management System and Product Certification.

International Laboratory Accreditation Cooperation for Testing, Calibration and Inspection.

International Accreditation Forum.

Whether a patent under the Patents Act 1994 is in force in respect of the product.

If the applicant is the patent proprietor, or has obtained the patent proprietor's consent.

If the patent is invalid, or will not be infringed by doing the act for which the licence is sought.

Publication in a newspaper, magazine, journal or other periodical.

Display of posters or notices.

Circulars, handbills, brochures, pamphlets, books or other documents.

Letters addressed to individuals or business entities.

Photographs or cinematograph films.

Sound broadcasting, television, the internet or other media.

Public demonstration of the use of the product.

Offer of trials of the product to the public.

Reference advertisements or trade advertisements (see Question 12).

A medical advertisement issued or published by a public authority or person authorised to issue a communication to the public, such as an advertisement by the Minster of Health. This would include, for example, public health programmes such as vaccination efforts since they are initiated by the MOH and other public authorities.

Chinese proprietary medicines.

Traditional medicines.

Homoeopathic medicines.

Quasi-medicinal products, such as medicated soaps, medicated plasters, medicated beverages, medicated toothpastes, lozenges, and vitamin and mineral preparations.

Medicated oils and balms.

Medicinal products not subject to licensing requirements, such as topical antiseptics.

Medical advertisements or sales promotion activities directed exclusively to persons who lawfully sell or supply medicinal products in the course of their trade, business or profession (such as healthcare professionals) which are not accessible to the general public.

Reference advertisements (containing a brief description of the product, its use, any contraindications and warnings appearing without charge) in a publication sent or delivered to practitioners or pharmacists by a person involved in the sale or dealings of the medicinal product (that is, not a manufacturer, supplier, retailer, importer or exporter).

Trade advertisements (in a catalogue, price list or other document for the wholesale supply) that do not contain recommendations on the product's use indicating a therapeutic classification other than as part of the product's name, or as part of any heading or sub-heading.

Advertisements distributed to relevant healthcare professionals.

Advertisements distributed at pharmaceutical trade fairs, exhibitions and scientific conferences, or forums which are restricted in attendance to medical or scientific professionals, and which are not open to the general public.

In articles for medical or scientific journals, reviews or publications.

When providing or exchanging scientific or medical information at a (private) scientific conference or forum, in accordance with its published programme or agenda.

At a (private) pharmaceutical trade fair, pharmaceutical trade exhibition, scientific conference or scientific forum. The therapeutic product must, however, be approved, licensed or registered in at least one country outside of Singapore and the advertisement must contain a statement that the product is not registered in Singapore.

Be directed, or contain any material that is directed, principally at any person below the age of 14 years.

Contain or give the impression of any endorsement or recommendation by:

Use the HAS's names or logos or those of any of its professional groups or associations.

The information must be non-promotional, consistent with its registration or supported by evidence.

The information must not contain promotional elements for the purpose of inducing sales or use of the product.

Discussion boards or forums relating to the product are not permitted.

Stop the advertisement with immediate effect.

Take reasonable and necessary measures to remove advertisements already published.

Publish a corrective advertisement in such a manner and/or containing information as specified by the HSA.

The responsible person may be guilty of an offence and liable on conviction to fines of up to SGD20,000, imprisonment of up to 12 months, or both.

The HSA will be authorised to take such steps as it thinks reasonable and necessary to implement the requirements of the order and can recover any costs and expenses reasonably incurred by it from the individual in so doing.

Substantiate all assertions of uniqueness and prominence with facts or objective evidence.

Not discourage the reader from medical or professional advice.

Not encourage inappropriate or excessive use.

State the nature, quality and properties of the product truthfully.

Not directly or indirectly cause fear, alarm or distress to consumers.

Not abuse the trust or exploit the lack of knowledge of consumers.

Not contain any claim or statement of guaranteed results, or that the product is free from side effects.

Not offer to refund money to users.

Not falsely indicate or suggest that the use of the product is promoted, supported, or endorsed by the government or any public authority.

Not contain material directed exclusively or principally at children under the age of 14 years.

Not include any recommendation by any health care professional, or any person with a celebrity, social or professional status that is likely to encourage the use of the product.

Not compare or contrast the therapeutic product with other named products or their brands (if the advertisement is directed at the public).

A medicinal product, in connection with the sale of that product.

Medicinal products of a particular description to a person, to induce that person to purchase them from a retailer.

Offering prizes through activities such as lucky draws, dips and contests as an inducement to purchase the therapeutic product.

Offering medicinal or health products with a therapeutic product.

Offering samples of the therapeutic product.

Agency for Care Effectiveness (ACE). This is the national health technology assessment (HTA) agency in Singapore within the MOH. ACE reviews clinical and economic evidence to determine how well health technologies (such as drugs, vaccines and medical devices) work in relation to how much they cost. The information is then used by MOH to make funding recommendations for public hospitals.

Consumer Engagement and Education (CEE). This was set up in 2021 to help patients, caregivers and the public become involved in ACE's work. Moving forward, the CEE will be inviting patient and volunteer organisations to provide input on ACE's HTA evaluations to ensure its recommendations are relevant to those affected by them.

After patients provide their input, they receive early feedback from ACE on the usefulness of their input along with suggestions for specific information to close gaps if necessary.

After a decision on funding is made, ACE shares details with the patients on how their input was used in its deliberation and the types of input it found most useful. This is then shared with other organisations providing input in the future.

Qualified practitioners.

Registered pharmacists.

Enrolled nurses, registered nurses and registered midwives.

Persons undergoing training with a view to becoming qualified practitioners, registered pharmacists, enrolled nurses, registered nurses or registered midwives.

The Health Products Act and the Medicines Act, and their subsidiary legislation, including the Health Products (Advertisement of Therapeutic Products) Regulations 2016 (Therapeutic Products Advertisements Regulations) and the Medicines (Medical Advertisements) Regulations.

The HSA Explanatory Guidance to the Therapeutic Products Advertisements Regulations (Therapeutic Products Advertisement Guidance).

The HSA Guide on Advertisements and Sales Promotion of Medicinal Products.

The SMC Ethical Code and Ethical Guidelines (2016 edition), and the accompanying SMC Handbook on Medical Ethics.

The offer of a prize as an inducement to purchase a therapeutic product.

Issuance of any false or misleading advertisements, and making false or misleading representations to practitioners, to induce them to prescribe or supply medicinal products.

Acceptance of gifts, promotional items and educational materials by doctors.

Invitations from pharmaceutical companies for doctors to travel overseas to attend medical conferences and associated travel grants.

A patient referral to a doctor should be in the patient's best interests, based on the doctor's expertise and reputation and not because the doctor has paid for the referral.

Any referral fees must reflect the fair work done by third party in handling and processing patients.

Any referral fees payable to third parties must be communicated and transparent to the patient.

Are based primarily on the services the doctors provide or the fees doctors collect.

Are so high as to constitute "fee splitting" or "fee sharing."

Render doctors unable to provide the required standard of care.

Be new.

Involve an inventive step.

Be capable of industrial application.

A method of treatment of the human or animal body by surgery, therapy or of diagnosis practised on the human or animal body, as it is not considered to be capable of industrial application (section 16(2), Patents Act).

An invention, the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour (section 13(2), Patents Act).

Notice of eligibility to proceed to the grant of a patent. The applicant can file a request for grant of the patent with the necessary fees within two months from the date of issue of the notice (section 30, Patents Act read with Rule 47, Patents Rules). The Registrar will then grant the patent by issuing to the patent proprietor a certificate of grant and publishing a notice of grant in the journal (section 35, Patents Act).

Notice of intention to refuse the application, based on objections disclosed in the examination report. The applicant can file a request for a review of the examination report within two months from the date of issue of the notice (section 29B, Patents Act read with Rule 46A, Patents Rules). An examination review report will then be issued. If there are still unresolved objections, the Registrar will issue a notice of refusal of the application. The application is deemed refused when two months have passed from the time the notice of refusal is forwarded to the applicant. If there are no remaining objections, a notice of eligibility is issued to require the applicant to file a request for grant (with payment of the grant fees) within two months from the date of the notice.

There was an unreasonable delay by the Registrar of Patents in granting the patent.

The patent was granted on the basis of prescribed documents relating to a corresponding patent application, there was an unreasonable delay in issuing the corresponding patent, and the patent office that granted the corresponding patent has extended the term of the corresponding patent because of that delay.

The subject of the patent includes an active ingredient of a pharmaceutical product, and there has been an unreasonable curtailment of the opportunity to exploit the patent because of the need to obtain marketing approval for the first pharmaceutical product using that substance as an active ingredient, and the patent term has not been previously extended on this ground.

Makes, disposes of, offers to dispose of, uses or imports the invention product, or keeps it for disposal or otherwise.

Uses the invention process or offers it for use in Singapore when they know, or it is obvious to a reasonable person in the circumstances, that such use without the proprietor's consent will infringe the patent.

Disposes of, offers to dispose of, uses or imports any product obtained directly by means of the invention process, or keeps any such product for disposal or otherwise.

Is done privately and for non-commercial purposes.

Is done for experimental purposes relating to the subject-matter of the invention.

Consists of the extemporaneous preparation of a medicine for an individual in accordance with a prescription by a registered medical or dental practitioner, or consists of dealing with a medicine so prepared.

Is done in relation to the subject-matter of the patent to support an application for marketing approval for a pharmaceutical product, provided anything used to support the application is not made, used or sold in Singapore, or exported outside Singapore.

Consists of the import, disposal or offer to dispose of a patented pharmaceutical product for use by or on a specific patient in Singapore, if certain conditions are met.

An injunction (including an interim injunction).

A court order for the infringer to deliver up or destroy infringing products.

Damages or an account of profits (a court will not award both for the same infringing act (section 67(2), Patents Act)).

A declaration that the patent is valid and was infringed by the infringing party.

Acts that done for experimental purposes relating to the subject matter of an invention would not constitute patent infringement (section 66(2)(b)).

Bolar exemption. This is a legal exemption from infringement that can be used when a third party "infringer" can prove that the acts (which otherwise would have been infringing) were done for the purposes of meeting the marketing approval requirements for the pharmaceutical product. The primary purpose of the bolar exemption is to protect parties that would be infringing, so that they can conduct research and/or trials to prove that their generic version of the product is the bioequivalent of the patented drug, or when they may, in the course of obtaining marketing approval for the release of a drug in Singapore, inadvertently infringe a patent.

Acts done privately and for non-commercial purposes (section 66(2)(a), Patents Act).

Acts involving the extemporaneous preparation of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner, or when such a person deals with a medicine so prepared (section 66(2)(c), Patents Act).

Acts that involve the use of a product or process in the body or operation of a relevant aircraft, hovercraft or vehicle which has temporarily or accidentally entered or is crossing Singapore (including the airspace above it and its territorial waters) or the use of accessories for such a relevant aircraft, hovercraft or vehicle (section 66(2)(d), Patents Act).

Acts involving the use, exclusively for the needs of a relevant ship, of a product or process in the body of the ship or in its machinery, tackle, apparatus or other accessories, when the ship has temporarily or accidentally entered Singapore's territorial waters of (section 66(2)(e), Patents Act).

Acts involving the use of an exempted aircraft that has lawfully entered or is lawfully crossing Singapore as mentioned in section 66(2)(d) of the Patents Act, or in relation to the importation into Singapore, or the use or storage, of any part or accessory for that aircraft (section 66(2)(f), Patents Act).

A sign (as defined in section 2(1), Trade Marks Act).

Capable of being represented graphically.

Distinctive (capable of distinguishing goods or services dealt with or provided in the course of trade).

Do not satisfy the legal criteria (see above).

Are contrary to public policy or morality.

Agreements between undertakings, decisions by associations of undertakings or concerted practices which have as their object or effect the prevention, restriction or distortion of competition within Singapore (Section 34 Prohibition).

Undertakings from abusing their dominant positions in any market in Singapore (Section 47 Prohibition).

Mergers that have resulted, or may be expected to result, in a substantial lessening of competition within any market in Singapore for any goods or services (Section 54 Prohibition).

Impose a fine up to 10% of the undertaking's annual turnover in Singapore for each year of infringement, up to a maximum of three years.

Issue directions to modify or cease behaviour, and/or require other necessary activity to end the infringement.

GSK Trading Services Limited's acquisition of distribution and marketing rights in Singapore from UCB Singapore Pte Limited (2009).

Novartis AG's acquisition of shares in Alcon Inc (2010).

Fresenius Medical Care Beteiligungsgesellschaft mbH and Fresenius Medical Care AG & Co KGaA's acquisition of Asia Renal Care Limited (2010).

The proposed Acquisition by Johnson and Johnson of Synthes Inc (2012).

Asia Renal Care (SEA) Pte Limited's acquisition of shares in Orthe Group (2012).

Fresenius Medical Care Singapore Pte Limited's acquisition of shares in RenalTeam Pte Limited (2020).

The proposed acquisition by Thermo Fisher Scientific Inc of PPD Inc (2021).

Parkway would have become the only commercial supplier of radiopharmaceuticals in Singapore.

In relation to providing radiology and imaging services, the merged entity would have had a very substantial market share, the merger companies were each other's closest competitors, entry barriers are moderate to high and the bargaining power of customers is weak.

A substantial lessening of competition would have been likely due to vertical integration of the merger parties' operations. The merged entity would have been able to restrict competition in the market for radiology and imaging services by controlling supply, prices and/or a range of radiopharmaceuticals available to its downstream competitors.

Supply tests at fair, reasonable and non-discriminatory rates to certain customers .

Remove exclusivity obligations in new and renewed agreements.

Allow for early termination without cause.

Not increase its prices.

Maintain the same terms and conditions as those set out in its existing agreements with certain customers.

The product has not previously been sold or distributed in Singapore by or with the consent of the patent proprietor or any person licensed by them.

The import will result in the product being distributed in breach of a contract between the patent proprietor and a person licensed by the patent proprietor to distribute the product outside Singapore, and the importer has actual or constructive knowledge of the breach.

Grantbacks. The licensee agrees to assign to the licensor rights to any improvements it may make to the licensed technology. This may have pro-competitive effects, for example, if it increases the licensor's incentive to license or promote dissemination of the improvements. However, anti-competitive concerns may arise if it significantly reduces the licensee's incentive to conduct research and development (R&D) and thereby restrict innovation.

Technology pools. At least two parties create a pool of technology which they cross-license as a package to each other and third parties. This is generally pro-competitive if the technologies in the pool are essential and complementary to each other. However, if the pool is largely made up of technologies that are solely or mainly substitutable with each other, the pooling may be an anti-competitive agreement in breach of the Section 34 Prohibition. In assessing if anti-competitive effects arise, the CCCS will consider the risk of foreclosing alternative technologies that are not in the pool. Furthermore, competition concerns may also arise if pool members discriminate against non-member licensees, restrict the independent licensing of the patents, or use the pool to share confidential business information so as to reduce competition in a downstream market.

Non-challenge clauses. The licensee agrees not to challenge the validity of the licensor's IP right. This includes clauses stipulating the licensor's right to terminate a licensing agreement if the licensee were to challenge the validity of any IP right of the licensor. These types of clauses may be anti-competitive, but the CCCS will consider various factors such as:

Refusal to supply a licence. An IP right owner can generally decide who to license its technology to. However, in certain circumstances a refusal to license by a dominant licensor may give rise to anti-competitive effects in breach of the Section 47 Prohibition, for instance if it refuses to license access to technology that is an essential facility. A facility may be seen as essential if there are no potential substitutes (through duplication or otherwise) and it is indispensable to the exercise of the activity in question.

Tying. If a dominant licensor, as a condition of granting a licence, requires licensees to buy additional products unrelated to the technology being licensed, this may result in anti-competitive effects in breach of the Section 47 Prohibition. It is open to the dominant licensor to objectively justify its conduct by showing, for example, that buying the additional products is necessary for the satisfactory exploitation of the licensed technology.

R&D. Licensing agreements which, directly or indirectly, restrict the ability or incentive of any of the parties to carry out independent R&D, including independent R&D with third parties, may have anti-competitive effects. In determining whether such agreements are likely to be in breach of the Section 34 Prohibition, the CCCS will consider whether the restriction is indispensable to prevent the disclosure of licensed know-how to third parties. To be covered by the exception, the restrictions imposed to protect the licensor's know-how against disclosure must be necessary and proportionate to ensure such protection. For instance, where the agreement designates particular employees of the licensee to be trained in and responsible for the use of the licensed know-how, it may be sufficient to oblige the licensee not to allow those employees to be involved in R&D with third parties. Licensing Approvals and Formalities

For patents, registration allows a person who acquires rights under the registered transaction to be entitled against a person claiming rights under an earlier transaction, provided that at the time of the later transaction, the earlier transaction was not registered, and the person claiming under the later transaction did not know of the earlier transaction (section 43, Patents Act).

For trade marks, a similar rule applies to certain transactions (for example, an assignment of a registered trade mark) but not to a grant of a licence (sections 39(3) and 39(5), Trade Marks Act).

For patents, a patent proprietor or licensee will not be awarded damages or an account of profits in a patent infringement action occurring before a registrable transaction is registered, unless the transaction is registered within six months of its occurrence (or the court or IPOS Registrar is satisfied that it was not practicable to register the transaction in this period and it was registered as soon as practicable thereafter) (section 75, Patents Act).

For trade marks, there is a similar restriction on claiming damages, an account of profits or statutory damages for infringement occurring before registration of certain transactions (for example, an assignment), but this does not apply to a grant of a licence (sections 39(4) and 39(5), Trade Marks Act).

Pre-Market Cluster (Therapeutic Products, Medical Devices, Complementary Health Products, Clinical Trials and Advanced Therapy Products branches).

Post-Market Cluster (Vigilance and Compliance, Enforcement, Tobacco Regulation, Audit and Licensing and Certification branches).

Group Director's Office and Stakeholder Engagement Office.

There was a duty of care owed by the person committing the tort to the consumer.

The person committing the tort did not meet a reasonable standard of care, as determined by the court.

The injury to the consumer is causally linked to the person committing the tort's act and the injury was reasonably foreseeable, as determined by the court.

The elements of the tort of negligence are not made out (for example, that the duty of care was not owed, or the standard of care was not breached).

Contributory negligence or voluntary assumption of risk.

For breach of contract cases, certain vitiating factors such as frustration, mistake, misrepresentation, illegality and unfairness.

Statutory defences for offences under the Medicines Act and the Health Products Act.

General damages for:

Special damages for pre-trial pecuniary loss, including: