The Pharma Legal Handbook: Malaysia
The Pharma Legal Handbook: Malaysia answers essential questions about the legal and regulatory environment for pharmaceuticals in Malaysia. It is a must-have for any company operating in the country or looking to enter the market.
Prepared in association with Skrine, a leading Malaysian law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents, medical cannabis, cannabinoid medicines and opioids.
October 2019
1. Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs: Malaysia
Cannabinoid drugs, medicinal cannabis and opioid drugs in Malaysia – a comprehensive legal overview. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.
CANNABINOID DRUGS
1. Are Cannabinoid Drugs authorized in your country?
The Malaysian regulatory authority does not authorise the use or sale of any specific drug per se, i.e. cannabinoid drugs, rather it regulates the registration of products which may include cannabinoid drugs as an active ingredient of such products. Products are registered on a case by case basis.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The primary authority with jurisdiction over Cannabinoid Drugs is the National Pharmaceutical Regulatory Agency (NPRA) established under the Ministry of Health (MOH) of Malaysia.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
We are not aware of any such regulatory framework in Malaysia. The only relevant regulatory framework lies in the registration of a product which may include Cannabinoid Drugs as an ingredient, and this would be carried out in accordance with the general authorisation, pricing and reimbursement scheme for registration of any product, medicine or device.
4. Which are the cannabinoid drugs that have received market approval to date?
Please see our comments in Question 1 above – there is therefore no Cannabinoid Drugs per se that has been approved to date.
5. Who can prescribe Cannabinoid Drugs?
We are not aware of anyone who can prescribed Cannabinoid Drugs. Upon registration of a product containing Cannabinoid Drugs however, any registered medical practitioner, registered dentist and registered veterinarian may prescribe the said product.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
We are not aware of any list of doctors who are authorised to prescribe Cannabinoid Drugs. As long as a product containing Cannabinoid Drugs is registered, any doctor registered with the relevant council may prescribe the use of the said product.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
We are not aware of any approval or notification required to prescribed Cannabinoid Drugs. The only approval we are aware of is from the NPRA for the registration of products containing Cannabinoids.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
We are not aware of any organisations authorised to sell/distribute Cannabinoid Drugs. Upon registration of a product it may be prescribed by a registered medical practitioner, registered dentist or registered veterinaries who would be authorised to sell/distribute the product containing the Cannabinoid Drug or by a licenced pharmacist.
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
We are not aware of any list of retailers/distributors authorised to sell Cannabinoid Drugs in Malaysia.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
We are not aware of any current proposal or reforms to the regulation of Cannabinoid Drugs. But we are made to understand that there are proposal and reforms to the status, legality and authorisation of Cannabis which may affect the status of Cannabinoid Drugs in the future. This is elaborated in Question 13 below.
11. When are they likely to come into force?
Not applicable.
MEDICINAL CANNABIS
12. Is Medicinal Cannabis authorized in the country?
The Malaysian regulatory authority does not authorise the use or sale of Cannabis in Malaysia. It recognises the strains of active ingredients in Cannabis which is used in products that are registered with the relevant authority. Such products are registered on a case by case basis. In addition, Cannabis is a drug controlled under the Dangerous Drug Act 1952 (“DDA 1952”) and in accordance with the provisions of that Act, the Minister charged with the responsibility for medical and health services (“the Health Minister”) may authorise the cultivation of Cannabis for medicinal purposes, however to date, no such authorisation has been granted.
13. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The primary authority with jurisdiction over Cannabis is the NPRA as is with all substance deemed to be a Dangerous Drug.
14. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
Whilst there are statutory provisions which empowers the Health Minister to regulate the authorisation of Cannabis for medicinal purposes, there is to date no such regulatory framework in place. The only relevant regulatory framework lies in the registration of a product which may include Cannabis as an ingredient, and this would be carried out in accordance with the standard authorisation, pricing and reimbursement scheme for registration of any product, medicine or device.
15. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
The production (manufacturing) and importation of medicinal cannabis is regulated by the NPRA. No cannabis, even for medicinal purposes, may be imported or produced without authorisation from the Health Minister. The NPRA does not authorise or regulate the production or importation of Cannabis, even for medicinal purpose but rather it regulates the production and import of products, which may contain Cannabis as an ingredient. In any event, all such products must be registered with NPRA.
16. What approval or notifications are necessary to produce or import Medicinal Cannabis?
The production and/or cultivation of Cannabis for medical purposes can only be authorised by the Health Minister and we are not aware of any such authorisation that has been issued to any person(s). Where any person(s) intend to import a dangerous drug, such as Cannabis, into Malaysia, an import authorisation in the prescribed form (Form C of the DDA 1952) must be approved by the Health Minister who will then issue an import certificate according to the prescribed Form A set out in the Second Schedule of the DDA 1952 which must be forwarded by the intending importer to the person from whom the drug is to be obtained. If the importer to whom the import authorisation is issued intends to import the drug in more than one consignment, a separate approval of import certificate must be obtained for each consignment.
17. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Cannabis cannot be marketed and distributed in Malaysia, even for medical purposes.
18. How can patients obtain Medicinal Cannabis?
Patients cannot obtain Medicinal Cannabis per se, only the products which may contain Cannabis as an ingredient. In the event that Health Minster approves of the importation of Cannabis in accordance with the procedure stated in Question 16 above, it can only be prescribed by licenced bodies or registered medical practitioners, registered dentists and registered veterinarians authorised by the Health Minister to make such prescriptions.
19. Who can prescribe Medicinal Cannabis?
We are not aware of anyone who can prescribe Medicinal Cannabis.
20. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
We are not aware of any list of doctors authorised to prescribe Medicinal Cannabis.
21. What approvals or notifications are required to prescribe Medicinal Cannabis?
We are not aware of any approval or notification required to prescribe Medicinal Cannabis as this is not permitted in Malaysia. The only approval required, is from the NPRA for the registration of products which may contain Cannabis as an ingredient for medicinal purposes.
22. Where is Medicinal Cannabis available?
We are not aware of anywhere in Malaysia which Medicinal Cannabis is made available.
23. Is there a list of retailers authorized to sell Medicinal Cannabis?
We are not aware of any list of reatilers who are autorished to sell Medicinal Cannabis.
24. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
We are made to understand that the Malaysia Psychiatric Association has called on the government to set up a review committee, consisting of medical and legal professionals, academicians and researchers, and other stakeholders in the community to review the status of medical cannabis before deciding on the legalisation of Cannabis in Malaysia as a whole.1 However, as of June 2021, there is no indication that medical cannabis is set to be legalised in Malaysia.
OPIOID DRUGS
25. Are Opioid Drugs authorized in your country?
Yes, opioids are controlled drugs under the Dangerous Drugs Act 1952 and are commonly used in Malaysia. The types of opioids used in particular are weak opioids i.e. dihydrocodeine, tramadol and tramadol combinations rather than strong opioids i.e. morphine, oxycodone, pethidine and fentanyl.2
26. What are the regulatory authorities with jurisdiction over Opioid Drugs?
The primary regulating authority on the possession, importation and exportation of raw opium is the NPRA under the MOH. In addition, the Poisons Board is an advisory board which reviews the list of poisons including opioid and is called upon to advise the Minister of Health on matters relating to poisons. The NPRA has jurisdiction over the registration of any drug-related product including those with opioid constituents.
27. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Opioid Drugs?
We are not aware of any regulatory framework for the authorisation of Opioid Drugs per se, rather all products constituting any traces of various types of Opioids as an active ingredient must go through the necessary registration with NPRA, without which it cannot be sold or used in Malaysia. We are also not aware of any regulatory framework for the pricing and reimbursement of Opioid Drugs.
28. Which are the Opioid drugs that have received market approval to date?
We are not aware of any Opioid drugs that have received market approval to date. However, there have been products registered in Malaysia which include Opioid Drugs as an active ingredient such as tramadol, codeine, dihydrocodeine morphine, oxycodone, pethidine, fentanyl and methadone.
29. Who can prescribe Opioid Drugs?
Opioid drugs are considered psychotropic substances and are thus regulated by the Poisons (Psychotropic Substances) Regulation 1989. Under the said regulation only a specific class of persons is permitted to possess psychotropic substances, and only a registered medical practitioner, registered dentist Division I, a veterinary surgeon or a person acting in accordance with the direction of a registered medical practitioner, registered dentist Division I or a veterinary surgeon is permitted to prescribe these psychotropic substances, like products containing Opioid Drugs.3
30. Is there a list of doctors authorized to prescribe Opioid Drugs?
We are not aware of any list of doctors authorised to prescribe Opioid Drugs.
31. What approvals or notifications are required to prescribe Opioid Drugs?
The main requirement for the prescription of psychotropic substances including Opioid Drugs as an active ingredient, is that the prescriber must be registered with the appropriate authorities, for medical practitioner with the Malaysian Medical Council, for dentists with the Malaysian Dental Council and for veterinarians with the Malaysian Veterinary Council.
32. Which organizations are authorized to sell/distribute Opioid Drugs available?
The only person(s) permitted to dispense any psychotropic substance whether or not for medical, dental or animal treatment is a licensed pharmacist or a pharmacist in the public service.
33. Is there a list of retailers/distributors authorized to sell Opioid Drugs?
We are not aware of any list of retailers/distributors authorised to sell Opioid Drugs in Malaysia.
34. Are there proposals for reform or significant change to the regulation of Opioid Drugs?
We are not aware of any proposals for reform or significant change to the regulation of Opioid Drugs given that these drugs are not being regulated in their raw form. We are not aware of any plans to reform the registration of products containing Opioid Drugs as active ingredients.
35. When are they likely to come into force?
Not applicable.
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- Set up medical marijuana review committee, says psychiatric association, The Star Online, 2018 at: https://www.thestar.com.my/news/nation/2018/10/09/set-up-medical-marijuana-review-committee/
- Trends and patterns of analgesic prescribing in Malaysian public hospitals from 2010 to 2016: tramadol predominantly used, US National Library of Medicine National Institutes of Health, Journal of Pain Research., Dovepress. 2018 at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6160284/
- Regulation 3 and regulation 16 of the Poisons (Psychotropic Substances) Regulations 1989.
Click the following links to read more legal articles from Malaysia:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Also from this Legal Handbook
2. Regulatory Reforms: Malaysia
An insight into regulatory reforms in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.
1. Are there proposals for reform or significant change to the healthcare system?
The followings are some of the regulatory proposals and reforms in the pharmaceutical industry in Malaysia:
i) online registration system. In 2017, the NPRA, MOH officially launched the upgraded online registration system, QUEST3+ including a membership registration module, a helpdesk module, admin module and cosmetic notification module and offer online payment services;
ii) online ADR reporting system. In 2017, the NPRA also launched an online ADR reporting system known as ConSERF Online;
iii) development of the Malaysian herbal monograph. This monograph was established under the National Key Economic Areas and the project has developed 10 herbal monographs which aids in ensuring that the production of local traditional products are safe, of high quality, competitive and comply with international standards;
iv) In 2006, the Malaysian National Medicines Policy (MNMP) was established to meet the Malaysian healthcare needs. Under this policy the Pharmacy Research Priorities was issued in order to further support the 11th Malaysia Plan, Ministry of Health Strategic Plan 2016-2020 and the Pharmacy Programme Strategic Plan 2017-2010. The report suggested that the areas which are given priority for research are as follows:
-
- access to medicines
- monitoring and evaluation of outcomes
- quality and safe use of medicine and sustainability
- optimization of therapy and pharmacy services delivery
- national databases/big data analytics, the aim of this Pharmacy Research Priorities gives an indication of the areas that will be focused on by individuals and healthcare organisations who conduct pharmacy researches in Malaysia;
v) price controls on pharmaceuticals and professional fees to reduce the costs incurred by the population. The Malaysian government published guidelines on professional fees under the Private Health Care Facilities and Services Act 1998 and 2006 Regulations. The Malaysian Medical Association also issued a recommended fee schedule that is now in place as a benchmark for professionals;
vi) advertisement of medical devices. The MDA has prepared a draft Code of Advertising for Medical Devices with the aim to help the industry and healthcare professional in complying with the Medical Device Act 2012 and MDA’s regulations.
The following are the 2021 budget updates with regard to the healthcare industry and the Covid-19 pandemic:
While the 2021 budgets shows massive cuts across all healthcare specialties, massive changes were also announced during budget 2021 as a means of combating the Covid-19 Pandemic. These include inter alia: (i) The National Development Scheme, with a budget of RM1.4 billion. This programme helps to strengthen the domestic supply chain and boosts the manufacturing of medical devices made locally. (ii) There are also RM1.4 billion in concessions for the privatisation of medical laboratories and stores. (iii) The Peka B40 project, which has a budget of RM80 million, aims to meet the non-communicable disease (NCD) healthcare needs of the bottom 40% of the population (B40). (iv) specific programme allocation of RM2.89 billion for health facilities and medical supplies is also included in the budget. (v) The Malaysian government is allocating RM35 million (US$8 million) to the Malaysia Healthcare Travel Council in order to boost the local health tourism industry’s competitiveness. Malaysian income tax exemptions for the export of private healthcare services will be extended through the 2022 assessment year.
2. When are they likely to come into force?
Many of the proposals and recommendations for the healthcare industry are still in the research and/or discussion stages and we therefore cannot confirm any fixed date for the implementation of any of the proposed reforms.
Click the following links to read more legal articles from Malaysia:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Also from this Legal Handbook
3. Patents and Trademarks: Malaysia
The key facts about patents and trademarks in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.
1. What are the basic requirements to obtain patent and trademark protection?
- Patent and trademark laws in Malaysia are mainly codified in statutes, but its jurisprudence is derived from the United Kingdom’s common law. Thus, there are similarities between the two jurisprudences, including the recognition of the tort of passing off as a cause of action.
- The Patents Act 1983 (“PA 1983”) provides for the protection of patentable inventions and utility innovations. An invention may be or may relate to a product or a process.1 A patentable invention must2 (i) be novel, (ii) involve an inventive step, and (iii) be industrially applicable. An innovation includes a new product or process, or any new improvements to a known product or process, including an invention3 To obtain utility innovation protection, the innovation must4 be (i) new, and (ii) industrially applicable.
- Trademark protection is now governed by the Trademarks Act 2019 (“TMA 2019”) which repealed Trade Marks Act 1976. The TMA 2019 explicitly affords protection to non-traditional signs such as shape of goods or their packaging, colour, sound, scent, hologram, positioning, and sequence of motion, so long as5 the sign is (i) capable of being represented graphically, and (ii) capable of distinguishing goods or services of one undertaking from another. Prior use is not necessary to apply for the registration of a trademark; a bona fide proprietor may apply if the proprietor is using or intends to use the trademark in the course of trade.6
2. What agencies or bodies regulate patents and trademarks?
- The Intellectual Property Corporation of Malaysia (“MyIPO”), which houses the Registrar of Patents and the Registrar of Trademarks, is the agency responsible for regulating the registration or recordal of intellectual property rights in Malaysia.
- While the Registrar of Trademarks may hear applications to revoke a registered trademark and preside over opposition proceedings under certain provisions of the TMA 2019, the Registrar of Patents does not have similar powers for patents under the PA 1983. There are no opposition proceedings under the PA 1983 and invalidation actions are heard by the High Court at first instance.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
1. The PA 1983 proscribes the following as non-patentable inventions7 (and innovations)8:
- discoveries, scientific theories, and mathematical methods;
- plant or animal varieties or essentially biological processes for the production of plants or animals, other than man-made living micro-organisms, micro-biological processes, and the products of such micro-organism processes;
- schemes, rules, or methods for doing business,
- performing purely mental acts or playing games;
- methods for the treatment of human or animal body by surgery or therapy, and diagnostic methods practiced on the human or animal body (except for products used in any such methods);
2. The Registrar of Patents will also refuse to grant patent protection9 (or utility innovation protection)10:
- where the performance of any act in respect of the claimed invention is contrary to public order or morality;
- where it appears that the grant of patent protection would be prejudicial to the interest or security of the nation.
3. The application for the registration of a trademark may be refused for various reasons including the following non-exhaustive list11:
- if the use of the trademark is likely to deceive or cause confusion to the public or contrary to any written law;
- if it is of such a nature as to deceive or mislead the public as to the nature, quality or geographical origin of the goods or services;
- the trademarks are contrary to public interest or to morality;
- the trademarks contain or consist of any scandalous or offensive matter or would otherwise not be entitled to protection by any court of law;
- the trademarks contain a matter which is in the opinion of the Registrar is or might be prejudicial to the interest or security of the country;
- the trademarks contain or consist of the name or representation of another person whether living or dead unless the applicant furnishes the Registrar with the consent of that person, if living, or of the representative of that person if deceased;
- the trademarks contain or consist of a flag of a country, national emblem, emblem, insignia or royal arms unless the applicant furnishes the Registrar with the authorisation of the competent authorities or international intergovernmental organisation;
- the trademarks contain or consist of a word which is commonly used as or is the accepted name of any single chemical element or single chemical compound, as distinguished from a mixture, or which is declared by the World Health Organization as an international non-proprietary name or which is deceptively similar to such name (there are exceptions to this);
- the trademarks contain or consists of “Patent”, “Patented”, “By Royal Letters Patent”, “Registered”, “Registered Design”, and “Copyright” or words to the like effect in any language whatsoever, or a sign similar to any of those signs as is likely to be taken for that sign; or
- if the trademark is identical or there is a likelihood of confusion with an earlier trademark and the goods or services for which the trademark is applied for are identical with the goods or services of the earlier trademark.
4. How can patents and trademarks be revoked?
1. Patent and utility innovation invalidation actions must be filed in the High Court, not at the Registry of Patents. Grounds for invalidation include12:
- the invention or innovation does not fulfil the requirements set out in the PA 1983;
- the invention or innovation is excluded from protection under the PA 1983;
- the description or claim does not comply with the requirements of the PA 1983 and the Patent Regulations 1986 (“PR 1986”);
- the necessary drawings have not been furnished to the Registry;
- the right to the patent or utility innovation does not belong to the person to whom the patent was granted;
- incomplete or incorrect information has been deliberately provided or caused to be provided to the Registrar of Patents.
2. Under the TMA 2019, the Registrar of Trademarks has the power to revoke the registration of a trademark where:
- the Registrar failed to take into account (i) a validly filed notice of opposition or (ii) a validly filed application for extension of time to oppose the registration, when it decided to register the trademark13, or
- if the Registrar is satisfied that the registration should be revoked considering Malaysia’s obligations under an international agreement or convention or any special circumstances.
3. An aggrieved person may apply to the High Court for the revocation of a trademark registration on, among others, the following grounds14:
- if there is no good faith use of the trademark for a continuous period of three years and there are no proper reasons for the non-use;
- in the instance of genericide as a result of any action or omission on the part of the registered proprietor;
- if the use of the trademark is liable to mislead the public;
- if the application for registration should have been refused by the Registrar of Trademarks based on the absolute grounds for refusal of registration such as if the trademark is not capable of distinguishing the registered proprietor’s goods or services or is devoid of distinctive character, or if the trademark consists exclusively of signs or indications which may serve, in trade, to designate the characteristics of the goods or services, or if the trademark consists exclusively of signs or indications which have become customary in the local language or established practices of the trade;
- if there is an earlier trademark right;
- if the registration was obtained by fraud or misrepresentation.
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
- Patent applications may claim priority of one or more earlier national, regional, or international applications filed pursuant to the Paris Convention for the Protection of Industrial Property or the Patent Cooperation Treaty.15 The Malaysian application must be made within 12 months of the earlier application.16
- The PR 1986 allows requests for modified substantive examination (a simplified examination process) of international applications to be made if a corresponding Australian, Japanese, South Korean, UK, US, or European patent has been granted for the same invention.17
- Malaysia has acceded to the Madrid Protocol and under the TMA 2019, brand owners may designate Malaysia in the international applications for registration of trademarks.
- Separately, trademark applications may claim priority from applications filed in a member state of the Paris Convention18 or any country declared to have arrangements with Malaysia for the reciprocal protection of trademarks.19 The Malaysian application must be made within 6 months of the earlier application.20
- An applicant for registration of a trademark may apply for temporary protection of a trademark which is the subject matter of an exhibition at an official or officially recognised international exhibition held in Malaysia or in any member state of the Paris Convention or declared foreign country.21
- A well-known trademark is entitled to protection regardless if the trademark has been registered in Malaysia or if the proprietor does not carry on business or has any goodwill in Malaysia.22
6. Are there any non-patent/ trademark barriers to competition to protect medicines or devices?
- All medicines must obtain prior marketing authorisation from the National Pharmaceutical Regulatory Agency. The marketing authorisation holder may also apply for data exclusivity.
- All medical devices must register with the Medical Device Authority prior to being imported, exported, or placed in the market. Any establishment intending to import, export, or place in the market any registered medical device must first obtain an establishment license from the Medical Device Authority.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
There are no specific restrictions on the types of medicines or devices that can be granted patent or trademark protection save for the general restrictions as described above.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
- The PA 1983 is equivocal as to whether a patent licence agreement must be entered into the Register of Patents; it provides that “where a licence contract is concluded between the parties, the contracting parties shall inform the Registrar accordingly”23. It is unclear as to whether this provision applies to all licence agreements or only licence agreements which have been initiated or negotiated by way of the mechanism set out in the preceding sub-sections 42(1) and 42(2). This issue has yet to be determined by the Malaysian courts but there may be risks associated with not recording such licences if the Malaysian courts ultimately determine that section 42(3) renders such recordals mandatory, including potential quasi-criminal liabilities for causing false entries in the Register.24 it is advisable that out of abundance of caution, all licence agreements are to be entered into the Register.
- The TMA 2019 suggests25 that a licence agreement should be approved by the Registrar of Trademarks, but the consequences for failure to apply for approval do not appear to apply to licence agreements.26 The TMA 2019 deems27 notice of a licence if the particulars of the licence have been entered in the Register, but the provision does not mandate a requirement to apply for approval of the licence agreement. Unlike the position under the Trade Marks Act 1976, the TMA 2019 allows28 for licensees to take action against infringers in certain circumstances and in relation to revocation actions for non-use, the TMA 2019 will consider use with the registered proprietor’s consent29 to be use of the trademark without having to register the licence agreement. However, there may still be some risks associated with the non-registration of licence agreements: paragraph 12(1) of the Guidelines of Trademarks 2019 issued by the MyIPO suggests that the MyIPO requires the particulars of licensing agreements to be registered and the TMA 2019 requires compliance30 with guidelines issued by the Registrar of Trademarks. Failure to comply may render an application as withdrawn, lapsed, refused, revoked, or as determined by the Registrar or may be an offence and shall, on conviction, be liable to a fine not exceeding MYR10,000.00.31
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- PA 1983, section 12
- PA 1983, section 11
- PA 1983, section 17
- PA 1983, section 17
- TMA 2019, section 3(1)
- TMA 2019, section 17(1)(a)
- PA 1983, section 13(1)
- PA 1983, section 17A(1)
- PA 1983, sections 31 and 85
- PA 1983, section 17A
- TMA 2019, sections 23(1), 23(5) and 24
- PA 1983, sections 17A and 56
- TMA 2019, section 4591)
- TMA 2019, sections 46 and 47
- PA 1983, section 27(1)
- PA 1983, section 27(1A)
- PR 1986, regulation 27A
- TMA 2019, section 26(1)
- TMA 2019, section 27
- TMA 2019, section 26(1)
- TMA 2019, section 28
- TMA 2019, section 76
- PA 1983, section 42(3)
- PA 1983, section 63
- TMA 2019, section 65(1)
- TMA 2019, section 65(4)
- TMA 2019, section 69(5)
- TMA 2019, section 70(3)
- TMA 2019, section 46(1)(a)
- TMA 2019, section 160(3)
- TMA 2019, section 160(6)
Click the following links to read more legal articles from Malaysia:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Also from this Legal Handbook
4. Product Liability: Malaysia
All legal aspects surrounding product liability in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.
1. What types of liability are recognized in your jurisdiction?
Product liability for medicines can arise through several grounds of action. These include liability arising from the tort of negligence or strict liability or from breach of contract. Since 1999, the Consumer Protection Act was enacted to protect consumers from defective or dangerous products (purchased for private or non-commercial purposes) that cause serious health risks or death. In addition, criminal liability may also arise under the Poisons Act 1952, the Sale of Drugs Act 1952, Dangerous Drugs Act 1952 and under the Penal Code.
Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities such as:
Civil Liability
- discontinuance of infringements;
- restitution (restoration of original condition);
- specific performance;
- compensation for loss;
- payment for breach of contract damages; and
- compensation for the defective product.
Administrative Liability
- warning;
- fine;
- forfeiture of illegal earnings, forfeiture of illegal property;
- search and seizure warrant;
- power to enter premises and take samples;
- order to stop production and business;
- closure orders (order to close premises, building or facility);
- impose conditions on permits and licences;
- suspension or withdrawal of permits, suspension or withdrawal of licences; and
- other administrative punishments as stipulated by law or administrative regulations.
Criminal Liability
- fines;
- confiscation of property;
- criminal detention;
- fixed-term imprisonment;
- life imprisonment; and
- death penalty.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Under s.68 of the Consumer Protection Act 1999, where any damage is caused wholly or partly by a defect in a product, the following persons shall be liable for the damage:
- the producer (i.e., manufacturer) of the product;
- the person who, by putting his name on the product or using a trademark in relation to the product, has held himself out to be the producer of the product; and;
- the person who has, in the course of his business, imported the product into Malaysia in order to supply it to another person.
An action for breach of contract may be brought for a violation of express or implied contractual terms. For example, under the Sale of Goods Act 1957, where there is a breach of an implied agreement that goods (medicines or devices) supplied should be of satisfactory quality.
The authorized officer under the TCMA 2016 may enforce his powers of investigation and impose a stop order requiring a practitioner to stop and cease practicing in a practice area or a closure order for any premises, building or facility. The authorised officer also possesses other administrative powers such as applying for a search and seizure warrant, power to enter premises and taking of samples.
Nevertheless, the primary penalty stated in the various Malaysian legislations for any defects in medical products and devices lie in criminal liability with the imposition of fines or fixed-term imprisonment. There are no provisions for a compensatory regime following any civil liabilities.
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
These liabilities extend to corporate executives, employees and representatives of a company. For example, a director or legal representative in breach of his fiduciary duty or breach of trust or duty may face civil, administrative and/or criminal liabilities.
4. How can a liability claim be brought?
Civil Claims
Civil liability claims can be brought up by the aggrieved party as plaintiff in a civil court, or through arbitration if there is an arbitration clause in the underlying transaction document. The Tribunal for Consumer Claims (established under section 85, Part XII of The Consumer Protection Act 1999) was formed to provide an aggrieved party with an alternative to the civil courts for seeking redress for purchases of products or services made from traders or service providers.
Administrative Claims
These actions are usually brought by the relevant regulators (i.e. NPRA, MDA, TCM Council, etc.) against the party in breach of their statutory duties or licensing obligations. Additional penalties may be imposed such as fines and/or revocation of licence.
Criminal Claims
Following a complaint brought by a consumer or the relevant regulator, if it is discovered that a director or employees or representatives of a company has committed a criminal offence, the public prosecutor will then follow up on the investigation and potentially institute prosecution proceedings against the Defendant in the criminal court.
5. What defences are available?
The defences available for any person in respect of a defect in a product are as such: –
- that the defect is attributable to compliance with any requirement imposed under any written law;
- that he did not at any time supply the defective product to another person;
- that the defect did not exist in the product at the relevant time;
- that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question may reasonably be expected to discover the defect if it had existed in his product while it was under his control; or
- that the defect is in a subsequent product to which the defective product was added to and that the defect is wholly attributable to the design of that subsequent product or compliance by the producer of the product in question with instructions given by the producer of the subsequent product.
- Defences to an action in tort includes voluntary assumption of risks, contributory negligence, unforeseeability or remoteness of harm, and absence of breach of the standard of care.
- Defences to a claim for breach of contract include waiver, laches, and estoppel.
- Defences to statutory liability vary and are set out in the relevant legislations.
Click the following links to read more legal articles from Malaysia:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs
Also from this Legal Handbook
5. Traditional Medicines and OTC Products: Malaysia
A brief overview of the situation regarding traditional medicines and OTC products in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for GBP 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Alternative medicine is regulated by the Traditional and Complementary Medicine Council (“TCM Council”) established under the Traditional and Complementary Medicine Act 2016 (“TCMA 2016”). Traditional and complementary medicine can only be practised in recognised practice areas decided by the Minister of Health. Regulation of traditional medicines follow pharmaceutical products in that they must be registered with the DCA and be given a registration number. All traditional medicine is prohibited from containing any caffeine, nicotinamide, paracetamol and poison within the meaning of the Poisons Act 1952 [Act 366].
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, only products registered with the DCA may be advertised and this includes any traditional, herbal, complementary, or alternative products.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Items that must be included on the natural products (including traditional, herbal, complementary and alternative product) are as follows: –
- product name;
- dosage form;
- name of active ingredient, including part of plant used;
- strength of active ingredient in weight;
- indication;
- batch number;
- manufacturing date;
- expiry date;
- dosage/use instruction;
- storage condition(s);
- registration number (MAL);
- name and address of product registration holder;
- name and address of manufacturer;
- warning label;
- pack size;
- name and strength of preservative;
- name and content of alcohol (where present);
- declaration on the source of ingredients derived from animal origin;
- additional statement;
- contraindication/precaution;
- security label;
- product description; and
- date of revision.
- To declare the source of capsule shell (if applicable)
- Recommended daily allowance (RDA) for vitamins/ multivitamins/Mineral preparations used as xxvi) dietary supplements (optional)
- The words “Keep medicine out of reach of children” or words bearing similar meaning in both Bahasa Malaysia & English
- other country specific labelling requirements (if applicable) 1
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
In Malaysia, pharmaceutical products are defined as either scheduled poisons, non-scheduled poisons or natural products under the Poisons Act 1952 (“1952 Act”). Scheduled poisons (also referred to as controlled medicine) are listed in the First Schedule of the 1952 Act. Non-scheduled poisons are products that do not contain scheduled poisons and are also known as over-the-counter (“OTC”) products.2 All products, including OTCs in Malaysia must be registered. Before registration, each product must undergo either a full or abridged evaluation. Those not listed in the Drug Registration Guidance Document (“DRGD”) for abridged evaluation will receive full evaluation.3
5. Are there any limitations on locations or channels through which OTC products may be sold?
All products including OTCs in Malaysia can only be sold by a person or business which holds the appropriate licence issued under the CDCR 1984.
6. What health, advertising, and marketing claims may be made for OTC products?
Advertising of OTC products must be factually true and cannot mislead the public, excluding any direct or implied exaggerated claim and superlatives. The word “safe” must not be used without qualification and claims must not state categorically that a product has no side effects, toxic hazards or risk of addiction.4 Reference to speed of absorption, dissolution, distribution and other preliminary activity are acceptable when supported by appropriate evidence. 5 Comparisons may be made so long as they do not mislead consumers. 6
7. Can OTC products be marketed or advertised directly to the public?
Yes, all marketing activities for OTC products are regulated by the Code of Conduct for Non-Prescription (OTC) Products issued by the Pharmaceutical Association of Malaysia and must conform to all existing governmental legislation governing the practice of pharmaceutical industry in Malaysia.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Given that all drugs are classified under the Poisons Act 1952 and prescription-only products should be scheduled poisons, they cannot strictly be converted in or out of the scheduled poisons list. The matter must be brought before the Poisons Board who will then hold a meeting to decide whether to table a specific drug as a scheduled poison or an OTC and this will then be brought before the Health Minister for consideration and to make the necessary regulation on such product(s).
9. What are the requirements for the importation of either traditional medicines or OTC products?
Traditional medicines and OTC products may be imported into Malaysia so long as it does not contain any caffeine, nicotinamide, paracetamol or poison within the meaning of the Poisons Act 1952 [Act 366]. In any event, upon importation, every traditional medicine or OTC product must still be registered in Malaysia through the standard registration process as provided in Regulatory Pricing and Reimbursement.
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- Appendix 19 Labelling Requirement, Table 1, DRGD, NPRA, 3rd edn., January 2021
- Controlled Medicine and OTC Medicine – What do they mean?, Medication General, MyHealth, MOH, at: http://www.myhealth.gov.my/en/controlled-medicine-and-otc-medicine-what-do-they-mean/
- Table VI: Method of Evaluation According to Product Categories, DRGD, NPRA, MOH, 2016, revised Jan 2019.
- Code of Conduct for Non Prescription (OTC) Products, Pharmaceutical Association of Malaysia (PhAMA), para 5.11.
- Ibid. at para 5.12.
- Ibid. at para 5.13
Click the following links to read more legal articles from Malaysia:
- Regulatory Pricing and Reimbursement Overview
- Preclinical and Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, Advertising
- Traditional Medicines and OTC Products
- Product Liability
- Patents & Trademarks
- Regulatory Reform
- Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs