The Pharma Legal Handbook: South Africa
The Pharma Legal Handbook: South Africa answers essential questions about the legal and regulatory environment for pharmaceuticals in South Africa. It is a must-have for any company operating in the country or looking to enter the market.
Prepared in association with Fasken, a leading international law firm, it should answer any questions linked to regulation, pricing, clinical and preclinical trials, marketing, manufacturing, trademarks and patents.
If legal handbook content is updated, you will receive a free updated PDF for up to one year after purchase.
October 2018
1. Cannabinoid Drugs and Medicinal Cannabis: South Africa
Structured legal guide to cannabinoid drugs, medicinal cannabis and opioid drugs in South Africa. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
CANNABINOID DRUGS
1. Are Cannabinoid Drugs authorized in your country?
Cannabis use is illegal in most countries and until recently this included South Africa.
In terms of the Drugs and Drug Trafficking Act (“the Drugs Act”) it is illegal to deal in, possess or sell Cannabinoid drugs in South Africa. This stance has however been changed recently by the Constitutional Court of South Africa’s Judgement that now make it legal to make use of or possess Cannabis in private by an adult person for his or her own consumption in private.
Furthermore, certain regulations which specifically govern medicines containing cannabis, cannabis extracts, and cannabis-derived substances such as cannabinoids, which must registered with SAHPRA, has been found to be inconsistent with the right to privacy entrenched in Section 14 of the Constitution.
These substances were rescheduled and listed in Schedule 6 to bring them in line with the scheduling status of other restricted medicines, thus allowing patients to access medicinal cannabis products by prescription at a pharmacy. Any cannabis products not registered by SAHPRA remain in Schedule 7 and were technically still illegal.
However, in August 2017 and prior to the Constitutional Court Judgement of 18 September 2018, SAHPRA released a Communication to Industry document in which they indicated that Cannabidiol specifically was down-scheduled from Schedule 6 to Schedule 4.
The above will however be affected by the Constitutional Court Judgement handed down on 18 September 2018.
2. What are the regulatory authorities with jurisdiction over Cannabinoid Drugs?
The South African Health Products Regulatory Authority (SAHPRA) is responsible for regulating all medicines and medical devices in South Africa by ensuring that they meet standards of efficacy, safety and quality. SAHPRA operates in terms of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) (“the Medicines Act”), the Regulations issued in terms of that Act, and associated Guidelines. The Department of Health is the Government structure responsible for the implementation and management of the Medicines Act.
The Drug Trafficking Act also applies in addition to, and not in substitution for, the provision of the Medicines Act or any regulation made thereunder (Section 2) and is administered by the Department of Justice and Constitutional Development.
The Judgement in the Prince matter has created somewhat of a disruption to the longstanding viewpoint on the matter from a legal and regulatory perspective. The Judgement state that the South African Parliament have the onus to ensure the correction and update of the Constitutional defects in the statutory provisions which it identified.
Parliament has 24 months from the date of Judgement handed down, to cure the constitutional defects, failing which, the reading-in as done in the Judgement, will become final.
3. Is there a specific regulatory framework for the authorization, pricing, and reimbursement of Cannabinoid Drugs?
Until the Prince matter had been adjudicated, Cannabinoid Drugs remained illegal in South Africa unless obtained through legal prescription of an authorised medical practitioner. At this time however, there are specific sections in the different Acts and regulations, which will be changed to become operational in line with the Judgement made in this regard.
The regulatory framework should potentially stay with the South African Health Products Regulatory Authority where it concerns Medicinal Cannabis and dealing in Cannabis for non-medicinal purposes, remains regulated under the auspices of the Drugs Act.
4. Which are the cannabinoid drugs that have received market approval to date?
To date, SAHPRA has registered one medicine containing cannabinoids appearing in the plant and has listed the medicine as a schedule 6 product making it illegal to possess the medicine provided that it has been obtained with a prescription from a medical practitioner. In addition, SAHPRA has also issued authorizations for the use of an unregistered medicine containing cannabinoids.
At the time of the Judgement SAHPRA was continuing to work towards implementing a detailed regulatory framework to enable applications for licences and permits for the cultivation, production and manufacture of medical cannabis products. The Prince-judgement however places doubt on the process in its entirety since an adult person is now allowed to cultivate, possess and use Cannabis in private for his or her personal consumption in private or in any other case.
5. Who can prescribe Cannabinoid Drugs?
In terms of Sections 21 and 22A (9) (a) (i) of the medicines Act, authorised practitioners can apply to the SAHPRA for permission to access and prescribe unregistered medicines when intended to treat individual patients7. Section 22A(9)(a)(i) read together with Part III of Schedule 2 of the Drugs Act have been found unconstitutional and as such, will in future not apply to the prescription of Cannabinoid drugs. The changes to the relevant legislation must be implemented by the South African Parliament within 24 months of the date of the Judgement, failing which, the parts read-in with regards to the specific Sections, Schedules and Parts of the Medicines and Drugs Act respectively by the Judges of the Constitutional Court, will become final and automatically part of the legislation.
It is uncertain however, how the latest Judgement regarding Cannabis cultivation, possession and use will affect the regulation of Cannabis for medicinal use.
6. Is there a list of doctors authorized to prescribe Cannabinoid Drugs?
Currently the list of medical practitioners who are authorized to prescribe Cannabinoid Drugs is not available to the public.
7. What approvals or notifications are required to prescribe Cannabinoid Drugs?
Prior to the Judgement, approval from SAHPRA in terms of Sections 21 and 22A (9) (a) (i) of the medicines Act were required for permission to access and prescribe the cannabinoid drugs without it being registered. There may be significant changes to how this process is managed in light of the changes which must be made in line with the Constitutional Court Judgement.
8. Which organizations are authorized to sell/distribute Cannabinoid Drugs available?
The cultivation, possession and use of Cannabinoid drugs were illegal in South Africa prior to the Constitutional Court Judgement in the Prince-matter. With this judgement, a person who cultivates, possesses or use Cannabis will not be committing a crime if it is done in private for personal consumption. The cultivation, possession and use of Cannabis have been decriminalised for this pupose.
9. Is there a list of retailers/ distributors authorized to sell Cannabinoid Drugs?
No.
10. Are there proposals for reform or significant change to the regulation of Cannabinoid Drugs?
Yes, there have been proposals to the SAHPRA, Minister of Health, Department of Health and Parliament – Regulations under the Medicines Act were published on 28 July 2017 in which Cannabidiol is listed as a Schedule 6 medication – this enables a person specifically authorised in terms of Section 22A(5)(f) of the Medicines Act to prescribe or supply, within their scope of practice and subject to indication for use of the substance and in conditions specified by the SAHPRA, Cannabidiol to patients under their care. SAHPRA published a Guideline on the Cultivation of Cannabis and Manufacture of Cannabis-Related Pharmaceutical Products for Medicinal and Research Purposes.
This Guideline indicate that to date, patient access to unregistered Cannabis or cannabinoid-containing medicines has been enabled by SAHPRA through importation of these products under strict control and regulation measures. A framework was developed in consultation with the Department of Agriculture, Forestry and Fisheries (DAFF), the Department of Health and SAHPRA. This framework has the goal to ensure the availability of standardised quality-assured locally grown Cannabis for the manufacture of suitable pharmaceutical products. The intention is to control the cultivation, production and manufacturing of Cannabis-containing products intended for medicinal use in South Africa.
Last mentioned however, will probably be reviewed and updated in light of the Constitutional Court Judgement and the legislative changes that will be following within the next 24 months.
11. When are they likely to come into force?
The above mentioned Regulation came into force on the date of publication in the Government Gazette which is 28 July 2017. They are however subject to change in light of the Constitutional Court Judgement.
MEDICINAL CANNABIS
1. Is Medicinal Cannabis authorized in the country?
The Medicines Act, through the provisions of Section 22A (9) (a) (i), allows for the acquisition, use, possession, manufacture or supply of Cannabis for medicinal use by a medical practitioner, analyst, researcher or veterinarian for the treatment or prevention of a medical condition in a particular patient, or for the purposes of education, analysis or research, provided that a permit is obtained from the Director-General of Health.
Section 22A(9)(i) has however been found to be unconstitutional and as such, will be changed to include wording that indicate in the case of cannabis, should the person be an adult male or female and the Cannabis is used or in their possession in private for personal consumption in private or in any other case. It would not be deemed a criminal act and will carry no punishment. This is in stark contrast to how Cannabis cultivation, possession and use were regulated prior to the Prince-matter. SAHPRA would need to make changes to the guidelines in this regard once changes to this Section in the Medicines Act have been changed in accordance with the requirements and findings as set out in the Constitutional Court Judgement.
2. What are the regulatory authorities with jurisdiction over Medicinal Cannabis?
The South African Health Products Regulatory Authority (SAHPRA) in conjunction with the Department of Health.
3. What is the regulatory framework for the authorization, pricing, and reimbursement of Medicinal Cannabis?
The current legislative framework to allow for domestic cultivation of medicinal cannabis is currently under development (and has been since 2016) by the Department of Health in consultation with the South African Health Products Regulatory Authority. It will undergo further changes to include the requirements as set out in the recent Constitutional Court Judgement which found that Cannabis cultivation, possession and use in private for personal consumption in private, is not illegal.
In terms of Sections 21 and 22A (9) (a) (i) of the medicines Act, authorised practitioners can apply to the SAHPRA for permission to access and prescribe unregistered medicines when intended to treat individual patients. Section 22A(9)(i) have been found unconstitutional and changes made to how it reads in order to exclude Cannabis cultivation, possession and use from being a criminal activity. How SAHPRA regulates Medicinal Cannabis will depend on the changes to be made to the Medicines Act in this regard.
Cannabis-containing products intended for medicinal purposes may thus be made available, in exceptional circumstances, to specific patients under medical supervision. In addition, the Medicines Act allows SAHPRA to issue a licence to manufacture either a medicine or a Scheduled substance (Active Pharmaceutical Ingredient/API). Section 22(C) (1) (b) of the Medicines Act enables the cultivation and manufacture of the Scheduled substances and ensures the required oversight of SAHPRA in regulating these activities. This provision allows SAHPRA to license cultivators of Cannabis for medicinal use and enables regulatory oversight in a way that is compliant with South Africa’s international obligations.
The legislative framework addresses three regulatory aspects:
- Authorisation of Cannabis cultivation and production domestically, for
medicinal and research purposes. - Satisfying the requirements of South Africa’s international obligations,
under the Single Convention. - Aligning the access of Cannabis-containing products for medicinal purposes
with that of other controlled medicines.
4. How is the production and import of Medicinal Cannabis regulated and by which agencies/authorities?
Until now, patient access to unregistered Cannabis or cannabinoid-containing medicines has been enabled by SAHPRA through importation of these products.
In order to ensure the availability of standardised quality-assured locally grown Cannabis for the manufacture of suitable pharmaceutical products, the Department of Health and SAHPRA may permit the cultivation of Cannabis solely for medicinal and research purposes. This process may however undergo changes due to the inevitable changes which will be made to the relevant legislation in this regard.
Access to medicines and Scheduled substances in South Africa are controlled through Scheduling of the substance. Cannabis is a prohibited narcotic substance listed under Schedule 7 of the Schedules to the Medicines Act and cultivation for any purpose other than that explicitly allowed for through the licence and permit system under the medicines Act, is a criminal offence.
Likewise cultivation by non-licensees remains a criminal offense under this and other legislation. SAHPRA currently hasn’t provided any indication as to how they plan to address the required changes proposed in the Constitutional Court Judgement or what timelines would be involved in the process of implementing the new legal requirements into their current Guidelines and Rules.
With the required changes needing to be updated and corrected in National Legislation, this process may take some time before SAHPRA would even be in a position to address the matter from their side and update their documentation accordingly.
5. What approval or notifications are necessary to produce or import Medicinal Cannabis?
In terms of Section 22C (1) (b) of the Medicines Act an applicant may apply to SAHPRA for a licence for any or all of the following activities:
- Cultivate/grow and produce Cannabis and Cannabis resin;
- Extract and test Cannabis, Cannabis resin and/or cannabinoids;
- Manufacture a cannabis-containing or cannabinoid-containing medicine;
- Import a Cannabis-containing medicine;
- Export a Cannabis-containing medicines;
- Distribute a Cannabis-containing medicine.
In addition to the licence application to SAHPRA, applicants are also required to apply to the Director-General of Health for a permit in terms of the provisions of Section 22A(9)(i) of the Medicines Act to acquire, possess, manufacture use or supply Cannabis for medicinal use13. This application process might undergo changes subject to the Constitutional Court Judgement proposed changes to the legislation.
According to the SAHPRA communication dated March 2017, Cannabis is confirmed as a Schedule 7 substance in the Schedules to the Medicines Act, making it illegal to have the plant in your possession. One medicine has been registered to date which contain cannabinoids appearing in the plant and has listed the medicine as a Schedule 6 product, making it illegal to possess the medicine provided that it has been obtained with a prescription from a medical practitioner. In addition to this one registration, authorizations were also issued for the use of an unregistered medicine containing cannabinoids.
Section 22A(9)(a)(i) has been changed to now read in such a manner that, despite cannabis being a Schedule 7 substance, if an adult male or female uses it or is in possession thereof in private for their personal consumption in private or, in any other case, it would not be a criminal offence. There are currently no details available on how SAHPRA intends to manage this change to the Medicines Act which governs how SAHPRA regulates Medicinal Cannabis.
6. What is the regulatory framework for the marketing and distribution of Medicinal Cannabis?
Access to medicines and Scheduled substances in South Africa is controlled through scheduling of the substance. Cannabis used to be a prohibited narcotic substance listed under Schedule 7 of the Schedules to the Medicines Act and cultivation for any purpose other than that explicitly allowed for through the licence and permit system under the Medicines Act, was a criminal offence. In the recent Constitutional Court Judgement, the Court found that the scheduling of Cannabis is inconsistent with the fundamental rights afforded every citizen in so far it relates to Privacy and this part of the legislation will be changed accordingly. Even though Cannabis is a Schedule 7 drug, the manner in which it’s cultivation, possession and use is regulated in Section 22A(9)(a)(i) and the Government Gazette no R509 of 2003 published in terms of this Section, was found to be inconsistent with the constitutional right to privacy.
7. How can patients obtain Medicinal Cannabis?
The only means by which a patient will be able to obtain Medicinal Cannabis in South Africa is through a medical practitioner who holds the relevant licence to prescribe it, which licence is obtained from SAHPRA. A Pharmacist registered accordingly with the relevant Pharmacy Council will be able to provide medicinal cannabis when provided with a legitimate prescription from a medical practitioner as discussed previously. Medicinal Cannabis products may thus be made available to specific patients under medical supervision and through legal channels as confirmed by SAHPRA in the guideline document in this regard.
According to the Constitutional Court Judgement the dealing in cannabis remain illegal and as such, it must be acquired through legal means if not cultivated by the person using it in private for their personal consumption.
8. Who can prescribe Medicinal Cannabis?
Under the Medicines Act, medical practitioners can apply to SAHPRA for permission to access and prescribe unregistered medicines – including cannabis – for their patients in certain exceptional circumstances.
Only registered medical practitioners may apply for authorisation to prescribe a controlled medicine for a specific patient. Authorisation from SAHPRA is dependent on the submission of an appropriate dosage regimen and acceptable justification for the proposed and intended use.
9. Is there a list of doctors authorized to prescribe Medicinal Cannabis?
No list of medical practitioners with authorisation to prescribe Medicinal Cannabis was available at the time of this document being drafted.
10. What approvals or notifications are required to prescribe Medicinal Cannabis?
Approval from SAHPRA after application to become an authorised prescriber of Medicinal Cannabis – this can only be obtained by a medical practitioner registered with the Health Professions Council of South Africa.
11. Where is Medicinal Cannabis available?
At this stage Medicinal Cannabis is only available once prescribed by an authorised medical practitioner with the relevant authority from SAHPRA(through a Section 21 Application which SAHPRA must approve). The dispending is only allowed to be done by an authorised pharmacist in terms of the Medicines Act.
12. Is there a list of retailers authorized to sell Medicinal Cannabis?
This information is not available at this time.
13. Are there proposals for reform or significant change to the regulation of Medicinal Cannabis?
Yes, there have been proposals to SAHPRA, the Minister of Health, Department of Health and Parliament – Regulations under the Medicines Act were published on 28 July 2017 in which Cannabidiol is listed as a Schedule 6 medication – this enables a person specifically authorised in terms of Section 22A(5) (f) of the Medicines Act to prescribe or supply, within their scope of practice and subject to indication for use of the substance and in conditions specified by the SAHPRA, Cannabidiol to patients under their care.
Related to the above, is the Constitutional challenge which was brought regarding the recreational use of cannabis. The Judgement has been discussed at length in this document and it is uncertain at this stage how the legislation changes will impact the regulation of medicinal cannabis if recreational cultivation, possession and use by adult males and females in private for their personal consumption is no longer considered a crime.
14. When are they likely to come into force?
The Regulations which were proposed to SAHPRA and the Minister of Health and Parliament relating to medicinal cannabis came into force on the date of publication in the Government Gazette which is 28 July 2017. Dealing in cannabis remains illegal, but the personal cultivation, possession and use of cannabis for personal consumption in private, has been legalised.
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2. Regulatory Reforms: South Africa
Regulatory reforms in South African Pharma – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
NATIONAL HEALTH INSURANCE BILL AND MEDICAL SCHEMES AMENDMENT BILL
On 21 June 2018 the Minister of Health Published the Medical Schemes Amendment Bill and the National Health Insurance (NHI) Bill for comment by the public and interested parties within the respective Industries.
In terms of the current environment in South Africa and the Minister of Health (and the Government) aim to achieve adherence to Section 27(2) of the South African Constitution which require for the State to “take reasonable legislative and other measures, within its available resources to achieve the progressive realisation of the right”.
The right referred to is the Right to access to health care in terms of Section 27(1) (a) which states “Everyone has the right to have access to health care services, including reproductive health care;”
In this regard the National Health Insurance Bill aims to provide mandatory prepayment health care services in the Republic in pursuance of section 27 of the Constitution; to establish a National Health Insurance Fund and to set out its powers, functions and governance structures; to provide a framework for the active purchasing of health care services by the Fund on behalf of users; to create mechanisms for the equitable, effective and efficient utilisation of the resources of the Fund to meet the health needs of users; to preclude or limit undesirable, unethical and unlawful practices in relation to the Fund and its users; and to provide for matters connected herewith.
There is a definite link created between these two Bills, where the Medical Schemes Amendment Bill in Section 17 state that the Registrar of Medical Schemes may, after consultation with the Minister, restrict the benefits offered by medical schemes having regard to the benefit and service coverage under the National Health Insurance Fund – the aim apparently being to eliminate duplicative costs for the same benefit.
Medical Schemes are not abolished by the NHI Bill and in its current draft there is provision for regulation of the relationship between the NHI Fund and medical and/or other private health insurance schemes. However, the crux of the matter is that the NHI Bill clearly state that where any conflicts between these two Bills are present, the NHI Bill and the Constitution shall prevail.
The deadlines on providing comments on these two Bills are three months from the date of publication. Until such time, the current legislative framework in so far it relates to public health care services and medical schemes and its functioning within the private health care sector, remains unchanged.
2. When are they likely to come into force?
These two Bills have only been published on 21 June 2018 and will go back to Parliament for consideration after the three-month period for comments have come to an end.
The publication of the NHI Bill and Medical Schemes Amendment Bill in the Government Gazette for public comment is followed by referral to the relevant committee within Parliament.
It is debated in the relevant committees of Parliament and amended if necessary. If the Bill passes through both the National Assembly and the National Council of Provinces, it goes to the President for assent (where he signs it into law). Once it is signed by the President the Bill becomes an Act of Parliament and a law of South Africa.
In so far this process relates to the two proposed Bills, there is still quite some time which will pass in allowing the full and correct procedure to take its course.
Therefore, a specific date or timeframe within which these two Bills might come into force is undeterminable at this time.
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3. Patents & Trademarks: South Africa
The ins and outs of patents and trademarks in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
Patents and Trademarks form part of Intellectual property in terms of South African law, where Intellectual Property is defined as: “a generic term used to refer collectively to a variety of diverse intangible products such as inventions and patents, trademarks and brand names, industrial designs, copyright, plant breeders’ rights, performances, trade secrets and know-how etc.”
The Patents Act 57 of 1978 and Patent Regulations provide the legal framework within which patent protection can be obtained.
Protection of TrademarkTrademarks are provided under the Trademarks Act No 104 of 1993.
PATENT PROTECTION
A South African Patent Application is not subjected to substantive examination; the Registrar merely examines the application for compliance with the formal requirements of the Act and if he is satisfied, the application will proceed to acceptance and grant.
For an application for a patent to be granted certain requirements must be met in terms of the Patents Act.
One being that an application for a patent in respect of an invention may be made by the inventor or by any other person acquiring from him the right to apply or by both such inventor and such other person.
There are some difficulties in obtaining protection for industrial property rights in any number of countries in the world as a result of the diversity in national laws, and the increasing need to file patent applications in every country in which protection is desired almost simultaneously to avoid a novelty destroying event, created an urgent need for the harmonisation of industrial property laws.
The Paris Convention and the Patent Cooperation Treaty (PCT) also apply and both have been accepted by South Africa and entered into force. The PCT is complementary to the Paris Convention. Benefits of the PCT include the effective harmonisation of the filing, searching and examination of patent applications.
It is possible to seek patent protection simultaneously in a number of countries by filing a single international application. It is also possible, in addition to last mentioned, for the international application to be subjected to international search and examination, providing the opportunity for critical evaluation and assessment of the application.
Since South Africa has acceded to the PCT, it is possible for South African Nationals to proceed by way of PCT international and PCT national phase applications. The Patents Act regulates applications filed under PCT in Chapter VA.
It is possible for an international application to be designated to South Africa, subject to provisions of Chapter VA, the application shall be deemed to be an application for a patent lodged at the South African patent office to act as receiving, designated and elected office as set out in Section 43C of the Act.
The National phase entry deadline in South Africa is 31 months from the earliest filing date, with allowance for the deadline to be extended for a further three months. This can only be done through a request to the Registrar. Should the applicant fail to enter the national phase within the prescribed deadline, it will result in the application being deemed abandoned for the purposes of the Act.
Regulation 22 of the Patent Act provides the information regarding the prescribed manner in which a provisional patent application must be made. Payment of the prescribed fee and provisional specification (as set out in Section 30(1)) of the Act, must accompany this application.
Form P1 is the application form which must be used when the applications are made and must be accompanied by the following documents:
- Form P1, in duplicate, one copy of which shall be returned to the applicant as proof of lodging;
- Form P2 in duplicate;
- A declaration and power of attorney on Form P3;
- Where the applicant has acquired a right to apply from the inventor, an assignment or other proof, to the satisfaction of the registrar, of the right of the applicant to apply;
- A single copy of a provisional specification on Form P6 or two copies of a complete specification on Form P7;
- Drawings, in the prescribed manner, if drawings are necessary to exemplify the invention; and
- An abstract on Form P8, in duplicate, if the application is accompanied by a complete specification.
In addition to the above requirements for an application with a provisional specification, an application accompanied by a complete specification must be accompanied by two copies of a complete specification (as required in terms of regulation 22(1) (e)), which must commence on the prescribed form and be signed by an agent.
TRADEMARK PROTECTION
The current Trademarks Act 194 of 1993 provides for the registration of trademarks, certification trademarks and collective trademarks.
Registration of a Trademark is required in terms of Section 16 of the Act. Regulation 11 provides details on the application for registration of a Trademark.
The mark must be: distinctive
- not be on the excluded list of marks as per Section 10 of the Trademarks Act;
- adhere to the requirements for
The procedure for registration of a Trademark in terms of Regulation 11 is as follows:
- An application for a trademark registration shall be made on Form TM1;
- The application shall be dated and signed by the applicant(s) or his/their duly authorised agent;
- The application shall be in triplicate and a separate and distinct applica tion is required for each class of goods or services and for each separate mark;
- If the application is made by a firm or partnership it may be signed in the name of or for and on behalf of the firm or partnership by any one or more members or partners thereof;
If the application is made by a body corporate it may be signed by any authorised person
It is further important to indicate whether the applicant claims convention priority under Section 63 of the Act in order for the Registrar to be aware of the type of application and which rules apply to the application being made.
2. What agencies or bodies regulate patents and trademarks?
Patents and Trademarks in South Africa are regulated by the Companies and Intellectual Property Commission.
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
PATENTS WHICH CAN BE PROTECTED
In terms of the Patents Act, Section 1 an “invention” is defined as one for which a patent may be granted under Section 25”.
In a very general manner certain positive requirements for patentability is set out such as:
- Any new invention which involves an inventive step and which is capable of being used or applied in trade or industry or
LIST OF EXCLUSIONS FROM PATENTABILITY
Section 25 provides specific indication on what shall not be deemed an invention for the purposes of this Act. Anything which consist of:
- A discovery;
- A scientific theory;
- A mathematical method;
- A literary, dramatic, musical or artistic work or any other aesthetic creation;
- A scheme, rule or method for performing a mental act, playing a game or doing business;
- A program for a computer;
- The presentation of
TRADEMARKS WHICH CAN BE PROTECTED
Certain Trademarks can be protected depending on whether or not they adhere to the requirement of distinctiveness.
To qualify for registration (and thus protection) under the Trademarks Act, a trademark must be capable of distinguishing the goods or services in relation to which it is used, or proposed to be used, from the same or similar goods or service.
l only fulfil this requirement if, at the date of application for registration it is inherently capable of distinguishing the goods or services in question or if, because of its prior use, it is capable of so distinguishing the goods or services. This test to determine whether or not the Trademark can be registered is a purely factual one
4. How can patents and trademarks be revoked?
A Trademark can be expunged, cancelled or removed in different circumstances – in all cases the term “expungement” will be used as a general term to describe each of the different scenarios.
Grounds for expungement of a Trademark include:
- Cancellation of a trademark upon request by the registered proprietor of the trademark;
- Removal of the trademark from the register if the original registration was a wrongly made entry or if it remains in the register wrongly or because of an error or defect in any entry in the register;
- A trademark can also be removed by any interested person who applies for the removal if the proprietor of the trademark, or any person permitted to use the trademark fails to comply with any condition entered in the register in relation to its registration;
- If the trademark has fallen into non-use – whether it appears that there is no bona fide intention to use it or if it can be shown that, there is no bona fide actual use of the trademark for a continuous period of five years or longer. This must be shown up to three months before the application is made;
- Removal from the register is also possible on the ground of failure to record an assignment in the case where the proprietor of the trade has ceased to exist, a body (e.g. body corporate) has been dissolved, or if the proprietor was a natural person, where such person has died not less than two years prior to the application for removal;
- Removal of the register if (after due notice has been given to the proprietor of the trademark to affect the renewal, of the registration) the prescribed tim has expired and the renewal has still not been
Grounds for Revocation of a Patent include:
- Revocation can be achieved through an application in the prescribed manner on specific grounds only:
- Where the Patentee is not a person entitled to apply for a patent;
- Where the grant of the patent is in fraud of the rights of the applicant or of any person under or through whom he or she claims;
- The invention concerned is not patentable under the requirements of the Patents Act;
- The invention, as it was set out in the complete specification concerned cannot be performed or does not lead to results and advantages as set out in the complete specification;
- The manner in which the invention is to be carried out by a person skilled to do so, is not fully described, ascertained and illustrated or exemplified (where necessary) in the complete specification of the patent
- Where claims of the complete specification of the invention are not clear or fairly based on the matter disclosed in the specification – this creates ambiguity and lack of fair basis and is in contravention of the requirements for an invention to be registered;
- The prescribed declaration lodged in respect of the application for the patent or the statement lodged in terms of the Act as required contains a false statement or representation which is material and which the patentee knew or ought to have reasonably known to be false at the time when the statement or representation
5. Are foreign patents and trademarks recognized and, if so, under what circumstances?
PATENTS
In cases where a patent application has been filed abroad, South African legislation state that the filing date in the country of first filing will provide the applicant or his successor in title, with the right to file a patent application in any number of contracting states within twelve months of the date of filing the first application. The later filed application will enjoy a priority status as if these later filed applications had been filed on the same date as the first application.
The priority status includes:
- Applications for the same inventions filed after the first application;
- Events, which in the normal course would be novelty destroying, and which take place after the date of the first application;
- Same invention must form part of the first and alter filed applications;
- Capacity of the first application to serve as the basis for priority is not destroyed on abandonment, rejection or withdrawal thereof;
- Multiple and partial priority rights, as recognised by the Convention, allow the priority of several earlier applications, possibly relating to different aspect of the subject matter to be
TRADEMARKS
The Paris Convention also provide priority where are trademark has been filed in a convention country. In these circumstances the following applies:
- the applicant for registration in that country or his successor or assignee, may file an application for the same mark in South Africa within six months of the first application for that mark filed in the convention country;
- The application filed in South Africa will bear the same filing date as the convention date, with priority to all other applications;
- In terms of the Trademarks Act, the South African Registrar will not permit the South African application to cover any specification broader than the specification for which the convention application was originally filed, though a narrower specification may be covered;
- Partial priority applications cannot be filed in South Africa (as is the case in many other countries by virtue of a registry practice followed);
- Applications filed claiming Convention priority all required documentation must be lodged (together with an English translation where applicable) with the registry within three months from the filing of the South African
Though the Madrid protocol has been approved by the South African Parliament, it has not yet formally been acceded to and not yet promulgated to enable legislation to give effect to international registrations in terms of the Protocol. Until such time, it is not possible to file international registrations with the World Intellectual Property Organisation (WIPO) through the office of the country of origin which would designate South Africa, for example.
6. Are there any non- patent/trademark barriers to competition to protect medicines or devices?
In many instances companies often apply for multiple patents on individual medicines over time in order to prolong their periods of patent protection. South Africa is a member of the World Trade Organisation (WTO) which set general standards of patent protection which all WTO members are required to provide under the Agreement on Trade-Related Aspects of Intellectual Property Rights – commonly known as the TRIPS agreement.
South African Patent law provide for 20-year patent protection and under Trademark Legislation a Trademark is protected for and should be renewed every 10 years.
Competition policy, in relation to patent granting, is more concerned with the questions whether the patent is warranted and necessary to achieve one of the means through which the patents system encourages innovation and whether a patent conveys market power.
If the patent is not warranted and does not encourage innovation, a patent should not be granted as such a patent could impose costs on the public.
The reasoning behind last mentioned suggests that the non-protection should then leave room for competition policy to spur innovation and provide consumers with what they want at optimal prices, quantity and quality. When taking this into consideration when determining whether a patent conveys market power, if an unwarranted patent confers market power on a patent-holder, it can deprive consumers of the benefits of competition without compensating value.
When keeping in mind that the South African patent system does not investigate the merits of each invention or the patent, multiple patents in a single medicine could easily be granted for a 20-year period and for longer if a second patent is granted. Patent-protection is well-known as it is given for a set period, which is important for innovation, particularly of pharmaceutical companies as this presumably enables pharmaceuticals to sustain the prices of medicines, recoup research and development expenditure and finance the development of new products.
Competition policy is seen as instrumental in ensuring access to medicines and ensuring medical technology and innovation in the pharmaceutical sector. International furore has been raised on whether pharmaceutical patents interfere with access to essential medicines in lower income countries.
South Africa is signatory to the TRIPS agreement that commits itself to having certain patent laws in the country. This agreement introduced the minimum standards for protecting and enforcing intellectual property rights and requires WTO members to make patents “available for any inventions, whether products or processes, in all fields of technology”. This also includes patents for pharmaceutical processes and products.
The TRIPS agreement has received some criticism over the years in so far the increased levels of patent protection of medicine prices are concerned. While TRIPS does offer safeguards to remedy the negative effects of patent protection or patent abuse, in practice it is unclear whether and how countries can make use of these safeguards when patents increasingly present barriers to medicine access.
The Companies and Intellectual Properties Council is currently reviewing and involved in preliminary research on a potential move from a depository patent system to a substantive examination system. In the process it has considered several structural options of patent protection systems.
There are some arguments against a substantive examination system where the fact that it will be costly and burdensome has been raised as a potential problem, as well as the fact that it requires an extensive human resource investment.
With that being said, it has the potential to discourage foreign business which South Africa obviously want to avoid, as the aim is to encourage foreign business and investment into the South African economy.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
LIST OF EXCLUSIONS FROM PATENTABILITY
Section 25 provides specific indication on what shall not be deemed an invention for the purposes of this Act. Anything which consist of:
- A discovery;
- A scientific theory;
- A mathematical method;
- A literary, dramatic, musical or artistic work or any other aesthetic creation
- A scheme, rule or method for performing a mental act, playing a game or doing business;
- A program for a computer;
- The presentation of
LIST OF EXCLUSIONS FROM REGISTERING A TRADEMARK
Section 10 of the Trademarks Act No 194 of 1993, set out the marks that are excluded from registration as trademarks. These include inter alia, a mark that:
- Does not constitute a trademark in terms of Section 10(1);
In terms of Section 10(2) it is a mark that:
- Is not capable of distinguishing within the meaning of section 9 of the Act (section 10(2)(a));
- Consists exclusively of a sign or indication which may serve, in trade, to designate the kind, quality, quantity, intended purpose, value, geographical origin or other characteristics of the goods or services (section 10(2)(b));
- A mark which consists exclusively of a sign or indication which has become customary in the current language or in the bona fide and established practices in the trade(section 10(2)(c));
- Is one in relation to which the applicant has no bona fide claim to proprietorship (section 10(3));
- The applicant has no bona fide intention of using as a trademark, either himself or through a person permitted by him to use the mark as contemplated in section 38 of the Act (section 10(4));
- Consists exclusively of the shape, configuration, colour or pattern of goods where such shape, is necessary to obtain a specific technical result, or results from the nature of the goods (section 10(5));
- Constitutes, or the essential part of which constitutes, a reproduction, imitation or translations of a well-known mark that is entitled to protection under the Paris Convention for the Protection of Industrial Property and is used on identical or similar goods; where use of the mark is likely to cause deception or confusion (section 10(6));
- Is the subject of an application for protection which was made mala fide (section 10(7)) ;
- Consists of or contains the national flag or the armorial bearing or any other State emblem of South Africa or of a convention country (section 10(8));
- A mark which contains any word, letter or device indicating State patronage (section 10(9));
- A mark which contains any word, letter or device indicating State patronage (section 10(10));
- Consists of a container for goods or the shape, configuration, colour or patent of goods, where the registration of such mark is likely to limit the development of any art or industry (section 10(11));
- Is inherently deceptive or the use of which would be likely to deceive or cause confusion, be contrary to law, be contra bonos mores, or be likely to give offence to any class of persons (section 10(12));
- As a result of the manner in which it has been used, would be likely to cause deception or confusion (section 10(13));
- Is identical to a registered trademark belonging to a different proprietor or so similar to the it that the use thereof in relation to goods or services in respect of which it is sought to be registered would be likely to deceive or cause confusion, unless the person making the earlier application consents to the registration of such mark (section 10(14));
- Is identical to a mark which is the subject of an earlier application by a different person, or so similar there to that the use thereof in relation to goods or services in respect of which it is sought to be registered and which are the same as or similar to the goods or services in respect of which the earlier application is made, would be likely to deceive or cause confusion, unless the person making the earlier application consents to the registration of such mark (section 10(15));
- Is the subject of an earlier application as contemplated in section 10(15) of the Act, if the registration of that mark is contrary to existing rights of the person making the later application for registration as contemplated in that paragraph (section 10(16));
- Is identical or similar to a trademark which is already registered and is well known in the Republic of South Africa, if the use of the mark sought to be registered would be likely to take unfair advantage of, or be detrimental to the distinctive character or the repute of the registered trademark, notwithstanding the absence of deception or confusion (section 10(17));
The Act confirm that a mark shall not be refused registration by virtue of the provisions of paragraph (2) or, if registered, shall not be liable to be removed from the register by virtue of the said provisions if at the date of the application for registration or at the date of an application for removal from the register, as the case may be, it has in fact become capable of distinguishing within the meaning of section 9 as a result of use made of the mark.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
TRADEMARKS
A licence refers to the relationship between the proprietor of a trademark and the entity authorised by the proprietor to use that trademark in relation to goods manufactured and sold or in respect of the services rendered.
In terms of Section 38 of the Trademarks Act, registration of a user of a mark shall be prima facie evidence that the use of the registered trademark by the user is permitted use as contemplated by section 38(1).
The Trademark regulations confirm in regulation 39 that an application must be brought to the Registrar for the registration under section 38(6) of the Act for a person to be able to act as a registered user of a registered trademark and such application must be made by the registered proprietor on Form TM7 with the relevant accompanying documentation included.
It can therefore be inferred that a trademark license agreement, whether it is with a foreign licensor or not, must be provided to the Registrar in order for the confirmation of approved usage to be on file and on record in South Africa.
PATENTS
A licence agreement in respect of a patent is an agreement in terms of which the licensor grants to the licensee exploitation rights in terms of the invention. The licence can take different forms such as an agreement in writing, oral agreement or tacit agreement.
There are specific timelines involved in the recording of a licence against a patent – it must be made within six months of the event entitling the recording of such licence, or within six months of the grant of the patent. In cases where the licence agreement had been before such a grant, the Registrar may extend this time limit on application and on payment of the prescribed fee.
There is no explicit indication that the licencing is affected by the fact that it is extended by a foreign licensor, nor is there direct indication that such licence is required to be registered against a patent.
This is confirmed by the wording in Section 53 (1) of the Patents Act which state: “At any time after the date of the sealing of a patent, the patentee may apply (own emphasis) to the registrar for the patent to be endorsed with the words “licences of right” and where such an application is made the registrar shall, if satisfied that the patentee is not precluded by contract from granting licences under the patent, cause the patent to be endorsed accordingly.
Also from this Legal Handbook
4. Product Liability: South Africa
The key facts about product liability in South African Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
1. What types of liability are recognized in your jurisdiction?
In terms of South African common law legal liability may arise from a breach of contract or from delict.
Liability in delict may arise irrespective of the existence of a contract between the producer and the injured party.
Claims from breach of contract usually take the form of an action for breach of a warranty concerning the fitness of the product. Under common law contractual liability for a defective product rests on an express or implied warranty that the product is free from defects, or on a misrepresentation by the supplier regarding the qualities of the product (which are claimed or stated to be defect free).
The rights of the purchaser are determined by the contract with the supplier of the contract and only parties to such contract derive rights and obligations from it – this is known as privity of contract, a doctrine which prevents out- siders to a contract from suing or being sued in terms of the contract.
2. How do these types of liabilities apply to the manufacturers of medicines and devices?
Currently in South Africa there is no specific liability regarding pharmaceutical products. Rights of Consumers are however governed by the Consumer Protection Act No 68 of 2008 (the CPA) and in this regard in terms of Section 55 there is an implied warranty on any products, good or services rendered to a consumer.
It should however be noted that in addition to an implied warranty of quality which applies ex lege to any transaction governed by the CPA, other provisions are also made in the Act pertaining to unsafe goods or a defect, hazard or failure in goods.
The Consumer Protection Act does not provide for special rules in respect of pharmaceutical products. In this respect South Africa will follow most European jurisdictions, where arguments for special treatment of pharmaceutical products have generally not prevailed. There are however strict quality controls in place which apply to the manufacture, importation and distributions of prescription medicines.
Most of these quality controls are involved in the monitoring of all stages of the different manufacturing and distribution processes (as would be required in terms of the Regulatory and Compliance requirements from the SAHPRA as well) and as such, contain risks effectively in most cases.
It has been suggested that the application of various safety standards in terms of Section 61(1) of the CPA, read with Section 53(1), requires particular consideration of different factors such as:
- Whether the medicine or medical device has harmful effects which exceed the limits considered tolerable in light of the current medical knowledge and technological advancement; and
- The balance between the risks of harm and the therapeutic benefits of the medicine and/or medical device
3. Does potential liability extend to the manufacturer only or could claims extend to corporate executives, employees, and representatives?
In terms of the South African Companies Act, Directors and prescribed officers can be held liable in specific circumstances as set out in Section 77 of the Act.
The purpose of the Act includes the registration of offices of foreign companies carrying on business within the Republic and to define the relationship between companies and their respective shareholders or members and directors.
Potential liability in terms of the CPA extends to any supplier, whether or not they reside in South Africa.
Directors (which in terms of this Section, includes an alternate director, and a prescribed officer or a person who is a member of a committee or board of a company, or of the audit committee of a company, irrespective of whether or not the person is also a member of the company’s board) may be held liable in accordance with the principles of common law relating to breach of a fiduciary duty, for any loss, damages or costs sustained by the company as a consequence of any breach by the director of a duty as contemplated in the Act.
A Director may also be held liable in accordance with principles of the common law relating to delict for any loss, damages or costs sustained by the company as a consequence of any breach by the director of a duty contemplated in the Act or breach of any provision of this Act not otherwise mentioned in Section 77 or any provision of the company’s Memorandum of Incorporation.
4. How can a liability claim be brought?
Claiming for liability from a manufacturer or supplier will depend on the basis on which the claim is brought. If the claim is a result of a breach in the contractual relationship between parties, the law of contract provides several remedies for circumstances where harm was caused by defective products.
In South Africa the delictual remedy provided by the common law is the Aquillian action, which is based on fault in cases where harm was caused.
Section 61 of the Consumer Protection Act does however now provide a similar remedy – it discards fault and gives its own content to the concept of a defect, but it still incorporates elements of an action in delict, which include damages, causing harm. The defences such as prescription and consent can however also be used in opposing a claim in this regard.
Common law liability exists as an alternative basis for recovery of damages for harm done by defective products and may remain relevant in the situation where the injured consumer is unable to meet the requirements as set out in the definitions contained in the Act.
The CPA provide each consumer with means to enforce their rights by means of Section 69 which provides for the consumer to refer the matter directly to the Consumer Tribunal, if such a direct referral is permitted by the Act in the case of the particular dispute – there are prerequisites for such referral which is set out in the CPA under a different section.
The consumer also has the right, in terms of Section 69 of the CPA, to: –
- refer the matter to the applicable ombud with jurisdiction, if the supplier is subject to the jurisdiction of any such ombud;
- if the matter does not concern a supplier who is subject to the jurisdiction of an ombud, the consumer has the right to refer the matter to the applicable industry ombud, accredited in terms of Section 82(6) of the CPA, if the supplier is subject to any such ombud;
- apply to the consumer court of the province with jurisdiction over the matter, if there is such a consumer court, subject to the law establishing or governing that consumer court;
- refer the matter to another alternative dispute resolution agent contemplated in section 70 of the same Act; or
- file a complaint with the Commission (in accordance with Section 71); or
- approach a court with jurisdiction over the matter, if all other remedies available to that person in terms of national legislation have been
Once all other remedies available to a consumer have been exhausted, they may institute legal action in a court with the relevant jurisdiction.
This process is regulated through the South African Civil Procedure Law and will be Action proceedings – this is where a person brings an action (Plaintiff) against another person or entity (Defendant) in for example a claim for damages due to defective medical device or harm that was caused by a medicine.
5. What defenses are available?
The claimant is only allowed to approach a court if all other remedies available to them in terms of national legislation have been exhausted. If the manufacturer is able to prove that this is not the case, the claimant will not be able to institute action in court.
There are also limitations placed on the consumer’s right to bringing an application, one being that an application may not be referred or made to the Tribunal or to a consumer court more than three years after the act or omission that is the cause of the complaint or in the case of a course of conduct or continuing practice, the date that the conduct or practice ceased.
A complaint in terms of this Act may not be referred to the Tribunal or to a consumer court in terms of this Act, against any person that is, or has been, a respondent in proceedings under another section of the CPA relating substantially to the same conduct.
A manufacturer can make use of Section 115(2) of the CPA as a defence when a claimant has instituted civil action in contravention of this section which indicate that a person who has suffered loss or damage as a result of prohibited conduct, or dereliction of required conduct may not institute a claim in a civil court for the assessment of the amount or awarding of damages if that person has consented to an award of damages in a consent order.
Also from this Legal Handbook
5. Traditional Medicines & OTC Products: South Africa
Traditional medicines & OTC products in South Africa – a legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: South Africa, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
In terms of the Medicines Act medication is classified into 4 categories from Category A- Category D depending on the
In terms of the Act, “Complimentary medicines” means any substance or mixture of substances that –
- Originate from plants, fungi, algae, seaweeds, lichens, minerals, animals or other substances as determined by the Authority;
- Is used or purporting to be suitable for use or manufactured or sold for use –
- In maintaining, complementing or assisting the physical or mental state; or
- To diagnose, treat, mitigate, modify, alleviate or prevent disease or illness or they symptoms or signs thereof or abnormal physical or mental state of a human being or animal; and
- Is used –
- As a health supplement
- In accordance with those disciplines as determined by the Council
- Is declared by the Minister, on recommendation by the Council, by notice in the Gazette to be a complementary
Combination Products means “a single product that contains:
- A mixture of substances of different discipline-specific origins or philosophies;
- A mixture of at least one substance of discipline-specific origin;
- A mixture of at least one substance of discipline-specific origin and one more of its isolated constituents.
It is important to note that the SAHPRA Guideline on Complementary Medicines – Discipline-specific Safety and Efficacy, specifically identify six major disciplines within the Complementary Medicines sphere namely: Homeopathy, Western Herbal Medicine, Traditional Chinese Medicine, Ayurveda, Unani Medicine (Unani-Tibb) and Aromatherapy.
All manufacturers of complementary medicines shall comply with all relevant aspects of Good Manufacturing Practice as outlined in the latest version of the SAHPRA “Guide to Good Manufacturing Practice for medicines in South Africa” and Good laboratory practice as well as the WHP Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants if applicable. Any alternative standards must be specified, referenced and justified.
The Regulatory Authority classify medicines into different categories and complementary medicine is categorised as a Class D medicine, which is medicine intended for use in humans and animals which are without further manipulation, ready for administration, including packaged preparations where only a vehicle is added to the effective medicine.
Under this classification there are two sub-categories which include discipline-specific medicines (which disciplines will be determined by the Regulatory Authority) and health supplements.
With regards to Traditional Medicine, it is considered to form part of Complementary Medicine for the purposes of regulation by the SAHPRA and in order for the relevant registration to be completed as set out in the Medicines Act. However, a Traditional Health Practitioners Act was published in the Government Gazette bringing forth the vision of having the practice of Traditional Health practitioners regulated by a Regulatory body functioning with similar onus and responsibilities as SAHPRA and the Health Professions Council of South Africa (last mentioned being responsible for the regulation of the practice of medical practitioners, physiotherapists, radiographers and other health care practitioners who fall within the ambit of the Act).
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Under the General Regulations relating to medicines, complementary medicines may only be advertised through a statement identifying the discipline of the medicine where relevant and an indication that the medicine must be used in accordance with the applicable complementary discipline and principles where relevant. It must also be stated whether the medicine has not received registration with the Authority and if so, the following disclaimer must be present when advertising is done:
“this unregistered medicine has not been evaluated by the SAHPRA for its quality, safety or intended use”.
Direct advertisement to the public thus in this regard must adhere to the above requirement and must be clear, direct and factual – no misleading or vague statements about the product can be made.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
According to the SAHPRA guideline on Complementary Medicines – Discipline-specific Safety and Efficacy, any advertisement or marketing claims for complementary medicine must adhere to specific requirements. An important aspect of this is that the claims made must not cause any member of the public to become anxious or stressed or have the effect that unnecessary concern about their health is created through the advertisement or marketing claims made for the relevant product.
In general, and unless specifically pre-approved as a disease risk reduction claim, indications that refer (explicitly or implied) to the treatment, or cure of specific disease are not suitable for use for health supplements. The following disclaimer must appear on the immediate (as appropriate) and outer container label: “Health supplements are intended only to complement health or supplement the diet”.
Reference to the relative Nutritional Reference Value as a percentage may also be included on the label where relevant.
Any use of artificial sweeteners must be clearly stated as in the Guideline: Complementary medicines: Registration Application ZA-CTD – Quality.
The General Regulations under the Medicines Act further state that Schedule 0 and Schedule 1 medicines may be advertised to the public directly.
From Schedule 2 through to Schedule advertising of the medication may only be done to Medical practitioners, Dentists, Veterinarians, Pharmacists and other persons authorised to prescribe medicines, Persons in receipt of certain publications containing the advertising.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
The SAHPRA determine the categories of medicines – the primary method in doing so is based on a Schedule system which is determined from Schedule 0 to Schedule 7.
Each Schedule is applied taking into account the various conditions which is attached to the distribution and sale of the medicine depending on the nature of the schedule that is applied.
In this regard Schedule 0 medicines are available off the shelf or without prescription in a supermarket.
This includes the complementary medicines with a Schedule 0 category, as the same rules apply though they are still required by law to now apply for registration and adhere to the regulatory requirements as set out by the SAHPRA. In terms of South African Regulations Schedule 1 and Schedule 2 medicines are available without prescription, but only from a pharmacist. They are referred to as “over the counter medicines” (OTC).
In the case of health supplements and complementary medicines which contain scheduled substances, it becomes an allopathic medicine which falls into the above categories. In this instance, when considering health supplements and complementary medicines, most will be schedule 0, or has the potential to fall into a category which will be in the general market but has not yet been determined.
5. Are there any limitations on locations or channels through which OTC products may be sold?
Schedule 0 medicines are available at supermarkets and other retail outlets and do not require the involvement of a pharmacist or other professional at all. These medicines may be sold by anyone and to anyone – which is why they are referred to as “over-the-counter” medicines. They must still be manufactured under controlled conditions in accordance with the Good Manufacturing Practice standards of the SAHPRA.
Schedule 1 medicines are made available only from pharmacies and may be sold only by a pharmacist or a pharmacist intern or pharmacist’s assistant under the supervision of a pharmacist. This Schedule medication should not be on an open shelf in a pharmacy.
Schedule 2 medication can be bought without a prescription from a medical practitioner and is considered within the South African context to be “pharmacist prescription medicines”. Only someone entitled to sell these medications (such as a pharmacist or a holder of a dispensing licence) may own Schedule 2 medicines for the purpose of sale.
6. What health, advertising, and marketing claims may be made for OTC products?
It is important that the presentation of OTC products must not be misleading or confusing as to the content of the content and proper use of the medicines. For purposes of making clear statements, the information provided must always include the correct information regarding which ingredients, components or characteristics the OTC product has. The name of the product must not be the same as the name applied to other products that are already supplied in South Africa. In addition to last mentioned, the label of the product must declare the presence of a therapeutically active ingredient and the presentation of the product must always indicate safe use of the product. The purpose and intended use of the product must always be explained to an extent which the consumer/patient/end-user will understand.
Generally, advertisements must not be misleading or disparaging (whether done directly or by implication) and claims and comparisons must be fair, balanced, objective, accurate, unambiguous and supportable – in this regard it is important that the advertisement is based on up-to-date reflections of evidence evaluated, and such evidence must be reflected clearly. Use of any terminology (medical or related) is not unacceptable; the consumer must just not be misled or confused by its inclusion.
7. Can OTC products be marketed or advertised directly to the public?
Only if the OTC product is registered as a Schedule 0 medications in terms of the Medicines Act.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Prescription-only medication will only be able to be converted to an OTC product if the composition of the medicine is changed to the extent that it becomes a Schedule 0, Schedule 1 or Schedule 2 medicine – which is available without prescription.
It must be remembered that a distinction is made between a Medicinal substance and a Medicinal product whereby last mentioned is known by both their proprietary (brand name) and by the non-proprietary (generic, scientific or “approved”) names of their active ingredients. Medicinal products are per sé not listed in the Schedules to the Medicines Act.
The Scheduling status of medicinal products depends upon the Scheduling status of their active ingredients. Thus, if the prescription-only product contains any active ingredient which falls within a Schedule 3 to Schedule 6 medicine, it will not be able to be converted to an OTC product. Such mechanism is not available under these circumstances.
9. What are the requirements for the importation of either traditional medicines or OTC products?
A licence to Import/Export medicines is required in order for any medication to enter or exit the country. This is set out in Section 22C (1) (b) of the Medicines Act and includes the requirement that an application must be made in the prescribed manner. No person is allowed to import or export any medicine unless they are the holder of a licence as contemplated in the above-mentioned Section of the Medicines Act.
The relevant licence to Import or Export medicines will be issued by the Regulator after due application and such a licence will be valid for a period of five (5) years from the date of issue.
Since traditional medicines and OTC products are also regulated under complementary medicines, they must be imported as per the requirements contained in the Medicines Act and as set out in the guidelines of the SAHPRA.
