A Q&A guide to life sciences law in South Africa.
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.
To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.
The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.
The regulation of medicines and related substances is governed by the Medicines and Related Substances Control Act No.101 of 1965 (Medicines Act), as amended, and the regulations issued under that Act.
The principal regulatory body, established by the Medicines Act, is the Medicines Control Council (Council). The Council is assisted by a number of directorates and committees when carrying out its functions, and is afforded wide-ranging regulatory competence relating to the regulation of medicines and related substances, and governs:
Manufacturing.
Marketing.
Importing
Exporting.
Any medicine that is manufactured or marketed in, and/or imported into, South Africa must first be registered with the Council. Following registration, a licence to manufacture, market and/or import must also be obtained from the Council before manufacturing, marketing and/or importation can be carried out. Licences are granted separately from the registration process, and are only granted where the applicant can show that they conform to the required standards and practices for manufacturing, marketing and/or importing.
Explicit provisions concerning biotechnology have not yet been incorporated into South African legislation. However, the Genetically Modified Organisms Act No. 15 of 1997 (GMO Act) regulates, in certain circumstances, the development, production, use and application of genetically modified organisms (GMOs), and regard must therefore be given to this Act where GMOs are employed in the manufacture of a medicine. The GMO Act establishes the Executive Council for GMOs, which is the regulatory body responsible for regulating the GMO-related matters to which the GMO Act applies.
The national healthcare policy provides for free primary healthcare to be given to all citizens who have no source of income. Certain groups, including pregnant women and children younger than five years old, receive medical care at primary healthcare facilities free of charge, regardless of their income. These services are fully funded by the government and are ultimately paid for by the taxpayer.
State health institutions purchase medicinal products from manufacturers through a state tender system, and tenders are awarded for two years. Tenders are only awarded for medicines on the Essential Drug List (EDL).
Currently, the government is considering establishing a public national health insurance scheme, which would be state funded and provide health insurance specifically to citizens who cannot afford to belong to a private medical aid or insurance scheme. To this end a national investigation and consultation process is being conducted by the National Health Insurance Advisory Committee. The focus of the process has, so far, principally taken the form of consultations conducted with interested parties. Whether and when the scheme will actually be established remains to be seen.
The prices of all medicines sold in South Africa in the private sector have been regulated since 2004 by regulations issued under the Medicines Act. The principal legislation is the Regulations Relating to a Transparent Pricing System for Medicines and Scheduled Substances (pricing regulations).
Medicine prices are regulated under the pricing regulations by reference to the "Single Exit Price" (SEP) of the medicine. An SEP is defined in the pricing regulations as "the price set by the manufacturer or importer of a medicine or Scheduled substance in terms of these regulations combined with the logistics fee and VAT and is the price of the lowest unit of the medicine or Scheduled substance within a pack multiplied by the number of units in the pack".
The SEP is determined, independently, by the manufacturer or importer of the medicine, following the guidelines provided by the pricing regulations.
The SEP, once determined, is subject to the approval of the Director-General of Health, before the sale of the medicine. Once the SEP has been approved, the SEP becomes a fixed price at which the manufacturer or importer must sell the medicine in South Africa. Wholesalers who buy the medicine for onward sale must sell the medicine at a price no higher than the SEP, as must pharmacists, whether they buy the medicine from the manufacturer, importer, wholesaler or distributor. The pricing regulations do, however, make provision for a "dispensing fee", which can be raised over and above the SEP by pharmacists or other persons licensed to dispense medicines.
Once the SEP is set, it cannot be increased unilaterally, and an application must be made to the Minister of Health who will, in consultation with the Pricing Committee, decide the matter. Further, only one increase per year is permitted. In practice, the Department of Health determines, on an annual basis, an industry-wide price increase, based primarily (among other things) on the Consumer Price Index and average exchange rates over the preceding period. This increase can then be applied to all registered drugs. The increase is usually between 6% to 8%, and the decision whether or not to increase the price of products, and the extent of the increase to products, within the limits determined by the Minister of Health is then decided by the manufacturer, wholesaler or importer, as the case may be.
No reimbursement scheme is provided for either by the Medicines Act or the regulations under that legislation. However, the national healthcare policy and the benefits it provides to end-users are discussed in Question 2.
The national healthcare policy is funded out of the Department of Health's budget, which is allocated according to what is agreed between the Department of Health and the Treasury. The supply of medicines to state hospitals is governed by a tender system in which both multinationals and generic companies participate.
Application for a licence to manufacture or market medicinal products is made to the Council.
There are a number of formal disclosures that are required for the licence to manufacture or market, including detailed specifications of the medicines to be manufactured or marketed. Applicants must also satisfy the Council that they are capable of complying with good manufacturing and marketing practices, as defined in the Guidelines on Good Manufacturing Practice, issued by the Council under the Medicines Act. These Guidelines include guidance on good wholesaling, best practice and marketing.
The Guidelines are prescriptive, not elective, and strict compliance is both required and enforced by the Council. The most recent Guidelines were adopted by the Council in 2010 and cover aspects such as (among other things):
Quality management.
Personnel.
Premises and equipment.
Self inspection.
These Guidelines are based on the Guide to Good Manufacturing Practice for Medicinal Products, version PE 009-2 dated 1 July 2004, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
To ensure that the Council is satisfied of compliance with the Guidelines, applicants usually provide the Council with a manual outlining which practices and procedures will be put in place to ensure that the requirements are met.
Applicants must also appoint, and designate as such, a pharmacist who will control the manufacturing or distribution, together with a natural person, resident in South Africa, who will be responsible for ensuring compliance with the Medicines Act.
An applicant for a manufacturing and/or marketing licence must be resident or have its place of business in South Africa. Foreign entities usually comply with this requirement by applying through a local responsible pharmacy, which is designated in the application documents. Foreign applicants with locally resident subsidiaries can also apply through their subsidiary. In practice, a foreign entity usually does not apply in its own name, but in the name of its designated pharmacy, which itself can be represented by a locally established and incorporated pharmacy, or subsidiary of a foreign company.
The licence is therefore granted to the applicant (usually a local responsible pharmacy) and manufacturing or marketing must be completed in their name, and not in the name of the foreign entity (unless the two are the same: the applicant foreign parent and its subsidiary local branch company). Where the applicant has had no previous dealings with the Council, and particularly with applications for a marketing licence, an inspection of the applicant's manufacturing premises is made to evaluate compliance with the Guidelines. This is still the case where an application is made through a local representative but the actual manufacturing is conducted abroad.
The Council aligns their policies and guidelines with those of certain foreign regulatory authorities, including the:
Food and Drug Administration (US).
Medicines and Healthcare Products Regulatory Authority (UK).
European Medicines Agency (EU).
Regulatory authority of Canada.
Therapeutic Goods Administration (AU).
South Africa has Mutual Recognition Agreements (MRAs) with these jurisdictions. There is an abbreviated process for the registration of a medicine with these jurisdictions, but not for an application for a manufacturing and/or marketing licence. However, the Minister of Health has the power to exclude any medicine from the provisions of the Medicines Act. Potentially, an exemption from the provision to acquire a manufacturing and/or marketing licence is therefore possible.
Once an application is made, the Council appoints an inspector to inspect the applicant's site to ensure:
It complies with good manufacturing practice standards.
Information provided in the application concerning the applicant's good practice is put into practice at the site.
This process takes between 12 and 24 months.
The process is quicker where the local representative is granted an exemption from inspection because the foreign entity manufactures and/or markets in a foreign jurisdiction covered by an MRA and aligned with the Council. The Council decides whether to grant or refuse the licence, and can also request further information from the applicant within a period of 28 days.
Application fees are payable as follows:
Licence to manufacture: about ZAR3,500.
Licence to distribute: about ZAR2,400.
Licence for wholesale: about ZAR2,400.
Licence to import: about ZAR2,400.
Licence to export: about ZAR2,400.
During the currency of the licence an annual retention fee of about ZAR625 is also payable.
The following inspection fees are also payable:
Local manufacturing site: about ZAR160 per hour.
International manufacturing site: about ZAR400 per hour.
Wholesale sites: about ZAR800 per site.
Distributor sites: about ZAR800 per hour.
Fees payable on applications for the registration of medicines are significantly higher than the amounts for licensing and inspection.
These fees do not include any professional charges that can be charged by a professional firm engaged to complete the application.
A manufacturing and/or wholesaling licence is granted for five years from its issue date. Licences can be renewed on application to either the Director-General or the Council, and must include substantially the same information provided in support of the original application. The application for renewal must be made 90 days before the expiry date of the existing licence. Renewal fees are the same as the original application fees (see above, Fee).
The Guidelines allow the Directorate: Inspectorate and Law Enforcement (Inspectorate) to carry out, on behalf and under the direction of the Council, regular inspections of manufacturing sites, both in South Africa and in countries with which the Council does not have an MRA. Inspection enables the Inspectorate to confirm that licence holders comply with:
The conditions of their licence.
The provisions of the Medicines Act.
Good manufacturing practice.
Legislation requires that licence holders make their premises available for inspection by the Inspectorate, acting through inspectors, at any reasonable time and in accordance with the Guidelines. Where quality control testing is contracted out to a third party, the testing site must both:
Be made available for inspection.
Obtain a licence.
Non-serious deficiencies found during the inspection are notified to the licence holder by letter, which requests proposals to remedy them. Serious non-compliance with the Guidelines regarding good manufacturing practice is referred to the Council for formal action.
The Council, once certain of the accuracy of the report, can revoke (in full or in part), amend or suspend a licence. Licence holders are usually given an opportunity to be heard before formal action is taken. However, where the Council believes public safety is at risk, it can suspend a licence with immediate effect for an indefinite period, or revoke the licence.
Appeal can be made to the Minister of Health to challenge the validity of the Council's decision within 30 days of notification of the decision.
Clinical trials are regulated by the Council under the Medicines Act and the regulations issued under it, including the Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa 2000 (Clinical Guidelines).
Authorisation to conduct a clinical trial must be obtained by making an application to the Council.
Proof of consent is a prerequisite for authorisation to be granted. The applicant should submit, with the application, an "informed consent document" which should also be used in the trial. This document, together with the trial protocol to be followed, should, among other things:
Be endorsed by an ethics committee recognised by the Council.
Outline the applicant's approach in obtaining informed consent from trial subjects.
Provide a comprehensive statement of the information to be communicated to the trial subjects.
The principal requirement for authorisation is compliance with the Clinical Guidelines, as determined by the Council. An undertaking that the trial will be conducted in accordance with the Clinical Guidelines must also accompany the application.
The Principal Investigator (PI) is responsible for ensuring that an adequate information package, in an acceptable format, is available for use in the process of seeking informed consent from subjects to participate in the clinical trial. In all instances both written and oral informed consent should be obtained. Where the subject is illiterate, oral consent should be obtained in the presence of, and countersigned by, a literate witness.
The subject's informed consent should be provided in accordance with the principles outlined in the Declaration of Helsinki.
If the clinical trial is a multi-site, and/or multi-country study, the site PI must ensure that informed consent procedures take into account the characteristics of the subjects at each site and tailor the content of the informed consent and procedures accordingly.
Both the informed consent discussion and the written informed consent form, and any other written information to be provided to subjects, should include explanations of the following:
That the trial involves research.
The purpose of the trial.
The trial treatment(s) and the probability for random assignment to each treatment (where appropriate).
The trial procedures to be followed, including all invasive procedures.
The subject's responsibilities.
The fact that participation in the trial is voluntary and refusal to participate or withdrawal from the trial will not prejudice the ongoing care of the person in any way.
Those aspects of the trial that are experimental.
The foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, foetus, or nursing infant.
The expected benefits of the trial. When there is no intended clinical benefit to the subject, the subject should be made aware of this.
The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.
The compensation and/or treatment available to the subject in the event of trial-related injury.
The anticipated pro rata payment, if any, to the subject for participating in the trial.
The anticipated expenses, if any, to the subject for participating in the trial.
That the sponsor and regulatory authority have access to patient records.
Provide the PI's and the directly responsible investigator's name and contact number.
The identity of a sponsor and details of any potential conflict of interests.
Once consent to participate in the study has been obtained, a copy of the signed informed consent form and a source document identifying the study and recording the dates of participation should be placed in the subject's medical record. The original signed informed consent form should be kept with the trial records and a copy of the signed informed consent form should be provided to the subject.
If the subject has a medical practitioner, the PI should seek the subject's consent to inform that medical practitioner of their entry into the study. This must only be done with the subject's consent.
Although a subject is not obliged to give their reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain those reason(s), while fully respecting the subject's rights.
Certain pre-conditions must be met for an application for authorisation to be successful. In practice, ethical endorsement of the trial, together with compliance with the Clinical Guidelines, must both be present before an authorisation will be granted.
During the trial, progress reports must be made to the Council on a six-monthly basis from the date on which the trial commenced, and 30 days after the completion or termination of the trial. All practices during the conduct of the trial must comply with the Clinical Guidelines.
See Question 5.
See Question 5.
See Question 5, Conditions (www.practicallaw.com/2-504-6252).
See Question 5.
See Question 5, Fee (www.practicallaw.com/2-504-6252).
See Question 5, Period of authorisation and renewals (www.practicallaw.com/2-504-6252).
See Question 5.
The Council provides, under the provisions of the Medicines Act and its regulations, abridged procedures for the registration of medicines in certain circumstances. In particular, provision is made for an "expedited review process" and an "abbreviated medicine review process".
The expedited review process allows the Council to speed up the registration process for specific medicines that either have important therapeutic benefit, or are urgently required to deal with key health problems. In these instances an accelerated review system is applied.
A request for expedited review must be submitted to the Minister of Health, and a copy must be provided to the Registrar of Medicines, before submitting the full application. Only the following medicines can be considered for expedited review:
Medicines on the EDL.
New chemical entities that are considered essential for national health, but that do not appear on the EDL.
The AMRP is a system created by the Council to limit the evaluation time for pharmaceutical products that are registered in countries with which the Council aligns itself, provided the evaluation report is readily available.
The AMRP is principally based on the expert reports of the pharmaco-toxicological and clinical data. It should be noted that the AMRP is an abbreviated evaluation process, and not an abbreviated application.
Foreign marketing authorisations are not recognised in South Africa. However, the Council does align their policies with those of certain foreign regulatory authorities, and recognises these foreign regulatory authorities, which can facilitate Council approval of marketing authorisation applications (see Question 5).
See Question 6.
See Question 6.
Parallel imports are allowed. The Medicines Act allows the Minister of Health to prescribe the conditions under which parallel imports of any patented medicine can be imported. This is governed by regulations issued under the Medicines Act, and specific guidelines to the Council's approach to applications have also been issued.
Only medicines that are registered under the Medicines Act, and that are sold outside South Africa with the consent of the patent holder for the medicine in South Africa, can be parallel imported. The person importing must have an export licence from a regulatory authority recognised by the Council.
Application must be made for a parallel import permit from the Minister of Health. The comparative selling price is a significant factor influencing the Minister's decision to grant a permit, and documentary proof confirming the lowest selling price of the medicine in South Africa, and the price at which the parallel imported medicine will be sold, must accompany the application.
Once the parallel import permit is obtained, application to the Council must be made to register the medicine to be imported. The following characteristics of the imported medicine must be the same as the corresponding registered and already available medicine:
Formulation.
Quality and safety standards.
Proprietary name.
The provisions of the Patents Act (regarding the exclusive right of the patent holder to import) and the Trade Marks Act are rendered ineffectual for the medicine for which the permit is granted (the Trade Marks Act actually specifically allows parallel imports).
The Medicines Act explicitly prohibits the supply of any medicine using a "bonus scheme, rebate system or any other incentive scheme".
No express provisions regarding internet, e-mail or mail order marketing are included in the Medicines Act, though the general provisions applicable to all marketing will still apply.
However, Schedule 2 to 6 medicines can only be sold with the intervention of a medical practitioner: the marketing of these medicines over the internet without the intervention of a medical practitioner before they are dispensed is therefore illegal.
Further, the marketing and advertising of Schedule 2 to 6 medicines by manufacturers or wholesalers can only be made to medical practitioners. This limits the audience that internet-based marketing is allowed to reach. A code on the practice of marketing medicines which provides explicitly for internet-related marketing has now been implemented and is in force (see Question 15).
The Medicines Act is the principal legislation governing the advertising of medicinal products. The Code of Advertising Practice (Advertising Code), regulated by the Advertising Standards Authority (ASA), also applies to the advertising of medicinal products, although the Advertising Code does not have the force of law and forms part of a self-regulatory system. The provisions relating to medicines have been updated since February 2010, and a redraft has recently been released in the form of a Marketing Code for pharmaceutical products, issued under the Medicines Act. The Marketing Code of October 2010 is in force since September 2012, and its provisions will be adopted by the ASA as part of the Advertising Code. It has an indirect application through enforcement of the Advertising Code.
The Consumer Protection Act No. 68 of 2008 (CPA) also applies to the extent that it deals with general advertising or marketing to a consumer. The CPA came into force on 31 March 2011.
There is no complete prohibition on advertising certain medicines. However, medicines containing a substance appearing in Schedules 2 to 6 of the Medicines Act can only be advertised to medical practitioners (and not to the general public). Advertising these medicines in a publication usually, or only, made available to medical practitioners is acceptable.
Generally, advertising to both medical practitioners and the general public must not conflict with the information (which has been incorporated into the package insert) submitted in support of the medicine's application to the Council for registration with regard to its:
Safety.
Efficacy.
Quality.
Where a medicine includes more than one active ingredient, no reference can be made to the specific properties of any specific active ingredient unless that reference has been approved by the Council for inclusion in the package insert.
There are no specific provisions in the Medicines Act or Advertising Code concerning the internet. However, the South African Code of Practice for the Marketing of Medicines (SA Code) covers internet advertising and marketing in section 21 (see Question 35, Advertising).
Under the SA Code, promotional material for medicine containing Schedule 2 to 6 substances should be limited to healthcare professionals only by using a password protection scheme. Information placed on the internet outside South Africa, but by a South African company, will fall within the ambit of the SA Code.
In practice, the Council regulates the advertising of medicines, through the application of the SA Code. Advertising-related complaints can be lodged with the Executive Officer of the Marketing Code Authority (MCA), who will then investigate complaints. The MCA is empowered to issue sanctions to ensure compliance with the SA Code. Parties involved in the complaint procedure can respond to all documents filed in support of the complaint. A hearing is co-ordinated and a ruling is made. Complaints can also be lodged with the ASA.
Packaging and labelling are regulated by the Medicines Act and the regulations created under that Act, and enforced by the Council through the Directorate: Inspectorate and Law Enforcement.
There are no provisions or regulations prescribing a particular type of packaging which must be used. Provisions relating to packaging are principally directed to labelling, and the information that must be included on the packaging.
It is a requirement that the immediate container of any medicine sold that is intended for administration to humans must have a label attached to it. The information on the label must be in English and at least one other official language of South Africa. For further information on the specific information that must be included on the label, see Regulation 8 of the General Regulations issued in terms of the Medicines and Related Substances Act 1065 (GN R510 and GG24727 of 10 April 2003, as amended). Information such as scheduling status, the proprietary name of the medicine and its registration number, the dosage form, the lot number and expiry date, is among the most relevant information that should be displayed in clearly legible, indelible letters, in English and at least one other official language.
No special provisions exist in relation to traditional herbal medicines and they are regulated by the same provisions and requirements as other medicine. Draft regulations providing exclusively for the regulation of traditional herbal medicine have, however, been drafted and published for comment (see Question 35, Regulation).
Patent protection is governed by the Patents Act No. 57 of 1978, as amended (Patents Act) and regulations created under it.
The Patents Act provides that a patent can be granted for any invention which is:
New.
Involves an inventive step.
Is capable of being used in trade, industry or agriculture.
The concept of invention is not strictly defined intrinsically, but the legislation lists a number of exclusions. Medicines and related substances (such as active pharmaceutical agents) are not listed as an excluded category. Medicines and related substances, and the processes by which they are obtained, are therefore patentable under the Patents Act.
The Patents Act provides that an invention consisting of a substance or composition "for use in a method of treatment" of the human or animal body can be patented, even though the substance (or substances) in the composition is previously known. The first medical use of a known substance is patentable: the substance itself cannot be protected a second time.
Protection granted through patent registration extends to the invention as it is claimed in the patent specification. It is possible to patent a pharmaceutical active agent, a pharmaceutical product containing the active agent, and/or a process for manufacturing the product or agent, provided that these comply with the patentability requirements (see above, Conditions and legislation). Under the Patents Act, any claim directed to a process (or apparatus) for producing a product extends to that product when produced by the process (or apparatus) claimed. Second and subsequent medical uses can be claimed in Swiss form in South Africa.
Application is made to the Companies and Intellectual Property Commission (CIPC). The application fee (excluding professional fees raised by a local agent for attending to the application) is about ZAR590. Guidance on the application procedure is available on its website.
The Patent Office takes about nine to 18 months to examine an application and accept or reject the specification. No substantive examination occurs. Once the formal requirements have been met, the specification is accepted and notification of the patent is published in the Patent Journal. This publication constitutes the grant of the patent. There is no provision to oppose pending or granted patent applications. However, at any stage after the grant of a patent, any person can apply to the Registrar of Patents to revoke the patent on one or more of a number of statutory grounds for invalidity. If the revocation proceeds, it will be determined before the Court of the Commissioner of Patents, a special court in the High Court that has national jurisdiction at first instance in all litigious patent matters.
The application process can be expedited on the payment of a fee. Acceptance of the specification can be delayed as of right for up to 15 months: further extensions are at the discretion of the Registrar of Patents (who can grant a request for delay indefinitely).
The Patent Office operates on a deposit system and applications are subject to only formal scrutiny. No substantive examination takes place.
A patent is valid for a period of 20 years from its effective filing date (the filing date differs depending on whether the application is made under the WIPO Paris Convention for the Protection of Industrial Property 1883 (Paris Convention) or the Patent Cooperation Treaty 1970). Renewal fees are paid annually, and the patent cannot be extended once it has expired. There is no provision to extend the term of a patent, or extend the monopoly rights that it confers.
South Africa does not provide for any form of patent term extension (for example, supplementary protection certificates). There are no statutory provisions in either South African patent law or in the medical regulatory laws which specifically deal with the issue of data package exclusivity. There are, however, provisions relating to the protection of confidential information in general which may be used in this respect.
An application to the Commissioner of Patents can be made to revoke a patent. The Patents Act explicitly provides nine grounds on which a patent can be revoked, including (among other things):
The invention to which the patent relates is not capable of being patented because it cannot be used or applied in trade, industry or agriculture.
Lack of novelty or inventiveness.
Insufficient disclosure.
The invention as disclosed cannot be performed or does not lead to the results and advantages set out in the specification.
Fraud.
Lack of clarity or fair basis of the claims.
The invention is contrary to public morals or well established natural laws.
The patentee was not entitled to apply for the patent in that it is not the inventor, or did not obtain the right to apply from the inventor.
There are a number of additional grounds relating to non-compliance with certain requirements.
A patent is infringed when any person, without the consent of the patent owner, carries out acts which are exclusively reserved, under the Patents Act, for the patent owner. This includes:
Making the invention.
Using the invention.
Exercising (in the sense of "carrying out", which indicates that this has a particular bearing on methods or processes) the invention.
Disposing, or offering to dispose of, the invention.
Importing the invention.
An action for infringement can be brought in the Court of the Commissioner of Patents. An application for a preliminary injunction to cease the infringement can also be made.
The claimant is entitled, if successful, to:
Relief by way of an injunction.
Delivery up of any infringing product or article, or any product or article of which the infringing product forms an inseparable part.
Damages.
Instead of damages, a claimant can elect to take a reasonable royalty, which would have been payable had the patent been licensed rather than used without consent.
There are no non-patent barriers to competition to protect medicinal products.
A medicinal product brand complying with the following requirements can be registered as a trade mark.
Trade mark protection is governed by the Trade Marks Act No. 194 of 1993, as amended (Trade Marks Act), and the regulations created under that Act. A trade mark is defined as any sign capable of being represented graphically, and includes, among other things, a:
Name.
Signature.
Word.
Numeral.
To be capable of registration under the Trade Marks Act, a trade mark must distinguish the goods or services for which it is registered (or proposed to be registered) from the goods or services of another person.
A trade mark is capable of distinguishing the goods or services if (at the date of application for registration):
It is inherently distinctive.
It is capable of distinguishing by reason of prior use.
A trade mark is inherently distinctive if it does not describe the goods or services, or any qualities of the goods or services, in any way. This category of trade mark includes invented words (for example, NOKIA and KODAK) and also ordinary words with an accepted meaning but which are not descriptive of the goods or services in question (for example, APPLE for computers). In contrast, certain marks that do not possess this inherent capacity to distinguish (because they are descriptive of the goods or services in question), have nevertheless acquired distinctiveness through use. Consumers have come to associate the particular mark with one enterprise and no other.
See above, Conditions and legislation.
Applications are made to CIPC, to the Registrar of Trademarks. The application fee is ZAR590. This fee does not include any professional charges which can be raised by a professional firm engaged to attend to the matter.
Once filed, the application is examined to determine both whether it:
Is inherently registrable.
Conflicts with prior registrations or applications.
It takes about 12 months to issue a report on the examination. The report will either accept the application, or constitute a preliminary refusal of it. A preliminary refusal will indicate any conditions subject to which the application can be accepted. The applicant then has an opportunity to make representations to address, and overcome, the concerns expressed in the report.
Once a trade mark application is accepted, it is advertised in the Patent Journal. If no objections are raised by third parties within a three-month period from the date it is advertised, the trade mark is granted and a certificate of registration is issued within about 18 months.
A trade mark registration is valid for ten years and can be renewed for the same period of time, in perpetuity.
A trade mark registration is renewed by making the necessary application to the Registrar of Trade Marks and paying the applicable fee. The application must be filed within the six-month period before the expiry of the registration but can also, subject to the payment of additional fees, be filed within six months following the expiry date.
A trade mark can be removed from the Register on application by an interested person, on any of the following grounds:
The trade mark is used in a manner which does not comply with any condition entered in the register concerning its registration.
The trade mark was registered without any genuine intention to use the trade mark in relation to the goods or services for which it has been registered, and there has been no actual use of the trade mark in relation to those goods or services from three months before the date of the application for removal up to the present time.
From three months before the date of the application, a continuous period of five years (or longer) has lapsed from the date of issue of the certificate of registration during which there was no bona fide use of the trade mark in relation to the goods or services for which it is registered.
In the case of a trade mark registered in the name of a body corporate, or in a name of a natural person, the body corporate was dissolved or the natural person died no less than two years before the date of the application for the removal of the trade mark, and no application for the registration of an assignment of the trade mark has been made.
The trade mark was wrongly entered on the register, or wrongly remains on the register. This will be the case where a mark is inherently unregistrable (for example, because it is offensive or not distinctive) or contrary to the prior rights of a third party.
The existence of any one of the grounds above is sufficient to obtain the removal of a registered trade mark from the register.
A registered trade mark is infringed by any of the following:
The unauthorised use, in the course of trade, and in relation to the goods or services in respect of which the trade mark is registered, of an identical mark or a mark so nearly resembling it as to be likely to deceive or cause confusion.
The unauthorised use, in the course of trade, of a mark that is identical or similar to a registered trade mark, in relation to goods or services that are so similar to the goods or services in respect of which the trade mark is registered, that such use is likely to cause deception or confusion.
The unauthorised use, in the course of trade, of an identical or similar mark to the trade mark registered, where that trade mark is well-known in South Africa and the unauthorised use is likely to take unfair advantage of, or be detrimental to, the distinctive character or repute of the registered trade mark (irrespective of the absence of deception or confusion).
A claim for trade mark infringement is made to the High Court. Proceedings can be brought by way of either:
Application, on notice of motion, when there is no dispute of fact.
An action, with the issuing of a summons, when there is an anticipated dispute of fact.
The available remedies are:
An injunction ordering the defendant to refrain from further infringement.
An order for the removal of the infringing trade mark from all material and, where the infringing mark is inseparable or incapable of being removed from the material, an order that all such material be delivered up to the trade mark owner.
Damages (which can only be claimed in proceedings brought by way of action).
Instead of damages, a reasonable royalty (which can only be claimed in proceedings brought by way of action).
Legal costs.
Licence agreements that contain royalty payments which are paid to a foreign entity must be approved by the Department of Trade and Industry.
South Africa is a signatory to the:
WTO Agreement on Trade-Related Aspects of Intellectual Property Rights.
Paris Convention.
Patent Cooperation Treaty.
At common law a claim for a defective product is based on delict, and the defendant's fault must be proved. Liability for defective products, including medicinal products, is also imposed on manufacturers to protect consumers from personal injury. The principal legislation is the Consumer Protection Act 2008 (CPA). The main effect of the CPA is that it imposes strict liability with regard to defective products. The CPA was brought into force in an incremental manner, commencing in October 2010, and by 1 April 2011 all the relevant provisions of the CPA had come into force. The CPA provides that a producer, importer, distributor or retailer of any goods is liable for any harm, caused wholly or partly, as a consequence of:
Supplying any unsafe goods.
A product failure, defect or hazard in any goods.
Inadequate instructions or warnings provided to the consumer.
The CPA provides that there should be a causal link between the defect and the harm suffered. Fault is not a requirement for the strict liability created under the CPA.
There are two principal types defectiveness in South African law:
Consumer expectations.
Risk-utility.
The CPA imposes the "consumer expectations" standard. The basic test for defectiveness is as follows:
Is there any material imperfection in the manufacture of the goods or components, or in the performance of the services, that renders the goods, or the results of the service, less acceptable than persons generally would be reasonably entitled to expect in the circumstances?
Is there any characteristic of the goods or components that renders the goods or components less useful, practicable or safe than persons generally would be reasonably entitled to expect in the circumstances?
The following parties are liable for any harm caused by a defective product:
Producer.
Importer.
Distributor.
Retailer.
The harm for which liability will arise includes:
Death or injury of any person.
Illness of any person.
Loss of, or physical damage to, any movable or immovable property.
Any economic loss resulting from the above.
The term producer is widely defined, and includes the manufacturer or producer of the defective product, or person(s) applying their name or trade mark to the defective product. A distributor is defined as the person who, in the ordinary course of a business, is supplied with the defective product and in turn supplies it to another distributor or retailer.
The court has authority to:
Assess whether any harm has been proven.
Determine the extent of the damages or loss.
Apportion liability among persons found to be jointly, or severally, liable.
The limitation period generally is three years from the date the claimant becomes aware of the damage (see also Question 33).
The Consumer Protection Act, 2008 (CPA) allows consumer protection groups to take steps to protect the interests of an individual consumer or a group of consumers collectively. However, such a group must be accredited by the National Consumer Commission. Section 76(1)(c) specifically contemplates the award of damages in a class action. It states that a court can award damages against a supplier for collective injury to all or a class of consumers generally, to be paid on such terms as the court considers just and equitable and suitable to achieve the CPA's purposes. However, since this kind of action is novel in South African law, it remains to be seen how the courts will deal with such actions.
Under the common law, a variety of defences can be raised by the defendant to show the absence of fault on his part.
Under the CPA, liability does not arise in the following instances:
When the product's unsafe characteristic, failure, defect or hazard causing harm is wholly attributable to compliance with any public regulation.
When the product's unsafe characteristic, failure, defect or hazard:
did not exist in the goods at the time it was supplied to another person alleged to be liable; or
was wholly attributable to compliance with instructions, which were provided by the person who supplied the goods.
Where it is unreasonable to expect the distributor or retailer to have discovered the product's unsafe characteristic, failure, defect or hazard, having regard to that person's role in marketing the goods to consumers.
Where the claim for damages is brought more than three years after the:
death or injury of a person for whom liability can arise;
earliest time at which a person had knowledge of the material facts of an illness suffered and for which liability can arise;
earliest time at which a person with an interest in any property had knowledge of the material facts about the loss or damage to that property for which liability can arise;
date on which a person suffered any economic loss for which liability can arise.
For both common law claims and claims brought under the CPA, the remedy is damages for the harm caused by the defective product. No provision is made in South African law for punitive damages. The claimant is limited to the damage that he can prove was actually suffered.
The Medicines and Medical Devices Regulatory Authority Bill has recently been tabled. This Bill, when enacted, will completely repeal the Medicines Act and replace the Council with the Medicines and Medical Devices Authority. The Bill provides much more extensively for the regulation of medicines, related substances and complementary medicines. There is, however, currently no indication when (or indeed if) this Bill will be enacted.
A South African Code of Practice for the Marketing of Medicines under the Medicines Act was recently issued and is to be enforced by both a Marketing Code Authority and on a self-regulatory basis. The Code is in force, and will be incorporated into the Advertising Code applied by the ASA. Its provisions are already being applied by the MCA.
Regulations relating to complementary and alternative medicines are also being considered. Draft regulations to the Medicines Act, intended to regulate complementary and alternative medicines, were published in 2008 for comment. These regulations are not yet in force, and there is no indication of when they are likely to be implemented.
Main areas of responsibility.
The Council has the responsibility to:
Screen and approve or refuse applications for registration of medicines for sale in South Africa.
Keep a register of the medicines registered.
Govern the process of clinical trials.
Ensure the safety and efficacy of medicines manufactured, imported and sold in South Africa.
Description. Website of the Medicines Control Council which is maintained by it. Contains legislation, official and regulatory information on pharmaceutical product registrations, which is potentially out-of-date.
W www.cipc.co.za/Patents.aspx
Description. Website of the Companies and Intellectual Property Commission which is maintained by it. Contains legislation and official information on patents and trade marks which is up-to-date.
Description. Website of the Advertising Standards Authority. Contains the Code regulating advertising in South Africa.
T +27 12 432 6201
F +27 12 432 6582
E danie.dohmen@adamsadams.com
W www.adamsadams.com
Professional qualifications. South African Attorney, 1998; South African Patent Attorney, 2002; Notary Public, 2004
Areas of practice. Patent litigation; design litigation; commercialisation and opinion work
Non-professional qualifications. BSc (physics and chemistry), 1993, Randse Afrikaanse University; LLB, 1996, Randse Afrikaanse University
Recent transactions.
Represented Aventis Pharma SA in a successful appeal to the South African Supreme Court of Appeal, for an urgent preliminary injunction on one of Aventis's patents covering its Taxotere oncology drug.
Represented Bayer Pharma AG in a successful preliminary injunction application and a pending action, for a final injunction on one of Bayer's patents covering its Yasmin and Yaz contraceptives.
Professional associations/memberships
Licensing Executives Society.
American Intellectual Property Law Association.
International Federation of Intellectual Property Attorneys.
South African Institute of Intellectual Property Law.
T +27 12 432 6396
F +27 12 432 6556
E jenny.pienaar@adamsadams.com
W www.adamsadams.com
Professional qualifications. South African Attorney, 1994; Trade Mark Fellow of the South African Institute of Intellectual Property Law, 2004
Areas of practice. Trade mark litigation; copyright litigation; advertising and consumer law; regulatory affairs.
Non-professional qualifications. Bachelor of Arts (BA), 1988, University of Stellenbosch; Bachelor of Laws (LLB), 1991, University of Cape Town
Professional associations/memberships
Law Society of the Northern Provinces of South Africa.
Licensing Executives Society.
South African Institute of Intellectual Property Law.
International Trade Mark Association (INTA).
Global Advertising Lawyers' Alliance (GALA).
