Medicinal product regulation and product liability in South Africa: overview

A Q&A guide to medicinal product regulation and product liability 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, and product recall and liability.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in South Africa: overview.

To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

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.

Regulatory authorities

The principal regulatory body, established by the Medicines Act, is the Medicines Control Council (Council) (www.mccza.com). 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.

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.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

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.

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

Medical devices are regulated under the Medicines Act. The definition of a medical device, in terms of the Medicines Act is wide and includes any diagnostic reagent, apparatus or machine that is used in the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or related symptoms.

The advertising of medicines and medical devices is governed by the Code of Marketing Practice (Marketing Code) which was issued in terms of Section 18C of the Medicines Act. The Code extensively sets out provisions relating to the marketing of health products and medical devices in South Africa.

The Marketing Code is supported by the Department of Health and has been adopted by various industry associations, including the South African Medical Device Industry Association, the National Association of Pharmaceutical Manufacturers and the South African Laboratory Diagnostics Association. The Marketing Code is adopted by those institutions in order to ensure that the marketing of health products and medical devices is carried out in a reasonable, ethical and professional manner, based on information that is practical and scientifically validated. 

The Marketing Code regulates the advertisement of medical devices.

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

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.

 
5. How are the prices of medicinal products regulated?

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.

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

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 4.

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.

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

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). In terms of Exchange Control Regulations, where clinical trials involve the transfer of any intellectual property including confidential information, data, copyright or inventions from the South African clinical trial sites to a foreign entity, prior exchange control approval is required from the South African Reserve Bank.

Authorisations

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.

Consent

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.

Trial pre-conditions

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.

Procedural requirements

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.

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

Application for a licence to manufacture or market medicinal products is made to the Council.

Conditions

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.

Restrictions on foreign applicants

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.

Key stages and timing

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.

Fee

Application fees are payable as follows:

  • Licence to manufacture: about ZAR21,800.

  • Licence to distribute: about ZAR13,000.

  • Licence for wholesale: about ZAR13,000.

  • Licence to import: about ZAR13,000.

  • Licence to export: about ZAR13,000.

During the currency of the licence an annual retention fee of about ZAR3,000 is also payable.

The following inspection fees are also payable:

  • Local manufacturing site: about ZAR650 per hour.

  • International manufacturing site: about ZAR4,000 per hour.

  • Wholesale sites: about ZAR5,500 per site.

  • Distributor sites: about ZAR5,500 per site.

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.

Period of authorisation and renewals

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 at least 90 days before the expiry date of the existing licence. Renewal fees are the same as the original application fees (see above, Fee).

Monitoring compliance and imposing penalties

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.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?
 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

In terms of Regulation 37 of the Regulations to the Medicines Act, the applicant or holder of a certificate of registration in respect of a medicine or Scheduled substance, must inform the Council of suspected adverse drug reactions reported to him or her, occurring as a result of the use of such a medicine or Scheduled substance. Further, the Regulations prescribe that the holder of the certificate of registration of a medicine or the applicant for registration of that medicine must, after having reported an adverse side effect, inform the Council of the steps to be taken to address the adverse drug reactions. If the Council determines that the medicine may not be safe to use, the applicant or holder of a certificate of registration must submit, if required to do so, case reports of all suspected adverse drug reactions in respect of the medicine, and other pharmacovigilance data such as drug usage figures, periodic safety update reports, and pharmacovigilance studies.

In 2003, the Council issued Guidelines (under Government Gazette 7659, and as amended) that deal with the reporting of adverse drug effects.

According to the Guidelines, an applicant for the registration of a medicine or the holder of a certificate of registration, should ensure that it has in place an appropriate system for pharmacovigilance that will provide for the proper management of safety data for medicines, especially during clinical trials. The Guidelines recommend that the applicant (or holder of a registration) has a full-time qualified person responsible for pharmacovigilance for pre- and post- marketing pharmacovigilance activities. Further, applicants or holders of medicine registrations must inform the Council within three days of first knowledge, of any new evidence that could significantly impact on the benefit/risk assessment of a medicine or that could change the conditions of registration of the medicine.

In terms of the Medicines Act and its Regulations, the advertising and promotion of medicines in Schedules 0 and 1 (over-the-counter medication) to the general public is allowed, without prescription. However, the advertising and promotion of medicines in Schedules 2 to 6 (prescription medication) to the general public is not permitted. The Medicines Act and its Regulations restrict the sale of medicines that fall in Schedules 2 to 6 to certain persons only, including:

  • Pharmacists.

  • Manufacturers of or wholesale dealers in pharmaceutical products for the sale to any person who may lawfully possess those products (that is, a pharmacist).

  • A medical practitioner.

  • A veterinarian.

  • A nurse.

These medicines are available on prescription, from the relevant healthcare practitioner only.

The Marketing Code regulates the advertisement of medicines and medical devices in South Africa and is enforced by the Marketing Code Authority. The Marketing Code applies to, among other things, all advertising and/or promotional material, which is directed to members of the public to inform the general public about the health products available for self-medication. The Marketing Code requires the appointment of a person for the approval of promotional material, meetings or activities. Promotional material and activities must not be approved nor issued unless its final form, to which no subsequent amendments will be made, has been certified by an individual on behalf of the company. Each company or individual should have a Standard Operating Procedure (SOP) for the approval process. The SOP and documentation must be available for auditing by the Marketing Code Authority or the medicines regulatory authority, according to the medicines regulatory authority's auditing requirements.

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

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".

Expedited 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.

Abbreviated Medicine Review Process (AMRP)

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.

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

Foreign marketing authorisations are not recognised in South Africa. However, the Council does align its 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).

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

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).

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in South Africa: overview ( www.practicallaw.com/9-564-9225) .

 

Restrictions on dealing with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

In general, no gift, benefit in kind, rebate, discount, kickback or any other pecuniary advantage can be offered or given to members of the health profession, administrative staff, government officials, or the general public as an inducement to prescribe, lease, loan, supply, stock, dispense, administer or buy any health product.

However, occasional gifts to healthcare professionals, appropriate administrative staff, sales and other staff are acceptable provided that they are all the following:

  • Inexpensive and within the cost limit set from time to time per annum by the Marketing Code Authority.

  • Not for personal use.

  • Educational and/or of scientific value, benefit the patient and/or are relevant to the practice.

Cash gifts or cash equivalents are not allowed.

Companies, organisations or individuals are permitted to organise or sponsor meetings and events provided that, among other things:

  • The merit and focus of the meeting should be clearly scientific and/or educational.

  • The venue and hospitality should be secondary to the meeting both in time allocation and focus.

  • The venue should be appropriate and conducive to the scientific or educational objectives and the purpose of the event or meeting.

  • Hospitality, meals and entertainment should be modest. As a general rule, hospitality must not exceed what the healthcare professionals would normally be prepared to pay for themselves.

  • Invitations should not be extended to spouses or other guests except if they are healthcare professionals or administrative staff and form part of the trainees or invited attendees at such a meeting/event.

  • Inappropriate financial benefit or material benefits including excessive hospitality cannot be offered and/or extended to healthcare professionals.

  • For speakers, payment of reasonable honoraria and reimbursement of out of pocket expenses including travel are permissible, provided it is in terms of a written contract.

The sponsorship of any stand alone social or entertainment event is not permitted.

The engagement of a healthcare professional to provide genuine consultancy or other genuine services to a company is permitted. Healthcare professionals who provide consulting services to a company and are still practising their profession must declare their employment arrangement with the company whenever they write or speak in public about a matter that is the subject of the employment or any other issue relating to that company. Such arrangement must be formalised in a written agreement, which may be subject to scrutiny by the Marketing Code Authority.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

See Question 10. No express provisions regarding internet, e-mail or mail order marketing are included in the Medicines Act, although the general provisions applicable to all marketing will still apply.

However, in terms of the Marketing Code, Schedule 2 to 6 medicines can only be promoted over the internet through a password protection scheme to healthcare professionals only.

Schedule 2 to 6 medicines can be advertised in a relevant, independently produced electronic journal intended for healthcare professionals or appropriate administrative staff which cannot be accessed by non-healthcare professionals.

Package inserts and patient information leaflets for medicines under Schedules 2 to 6 can be included on the internet and be accessible by members of the public provided that they are not presented in such a way as to be promotional in nature.

The Marketing Code prohibits the promotion of all medicines by e-mail, unless the option to opt out is given and the decision is subsequently respected. The option to opt out should also be provided on all subsequent communications, even if the addressee has not opted out after the first contact.

Postcards, other exposed mailings, envelopes or wrappers must not carry matter which may be regarded as advertising and/or promotion to the general public.

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

The Medicines Act is the principal legislation governing the advertising of medicinal products.

The advertising of medicines and medical devices is governed by the Marketing Code, in terms of section 18C of the Medicines Act. The Marketing Code extensively sets out provisions relating to the marketing of health products and medical devices in South Africa.

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.

Restrictions

There are restrictions regarding the advertisement and sale of medicines falling in Schedules 2 to 6 (prescription medication) and medicines falling in Schedules 0 to 1 (over-the-counter medication) (see Question 10).

In general, advertisements must not mislead or disparage either directly or by implication. Information, claims and comparisons must be accurate, balanced, fair, objective, unambiguous and supportable and must be based on an up-to-date evaluation of all the evidence and reflect that evidence clearly. The use of medical terminology is acceptable provided that this does not confuse or mislead the consumer.

In addition to these general requirements, there are specific exclusions relating to the marketing and promotion of medicines directly to the public, including, but not limited to:

  • Advertising and/or promotion can refer to the prevention of symptoms and use of a product in chronic conditions, if in line with the registered indication.

  • Advertisements must not suggest that using a health product could enhance normal good health or be a substitute for a healthy diet and lifestyle.

  • Advertising and/or promotion must not be aimed principally or exclusively at children, under the age of 12 years.

  • Advertising and/or promotion must not show children using, or within reach of health products without adult supervision.

  • Advertising and/or promotion will encourage responsible self-medication and should not encourage individuals to exclusively self-diagnose.

  • Advertisements should encourage individuals to share information with the pharmacist or healthcare practitioner so that they can ensure the health product will be suitable for the intended user.

  • Advertising and/or promotion must not suggest that a medical consultation or surgical operation is unnecessary nor must it discourage consumers from seeking medical or pharmaceutical advice.

  • Advertising and/or promotion must not offer to diagnose, advise, prescribe or treat persons by correspondence.

  • Advertising and/or promotion must not claim guarantees on a health product's effects, safety or quality.

  • Advertising and/or promotion must not encourage consumers to discontinue the use of prescribed health products.

  • Advertising and/or promotion must not contain recommendation of a product by scientists or healthcare professionals unless substantiated.

  • Advertising and/or promotion must not include the appearance and/or recommendation and/or endorsement, whether directly or indirectly by a person who, because of their celebrity status in any field (irrespective of whether this is a local or international celebrity status), may encourage consumers to use a particular health product.

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.

Internet advertising

See Question 15.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

The National Health Act states that all patients have a right to confidentiality. It provides that patient information must not be given to others, unless the patient consents or the healthcare practitioner can justify the disclosure. Practitioners are responsible for ensuring that clerks, receptionists and other staff respect confidentiality in their performance of their duties.

A practitioner can only divulge information regarding a patient in the following circumstances:

  • In terms of a statutory provision.

  • At the instruction of a court.

  • In the public interest.

  • With the express consent of the patient.

  • With the written consent of a parent or guardian of a minor under the age of 12 years.

  • In the case of a deceased patient with the written consent of the next of kin or the executor of the deceased's estate.

According to the Guidelines, regarding the reporting of adverse drug effects (see Question 10), patient confidentiality is strictly maintained. It is, however, important to provide some patient identification for ongoing communication between the reporter and the Council and NADEMC. Patient initials and age are sufficient as an identifier. A practice or hospital number may also be provided.

The Protection of Personal Information Act, which has been proclaimed but is not yet in force, will also affect, among other things, the collection, dissemination and/or destruction of personal information of patients in South Africa. The processing of personal information concerning a person's health is prohibited unless this is conducted with his consent and by medical professionals, healthcare institutions or facilities or social services, and only if such processing is necessary for the proper treatment and care of the individual or for the administration of the institution or professional practice concerned.

 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.

Legislation and regulatory authority

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.

Information requirements

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.

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

In terms of section 23 of the Medicines Act, the Council can declare a medicine as "undesirable" if it is of the opinion that it is not in the public interest that a medicine be made available to the public. The Council can, in those circumstances, by notice in writing direct any person to return any quantity of such medicine which he has in his possession to the manufacturer of it or, in the case of an imported medicine, to the importer concerned or to deliver to any other person designated by the Council.

Further, the Council can conduct an investigation into a medicine if the medicine is recalled in South Africa or if, in any other country, an adverse reaction is reported if, or for any other reason, the Council deems it fit to conduct an investigation into the medicine (Regulation 39, Regulations to the Medicines Act).

In terms of the Medicines Act, an inspector, authorised in terms of the Medicines Act, can seize a medicine if it has been declared as undesirable in terms of the Act.

 
20. Are there any mandatory requirements relating to medicinal product safety?

For the reporting of adverse drug effects, see Question 10.

In terms of Regulation 30 of the Regulations to the Medicines Act, it is a criminal offence to disregard an order of the Council to return a medicine that has been declared undesirable (see Question 19) and that person is liable to a fine, or to imprisonment for a period not exceeding ten years.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Legal provisions

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.

Substantive test

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?

 
22. Who is potentially liable for defective medicinal products?

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.

 
23. What defences are available to product liability claims? Is it possible to limit liability for defective medicinal products?

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.

 
24. How can a product liability claim be brought?

Limitation periods

The limitation period generally is three years from the date the claimant becomes aware of the damage (see also Question 23).

Class actions

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.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

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.

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

In 2008 and 2015, amendments to the Medicines Act were passed by parliament and are known as the "Prelex" to the Medicines Act. However, those amendments which, among other things, provide for the registration and regulation of medical devices, the establishment of the South African Health Products Regulatory Authority (SAHPRA) (which will replace the current Medicines Control Council) have not yet come into effect.

The General Regulations to the Medicines Act were amended in November 2013 to include the registration of complementary medicines. The amendments, relating to the registration of complementary medicines came into effect in November 2013. The Government Notice, setting out the amendments can be viewed at

www.mediscor.net/docs/GG/Government-Gazette-37032.pdf.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and Competition Law in South Africa: overview ( www.practicallaw.com/9-564-9225) .

 

Online resources

South African Medicines Control Council

W www.mccza.com

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.



Contributor profiles

Danie Dohmen, Partner

Adams & Adams

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.

  • Representing multinational and national clients in the pharmaceutical and other fields, including agriculture, agro chemical, mining, manufacturing, transport, security and safety.
  • Acting in multi-jurisdictional patent and design litigation in several African countries.
  • Represented successful parties in the South African Court of Appeal and before the Constitutional Court, in cases setting the current law on inventiveness, clarity, interim injunctions in patent infringements, contributory patent infringement, public interest in interim injunctions on patents for life saving drugs, evidentiary requirements to prove patent infringement, and requirements for divisional patent applications.
  • IP policy issues on a national and international level, and has represented national and foreign manufacturing groups in both national and international meetings, workshops and seminars on IP policy.

Professional associations/memberships

  • Licensing Executives Society.
  • American Intellectual Property Law Association.
  • South African Institute of Intellectual Property Law, chairperson of the Patent and Design Law Committee.
  • Lecturer and examiner for the Patent Examination Board of South Africa.

Jenny Pienaar, Partner

Adams & Adams

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. General commercial litigation; trade mark litigation; domain name registration; litigation relating to copyright, passing-off, unlawful competition, close corporation and company name objections; advertising law and regulatory compliance issues.

Non-professional qualifications. Bachelor of Arts (BA), 1988, University of Stellenbosch; Bachelor of Laws (LLB), 1991, University of Cape Town

Professional associations/memberships

  • South African Institute of Intellectual Property Law (SAIIPL).
  • Business Women's Association (BWA).
  • Licensing Executives Society.
  • Law Society of the Northern Provinces.
  • French/South African Chamber of Commerce and Industry.
  • Chairperson of the Marketing Committee of Global Advertising Lawyer's Alliance (GALA).
  • International Trade Mark Association (INTA).

Alexis Apostolidis, Partner, Head of Competition Law

Adams & Adams

T +27 12 432 6202
F +27 12 432 6582
E alexis.apostolidis@adamsadams.com
W www.adamsadams.com

Professional qualifications. South African Attorney, 2002; South African Patent Attorney, 2004

Areas of practice. Patent litigation; competition law; opinion work and patent litigation in the life sciences, agrochemical, petrochemical, IT and consumer goods sectors.

Non-professional qualifications.

  • Bachelor of Science (Chemistry and Law), University of the Witwatersrand, 1999.

  • Bachelor of Laws (Cum Laude), University of the Witwatersrand, 2002.

  • Postgraduate Degree in European Competition Law (With Merit), King's College, University of London, 2012.

Recent transactions.

  • Litigating on behalf of originator pharmaceutical companies, OEM German car manufacturers, banks and television content providers.
  • Litigation concerning design registrations, the licensing of IP and regulatory matters in the life sciences sector.
  • Litigating competition law aspects of the enforceability of IP rights to the Supreme Court of Appeals in South Africa.
  • Representing clients before the South African Competition Commission and the Competition Tribunal.
  • Advises and represents clients in litigious work in a number of African countries.

Professional associations/memberships

  • Law Society of the Northern Provinces – competition law committee.
  • South African Institute of Intellectual Property Law and convenor of competition law committee.
  • International Bar Association – member and rapporteur for competition law developments in South Africa.

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