The Consumer Protection Act (CPA) interpretation
The CPA is a watershed advance in the field of consumer protection. It will have a material impact on the relationship between consumers and industry under the banner of “consumer interest”, the overarching theme of the CPA.
The CPA must be interpreted in a manner that gives effect to its purposes which are to promote and advance the social and economic welfare of consumers in South Africa. The provisions of the Medicines and Consumer Protection Acts are to be read conjointly (together as one) and in the light of the values enshrined in the Constitution and, unless it does not prove possible to do so, interpreted in a manner which respects those values. To the extent that this method cannot apply, the provision that extends the greater protection to a consumer prevails over the alternative provision.
Medicines are not a commodity of trade
Medicines differ from ordinary commodities in four crucial ways:
- Prescribed medicines have a four-tiered demand structure – the patient, the prescribing doctor, the dispensing pharmacist and the payer (medical aid);
- Medicines technical qualities are difficult to assess;
- Medicines information is hard to interpret objectively, competitive bias may be present;
- Medicines are inherently unsafe.
The CPA’s sting – strict liability
The law has changed from caveat emptor (“let the buyer beware”) to strict liability for manufacturing defects that make a product unreasonably dangerous or unsafe for its intended purpose or use.
Strict liability involves extending the responsibility of the vendor or manufacturer to all individuals who might be injured by the product, even in the absence of fault. An injured party must prove that the item was defective, the defect proximately caused the injury, and the defect rendered the product unsafe for its intended use.
A manufacturer and those in the distribution chain are strictly liable in law when an article they place on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a person.
Although in these cases strict liability has usually been based on the theory of an express or implied warranty running from the manufacturer to the plaintiff, the abandonment of the requirement of a contract between them, the recognition that the liability is not assumed by agreement but now imposed by law (CPA) and the refusal to permit the manufacturer to define the scope of its own responsibility for defective products make clear that the liability is not one governed by the law of contract but by statutory strict liability law (CPA).
The purpose of such liability is to insure that the costs of injuries resulting from defective products are borne by the manufacturers or vendors that put such products on the market rather than by the injured persons who are powerless to protect themselves. The remedies of injured consumers ought not to be made to depend upon the intricacies of the law of sales. To establish the manufacturer’s liability, it is sufficient that plaintiff proves that she was injured while using the product in a way it was intended to be used as a result of a defect in design, labelling or manufacture of which plaintiff was not aware that made the product unsafe for its intended use.
The Medicines Act requirements
In deciding whether or not the registration or availability of any medicine (registered or not including CAM) is in the public interest, consideration must only be given to the safety, quality, therapeutic efficacy and suitability of the medicine for its intended purpose. Medicines must comply with all these provisions. All medicines must be labelled correctly which would include the addition of a package insert (PI) and patient information leaflet (PIL) that clearly points out both the benefits (indications) and foreseeable risks (contra-indications, warnings etc) associated with the use of a product. No medicine is risk free. It is by character, an inherently unavoidably unsafe product.
Liability for damage caused by goods
To avoid CPA liability, all medicines must:
- Be effective and safe for its intended purpose;
- Be of good quality throughout its shelf-life; and
- Have adequate instructions and warnings (label, PI and PIL) provided to the consumer pertaining to danger arising from or associated with the use of the medicine.
This is irrespective of whether the harm resulted from any negligence (damages product caused, regardless of any “fault”) on the part of the producer, importer, distributor or retailer, as the case may be. Strict liability applies.
Avoiding CPA liability
- Preparation: If the medicine is ineffective then it is defective, so if adulterated. It must be manufactured correctly and be stable;
- Marketing: The product must be appropriately marketed. If the directions accompanying the product are faulty, or if the product is sold with inadequate warnings; it may not fall within the exception;
- Utility vs Risk: The utility or usefulness of the medicine must outweigh its risk of danger. So, for example, if a medicine cures a mild case of hiccups but causes death in half the people who use it, it may not qualify as being safe;
- Available alternatives: If there is an alternative medicine that would be as effective in accomplishing the purpose of the product then the product may not be safe. In the case of the hiccup cure, a bottle of water would be a safe alternative product making the hiccup cure unlikely to qualify as a safe product.
Pharmacists can now be held liable for all medicines they sell in their pharmacies irrespective of the registration status of such medicines (including complementary medicines) if they do not comply with the requirements as outlined.
The fact that any medicine is supplied from the pharmacy means that the pharmacist is satisfied that the product is safe, of good quality, efficacious and suitable for its intended purpose. If not then an alternative medicine should be sold. A medicine is not a commodity of trade and must be treated with professional respect and caution.