Prophylactic Law vs. Prophylactic Medicine: Are they really in conflict?

For Africa to move forward, you really got to get rid of malaria” – Bill Gates

The words PROPHYLAXIS and PROPHYLACTIC are derived from the 16th century French word “prophylactique”, from the Greek “prophulaktikos”, from pro meaning “before” and phulassein meaning “to guard”. Thus prophylaxis entails taking an action beforehand to prevent some negative effect or occurrence, such as disease or unwanted pregnancy. In the medical field, prophylactic medicine such as vaccines are administered to a healthy person to prime the immune system against infection thus to prevent or minimise the chances or effect of infection.

On 25 April 2016, the 8th annual World Malaria Day, the World Health Organisation (WHO) disclosed that a vaccine against malaria has successfully been developed by Glaxo Smith Kline (GSK), with funding from the WHO and PATH, a non-profit health organisation receiving funding from the Bill and Melinda Gates Foundation. This vaccine, RTS,S, is the culmination of nearly two decades of research.

Malaria is an illness of particular concern in sub-Saharan Africa with 88% of malaria cases occurring here and contributing to 90% of global malaria deaths. Malaria is caused by the plasmodium parasite which is transmitted to people through the bite of a mosquito.  Current malaria therapy includes the use of anti-malarial drugs, but the treatment itself can be complicated, due to drug-resistant malaria strains. The best method available in the fight against malaria has always been prevention. Prevention currently includes bed-nets, insecticides and preventative medication, all of which may be either unaffordable or inaccessible to the people most in need thereof, particularly those in remote locations.

RTS,S has the potential to fill an enormous gap and such a remedy is eagerly awaited by people living in malaria affected areas across the globe. The WHO recommends that RTS,S pilot implementations should be focused on areas in Africa experiencing moderate-to-high risk of parasite transmission. These implementations could be ready to commence in early 2018. The ultimate goal for the WHO would be to virtually eradicate this disease similarly to smallpox, proving the effectiveness of vaccine use.

It is generally accepted in medicine that the side effects of prophylactic medicine are less than that of the disease itself. It is a fact that the cost of prophylaxis is a fraction of the cost of treating a sick patient. The same applies to prophylactic law, in particular in the field of intellectual property (IP) law. In the same way as prophylactic medicine is used to combat the onset of disease, taking the correct steps in the protection of the IP of a business limits the extent of the harmful effect of infringers and competitors trying to impinge on the business’ domain. By taking the appropriate steps to protect the IP of the business, the business is able to inhibit others from infringing and copying its work, by enforcing the exclusive right vested in its IP. Without the exclusivity afforded by the prophylactic effect of the IP protection, the business’ domain will soon be overrun by the competition benefiting from its efforts. Furthermore, the ability to protect IP drives research and development incentive in that the business has the opportunity to regain the expenses spent during the R&D process and beyond that, to gain profit. Part of that profit is reinvested into subsequent research projects.

It is, however, common knowledge that patented medication is much more expensive than generic counterparts, so how does IP protection support the availability of crucial medicines to the poorest populations? There is a fine balance struck between IP protection and availability of patented medications at affordable prices. Many countries are now members of the World Trade Organisation’s (WTO) agreement on Trade-Related Aspects of Intellectual Property (TRIPS) and therefore are obliged to enforce patents for pharmaceuticals and other medical inventions. It is the purpose of TRIPS to maintain the balance between the reward for innovators and businesses and the affordability of patented medicine. Patents are granted for a limited 20 years only and are not extendible. Patents for medicinal inventions are usually granted years before the patented medication is approved and released for consumer use, thus limiting the window of opportunity for the patentee to regain researching, patenting and clinical trial costs. Furthermore, the patentee also has to disclose its invention in the patent specification in such a way that anyone skilled in the art is able to recreate the patented invention, creating a platform for sharing knowledge and information. Most governments also have the power of making pharmaceutical products available to its people by granting compulsory licences. According to Section 56 of the Patents Act No. 57 of 1978 of South Africa (the Act) the government is allowed to license patents to other companies, if the patent holder refuses to do so on reasonable commercial terms and provided that the patent holder is still sufficiently compensated.

Similarly to prophylactic treatment benefiting persons exposed to risk of malaria, it is also beneficial for a business to apply proper prophylactic law and to ensure that the IP which is generated is properly protected by way of patents and other forms of IP protection before publication and commercialisation.

If multinational pharmaceutical companies are not sufficiently compensated for their R&D through patent protection, they may be discouraged to conduct R&D in fields where there is a dire need for remedies. Once the patents for these remedies are granted, these companies may decide to make the remedies available through funding of non-profit organisations or under favourable licence terms to the poorest of the poor, thus removing the conflict between Prophylactic Law and Prophylactic medicine.