Pharmaceuticals companies in South Africa are granted patents and, thus, a monopoly on the local market to incentivise research and development (R&D) within the pharmaceuticals field, and not to hike prices, as many people believe, says patent law firm Spoor & Fisher.
A patent lasts for 20 years and, during that time, the cost of that particular patented medication is higher to enable the company developing the medication to recoup its costs and make a profit, explains Spoor & Fisher patent attorney David Cochrane.
“A monopoly is important for generating new medication. Once medication has been developed, it is relatively easy to copy and create generic versions. If pharmaceuticals companies were not guaranteed a monopoly over a particular patent for 20 years, they would most likely not invest a lot of money in R&D,” he says, adding that the cost of developing new pharmaceuticals is substantial.
Cochrane adds that there are many generic medications on the market, a situation that exists because patents, while initially essential, expire.
“Many people believe that patents lead to medication being more expensive. However, that medication would not exist at all if it were not for the patents,” he notes.
Cochrane explains that real public-health problems on the ground have little to do with the cost of medicine but rather with the lack of infrastructure in remote areas in Africa, which prevents the transportation of medication to those who need it.
He notes that research in South Africa is not extensive, but is ongoing, adding that the biggest research facilities are government- funded programmes at universities.
“Government is putting a lot of effort into encouraging research at universities and the Department of Trade and Industry is focused on increasing the protection of intellectual property (IP) by publicly funded research. For example, the University of Cape Town is doing research on and filing patents to protect new vaccines and diagnostics for human papillomavirus that may be used in the diagnosis and treatment of diseases such as cancer,” explains Cochrane.
He states that, although medication is more expensive when it is under patent, essential medications, such as antiretrovirals, which are still patent-protected, have been licensed to generic pharmaceuticals companies by pharmaceuticals companies Boehringer Ingelheim and GlaxoSmithKline, albeit under pressure from the South African government and in the face of competition-law challenges.
There is no reason why licences cannot be granted for other essen- tial medicines that are important for public health and there are also other avenues, such as compulsory licences, in South African law that can be used to achieve this, he adds.
“Even under the current patent system, there are mechanisms to ensure that essential medications can be made available in South Africa. Many other African countries have also ensured that medication for the treatment of HIV/Aids and tuberculosis has been made available through compulsory licensing,” says Cochrane.
South Africa uses a deposit patent system, which means that all a company has to do is apply for a patent, fill in the right forms and the patent is granted, he explains.
“When a company applies for a patent in Europe and the US, a patent examiner checks the patent to ensure that the idea is new, inventive and complies with patent laws. If a patent does not comply with these aspects, it will not be granted,” he says.
Cochrane concedes that the current deposit patent system can result in patents being granted for medicines that are not new and inventive. However, he points out that a patent such as this is worthless because a court in South Africa will not enforce a patent even if just one claim is invalid.
He states that the current deposit patent system in South Africa works, but agrees that a patent examination system does have advantages. South Africa receives about 7 000 patent applications a year that need to be examined. A well-functioning South African patent office will require about 80 to 100 patent examiners, trained scientists and engineers, to handle the workload. Each patent examiner will need to have a university degree in a field of technology, and would have to have been trained to examine patent applications in his or her field.
“If South Africa decides to implement a patent examination system, it is important that we have the resources and expertise to carry out patent examinations properly. If we are to replace the current system, which is working, we must make sure that the new system works,” he says.
He notes that the top two pharmaceuticals companies in South Africa are Aspen and Adcock Ingram, which produce generic medications.
“South Africa’s patent system has not stopped generic companies from being successful. Therefore, it is an indication that the patent system does not stop access to medicine, as some people believe,” he says.
Cochrane notes that, with limited access to health services, there is always the threat of counterfeit medication infiltrating the mainstream market.
“South Africa has strong anticounterfeiting laws, which make it more difficult to distribute counterfeit medication,” he says, adding that IP laws protect public health in South Africa.
Cochrane explains that counterfeit medica- tion often has ineffective ingredients and can even be toxic.
“Counterfeiters copy both generic and patented medications. It is not a massive problem in South Africa, owing to the country’s strict laws, but it is a big problem throughout the rest of Africa,” he concludes.