Nawa Nawa
In the imminent third wave, the Namibian President has announced tighter Covid-19 restrictions for two weeks.
However, there is a need to complement the existing prevention, treatment and care efforts targeted to mitigate Covid-19.
An effective response to the Covid-19 pandemic requires that all Covid-19 medical equipment, including supportive treatment, vaccines, and tests, are affordable, available, and accessible to everyone and allocated based on public health needs.
However, experience has shown that IP barriers severely hamper the development of and access to medical equipment and supplies, especially in low and middle-income countries.
Namibia as a developing nation and member state to most IP Conventions can utilise the IP regime to acquire much needed utilities in response to the pandemic. Namibia has clear development policies; strategies and plans, which can be effectively supported by intellectual property. However, little effort is made to use the IP system. We have a National IP policy and strategy that will guide and promote the utilisation of the IP system in a way that will support development and health objectives and goals. This could be approached if not yet happening.
TRIPS flexibilities on public health
Parallel importation
Exhaustion of rights under IP theory refers to the point at which the right holder loses legal control over a protected product by virtue of selling or releasing it into the channels of commerce. The rules on exhaustion determine whether the patent holder can prevent a third party from importing a pharmaceutical product where the patent holder or his licensee may have sold the product into another country where they also have a patent. Several countries allow such imports, which are commonly known as parallel imports. These rules, therefore, address what is commonly referred to as parallel importation. In the context of medicines, parallel importation allows procurement agencies and treatment providers or third-party importers to import medicines from other countries where the prices are lower than the prices set in the local market by the patent holder or his licensees.
Patentable subject matter
The three criteria for patentability (novelty, inventive step, and industrial application) are not defined under TRIPS. Each member is free to interpret their meanings, which can determine what is patented in the pharmaceutical sector. In addition, governments can refuse to grant patents for three reasons that may relate to public health, including inventions whose commercial exploitation needs to be prevented to protect human, animal or plant life or health; diagnostic, therapeutic and surgical methods for treating humans or animals; and certain plant and animal invention. The key impact is that countries can ensure that only true inventions are patented, so that far fewer products will be under patent than would otherwise be the case if the patentability criteria were not carefully defined or where the power to refuse patenting in certain cases was not exercised. The impact is that a greater number of medicines can be available in generic forms in a competitive market, which has a positive impact on prices.
Research and experimental use exception
Under this exception, countries allow the use of a patented invention for research to understand the invention more fully and for other related purposes. The intent of this exception is to ensure that patents do not prevent scientific research that uses existing knowledge to generate new knowledge. The research exception is important for improving the effectiveness of products or the development of better-adapted formulations. This exception fosters pharmaceutical technological progress and innovation by exempting experimentation acts for purposes such as inventing around the initial invention, improving on the invention, or evaluating the invention.
Regulatory (bolar) exception
This exception allows a potential competitor to use an invention to undertake acts necessary for obtaining regulatory approval and registration of a generic product before the expiry of the patent term without the authorization of the patent holder. This exception is provided to Doha+10 TRIPS flexibilities and access to ensure that generic versions of the product are available on the market immediately, or within a reasonable time, after the expiry of the patent. More rapid introduction of generics into the market leads to more rapid competition and lowering of prices.
Compulsory licensing
A non-voluntary licence is a licence granted by an administrative or judicial body to a third party to exploit a patented invention, without the consent of the patent holder. Pharmaceutical patent holders to sufficiently supply the market with needed medicines; and in emergency, public health situations use compulsory licensing in public health to address a variety of situations including high prices of medicines; anti-competitive practices by pharmaceutical companies. In practical terms, compulsory licensing can be used to bring down the prices of medicines and to ensure a sufficient supply of medicines in the market in cases where the patent holder cannot or will not provide sufficient supplies at the right price. It is also a critical tool in emergency situations where the patent holder cannot respond to an urgent situation.
Public, non-commercial use
The TRIPS agreement, although not specifically mentioning government use, recognises such use by its references to the concept of public, non-commercial use of patents “used by or for the government”. Where the state or a state agency uses patents without the consent of the patent holder, it is, like compulsory licensing, covered under Article 31. The distinction between government-use provision and compulsory licensing primarily relates to the nature or purpose of the use of the patent. In the case of government use, it is limited to “public, non-commercial purposes”, whereas compulsory licences can also cover private and commercial use. As with compulsory licences, government-use orders can be used to bring down the prices of medicines, to ensure a sufficient supply, and address emergency situations.
Scope of pharmaceutical test data protection
An approach to test data protection, which allows regulatory authorities to rely on the data but not provide generic companies access to it, has important public health benefits. It ensures that generic producers do not need to conduct trials on compounds that have been proven to be efficacious, thus avoiding the imposition of additional costs that may be passed TRIPS flexibilities and action to address public health problems faced by developing countries, especially those resulting from HIV, tuberculosis, malaria, and other epidemics. While IP protection is important for the development of new medicines, such protection also has effects on medicine prices. The TRIPS agreement does not prevent WTO members from taking measures to protect public health and it can and should be interpreted and implemented in a manner supportive of members’ rights to protect public health and to promote access to medicines for all. The importance of the Doha Declaration should be judged for what it said and the implications of TRIPS Council decisions that derived from it. The declaration provided both general and specific interpretive guidance on the use of TRIPS flexibilities for promoting access to medicines.
Competition law
Under Article 40 of the TRIPS agreement, it is recognised that licensing practices or conditions pertaining to IP rights that restrain competition may have adverse effects on trade and may impede the transfer and dissemination of technology. Consequently, the TRIPS agreement allows WTO members to specify in their legislation the specific licensing practices or conditions that may constitute an abuse of IP and have an adverse effect on competition in the relevant market. They may also adopt appropriate measures to prevent or control such anti-competitive practices. Countries that use this provision appropriately can ensure adequate and healthy competition in the pharmaceutical market, improving pricing and availability of needed products.
Transition periods
The TRIPS Agreement provides four transition periods for the implementation of its minimum standards. Hence, until 2016 or later, LDCs have no obligation to provide patent protection to pharmaceuticals, including medicines and diagnostics. LDCs that take advantage of this transition period can achieve two broad goals. They can obtain medicines at generic prices since there will be no patents in their territories. Second, by not granting patents, LDCs can also foster the development of a generic industry to supply low-cost medicine.
* Nawa Nawa, a lecturer at NUST in the Department of Social Sciences, writes in his personal capacity.