Harness TRIPS Flexibilities to Promote access to medicines in Mozambique

Aquinaldo Mandlate

According to the United Nations Development Program (UNDP), at least 400 million people lack basic healthcare and 1.6 billion live in countries where there is weak national capacity to deliver basic health services, posing a huge challenge to global health.

Mozambique records high deaths due to non-communicable diseases including HIV (24%), malaria (15%), respiratory infections (6%), and diarrhoea (4%). There are challenges accessing essential medicines to treat these illnesses in rural areas and in some urban centres where a capitalist private sector controls distribution and sale of essential drugs.

This contribution analyses Mozambique’s legal and regulatory framework on Intellectual Property and how it can be used to increase the country’s access to adequate and affordable essential medicines and therapeutic services. It also alludes to recent initiatives by civil society groups to promote access to universal health care and treatment.

The domestic IP protection in Mozambique comprises international, regional, sub-regional commitments and national normative and policy instruments. The Industrial Property Act (Decree No. 47/2015) is the main instrument regulating IP rights. It is complemented by the Regulation governing Intellectual Property Agents (Decree No. 19/1999). Several provisions in the Intellectual Property Act complement international and regional IP commitments and can advance the right to access to affordable treatment and therapeutic services.

Reference is made to provisions incorporating TRIPS flexibilities. The Treaty Related Intellectual Property Aspects (TRIPS) are minimum standards in international instruments requiring member States to protect IP rights in their jurisdictions. By incorporating TRIPS “flexibilities” a member state to the agreement is exempted from implementing TRIPS standards on IP protection in its jurisdiction. This has relevance when dealing with health and developmental issues.

The AIDS and Rights Alliance for southern Africa (ARASA) contends that strict protection and enforcement of IPs can undermine access to essential medicines because they are tools that right holders use for extracting monopoly prices from the market.

Article 38 of the Industrial Property Act prohibits patentability of inventions that are contrary to public order and morality, and the protection of human, animal, plant and environmental health. It also bans patentability of any such inventions relating to discovery of plants and animals, or parts of such plants or animal, and biological processes employed for the acquisition of such plants or animals.

In line with article 27(1) of the TRIPS Agreement and article 32 of the Industrial Property Act, a patent is granted for an invention that involves an inventive step and is capable of industrial application. This means the patent holder has the right of exclusive (monopoly) use of his/her invention for a period of 20 years. To improve the country’s health system, the IP Act must be revised to explicitly exclude medicines from the list of patentable inventions.

Parallel importation

The Mozambican Intellectual Property Act permits parallel importation of essential medicines as well as parallel importation of other inventions enjoying IP protection in Mozambique. By permitting parallel importation of essential medicines as a TRIPS flexibility incorporated in domestic law, Mozambique took a step in the right direction heightening chances for importation and availability of treatment. Parallel importation means an interested party can import a product protected for IP purposes in another country where the inventor/patent holder also enjoys IP rights relating to the product. As a result, in interested party can commercialise the product in the same jurisdiction/country where the investor or patent holder enjoys IP protection over that same product.

Compulsory license

In Article 92 of the Industrial Property Act “[t]he Minister that oversees the Institute of Intellectual Property may, on grounds of public interest, authorize the use of an invention without prior consent of the patent holder”. Thus, ‘compulsory license’ may be issued to meet public interest. In article 92(2) “an invention that is of primary importance for public health is regarded as an invention in the public interest”. If employed in Mozambique, this flexibility will promote access to essential medicines by eroding monopoly of a patent holder barring manufacturing of generic medicines. Article 92 can be strengthened to promote the health system by expanding its scope so that compulsory licenses are allowed for ‘importation of patented products by Government or by a third party’. The compulsory licenses regime should also be implemented when a patent holder fails to explore the patent, and particularly, when such patent relates to essential medicines.

Recent initiatives by civil society

Increasingly, civil society is taking stock of gaps in the Mozambican health system and their consequences. Their concerns stem from large profits made by an emerging elite in the private sector that sells essential medicines not available in the state-run health system. Partly, this is due to policy makers’ lack of awareness about TRIPS flexibilities and IP law barriers impacting on the enjoyment of the right to the highest attainable standard of health.

In December 2020, the AIDS Rights Alliance (ARASA), promoted a training on Intellectual Property Rights and Access to Medicines. The three-day event focused on implementing public health sensitive TRIPS flexibilities in Mozambique. The event inspired an advocacy work plan for CSOs to engage on the subject. Participants in the training included lawyers and selected members of local organisations.

In June 2021, the Mozambican based Associação Mulher, Lei e Desenvolvimento (MULEIDE) hosted a public debate on Intellectual Property Rights and Access to Medicines. The event emphasised the need to review the patent regime to promote importation of medicines in Mozambique. Participants agreed to develop a policy brief raising awareness of Parliamentarians and the IP regulators about the opportunities and challenges that the current IP system poses for access to medicines in the country.

The above initiatives may help Mozambique address challenges affecting its health system and combat diseases such as COVID-19. By promoting them, Mozambique can hope to achieve SDG No. 3 and to promote sustainable development.

*Aquinaldo Mandlate is a lawyer. He holds an PhD from the University of Western Cape and is interested inhuman rights law, tax, banking investment, intellectual property rights, real estate, and good governance.

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