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Through a joint communication to the TRIPS Council of the World Trade Organization (WTO) last month, India and South Africa called the world trade body to temporarily waive certain provisions of the WTO TRIPS Agreement related to obligations on protection and enforcement of patents and other intellectual property rights to support the global COVID-19 pandemic response.
The joint statement argued that in addition to patents, other forms of intellectual property (IP) rights, such as, copyrights, industrial designs and trade secrets may also apply to products and technologies required for the fight against COVID-19 negatively impacting on their availability to patients.
Accordingly, the statement requested waiving specific obligations of the TRIPS Agreement on protection and enforcement of patents, copyright and related rights, industrial designs and protection of undisclosed information during the current pandemic.
Supporting the joint statement, Sri Lanka Ambassador and Permanent Representative to the WTO in Geneva Gothami de Silva pointed out the adoption of this proposal will overcome potential obstacles that various categories of intellectual property rights may create to timely and unfettered access to technologies and products needed to address the pandemic.
Therefore, the adoption of this proposal is critical to ensure availability of medicinal products at affordable prices for the prevention, containment and treatment of COVID 19 as well as other diseases.
The Sri Lankan Ambassador pointed out that the COVID-19 pandemic has put a strain on global pharmaceutical supply chains, which is leading to inequitable distribution of medicines that could disproportionately affect low and middle-income countries.
Showcasing Sri Lanka’s proud record of universal access to healthcare provided free to its citizens at the point of delivery, the Sri Lankan representative to the WTO described efforts of the National Medicines Regulatory Authority (NMRA) to safeguard patients’ rights to access affordable medicine in Sri Lanka and the work done to ensure equitable distribution of medicines.
The representative went on to explain that an effective response to the pandemic requires rapid access to affordable medicinal products including diagnostic kits, personal protective equipment and ventilators, as well as vaccines and medicines for the prevention and treatment of disease.
During these difficult times, intellectual property rights may hinder timely provisioning of affordable medicinal products to patients and some WTO Members have already carried out urgent legal amendments to their national patent laws to circumvent potential challenges.
Making a strong statement, the Ambassador highlighted how the NMRA has transformed the pricing of essential medicines to make them more affordable for patients during the last few years. These important measures taken to increase affordability of medicines have an enormous impact on the health of the population.
The revised pricing policy introduced by the National Medicines Regulator mandates that essential medicines should be sold below a recommended maximum retail price at all times. This is a major achievement in safeguarding patients’ rights to access affordable medicine in Sri Lanka, the Ambassador asserted. Going further, the Sri Lankan Ambassador brought to the attention of the WTO a disturbing development witnessed in Sri Lanka during the current pandemic where some Pharma Companies gradually increased domestic prices of medicines when the Regulatory Authority’s’ attention is focused on containing the spread of the pandemic. The increase in retail prices of medicines by five companies in violation of conditions of registration issued by the NMRA caused much hardship to patients especially during COVID-19 pandemic.
There have been investigations into these alleged anti-competitive practices, and the Regulatory Authority later issued notices of cancellation of registrations and import licenses to five pharma companies for violating conditions of registration under Section 65 of the NMRA Act No. 5 of 2015. These punitive actions have been taken against such offending companies to ensure affordability of medicines available to the public.
Sri Lanka’s permanent representative praised the efforts of the NMRA for striving to ensure universal access to affordable medicines, while criticising the errant companies for attempting to maximise profits during a national crisis.
The Ambassador also highlighted plans made by the Government to increase local production of medicines to ensure the supply of high quality drugs at affordable prices to its citizens as well as to increase export production capacity of items used against COVID-19.
Sri Lanka has also decided to establish a special trade zone to accommodate such investments in the pharmaceutical sector, she added. Through this initiative, the Government intends to meet at least 50% of country’s current pharmaceutical requirements through local production.
Concluding her statement supporting the joint resolution tabled by India and South Africa, the Ambassador urged WTO members to work together to ensure intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to timely access to affordable medicinal products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medicinal products essential to combat COVID-19.