Background:
While the first case of the notorious coronavirus disease (Covid-19) was reported in Wuhan, China, on 31 December 2019 it took only two months to spread all over the world. First year of COVID 19 pandemic already caused the death of around 3 (three) million people all over the world. However, medical science has shown unprecedented swiftness to come up with a vaccine for COVID 19. According to the World Health Organization, till now there are 214 Covid-19 vaccine projects exist around the world. Among these, 52 are in clinical trials and 13 of which are in the most advanced phase of testing. Till now World Health Organization (WHO) approved seven vaccines for emergency or limited use in various countries. Many countries started bringing their populations under vaccines approved by the WHO. However, ‘novel’ Corona virus is continuously mutating its form and nature. In this context, it is still not known how much efficiently the currently available vaccines will work against the future variants of the virus. Even if it becomes proved that the currently available vaccines are efficient enough to shield any new variant of COVID 19, it will take several years to ensure ‘vaccine’ for each citizen of every nation. It is not only for the reason that the vaccine producing pharmaceutical companies are not capable of producing huge amounts of vaccines within a short period of time, but also for some other factors like proper distribution of vaccines as well as lack of many developing or least developed countries’ vaccine purchasing ability. Besides, one person may require having two shots of vaccine every year. In future, this will create a continuous demand of corona vaccine all over the year. Hence, instead of being dependent on few pharmaceutical companies, nations might start thinking of some alternative methods to ensure quick and sufficient access to Corona vaccine for their citizens. One effective alternative method can be producing the vaccines by countries themselves.
However, efforts to produce Covid-19 vaccine by countries on their own directly concern intellectual property rights (IPRs) of the vaccine inventing companies or institutes. Although at the beginning some vaccine inventing institutes (e.g. Oxford University) declared not to own IPR over their invented vaccines, finally it did not happen. Oxford concluded a contract with AstraZeneca whereby it confers sole rights of producing vaccines to AstraZeneca.
In October 2020, India and South Africa asked the World Trade Organization (WTO) to temporarily waive IPRs over COVID-19-related medical tools and technologies. The proposal has received support from around one hundred countries, and a diverse coalition of organizations. The proposal was discussed at a WTO meeting on 10 and 11 March 2021 and discussions are due to be continued. But this proposal might not be granted by WTO if all member states do not favour the proposal.
However, whether this proposal is approved or rejected, from legal point of view, countries are allowed to think of compulsory licensing, a provision in the Agreement on Trade Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) (concluded in 1994) that enables nation states to provide its citizens with generic versions of IP protected medical tools or technologies either through domestic production or through foreign imports. The use of compulsory licensing was found as a successful policy tool by some countries to increase access to antiretroviral drugs at the time of the AIDS epidemic.
Legal Bases of Compulsory License:
Generally, under a TRIPS-compliant IP regime, all WTO members are required to make sure both product and process patents have such exclusive marketing rights in favour of the inventors. But member states may derogate from this general requirement under some certain circumstances. Art. 31 of the TRIPS allows WTO member states to order local manufacturers to produce any patented product without receiving permission from the original patent holder. Later on, Clause 5 of the Doha Declaration on the TRIPS Agreement and Public Health (Adopted in November 2001) reassured that “each [WTO] [m]has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted”.
Besides, in the time of “national emergencies” and “other circumstances of extreme urgency,” governments can issue compulsory licenses in favour of local manufacturers without fulfilling standard requirements (e.g. prior negotiation with the patent holder). Clause 5(c) of the Doha Declaration further clarified that “a national emergency or other circumstances of extreme urgency” can be constituted by “public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics''. It means, the current COVID-19 pandemic can be considered as a justifiable public health crisis to constitute “a national emergency or other circumstances of extreme urgency” within the meaning of clause 5(c).
The low- or medium-income countries which are not able to manufacture drugs themselves, meaning which are not be able to take the advantage of compulsory licensing provision under Article 31 of the TRIPS, can take advantage of Article 31bis. This is because Article 31bis permits any developed WTO member country to export a generic drug produced under a compulsory license to any less developed WTO member country.
However, for the purpose of using compulsory licensing for COVID-19 related purposes, the WTO member states need to be sure that their national laws allow such government action. Some WTO member states have already taken some legislative steps at national level as part of their COVID-19 response so that the concerned governments can issue compulsory licenses in favour of local manufacturers. For instance, Canada, Chile, and Ecuador already adopted the legal groundworks for the purpose of issuing compulsory licenses to address COVID-19 pandemic. COVID-19 Emergency Response Act of Canada has amended the Canadian Patent Act for the purpose of assuring a quicker process for issuing a compulsory license on the ground of public health. Other countries may also think of amending their national patent laws if it is required for the purpose of issuing compulsory license to address the COVID 19 pandemic.
It is important to note that if vaccine innovating pharmaceutical companies protect their vaccine formula by trade secret (instead of patent), then it will not be possible for others to gain access to the formula as such reproduce the vaccine.
Other Practical Issues:
In practice, application of compulsory license may not be necessary for COVID 19 vaccine. This is because, COVID 19 vaccine patent holders may decide not to exercise their patent rights for a certain period, or the patent holders may agree to provide voluntary licenses at affordable rates. For instance, Moderna has already declared that it would not exercise its patent rights (over COVID 19 Vaccine) until the pandemic ends.
For this reason, apart from legal issues like compulsory licensing of patent rights or temporary waiver from IPRs on COVID 19 vaccines and COVID 19 related medical products or technologies, there are some practical issues which should be considered by all countries, specially by all medium or low-income developing countries. These countries should determine whether they have a sound technological base and capability to reverse-engineer or reproduce the COVID 19 vaccines. For instance, during the early phase of the COVID 19 pandemic, remdesivir drug received a wide-ranged focus. Bangladesh could easily produce this drug without receiving any permission or license from Gilead Science Inc., the originator of the drug. But it may not be an easy task for Bangladesh to produce COVID 19 vaccine invented by Oxford or Pfizer or Moderna. Since some effective COVID 19 vaccines are based on new forms of technology (For instance, Pfizer and Moderna are producing new form of vaccine i.e. mRNA Vaccines), like many other low or medium income developing and least developed countries, Bangladesh must require improving its technological capabilities to produce these kinds of vaccines.
However, it is a matter of hope for Bangladesh that the claimed vaccine invention of Globe Biotech (i.e. Bongo Vax) is also a mRNA vaccine. It means, researchers, scientists, and pharmaceutical companies of Bangladesh have minimum expertise on this new kind of technological bases of COVID 19 vaccines.
To enhance such local expertise, the government of Bangladesh may think of building an enabling environment by way of developing public-private partnership (PPP). In this manner the country can engage private sectors to enhance their capabilities to invent (or at least reverse engineer or reproduce) COVID 19 vaccines. To address COVID 19 vaccine issue, building PPP can also be helpful for other low or medium income developing and least developed countries. However, it is important that concerned government authorities of these countries work diligently to address the needs of the private sectors. One may bring it as an instance that the Bangladeshi pharmaceutical company Global Biotech applied for human trial permission for one of their claimed COVID 19 vaccine innovations – 'Bongo Vax' (a mRNA vaccine) around four months before, but not received any response from the concerned authority yet. In similar circumstances, concerned authorities of the United States took less than a week to approve human trial permission for the vaccine invented by Moderna. Taking this as an example, one may remark that the governments or concerned authorities all over the world must understand the urgency of the issue and avoid any unexplainable delay in taking decisions especially when it concerns an issue like potential of developing or manufacturing drugs or vaccines against COVID 19 .
Conclusion:
Everybody understands that the whole world is affected by the adversities posed by COVID 19 pandemic. But the nature, scope, and severity of these effects are not the same. In fact, like all other disasters, pandemics hit the marginalized group of the society. At macro level, medium and low-income countries are marginalized groups of the global. Hence, these countries need special focus as to how they will protect their citizens from the COVID 19 pandemic. Since this pandemic is caused by a 'novel ' kind of virus, nobody can predict when and how it will end. Like many other scientists, WHO thinks that this virus may never go away from planet earth. If it is the case, all countries should adopt both short-term and long-term plans and appropriate vaccine policy as to how they will ensure vaccines on a regular basis for all their citizens. The proposed vaccine policy might also consider granting compulsory license, if required. At the same time, the policy should put appropriate focus on other relevant factors, which are essential to build the country ' s capacity of developing or reproducing COVID 19 vaccines. Urgency of adopting such a plan and policy is more acute for low or medium income developing and least developed countries, as most populations of these countries will not be able to afford measures like ‘lock-down' or 'stay at home' very often.
References:
BANCOVID, the first D614G variant mRNA-based vaccine candidate against SARS-CoV-2 elicits neutralizing antibody and balanced cellular immune response | bioRxiv
Bangladesh joins global COVID-19 vaccine race with Bongavax set for clinical trial (arabnews.com)
Calls for Compulsory Licensing and IP Waivers of COVID-19 Vaccines Ignore Technical Complexities (ipwatchdog.com)
Countries look to acquire the IP of vaccine makers to fight pandemic (cnbc.com)
How patent laws get in the way of the global coronavirus vaccine rollout (theconversation.com)
Opinion | The Risk of Suspending Coronavirus Vaccine Patents - The New York Times (nytimes.com)
Senator calls on Biden to reject COVID IP waiver (lifesciencesipreview.com)
Statement by Moderna on Intellectual Property Matters during the COVID-19 Pandemic | Moderna, Inc. (modernatx.com)
They Pledged to Donate Rights to Their COVID Vaccine, Then Sold Them to Pharma | Kaiser Heath News (khn.org)
What it will take to vaccinate the world against COVID-19 (nature.com)
Apr - 2021
Mahatab U. Shawon
Robi, the second largest mobile operator in the country, on April 08 declared a 3% interim cash dividend for its shareholders, financials ended on December 31, 2020. The record date for entitlement of interim cash dividend is set on May 2 later this year. Meanwhile, the earnings per share-EPS of the company stood at Tk0.07 in three months (January-March '21) this year, which was Tk0.33 ended on December 31, 2020. The operator disclosed the first quarter of this year financial results at its board meeting on the day. It also declared no dividend for its shareholders despite earning Tk 155 crore in profits in the financial year 2020. Robi made its debut on the Dhaka and Chittagong stock exchanges on December 24, 2020. The company raised Tk387.7 crore from the general investors including eligible institutional investors through the IPO. Applications submitted for the IPO exceeded the IPO amount by 5.74 times, indicating a high demand for the stock among investors.
Apr - 2021
BDLT Report
The Bangladesh Securities and Exchange Commission - BSEC on April 22 relaxed the deadline for listed companies on submitting monthly and quarterly statements, as a step towards curbing the spread of Covid-19. The commission asked Dhaka and Chittagong Stock Exchange authorities and all listed companies to comply with the new directive. The stock market regulator issued an official notice in this regard following appeals from some listed companies, seeking revision on the existing rule. As per the directive, listed companies will be able to make their monthly/quarterly submissions to the commission and bourses up to May 25. Earlier, the Bangladesh Association of Publicly Listed Companies - BAPLC in a letter to the BSEC Chairman Prof Shibli Rubayat-Ul-Islam wrote that the companies were facing difficulties to prepare, audit, and submit their financial statements in time, due to the countrywide restrictions put in place to curb the alarming surge in Covid-19 cases. The BAPLC said banks, non-bank financial institutions, insurances, and most multinational companies closed their accounting year on 31 December. According to the rule, it said that the companies have to accomplish the financial statement preparations and external audits within 120 days and submit the statement copies in 14 days after that. Hence, the above listed companies had to submit their 2020 annual statements by May 14. Also, they have their deadline on 15 May to submit the unaudited statements for the January-March quarter of this year as companies get 45 days to submit their first quarterly statements and 30 days for the second and the third quarterly statements since the end of the respective quarters.
Apr - 2021
BDLT Report
Commercial Banks will have to allocate around Tk 116 crore to carry out corporate social responsibility-CSR programmes in the form of providing essential goods and medical equipment to the underprivileged affected by the coronavirus pandemic. The banks will also have to set aside one per cent of net profits earned this year to cater supports to people in the categories of jeopardised, unemployed poor, rootless and despaired persons, according to a central bank notice issued on April 27. The one per cent net profit of banks stands at Tk 116 crore, given the overall net earnings by them this year, said a Bangladesh Bank official. This fund has to be allocated in addition to the lenders' existing CSR budget for this year. They will be allowed to adjust the one per cent additional fund in the next three years between 2022 and 2024 by way of cutting down their allocation for CSR programmes. Banks will disburse this year's special fund through deputy commissioners -DCs, non-government organisations-NGOs and microfinance institutions-MFIs. The DC offices, NGOs and MFIs will have to open accounts with the respective banks, which will disburse the funds through them. A bank will have to disburse 50 per cent of the allocated fund in city corporation areas and the rest must be distributed for the people living outside of the cities. Banks will have to give emphasis on providing essential food products and safety equipment to protect the poor from the virus and provide financial support for treatments. The Association of Bankers, Bangladesh, an organisation of the top executives of banks, will monitor the special CSR activities, said the central bank directive. Banks must complete the CSR activities in the quickest possible time, after which they will have to submit statements to this end to the central bank.
Apr - 2021
BDLT Report
The Asian Development Bank-ADB has downsized its projection about the Bangladesh's GDP growth in the current fiscal year of 2020-21, considering the second wave of Covid pandemic and fresh lockdown that restricted economic activities. The ADB in its annual flagship publication titled 'Asian Development Outlook-ADO 2021' released on April 28 projected that Bangladesh's GDP growth would pick up to 6.8 per cent in 2020-21 with stimulus package implementation and recovery in global growth and trade. However, during the launch of the report, ADB Country Director Manmohan Parkash said, "As the second wave of Covid-19 is ongoing and the situation is still fluid, these impacts were not considered in our outlook." "These impacts could possibly shave off at least one percentage point from our current projection…it may be in the range of 5.5 to 6 per cent," he said. According to the ADB outlook, Bangladesh's GDP growth in fiscal 2021-22 is expected to edge up further to 7.2 per cent as both exports and imports were picking up under sustained global recovery. The Government also recently, for a second time, revised down the GDP growth forecast to 6.1 per cent for FY21, reflecting the devastating impacts of the second wave of the coronavirus pandemic on the battered economy. It had initially targeted to achieve an 8.2 per cent expansion of the gross domestic production-GDP in the current fiscal year and later the target was reset at 7.4 per cent. Earlier in March, World Bank projected that Bangladesh's GDP might grow as high as 5.6 per cent in FY21. International Monetary Fund-IMF in its latest World Economic Outlook on April 6 forecast that the country would achieve a GDP growth of 5 per cent in FY21.
Apr - 2021
BDLT Report
Prime Minister Sheikh Hasina has said Bangladesh firmly believes that coronavirus vaccines should be declared "global public goods", and called for a strong partnership to tackle challenges posed by the pandemic. The PM said this in her prerecorded video speech at the opening plenary of the four-day annual conference Boao Forum for Asia (BAF) titled "A world in change: Join hands to strengthen global governance and advance Belt and Road Initiative (BRI) Cooperation" held on April 20. The coronavirus pandemic, she noted, has brought mankind at a crossroad of history, confronting possibly the gravest global challenge of our times. "The socio-economic impacts of the pandemic are massive and are still unfolding. It is, therefore, extremely important to strengthen global and regional partnerships through coordinated efforts to address these challenges," the Prime Minister said. In her proposal, Sheikh Hasina outlines three key issues. First, the need for strong partnership to address the challenges posed by the pandemic, and to make vaccines available to everyone by declaring it as global public goods. Second, the need to work together for harnessing the power of technology as the future will be driven by the 4IR, which comes with opportunities and challenges. Third, seamless physical and digital connectivity which will be the key to reaping the benefits of the "Asian Century". She said that under the current state of globalisation, every country has to do its part for common good. Nations and economies will have to look out for each other as no single country in this world can sustain on its own. "Let's think together, work together and grow together," she said. The prime minister said that the pandemic highlights the crucial role of global governance to ensure that nobody is left behind even during crisis. "Bangladesh believes in the primacy of global institutions. All nations need to work together to make the UN and other international organisations effective so that everyone's vaccine and medical requirements are met," she said.
Apr - 2021
BDLT Report
The Government will consider the merger of troubled Padma Bank with a state-owned bank after bringing necessary changes to the Bank Company Act. Finance Minister AHM Mustafa Kamal said on September 29 that the Government had drafted the amendment on necessary mergers and it was awaiting passage by Parliament. “The merger process will kick off after the approval [of the amendment],” he said after a meeting of the cabinet committees on economic affairs and Government purchase. Section 77 of the Bank Company Act allows the merger of banks or financial institutions, but it does not stipulate the unification of weak lenders. As the banking sector is struggling with troubled lenders, such as Padma Bank, the government has moved to make changes to the law for their merger.
Sep - 2021
BDLT Report
Prime Minister Sheikh Hasina has received the ‘SDG Progress Award’ in recognition of Bangladesh’s achievements in sustainable development from 2015 to 2020. The award was given to the Prime Minister as part of the 9th Annual International Conference on Sustainable Development in New York on September 20. The virtual event was jointly organised by the UN Sustainable Development Solutions Network-SDSN and other organisations including the Master of Development Practice-MDP and the Earth Institute of Columbia University. “SDSN and several other organisations have presented Prime Minister Sheikh Hasina with the award in recognition of Bangladesh’s surprising achievements from 2015 to 2020. She dedicated the award to the people of Bangladesh,” Foreign Minister AK Abdul Momen said in a media briefing in New York afterwards. Bangladesh features among the top three countries that have progressed most on the SDG Index score since 2015, when the UN member states agreed the 17 Sustainable Development Goals. “The award is a recognition of our endeavours engaged in achieving SDGs. ‘Leaving no one behind’ is the key part of the SDGs. We will continue our efforts to march towards progress and prosperity so that no one is left behind,” Momen said. SDSN President Prof Jeffrey D Sachs has lauded Sheikh Hasina's leadership for maintaining the country's progress in achieving the sustainable development goals amid the COVID-19 pandemic. The prime minister was introduced as the ‘jewel in the crown of the day’ at the event.
Sep - 2021
BDLT Report
The Cabinet has approved the draft of the Speedy Supply of Power and Energy (Special Provision) (Amendment) Act 2010 in a meeting presided over by Prime Minister Sheikh Hasina on September 6. The extension will ensure power supply without disruptions as Bangladesh aims to become a higher-middle income country by 2030 and a developed nation by 2040, Cabinet Secretary Khandker Anwarul Islam said. The Law, passed in 2010, was extended for the last time by three years to 2021. After the Awami League returned to power in 2009, the Government began signing deals for renting power plants for up to 16 years. The Law was passed to legalise the plants. Although the government considers the plants as very useful in maintaining dynamism in the economy with increased power supply, subsidies to pay high cost of electricity from the plants have drawn criticism. The Power, Energy and Mineral Resources Ministry in a report to the Parliamentary Standing Committee in March said the plants would be shut down by 2024. Secretary Anwarul said Bangladesh had surplus power some days ago, but new analysis shows rising demand in industries, and it will continue to rise massively after the Padma Bridge is built.
Sep - 2021
BDLT Report
The central bank has allowed all scheduled banks to invest in a private Green Sukuk bond from their special funds meant for investment in the capital market. Under the new provisions, the banks are now eligible to invest money from their special funds in 100-per cent asset-backed listed or supposed-to-be-listed-within-a- year tools from the subscription-closing data Green Sukuk, issued by a private entrepreneur, to run the project with a minimum 70-per cent renewable energy, according to a notification, issued by the Bangladesh Bank (BB) on September 27. However, no bank will invest more than 10 per cent of the total amount of Sukuk issued through private placement or secondary market, it added. The Sukuks include Istisna, Salam, Ijarah and Hybrid, which will be formed with more than one Sukuk and will be treated as investable Sukuk securities. Sukuk is an Islamic financial certificate, similar to a treasury bond and structured to generate returns in compliance with Islamic finance principles. The central bank has set some conditions on the use of Sukuk funds. As part of the conditions, the letter of credit-LC will be opened by paying 100-percent margin. Besides, a bank account named Special Purpose Vehicle-SPV will be maintained for Sukuk Fund. That should not be allowed to invest or spend excepting specific expenditures from the bank account. A tripartite agreement will be signed among the trustee of Sukuk, SPV and investor banks in this connection, according to the notification. In case of the Green Sukuk, the banks will be allowed to invest from their special funds for the capital market until December 31, 2028 instead of 10 February 2025 earlier. Earlier on February 10 last calendar year, the banks were allowed to create special fund worth Tk 2.0 billion, each of five-year tenure, only for investment in the capital market. Under the arrangement, the banks may form the special fund with their own resources or with fund received from the BB through repo or re-financing mechanism.
Sep - 2021
BDLT Report
