The Way Forward to Vaccine : Procurement and Preparation

Farid Ahmad

6 October, 2020 12:00 AM printer

Coronavirus has already disrupted our society and economic well-being horribly. It has snatched thousands of lives from the country. We all are afraid that the corona situation may worsen in winter and cause more havoc. Amid the growing concerns, it is heartening that countries around the world are in the final stages of developing vaccines. And during this pandemic scare, vaccines may become a wonderful business for some countries. Manufacturers are considering the vaccine as pure gravy that can create an enormous opportunity to spin money. Some countries seem to be involved in using it as a political tool. The sole motivation behind vaccine production cannot be making a profit. That is surely an unethical approach. There should not be any politics for such a serious health issue born of coronavirus. We should keep it in mind that regardless of profits, the economic and social benefits of vaccination are huge for saving lives. 

People are least interested in interpretations of global politics for certain. Rather billions of people across the world are counting days eagerly for an effective vaccine against this deadliest pathogen.  People of both least-developed countries (LDCs) and developing countries (DCs) want an effective vaccine at the earliest at no cost or the least cost. However, as soon as the dream of developing a safe and effective Covid-19 vaccine is realised, the first innovator will certainly file a patent to bring the vaccine to the market in a hurry and recover his/her costs. This patent will allow the manufacturer to secure a better profit margin while, at the same time, it will hinder other vaccine innovators from entering the market for a finite period, thus making the vaccine expensive and limiting its availability.

Many policy researchers and public health advocates have argued that the existing Intellectual Property (IP) regimes act will inhibit innovation and access to life-saving drugs. Thus, the question arises on how a balance can be found between IP protection and the needs of individuals in access to medicine. In response, several groups have proposed changes in IP rules and institutions, including the creation of various forms of joint IP management, known as Patent Pools (PP), to address these alleged IP barriers. ‘Patent Pools and Antitrust’, a comparative analysis published by the Secretariat of World Intellectual Property Organization (WIPO) defines PP as an agreement between two or more patent owners to license one or more of their patents.

The Patent Pool is not a new concept. It has been successful in facilitating innovation for technologies ranging from aircraft to consumer electronics. For these innovations, it is generally formed by two or more patent holders who license their individual patent rights to each other or third parties, in return for royalties on sales of the resulting products.

The formation and use of PP for global health technologies, which is not yet fully tested, are different from the approaches practiced for other innovations because here it entails distinct groups of patent donors: mainly multinational biopharmaceutical companies or universities in the most affluent countries, and patent users: mainly generic drug companies and smaller biotechnology firms, instead of involving firms that both contribute and use the IP within the pools.

Health innovation and distribution require robust licensing models that enable the inventor and the patient to receive benefits from the successful transfer of health technologies. Hence, Unitaid, hosted by the World Health Organization (WHO), works with its partners to bring about innovations to prevent, diagnose and treat major diseases in low- and middle-income countries. From its inception, Unitaid is helping create transformative solutions to address global pandemics. Another United Nations-backed public health organisation, the Medicines Patent Pool (MPP) is working to leverage price reductions for quality diagnostics and medicines, thereby accelerating the pace at which these are made available in LDCs.

Through its innovative business model, MPP has attracted support from a wide range of national governments, civil society groups, international organisations, industry, patient groups and other stakeholders in prioritising and licensing needed medicines; creating patent pools to encourage generic manufacturers and the development of new formulations. MPP was founded by Unitaid, which continues to be the main funder. WIPO was with the UN during the formation of Unitaid and MPP. Therefore, the patent pooling and cross-licensing model envisaged under Unitaid can address issues of exorbitant vaccine pricing and distribution in resource-poor settings under the existing IP regime. The framework may facilitate the conclusion of licensing agreements in a way that both addresses the public health needs in low- and middle-income countries and ensures a fair return for patent holders. It generally solicits voluntary licenses from patent owners to create a pooled resource. Drug manufacturers, developers and innovators can then access the rights they need to manufacture or develop the new and adapted formulations required for sale in LDCs.

According to the 2009 U.K. parliamentary report, pharmaceutical companies were once called on to sign up to mechanisms like MPP that promotes to avert the “treatment time bomb.” In an address to Harvard Medical School, the CEO of GlaxoSmithKline said, “One idea we are proposing is a least developed country patent pool for medicines for neglected tropical diseases. We would put our relevant small molecule compounds or process patents for neglected tropical diseases into the pool, allowing others access to develop and produce new products. The pool would be voluntary, so as, to encourage others to participate and any benefits from the pool must go in full and solely to least developed countries.” Hopefully, the top vaccine manufacturer will assume the same idea in the case of the Covid-19 vaccines as well. And there were attempts to establish a PP for the viral illness SARS. This sort of initiative may limit its scope of work in both LDCs and DCs to bring down the price of licensing knowledge to produce the Covid-19 vaccines as such it does not affect higher-income markets.

To provide cheaper and better medicines, pharmaceutical companies need to pursue extensive R&D activity. By signing agreements through PP, the hindrances to access into required knowledge can be eliminated. Extracting information through a general licensing agreement is much costlier than that through the PP framework. It can increase market competition between different drug manufacturers and bring more pharmaceutical producers in the arena by enabling easy access to newly invented formulations of vaccines and offering royalty streams from a wide variety of different countries. Thus, this will increase in market supply of vaccines, resulting in a decrease in vaccine prices and enabling poor countries to meet their prospective demands of vaccines.

For example, Gilead Sciences Inc's revolutionary drugs Sofosbuvir and Velpatasvir for treating all types of hepatitis C virus infections costs $1,000 (around Tk. 85,000) per tablet under the brand name of Sovaldi and Epclusa in the developed market, making it one of the most expensive medicines in the world. Completion of a 12-week course of treatment will require approximately $100,000. A few Bangladeshi top drug-makers by the virtue of strong R&D team produce copycat versions of Gilead Hi-Tech products Sovaldi and Epclusa at a price of Tk.1,000 which is currently the lowest in the world. These manufacturers are part of Gilead's licensing pact for low-income countries and authorised to produce low-cost versions of the drugs for 45 countries that are mostly poor. Nations not covered by Gilead's license, India, Thailand, Malaysia and Morocco, and countries where Sovaldi is not patented could benefit from the new source of cheap copies. Gilead is “aware of unauthorised generic versions of Sofosbuvir being offered in the marketplace,” Bloomberg News quoted Gilead’s statement in a report on 8 March 2015.

In WHO’s report titled 'Advancing the right to health: the vital role of law’, Professor Roger Magnusson of the University of Sydney emphasised that all countries must have a national medicine policy. Roger opined that a national procurement strategy may assist governments to formalise a range of measures to purchase quality medicines at cheaper prices. Government strategic activities like addressing corruption, eliminating tariffs on imported drugs, controlling mark-ups on drugs at wholesale and retail levels, creating incentives for the supply of generic versions of drugs by pharmacists and medical practitioners, and banning or limiting direct-to-consumer advertising of medicines may reduce prices of essential medicines.

We should check our national medicines policy and procurement strategy minutely and immediately to take necessary measures to purchase vaccines at cheaper prices. Our top drug-makers should perform R&D in advance to produce affordable versions of the most wanted vaccine. Most essential medicines are generally not under patent, and generic versions can be produced or imported without infringing patent rights. But there is also a big problem when the definite duration of patent protection of any medicine expires. As soon as the period ends, the market will be flooded with cheaper generic versions. Hope this will not be the case for the Covid-19 vaccines.

A patent holder may enter into a voluntary license with third parties, such as generic producers, to produce, market and distribute a particular drug within a specified territory. Royalty-free, non-exclusive licenses that include a large number of countries within the licensed territory, permit the sale to both the public and private sector and permit licensees to source active pharmaceutical ingredients from anywhere in the world at substantially reduced prices.

The Agreement on Trade-Related Aspects of International Property Rights (TRIPS) includes a number of flexibilities that can be used to reduce the prices of essential drugs and to better meet the goal of universal access. Hope these flexibilities will be given for Covid-19 vaccines. Other strategies that might support the access to essential medicines include tiered pricing, donation of drugs, non-filing of patents in LDCs, and non-enforcement of patents.

UN Children’s Fund (UNICEF) is the world’s largest single vaccine buyer. It procures more than 2 billion doses of various vaccines annually for routine immunisation and outbreak response on behalf of nearly 100 countries. Very recently, UNICEF has said it will lead the global procurement and supply of Covid-19 vaccines to ensure that all countries have safe, fast and equitable access to initial doses when they are available. As a lower-middle-income country, we can take support service from UNICEF or participate in its collaboration mechanism for purchasing vaccines.

On 11 August 2020, Hindustan Times reports that though none of the coronavirus vaccines under development have completed the final trials and proved its full efficacy yet, at least 5.7 billion doses have been pre-ordered around the world. Bangladesh government has already decided to allocate Tk.765 crore to purchase about 22.5 lakh vaccines against the Covid-19. In the first phase, the Covid-19 frontline workers – doctors, nurses, health workers and others concerned – will get the vaccines followed by the elderly. Vaccines may be available for the common people afterward.

The government is taking away Tk.510 crore from two ongoing projects funded by the World Bank and the Asian Development Bank (ADB) to make allocations for the vaccine purchase. According to an estimate by the health directorate, this fund will be able to buy about 15 lakh vaccines. Besides, the Asian Infrastructure Investment Bank (AIIB) is joining the ongoing World Bank-funded project to tackle Covid-19 with the assistance of Tk.850crore. From the amount, the government will spend Tk.255 crore to buy an additional 7.5 lakh vaccines. The concerned personnel guess that the minimum price of a vaccine could be $40 (around Tk. 3,400). 

Both China and India have promised to supply vaccines to Bangladesh on a priority basis. Most importantly, the Chinese biotech company has committed to transfer the technology for production of the vaccine, as well as bulk vaccine, to a qualified Bangladeshi producer at a discounted price to meet the need of the larger population of Bangladesh. Since the government has an avowed policy of keeping all options open as far as the Covid-19 vaccine is concerned, we believe that it will not miss any opportunity to participate in the clinical trial of the vaccines and to procure them immediately.

Government branches concerned are working to bring the Covid-19 vaccine to the country with shorter lead time and lower costs. Besides, Bangladesh may get free shots for its four-crore people, as the Global Alliance for Vaccines and Immunisation (Gavi) will purchase 200 crore doses of the finally approved vaccine and distribute them to 20-23 percent of each country's population. Our finance minister has assured that there would be no fund problem in buying the vaccines. In the budget for the current financial year, a bulk fund involving Tk.10,000 crore has been earmarked to meet emergency needs, including buying Covid-19 vaccines.

In a press conference held on 2 July 2020, Bangladeshi company Globe Biotech Limited (GBL) announced that they were developing a Covid-19 vaccine. GBL claimed that they have gotten encouraging results from pre-clinical trials of ‘BANCOVID’, initially done on rabbits and then mice. Their pre-clinical trial results were pre-published in the international platform ‘Biorxive.org’, an archive for unpublished pre-prints in life sciences, on 30 September 2020. R&D head of GBL, Asif Mahmud is hoping that if everything goes smooth and according to plan, all three phases of the human trial will be completed by January. And every day, a substantial number of people are volunteering to sign up for the trials.  Prime Minister Sheikh Hasina has said that the government is ready to procure the Covid-19 vaccine from the country where it will be developed first.

We hail all these cordial bustling activities with gratitude. Yet access to Covid-19 vaccines may be beyond the reach of millions in resource-poor settings. As for Bangladesh, newspaper headlines like "Big business in Bangladesh: Selling fake coronavirus certificates" is still looming large in the minds of the general people. Unfortunately, a section of dishonest people cheated commoners, luring migrant workers with virus-free certificates. These fake certificates have not only posed a risk to public health but also put the millions of Bangladeshi workers overseas in trouble. Actually, those who have no affection for their country but only for themselves and the material world, they are moved to action by motives of wealth. They prefer themselves to their country, or their own good to the general good, and are respectively forbidden and mean. However, the government has taken commendable steps against all these scams, criminal syndicates, and irregularities. And it is imperative to take proactive approaches to better control any sort of corruption, eliminate tariffs on importing vaccines, and control market prices and storage of vaccines at wholesale and retail levels.

We must keep a positive mind-set that Covid-19 vaccines are for all and we shall have to make them available to people. Simultaneously, we ought to plan for procuring safe injection equipment, maintaining cold chain requirements for the vaccine, appropriate handling, storing and distribution of the vaccine. We shall have to work with manufacturers on freight and logistics solutions to get vaccine doses to the country as quickly and safely as possible once they are allocated. We must take care of the transport and storage of vaccines at point of service delivery and ensure that people are well-informed about the Covid-19 vaccination process. We must put measures in place to enhance trust and tackle misinformation about vaccines. Finally, we should have a plan to join a pool to gain the required knowledge and know-how for the Covid-19 vaccine preparation in near future.

The different sources of information are acknowledged with gratitude.

 

The author is Assistant Professor, Institute of Appropriate Technology, BUET and Reviewer, Advances in Economics and Business, HRPUB, USA.


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