Vaccine Crisis in Developing Countries during the COVID-19 Outbreak

Reading time : 8 minutes

1.Abstract:

One billion people reside in developing nations, and low- and middle-income countries account for 90% of global disease but just 12% of global health spending, yet only a few minds are focused on this issue. This scale has increased with the arrival of the extraordinary times of covid.[1] While many variables contribute to extreme poverty, a few stand out in the current situation. Poverty is expanding and existing disparities are being exacerbated by falling economic development. Factories have closed, domestic demand has been slashed, investments have been postponed, and global trade has plummeted, putting countless jobs in jeopardy. Developing countries and under developed countries find it hard to sustain themselves during this time, hands bound to the patentability of the vaccines and troubles in accessing them, they often find themselves burying bodies instead of treating the individuals of their country. A patent is a type of public policy tool that can be employed in a variety of ways. Contrary to popular belief, a patent is first and foremost about gaining ‘control’ rather than merely making money, where again the developing countries are placed at the mercy of the rich countries for relief. The paper attempts to highlight the drawbacks developing countries faced due to the Covid -19 outbreak, it does so by investigating into the agreements made by several countries, its implication, the impact of intellectual property on vaccines, and how countries must take steps to overcome the lack in access of the vaccines.

2.Introduction:

During the COVID-19 outbreak, the significance of having access to intellectual property was re-emphasized. This is particularly true in two components of importance: public health and academic and social involvement. As the COVID-19 problem intensifies, the impact on developing countries’ democratic growth is becoming a prime concern. The subject of its implications for electoral processes has gotten a lot of attention. Its influence on constitutionalism and the due process of law in these states has received less attention.[2]

Prior to diving profound into the concerned issue, it is fundamental to get comfortable with Trade-Related Aspects of Intellectual Property Rights (herein forward alluded to as “Outings”). It’s anything but an understanding among all the individuals from World Trade Organization (WTO), haggled during 1986-94 in the Uruguay round. Turning into the primary consent to bring licensed innovation rights into the multilateral exchanging situation acquired more request and consistency world financial matters and takes into account the requirement for precise question settlement among the countries on the issue concerning protected innovation rights. The public authority of every country award licensed innovation right to the trailblazers, and thusly, the degree of assurance furthermore, implementation of the rights generally differed across the world. Those distinctions, now and again, make strain in the worldwide monetary connection. Excursions overcome any barrier in these rights ensured across the world and bring them under a typical global umbrella by building up least principles for assurance and implementation that the public authority needs to keep up in their country. Also, the arrangement assumes an imperative part in working with exchange information and innovativeness by boosting the trailblazers, accordingly cultivates a sound climate for advancement.

As we approach the one-year mark of the COVID-19 global pandemic, with a handful of new vaccines already approved for emergency authorization and millions of people recently inoculated, it is becoming increasingly likely that the world may soon look quite lopsided.[3] A global advocacy effort is currently attempting to exclude COVID-19 vaccines from intellectual property restrictions, claiming that doing so will assist to mobilize additional manufacturers and solve vaccine access gaps. Others say that doing so would discourage further manufacturing investments and jeopardize long-term vaccine development, including for COVID-19 variations that are emerging. One must forget amidst this tussle of opinions, it’s the developing countries that have to face the music for several reasons like down scaled economy, lack of in fracture and an inferior quality of education.

For three reasons, we confront a worldwide access dilemma. First, while the funding of R&D and manufacture by governments in high-income countries (HICs) has been critical to the development of novel vaccines, prior purchase agreements have pre-empted supplies. Second, we require additional bandwidth. Diverting current vaccine capacity would jeopardize Gavi, UNICEFs, and national vaccination programs that have worked hard to achieve their goals. The lack of funds to pay for vaccines in low- and lower-middle-income countries is the third cause. The paper goes on to shed light on different aspects such as: the relation between intellectual property and vaccines, sharing of know-hows, lack in access of vaccines in developing countries

3. Vaccines and Intellectual Property: An Overview

There has been a lot of discussion in recent years regarding how intellectual property affects medications, particularly how the TRIPS Agreement affects medication adherence in developing countries. Vaccines, on the other hand, differ from medications in a number of key ways (at least in terms of small molecule ‘pill’ medicines, if not the newer ‘biotech’ medicines).[4] Because of these distinctions, the difficulties discussed in the debate over access to pharmaceuticals may apply to vaccinations to a greater or lesser level. This section looks at a number of the many types of intellectual property rights that apply to vaccines, as well as the implications of some of the variations between vaccines and medications.

The term “intellectual property” is a mantra that encompasses a variety of ideas. Patents, trademarks, copyright, designs, and non-public information are only a few types of intellectual property protected under the TRIPS Agreement.[5]. Inventions are protected by patents (Articles 27-38 TRIPS). Both information linked to vaccine production techniques and components of vaccine drug development or other test data are potentially included in a broad category of “undisclosed information” (Article 39 TRIPS).[6]

3.1 Patents: A patent will be awarded for an invention if it can be proven that it meets specific criteria, such as being “new” and requiring an “inventive step” (TRIPS Art 27.1). A novel vaccination could contain a multitude of distinct ideas, each of which could be patented independently, resulting in a patent portfolio. On principle, the number of independent inventions that are allowed to be patented in the field of biotechnology has increased dramatically, which has significant ramifications for the patent protection of new vaccines.[7] Products (e.g., a microorganism in a living but attenuated state, (recombinant) antigens and antibodies, an adjuvant, or a vaccine delivery device) and processes (e.g., a microorganism in a living but attenuated state, (recombinant) antigens and antibodies, an adjuvant, or a vaccine delivery device) may be relevant patented inventions (e.g. relating to a method or steps in a method for producing a vaccine).

A patent filing will also reveal the patent ‘claims, which are the limitations of the monopoly sought, based on the description of the discovery in the patent application. As the preamble to the TRIPS Agreement clearly states, patents are, or should be, private rights, and it should be up to the patent holder to sue a third party if they “infringe” on the patent holder’s right. A patent holder can either agree to license their patent to a third party, allowing them to conduct things that would otherwise be considered patent “infringement,” or they can assign their patent outright (TRIPS Art 28.2).

As stated further below, the scope of a patent monopoly is intrinsically limited in terms of subject matter, geographical breadth, and time. Particular activities can be classified as exceptions to the patent monopoly, such as acts carried out for the research purposes within certain boundaries (TRIPS Art 30). In addition, if a patent holder abuses their patent monopoly and/or it is in the public interest, a “compulsory license” may be given to allow a third party to perform any act that the patent holder would normally prohibit (TRIPS Art 31). If a patent monopoly is shown to have been awarded improperly, it might be cancelled (see e.g., TRIPS Art 32).

3.2 Undisclosed -test Data: The term “undisclosed test or other data” refers to a concept that is even more limited than “trade secrets.” It is a pretty modern sort of intellectual property protection that protects investment rather than innovation or ingenuity in general. Before a pharmaceutical product can be marketed, it has to be approved (licensed) by the regulatory authorities, and this involves among other things carrying out clinical trials.

However, there is still much discussion about how to enforce the “unfair commercial usage” provision in national legislation. One interpretation favors the data owner and calls for a term of exclusivity, usually 5 years, during which time a third party cannot rely on the originator’s data by obtaining consent after establishing that their product meets the requirements. Alternative perspective, which favors accelerating the entry of competitive items onto the market, allows third-party products to be registered if they are bio-equivalent.

Nonetheless, in the case of vaccinations, the protection of “undisclosed test or other data” may have a smaller influence than in the case of medications. Because of the nature of small-molecule ‘pill’ medicines, bio-equivalence techniques can be used to assess with certainty if a generic medicine is totally equal to an originator medicine. A bio-equivalence comparison for more complicated biological constructions like vaccines (or the newer “biotech” treatments) is not yet conceivable. Given the sensitivity of vaccine products to the intricacies of the manufacturing process, it appears that each vaccine manufacturer must do their own clinical trials and acquire license based on their unique unintended consequences.[8]

3.3Vaccine delivery devices[9]:In terms of the distribution of the end product vaccine, IP protection of vaccine delivery devices is equally critical. Given that vaccine delivery devices will differ significantly from vaccines in terms of properties, such as being mechanical rather than biological, IP issues will have a different impact. Patents are likely to remain important, but know-how issues may become less so. “There are important delivery systems in delivery systems such as nasal sprays, patches for administering drugs through the skin, and ballistic delivery systems [and] when used in combination with vaccines (i.e., licensed vaccines are contained or administered via specific equipment). Intellectual property products are covered by the intellectual property of the vaccine component, the intellectual property of the delivery device, and the PI of the vaccine usually delivered by the device with specific characteristics “[10]

4. The impact of patent regulation and vaccine access:

With a handful of new vaccines already approved for emergency authorization and millions of people recently inoculated, it’s becoming increasingly likely that the world will soon look quite lopsided in one distinct way – hundreds of millions of residents in wealthy countries will be vaccinated before billions of people in developing countries have similar access. A global advocacy effort is currently attempting to exclude COVID-19 vaccines from intellectual property restrictions, claiming that doing so will assist to mobilize additional producers and solve vaccine access gaps. Others say that doing so would discourage further manufacturing investments and jeopardize long-term vaccine development, including for COVID-19 variations that are emerging. In three ways, IPRs obstruct global vaccination access:

First, IPRs give the pharmaceutical industry sole authority over who gets vaccines and at what price. Companies that own intellectual property have exclusive rights to create vaccines under the WTO’s Trade Related Intellectual Property Rights Agreement (TRIPS), which prevents generic products from entering the market. As a result, they are able to maintain a stronghold on the market and maintain high prices, as there is minimal competition for identical products. Vaccines that are currently on the market are too expensive for developing countries to afford. Prices may also vary depending on the contract: for example, and contrary to social justice theory, prices may fluctuate depending on the contract, the AstraZeneca vaccine was sold to South Africa at $5.25 per dose but to EU at a lower rate of $2.16.[11]

The first reason leads to the second. Vaccines are made available at the national level thanks to bilateral prepurchase agreements between vaccine makers and countries or regions like the European Union or the African Union. The African Union has negotiated a deal to 1prefinance 670 million vaccine doses while African countries pool their funds,[12]but relatively few low-income countries have contracts that provide adequate volumes to reach their whole populations.[13]

Third, the COVAX programme was launched in April 2020 to ensure that vaccinations spread at the same rate over the world after they were approved for licensure. COVAX is frequently praised as a vehicle that promises universal vaccine access, although its public image is rosier than reality. COVAX is supported by philanthropic organizations and affluent countries; It seeks to reach 20% of the population in nations that have sponsored it, as well as offer 1 billion doses to 92 low-income countries who are not paying it.[14] COVAX was on the verge of collapse in December 2020 due to a lack of funding,[15]but one of President Joe Biden’s first moves as part of his new government was to assist COVAX,[16]improving its chances of success. Rich countries, such as Canada, have also gotten immunizations under the COVAX programme. [17]Canada has five times as many immunizations as it needs to protect its whole population. The surplus of some comes at the expense of others due to the realities of manufacturing rates, bringing to light the fundamental inequity in how access is molded by the purchasing power of countries where people happen to be born. While the COVAX programme began vaccinations for frontline caregivers in a number of low-income countries in February and March 2021, the bulk of the inhabitants in these countries are still without vaccines.

The proposed waiver is time-limited and limited to pandemic-related items, but a more fundamental change that questions the capitalist model of vaccine production could have far-reaching implications for how innovation is organized in the future. In short, in the discussions, different countries are not on an equal basis when it comes to finance and networks, and the African Union has been a low priority.

5. Access to IP protected vaccine technologies:

In far too many aspects, the distinction between access to new vaccinations and vaccine R&D is false, because how the R&D is carried out will almost certainly have a considerable impact on access to the end product. The following section looks at how to get access to end product vaccines that have been produced with intellectual property rights in mind.

5.1Intellectual Property and the Access Issue: It goes without saying that a new medicine’s or vaccine’s high price will have a significant impact on its availability in underdeveloped countries. As a result, a high-end pricing might be influenced by a variety of factors, including patent protection. Nonetheless, considering that patents are designed to grant market monopoly rights, they are clearly a major source of concern.

The vaccine access gap is addressed in the latest WHO/UNICEF/World Bank book “State of the World’s Vaccines and Immunization”[18]. “The disparity in access to vaccines between wealthy and poorer countries has widened even so far over the past two decades, as new life-saving vaccines have become available — at prices that most low-income countries could not afford,” according to the article (page 7). This is why the Global Alliance for Vaccines and Immunization (GAVI) was established, not only to address long-standing issues like Hepatitis B and Hib vaccines, but also to address the new Accelerated development and Introduction Plans (ADIPs).[19]

5.2Know-How and Competition: The current discrepancy in technological capabilities between, say, an OECD vaccine producer and an emerging vaccine producer in the developing world appears to make the occurrence of such a know-how gap more feasible (at least in respect of the newer and more sophisticated vaccines). Not only is there, of course, a wide range of technological capabilities among rising providers, some of which are fairly advanced. Nonetheless, this is an important topic to research. Is there a significant knowledge gap between vaccine makers in developed and developing countries? What is the scope of it, if there is one? Is there anything that can be done about it? What will the long-term consequences be?

When comparing the effects of patents and know-how, it appears that the greater the technical gap between, say, an OECD patent holder and a potential emerging competitor, the more likely ‘secret’ know-how (and the body of more general technical know-how) will form the greater ‘barrier to entry’ for the competitor. If, on the other hand, the patent holder and the potential rival have similar technical capabilities and know-how, the patent may serve as a more immediate “barrier to entry.” This may be the case, for example, with a modified EPI- schedule vaccine, where numerous developing manufacturers for these more straightforward items may have similar levels of expertise, of know-how as OECD firms.

6. Measures to increase access:

Patent proprietors have a lot of options for avoiding patent-related access issues. If so, there are tools available under TRIPS, at least in theory, to enable price-lowering competition without their approval. Tiered pricing, bulk purchase (including procurement implications), and voluntary and obligatory licensing are all discussed in the sections below.

Tiered pricing: Tiered pricing is a well-known strategy for making vaccinations more affordable to developing countries than to affluent countries[20]. Of course, pricing decisions are left to the patent holder, and underdeveloped countries may be able to benefit from the fact that wealthier countries bear the majority of R&D costs.

Due to the nature of the product and the manner it is provided, ‘parallel importation,’ which makes tiered pricing less likely over the area where parallel importation can take place, appears to be almost non-existent for vaccinations. These factors make it significantly less probable that other parties will be able to buy up vaccination stock and use parallel importation to take advantage of price discrepancies between markets.

The so-called “schedule divergence,” in which various vaccination products wind up being employed in diverging vaccine markets, must be a substantial barrier to tiered vaccine pricing. The Worldwide Alliance for Vaccines and Immunization (GAVI) hired Mercer Management Consulting to write a report on procurement techniques, which included a breakdown of the global vaccine industry, discussed.[21]

Increasingly, high-income country immunization schedules are diverging from those in low and middle countries. This trend threatens one of the bases for tiered pricing, whereby high-income and low-income countries bought the same products, but high-income countries’ pricing covered most of the production costs. Historically, tiered pricing has been critical to affordability and broad access.

Bulk Purchase: Bulk purchasing success is simply due to the fact that lower pricing can typically be provided for larger quantities of merchandise. Bulk purchase methods are extremely essential in the field of vaccinations, for example: as well as in the field of contraception.[22] Given the scale challenges involved in vaccine manufacturing and the requirement to link production plans with effective disease burden assessment, bulk purchase is intrinsically crucial for vaccines. This section goes into further detail on the link between intellectual property and procurement. One type of high-volume purchase that may be especially important for vaccinations is one that occurs in advance, i.e., an advance purchase commitment. Some people support such a method,[23] while others are skeptical. An early purchase commitment may be more effective in stimulating a quick transition from the latter phases of development to the completed product than in stimulating long-term research-intensive initiatives.

Volunteering licensing: As mentioned earlier, a patent holder may use his or her patent to provide authorization to other parties to perform activities that would otherwise be patent infringements. This is a voluntary patent license that generally comes with certain royalty payments in exchange.

One type of voluntary patent licensing would include a global patent holder (one who owns patents in many countries) providing a non-exclusive license to anybody who desired one.  Another option would be for the international patent holder to give an exclusive license to another business together with technology transfer, such as all applicable know-how, to help put this other company in the same position as the patent holder in terms of manufacturing the product. Another option in which the patent holder does not desire to share all of the technology with the licensee would see the patent holder offer a patent license and a limited degree of technology transfer so that the licensee may carry out

There is evidence of a trend for OECD companies to carry out high-technology bulk production themselves, but to enter into agreements with emerging manufacturers in developing countries to complete the packing and filling stages of production, as discussed further below in the technology transfer section. As acknowledged one basic difficulty with voluntary licensing is that the impact of royalty payments to price will almost certainly be less important than the lack of competition. In a licensing scenario, “tooth and nail” rivalry between third parties is replaced by a controlled partnership between the licensor and the licensee.

As a result, voluntary patent licensing cannot be anticipated to result in inevitably reduced prices in the same way that market competition does.

Compulsory licensing: Compulsory licensing has the potential to be a powerful instrument for reducing the consequences of patent monopolies. The public interest may require that the patent monopoly be “broken” at times.

The potential of enforcing compulsory licensing, as well as the flexibility to determine the grounds for doing so was reaffirmed in the Doha Declaration. As mentioned above in section 3.2, one example of a compulsory license that has previously been awarded in the vaccine area was that coming from an Israeli patent lawsuit pertaining to Biogen’s Hepatitis B patent.

However, as mentioned above in section 3.3, the difference in technological sophistication between, say, an OECD originator vaccine business and an emerging vaccine firm may be such that there is a significant knowledge gap between the two.

If the developing provider cannot create this missing know-how on its own, or if it cannot contract with another business to develop and convey the required know-how, then a ‘naked’ forced patent licensing may be ineffective: Although the fear of legal action by the patent holder to halt vaccine research and production would have been withdrawn, this would have had no practical impact if the emergent provider could not produce or manufacture the vaccine in the first place. Again, as stated in section 4.6, the MVP model may be of relevance here.

If it turns out that vaccine-producing companies are unwilling to apply for compulsory licenses or that governments are unwilling to grant them, one of the most potentially effective tools for dealing with the potentially negative effects of patent monopolies will be lost, and single suppliers may become more common.

7. TRIPS, Doha and TRIPS plus:

Much of the argument over access to pharmaceuticals has centered on WTO members’ ability to interpret and enforce the TRIPS Agreement. All WTO members agreed to the WTO Doha Declaration on TRIPS and Public Health on November 14, 2001. The Doha Declaration acknowledges the “gravity of the public health problems afflicting many developing and least developed nations,” according to the Declaration, but simultaneously recognizes the “concerns about its effects on prices”.

Although an outstanding legal problem with compulsory licensing under the TRIPS Agreement could not be solved in Doha – how to enable compulsory licensing (or any other mechanism) that would permit production of pharmaceutical products for export to countries – compulsory licensing is one of these flexibilities, as explicitly noted by the Doha Declaration, “with insufficient or no manufacturing capacities in the pharmaceutical sector”[24] On the 20th of August, 2003, all WTO members agreed on a new legal procedure to address this lingering issue. Vaccines appear to be included within the scope of this novel mechanism.[25]

The following are some examples of TRIPS plus provisions.

  • “To compensate the patent owner for the unjustifiable shortening of the effective patent period as a result of the marketing,” the patent life is extended beyond 20 years. (CAFTA 15.10(2) explains the approval process.
  • Where a pharmaceutical product is covered by a patent, the marketing approval process must prevent persons other than the patent owner from marketing a product during the lifetime of the patent unless the patent owner consents or acquiesces (CAFTA 15.10(3)(a))

As a result, in any developing country that agrees to such provisions, the patent lifetime may be extended beyond the customary twenty years, and the marketing approval procedure will ensure that any items regarded to be covered by such a patent over the extended period will be approved lifetime has been turned down for marketing authorization .The patent owner will benefit from a longer patent monopoly, and the country’s government will effectively enforce the patent without the need for the patent owner to intervene (as TRIPS would usually require).

If a country wants to buy pharmaceuticals, for example, only the patent owner, or at least someone with their consent, will be allowed to do so under this regime. Unless steps are done, such as the awarding of a compulsory license, the price competition associated with it will continue. Until the now-expired patent expires, open tendering and generic competition will be precluded. The monopoly has ended.

9.Conclusion:

One of the most important functions of intellectual property is to provide an incentive structure within which creativity can be encouraged and given a safe passage through the many, often risky stages that lead from discovery to marketable service or product. Similarly, in the creative industries, IP is at the heart of the business model that rewards and facilitates relationships and transactions between authors and composers, performers, publishers, music and audiovisual producers, broadcasters, and distributors like libraries and electronic distribution platforms.

Using a combination of incentives, requirements, and subsidies, policymakers should take steps to abolish or reduce monopolies on the know-how needed to manufacture a COVID-19 vaccine. Today, none of the producers are even close to being able to supply demand on a timely basis. The longer the pandemic lasts, the more damage it causes to our health, economy, and social well-being. Though some countries plan to get the majority of their populations vaccinated by the fall, others will have to wait years. We don’t know how long current vaccine immunity will last, or how effective it will be against new strains that will emerge if the virus isn’t contained globally.


[1] Bale, Global Economic Symposium. Improving Access to Health Care for the Poor, Especially in Developing Countries

[2] Statement from Ambassador Katherine Tai on the Covid-19 Trips Waiver | United States Trade Representative

https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver

[3] https://www.cgdev.org/debate/would-exempting-covid-19-vaccines-intellectual-property-rights-improve-global-access

[4] Murphy A, Mbau L, McKee M, et al. Can we do for other essential medicines what we are doing for the COVID-19 vaccine?

[5] For an in-depth introduction see, for example, “Intellectual Property Rights in the WTO and Developing Countries”, Jayashree Watal, Kluwer Law International, 2001.

[6] J. World Intell. Prop. 723 (1998), Protection of Trade Secrets under the TRIPS Agreement, and Developing Countries

[7] “Biotechnological Inventions”, Chapter 13 in “Patents for Chemicals, Pharmaceuticals and Biotechnology”, Grubb, Oxford University Press, 1999.

[8] FDA Commissioner Mark McClellan quoted in “US is Setting a Path for Biotech Generics”, The Wall Street Journal Europe, February 18th 2004.

[9]  “Technologies For Vaccine Delivery in the 21st Century: A White Paper of WHO, UNICEF, USAID and PATH”.

[10] Martin Friede, WHO, personal communication.

[11] Sullivan H. South Africa paying more than double EU price for Oxford vaccine. guardian, 2021. https://www.theguardian.com/world/2021/jan/22/south-africa-paying-more-than-double-eu-price-for-oxford-astrazeneca-vaccine

[12] Berkeley S. The Gavi COVAX AMC explained. Gavi vaccine alliance,2021. https://www.gavi.org/vaccineswork/gavi-covax-amc-explained

[13] Asala K. Egypt Begins its COVID-19 Vaccination Campaign with China’s Sinopharm. Africa News, 2021.  https://www. africanews.com/2021/01/25/egypt-begins-its-covid-19-vaccination-campaign-with-china-s-sinopharm/

[14] Supra 11

[15] World Health Organisation. COVAX expects to start sending millions of COVID-19 vaccines to Africa in February, 2021.  https://www.afro.who.int/news/covax-expects-start-sending-millions-covid-19-vaccines-africa-february

[16] Schuster-Bruce C. Fauci confirms that Biden will remain in the WHO and join its vaccine scheme, COVAX, which Trump claimed was ‘China-centric’ and refused to be a part of. Insider, 2021.

https://www.businessinsider.com/biden-join-who-world-health-organization-covax-vaccine-trump-2021 1?r=US&IR=T [Accessed 2Mar 2021].

[17] Cecco L. ‘We’re double-dipping’: Trudeau pressured to speed vaccine distribution amid COVAX backlash. The Guardian, 2021.

https://www.theguardian.com/global-development/2021/feb/09/canada-coronavirus-vaccine-covax-trudeau

[18] “State of the World’s Vaccines and Immunization”, WHO, 2002

[19] “The Global Alliance for Vaccines and Immunization was formed to harness the strengths and

experience of multiple partners in immunization. It is an historic alliance between the private and

public sector committed to the mission of saving children’s lives and people’s health through the

widespread use of vaccines.”  http://www.vaccinealliance.org

[20] the WHO and WTO Secretariats held a joint workshop, Norway on 8-11 June 2001 to “examine the legal, institutional and political environment that would favour widespread use of differential pricing…”, report and working papers available on WHO, WTO websites.

[21] p 105, Mercer report, “Lessons Learned: New Strategies for Vaccines, Final Report to the GAVI Board”, June 28, 2002, reproduced in Eight GAVI Board Meeting document, June 2002

[22] Asian Development Bank report, supra note 28, p 39 et set

[23] Michael Kremer has provided influential analyses to both the CMH and UK government indicating the use of APCs as a particularly cost-effective intervention for the development of new health products. It is understood that the Gates Foundation is presently looking at vaccine APCs in particular

[24]  In fact the discussion focused on the TRIPS Agreement requiring that the authorisation of the

compulsory licence be made “predominantly for the supply of the domestic market” (TRIPS Art 31(f)).

In other words, an authorisation could already be given under TRIPS in respect of a non-predominant

portion of the production (e.g., 1-49%) and what had to be found was a way to extend that under the

circumstances discussed to include a predominant portion of the production (51%-100%).

[25] Although the Japanese government reportedly asked for the word “vaccines” to be removed from a

draft of the text this was apparently not regarded by other negotiators as an exclusion of vaccines from

the mechanism. The definition of “pharmaceutical product” in the text is apparently regarded as

sufficiently broad to include vaccines, e.g. “The WTO Decision on Paragraph 6 of the Doha

Declaration on the TRIPS Agreement and Public Health”, Vandoren and Van Eeckhaute (EC

negotiators), Journal of World Intellectual Property, Vol.6, No.6, November 2003.

Author: R. ABHINAYA KRISHNA, PES UNIVERSITY

Editor: Kanishka VaishSenior Editor, LexLife India.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s