WTO Headquarters in Geneva

A growing consensus seems to be emerging out of this week’s high-level WTO meeting that glaring inequities in access to vaccines can be remedied by strengthening supply chains, avoiding export bans across borders, and ensuring that big pharma voluntarily transfers its vaccine technologies to poorer countries so they can produce their own vaccines. 

“The significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable,” said United States Trade Representative Katherine Tai, in a statement published out of her appearance Wednesday at the WTO’s closed-door discussion with high-level representatives from industry, government and civil society on Wednesday.

“As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis”, she added. “The same needs to be demanded of industry.” 

Broader Technology Transfer in Poorer Countries is Possible, Says Iweala  

Ngozi Okonjo-Iweala, WTO’s newly elected Director-General

While Tai’s comments at the WTO forum were deemed “unfair” by the US Chamber of Commerce, the WTO’s new director-general, Ngozi Okonjo-Iweala, seemed to agree that the vaccine industry should more aggressively expand technology transfer in low- and middle-income countries – noting that in one case, technology transfer took only six months.

“One of the things that came out [of the discussions at the WTO] is that yes indeed, there is manufacturing capacity that exists now that can be turned around to produce more [vaccine],” she said.

However, she did acknowledge that scaling-up vaccine production will also require the training of more skilled personnel, recruitment of raw materials, and stable supply chains.

Going forward, “more active” matchmaking between companies with investment capacity and those with untapped production capacity could be fruitful to boost vaccine production in low-income countries, she added.

Discussions On Intellectual Property Waiver Have “Advanced Knowledge”

Okonjo-Iweala also said that the closed-door discussions had “advanced knowledge” about the issues surrounding the proposed waiver on WTO rules related to Trade Related Aspects of Intellectual Property (TRIPS).

Since it was proposed last year by South Africa and India, the intellectual property waiver has been backed by almost a half of WTO members and discussed eight times at the WTO. However, it seems to have remained in limbo, mostly due to fierce opposition by industry leaders and high-income WTO countries, including key European Union members, the United Kingdom,  United States, Switzerland, and Japan. 

Rather than a wholesale waiver, existing “flexibilities” in the TRIPS agreement could be used to fast-track solutions where needed, said the EU’s Executive Vice-President in a statement after Wednesday’s WTO meeting. 

“Should voluntary solutions fail, the TRIPS Agreement already provides a framework for sharing technology through the granting of compulsory licences,” said the EU’s Valdis Dombrovskis. “This includes fast-track compulsory licences for export to countries without manufacturing capacity.”

Civil Society Call To Revise TRIPS agreement; No Mention Of IP Waiver 

At the same time, civil society advocates joining the discussions seemed to be steering away from a focus on the IP waiver proposal, instead calling on the WTO to make a series of meaningful technical amendments in the existing TRIPS Agreement – as well as helping low- and middle-income countries to make more effective use of the exceptions contained in the rules.

Currently exceptions in the TRIPS agreement are difficult and cumbersome to implement, KEI’s James Love said. He called on WTO members to act on a seven point plan – some related to the easing of existing TRIPS legalities and others outside of its current scope, that he said would ramp up manufacturing capacity. Specifically, he called on WTO and its members for the following measures:

  1. Transparency of contracts: Encourage greater transparency of contracts made between by pharma and member states – in line with a recent International Monetary Fund proposal; also, he urged greater transparency from pharma and member states in reporting about drug and vaccine R&D costs, vaccine revenues and the number of doses distributed.
  2. Exports of products produced by compulsory licenses: Revise what he called a “flawed” Article 31f and 31bis of the TRIPS agreement, which allows generic producers to export products manufactured under a compulsory license to other low- and middle-income countries only under very restricted conditions; “during a pandemic, there should be no restrictions on the ability to export a useful product under a compulsory license,” added Love. 
  3. Model Exceptions. The WTO should collaborate with WHO on the development of model patent exceptions for emergencies, Love said, citing Germany and Canada as examples of countries that have already created such legal frameworks – which are often lacking elsewhere. 
  4. Sharing know-how. Love cited the “failure” of governments that invested heavily in vaccine R&D to include in their funding agreements “measures to require the sharing of manufacturing know-how and access to working cell lines and rights in data.” In the future, the WTO can work with the WHO to develop “initially soft norms” on how such know-how sharing provisions should be included in future R&D funding agreements.
  5. WTO Agreement on the Supply of Public Goods. “The pandemic is part of the larger challenge of supporting the global commons. The WTO has been asked to consider a new agreement, based in some ways on the GATS, to create voluntary offers of binding commitments to supply public goods.” 
  6. Buyouts of know-how. While not the best option last year when governments were funding R&D, today it should be given consideration, he said.
  7. Remove sanctions on Cuba, with respect to health related products. “There should be no sanctions on Cuba that relate to the development and distribution of its two promising vaccine candidates.”

“There has been an appalling lack of transparency, including regarding the agreements to subsidize and de-risk the research and development of vaccines, as well as procurement contracts and licensing agreements,” Love said.

“WTO agreement patent flexibilities have been used in some cases, but many countries have laws poorly equipped to deal with pandemics, vaccines or biologic products, and the provisions in the agreement on exports are flawed.”

“And while it is possible to issue a compulsory license on patented inventions, there are few national laws and no global agreements on providing access to manufacturing know-how, working cell lines and rights in test data.”

As a further step to support public acquisition of critical know-how, Love has suggested that governments create a buyout fund to allow for “full technology transfer”, including rights to inventions, data, know-how, and biologic resources – similar to the deals reached by private pharma companies such as AstraZeneca when it purchased Oxford’s vaccine technology and/or Pfizer’s acquisition of BioNtech. He has emphasized that governments may not need to buy out the know-how for all vaccines – and suggested that as little as $20 million in funding, with an aim of an initial $1 billion, could help kick off negotiations with manufacturers. 

Image Credits: @WTO/Bryan Lehmann.

africa cdc
Dr John Nkengasong warns delays in shipments could threaten achieving set vaccination goals in Africa


IBADAN – The Africa CDC has expressed concerns over the disruption of the COVID-19 vaccination drive in Africa saying it was preventing many Africans who have received the first dose of the Oxford/AstraZeneca vaccine may not be able to receive the second dose 12 weeks after the first dose as recommended in the vaccination guideline. 

Rwanda has already exhausted its doses, Ghana is administering its last 100,000 doses even as Nigeria is also racing to administer its remaining doses.

While it is not clearly known what the implications of delay in receiving the second dose will be, recipients of the first dose already have some form of immune protection against the virus,  Dr John Nkengasong, Director of the Africa CDC said  while addressing a Thursday morning press briefing.

“We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said.

At a WHO African region press briefing, Dr Richard Mihigo, Immunization and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, noted that African countries did the right thing by using the first shipments they received to immunise as many people as possible instead of halving the recipients in order to fully immunise some recipients.

Dr Richard Mihigo

“African countries, I must say, took the right decision with the limited supply to use most of their doses as the first dose with the expectation that the second dose will come quite soon,” he added. 

While admitting that there have been some challenges regarding the arrival of the second doses, the WHO said indications from COVAX Secretariat and other ongoing discussions pertaining to the AstraZeneca vaccine for which many African countries have applied a 12-week interval between dose one and dose two, suggest the additional shipments will be available soon.

“I think everything is being put in place to make sure that they can receive the second shipment on time to deliver the second dose of the AstraZeneca vaccine,” he added. 

Wakeup Call for Africa
Prof Oyewale Tomori

Oyewale Tomori, Professor of Virology at Nigeria’s Redeemer’s University, noted that the circumstances surrounding delays in receiving shipments for second doses of the vaccine is a wakeup call for Africa as a continent to be more proactive regarding its vaccine sources.

“We’ve been at the receiving end of global omission for too long. Now is an opportunity for us to plan for the future. We shouldn’t be in this position again,” he said. 

He enjoined African leaders to be more proactive, move the continent forward and stop its dependence on the rest of the world. 

“Our leaders must be proactive in getting this. We shouldn’t repeat this issue when we are at the mercy of  the rest of the world. We’ve been in this position for too long,” Tomori said.

South Africa, DRC to Resume COVID-19 Vaccinations
Dr Boitumelo Semete

There are meanwhile indications that COVID-19 immunizations with the Johnson & Johnson vaccine will soon resume in South Africa and begin in the Democratic Republic of Congo with the AstraZeneca vaccine – despite the concerns registered in the USA and Europe over rare occurrences of blood clots from those jabs. 

On 13 April, the Minister of Health of South Africa, the only African country that is rolling out the Johnson & Johnson COVID-19 vaccine, announced that the country has decided to pause rollout of the vaccine as a precautionary measure as review of the situation is ongoing.

But while addressing the WHO press briefing, Dr Boitumelo Semete, CEO of the South African Health Products Regulatory Authority, announced the country will soon resume J&J vaccinations.

“We anticipate the pause will be lifted in a couple of days to come,” Semete said.

Semete noted that the decision to pause the vaccine rollout was to enable the country to review available data considering only a few countries have rolled the vaccine. 

For DR Congo, Africa CDC announced the country is ready to nationally roll out the Oxford/AstraZeneca COVID-19 vaccine from 19 April.

“The Democratic Republic of Congo’s Minister of Interior announced yesterday that the country will finally launch the national COVID-19 vaccination campaign on 19 April, initially suspended due to concerns about adverse events related to the AstraZeneca vaccine,” Nkengasong said.

By 12 April 2021, over 34.6 million vaccine doses have been acquired by African countries with nearly 14 million doses administered so far. 

Morocco, Nigeria and Ghana are leading with 8.6 million, over 1 million and nearly 700,000 doses administered respectively. Moreover, 32 African countries have received consignment of COVID-19 vaccines from the COVAX facility, with 12 additional countries receiving allocation through the African Vaccine Acquisition Task Team (AVATT).

Image Credits: Paul Adepoju, Paul Adepoju .

Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects.

The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre.

Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday.   

“Denmark has had an ability to bring down cases to really controlled levels, has  widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. 

At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. 

But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. 

Denmark Is First Country To Permanently Halt AstraZeneca Use  

Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder.

Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna.

Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”.

“If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.”

A man receives his Covid-19 vaccine in Jutland, Denmark.

The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month.

Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. 

“Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering  to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta.

With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths.

Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine.

Denmark Urged to Share Leftover AstraZeneca Vaccines

WHO Regional Director Hans Kluge

Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used,  Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”.

Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible.

“For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19  quickly as possible.”

WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it.

Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious,  1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. 

To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some  13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered.

Green Passports Could Lead to Prioritisation of Vaccines for Travellers

Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine.

Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. 

“We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time.

Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport.

WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge.  Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May.

Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre  in Athens.  

He said the centre will serve the needs of countries of the south eastern part of the  region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety.

A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security.

Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT).

The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions.

The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa.

Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said.

Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said.

Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases.

Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio.

Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda

Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics.

South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent.

“Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said.

South African President Cyril Ramaphosa

Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent.
“We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added.

The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products.

“Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said.

President Paul Kagame of Rwanda

For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security.

In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040.

“We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said.

He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure.

He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers.

This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. 

The conflict about patents and medicines is long-standing.  But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst,  would seriously undermine the kinds of medical innovation so long supported by the US. 

Pro IP Waiver is Strong on Beliefs, Thin on Facts
Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the  new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines

The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the  new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing.  

Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable.  Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good.

The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. 

To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.”  Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers.

IP Supports an Innovation System That Puts the Risk of Failure with Innovators
patent
Those defending patents argue that it is has been the basis of pharmological innovation for over a century

The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts.

Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years.

Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion.  If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment.   Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion.  The odds are low for vaccines too.  Experience is no guarantee of success.  In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates.

The business model of big pharma depends on finding new successful medicines.  The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10  years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D.  

Academics, Generic Producers, All Need Strong IP to Thrive
Most of the medicines on the WHO Essential Medicines List are no longer patented

Fact; Most important medicines are no longer protected by patents.  Around 95% of the products on the WHO List of Essential Medicines, are no longer patented.  Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole.

Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market.  What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market.  But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government.

Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines.  It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich.   

Defenders Do Not Say That the System is Perfect 
Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits

The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits.  But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). 

COVID-19 has intensified the arguments between critics and defenders of the current IP system.  Much of the debate has been largely irrational, both about medicines and vaccines. 

It is largely a trumped-up cause.  There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production.  But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply.

Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines
The real challenge is manufacturing the vaccines, not the patents for them

Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe.   

And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. 

Patent System, Even in Extraordinary Circumstances, Stands the Test of Time

Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now?  Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow.

It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792:

“So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.”

The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”.  

___________________

Professor Sir Robin Jacob, University College London

The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List.  He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury.

 

Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions.

The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. 

Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. 

The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. 

B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update.  The variant is now the most common COVID-19 strain in the United States. 

In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020.

The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. 

Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection.

This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. 

Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “

Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 

58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain.  

“We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead.

Patents are not the main roadblock to producing enough coronavirus vaccines for the world – rather the challenge is technology transfer with manufacturers, said a top official at the Bill and Melinda Gates Foundation (BMGF) on Wednesday. 

His comments joined those of pharma voices in what seems to be a growing counter-trend to that of civil society advocates who say that intellectual property (IP) monopolies are blocking the rapid scale-up of manufacturing. 

Speaking at an event sponsored by the Geneva Graduate Institute’s Global Health Center, Chris Elias also said that the Foundation is presently working on a number of new tech transfer agreements to expand vaccine manufacturing in low- and middle-income countries – which have not yet been made public. 

“I don’t want to say patents are never the problem, but I think the bigger problem in vaccines is how do we get as many of these tech transfers so that we can get high quality, low cost vaccine at scale as soon as possible,” said Elias, President of the Foundation’s Global Development Division. 

“As we’ve been working with the vaccine companies, now, the challenge seems to be more about the tech transfer, the rapid scale-up, the capacity for producing vaccines,” he said at the webinar on “Public and private responsibilities in COVID-19”. 

“We are actually supporting a range of different tech transfer efforts,” said Elias. “We are working on other tech transfer agreements that are just not ready to be announced yet.”

The Foundation played an important role in mediating the successful licensing deal for the AstraZeneca vaccine with one of the world’s vaccine manufacturing powerhouses – India’s Serum Institute – which has enabled hundreds of millions of doses of the AstraZeneca vaccine to be produced for the world. 

“We were able [with] Gavi to move quickly with Serum Institute of India because it is such a large scale and well established partner of COVAX, but it’s not exclusive in any regard,” Elias noted. 

Gates Was Not Part Of Oxford-AstraZeneca Decision To Exclusively License Vaccine Technology

Chris Elias, President of the Foundation’s Global Development Division.

But Elias denied that Gates had played a role in Oxford University’s decision to exclusively license its vaccine technology to AstraZeneca, instead of sharing the vaccine recipe openly – a  decision that has come under intense fire from vaccine access advocates.

“We were not part of the individual licensing agreements, I’d have to defer to Oxford. We weren’t a part of those negotiations between them and AstraZeneca,” he said.

Rather, he said that the Gates Foundation tried to help Oxford University “align” with pharma  companies that could ensure its technology could be brought to scale.  

“No university is positioned to start making billions of doses of vaccine,” said Elias. “In my experience of 20 plus years, every case where a university has found a new innovation they have to have a partnership with pharma to get to scale.”

“There were a number of organizations including the Gates Foundation that had discussions with Oxford. And they discussed the importance of aligning with a multinational company in order to ensure that they could bring their innovation to scale and benefit humanity.”

Waiving Intellectual Property Is Not Way Forward, Says Elias

With regards to the proposed World Trade Organization waiver of IP rules under the WTO’s  Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, Elias expressed skepticism, noting that the Foundation “hasn’t been very involved” in those discussions.   

“It could be debated whether waiving TRIPS is going to get you there faster so I think we really want to focus on what can we do now to secure as much supply for the the advanced market commitment and COVAX for vaccines,” he said, referring to the WHO co-sponsored global vaccine facility. “I’m not aware that we’ve used our voice to try and influence people’s position on that [the WTO waiver].”

And although he acknowledged that mechanisms like the WHO’s proposed COVID-19 Technology Access Pool (C-TAP), to share intellectual property for COVID-19 health technologies, may be “useful” at some point, he argued that it is not needed at this moment. 

“It’s not correct to say that we’re not in favor of it [CTAP],” he said. “I think it’s a useful mechanism…If a patent proved to be the obstacle, C-TAP or some other mechanism could be part of the solution….In our experience, patents haven’t been so much the problem,” Elias  said. 

“The real issue is to “build more manufacturing capacity”, he said, “that’s a different kind of problem that’s not going to be solved by C-TAP, so we’re not opposed to C-TAP [but] it’s just not in our experience the solution we need at this moment.”

Beyond IP and even vaccine technology know-how, there are many other bottlenecks to expanding manufacturing capacity, like high-quality medical glass, which is currently in shortage, Elias stressed. 

WHO DG Asserts That IP Waiver Is Relevant  

Meanwhile, in a parallel forum underway Wednesday at the WTO, the WHO Director General Dr. Tedros Adhanom Ghebreyesus outlined a countervailing view that a proposed WTO waiver of COVID-related IP could expedite the sharing of know-how and technologies – stating that the WHO’s C-TAP IP pool may be immediately relevant.

The closed door WTO meeting brought together leading pharma manufacturers, banking officials and health ministers to discuss WTO Director General Ngozi Okonjo-Iweala’s proposed “Third Way” to expand access through more voluntary licensing to manufacturing companies in LMICs. 

“This is an unprecedented emergency that demands unprecedented measures,” Tedros said at the high-level forum, including representatives from Pfizer, Moderna and AstraZeneca, as well as the International Federation of Pharmaceutical Manufacturers (IFPMA) and the Developing Countries Vaccine Manufacturers Network.

“We must leave no stone unturned. We must explore every option for increasing production, including voluntary licenses, technology pools, the use of TRIPS flexibilities and the waiver of certain intellectual property provisions,” he said. 

Tedros also defended the COVID-19 Technology Access Pool (C-TAP), which has failed to generate interest from big pharma, even though it has been backed by 40 countries so far. 

“Like COVAX, it [C-TAP] holds enormous potential, but like COVAX, that potential has not been fulfilled,” he said. “WHO is also calling for expressions of interest to establish technology transfer hubs to assist countries acquire vaccine technology and know-how as rapidly as possible.”

“The current company-controlled production sharing agreements are not coming close to meeting the overwhelming public health and socio-economic needs for effective, affordable and equitable access to vaccines, as well as therapeutics and other critical health technologies.“

IFPMA Comments At WTO

Thomas Cueni, director general of the IFPMA

In an IFPMA statement at the WTO event, Director-General Thomas Cueni offered a pharma counterpoint that echoed the Gates official, saying: 

“We tend to forget the daunting task of scaling up manufacturing. Vaccine manufacturing is a complex biological process. Vaccine development is not granted for success. We have seen problems with scarcity of raw materials ingredients, and we have problems with export restrictions. 

“We are on track with this target of 10 billion doses, because industry is doing what society and all of you would have expected it to be doing, namely: engaged in unprecedented partnerships, in unprecedented technology transfers. I’ve counted 272 partnerships, which the industry has signed on COVID-19. More than 200 of them involving technology transfer.  I expect that we will see more also in terms of partnership, building capacity.  

“We are willing to sit down with our partners in COVAX to see what can be done in terms of supply chain visibility, in export restrictions to accelerate trade – WTO will play an important role there. We truly know that no one is safe until everyone is safe.”

Civil Society Calls on United States To Play A Bigger Leadership Role 

Meanwhile in Washington DC, some 66 health and development organisations called on US President Joe Biden to launch a global vaccine manufacturing program to end the pandemic.

The open letter, published by Public Citizen on Tuesday, called upon the United States to invest US$ 25 billion to establish in collaboration with the WHO hubs for vaccine production in Africa, Asia and Latin America; and to ensure open sharing of technology via WHO’s C-TAP access pool. 

The group called on President Biden to “announce and implement a global vaccine manufacturing program to end the pandemic and build a globally-distributed vaccine infrastructure for future pandemics.

“Much more ambitious U.S. leadership is needed to end the global pandemic,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines program. “The U.S. government should establish, urgently, a manufacturing operation for the world, that would share vaccine recipes and work with the World Health Organization to alleviate suffering and bring billions of additional vaccine doses to humanity.”

Image Credits: IFPMA .

It is “unacceptable” that millions of people diagnosed with diabetes do not have access to insulin because of financial hardship – 100 years after the lifesaving medication was discovered.

World Health Organization Director General Dr Tedros Adhanom Ghebreyesus was speaking at a Global Diabetes Summit that saw the launch of a new Global Diabetes Compact between governments, care providers, and patient advocates. 

The WHO DG said a key aim of the new compact, first announced last November on World Diabetes Day, is to improve access to comprehensive affordable and quality care, including insulin – as well as supporting diabetes prevention and other health sector measures to reduce the burden of diabetes-related illness and mortality. 

“Through this ambitious and much needed collaboration, we can prevent diabetes, save lives and move one step closer to the healthier, safer, fairer world,” said Dr Tedros, noting that diabetes is on the “rise globally and rising faster in low-income countries”.

“It is a failure of society and the global community that people who need insulin should encounter financial hardship to buy it or go without it and risk their life. This year has been a wake-up call. People living with diabetes are at an increased risk of severe illness and death from COVID-19, while diabetes care has been severely disrupted due to the pandemic. We must and can do better.” said Dr Tedros.

About 422 million people worldwide have diabetes, the majority living in low-and middle-income countries, and 1.6 million deaths are directly attributed to diabetes each year. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades

Launch of the Compact was led by a range of high- middle-  and lower-income countries, including Canada, Fiji, Norway, Singapore and Kenya.

More Needs to be Done to Protect and Save Lives

Canadian Health Minister Patty Hajdu

Patty Hajdu, Canadian Health Minister, said not enough was being done to deal with the diabetes pandemic and urged countries to share knowledge and foster international collaboration to help people with diabetes live longer and healthier lives. 

Her government is currently debating a bill in parliament  to provide a national framework to prevent diabetes and to support people living with the condition. The Canadian Institute for Health Research also continues to invest in ongoing research and innovation to break through barriers for people living with diabetes, and to understand the role that the social determinants of health play in both acquiring the illness and living and managing it. 

Canada has instituted measures that will directly and indirectly impact the incidence of diabetes, said Hadju. “Together we will make a difference. We will reduce the cases of diabetes and we will help people who are living with diabetes, live longer, healthier and save lives.”

The new Compact, said Ren Minghui, WHO Assistant Director-General, offers the world a second chance to change the course of diabetes management.

Current models of diabetes prevention and management have failed to provide equitable diabetes care to those in need, especially in poorer countries because of lack of reliable and affordable access to diabetes medicines, glucose testing and monitoring, he said adding: “We can and we must change this.”

Minghui said the COVID-19  pandemic is “shocking” reminder to protect people living with or at risk of diabetes. He urged the private sector to step up and provide “ immediate concrete solutions” to governments to help lower the price and improve the availability of diabetes medicine and essential technology.

Areas that needed urgent attention include access to diabetes diagnostic tools and medicines, particularly insulin, in low- and middle-income countries.

Global Diabetes Compact

Innovation is to be one of the core components of the Compact, with a focus on developing and evaluating low-cost technologies and digital solutions for diabetes care.

Minghui highlighted six imperatives of the Compact, including: 

  • Calling on everyone working in the field of diabetes to unite around inclusive and action-oriented narratives on diabetes prevention and treatment with ambitious yet realistic targets;
  •  Bringing together all the top tools and resources available for prevention and management of diabetes, both existing and new into one seamless package;
  • Accelerating prevention to help promote healthy living with a focus on reducing childhood obesity;
  • Working towards improving access to diabetes medicines and technologies in the poorest countries and humanitarian setting;
  • Ensuring that people living with diabetes have a seat at the decision making table and;
  • Aiming to close knowledge gaps and stimulate innovations related to technology.

Singapore’s Battle To Prevent and Treat ‘Invisible Disease’   

Speaking at the session, Prime Minister of Singapore Lee Hsien Loong said diabetes is an “invisible disease” and  major priority for his country with one in three Singaporeans expected to develop diabetes in their lifetime.

Singapore has launched a range of  programmes that seek to deal with the scourge of diabetes. These include grading and labeling of ready- to- drink beverages; banning advertising of beverages with high sugar and saturated fat content and promoting regular physical activity to maintain fitness and reduce obesity.

“We’ve built parks and fitness corners all over our island, and are happy to see them well used by joggers, cyclists and exercise groups, old and young. A national health screening program encourages Singaporeans to go for regular health checkups, in order to earlier detect the onset of disease, said Loon, adding that the island has optimised disease management, emphasizing prevention of complications for those living with diabetes.

“We’ve set up a Diabetes Center to bring together different specialists and allied health professionals. The center organizes care around the needs of diabetic patients and aims to raise standards of care, education, and research centers,” said Loong.

Kenya’s Recognizes Diabetes Dilemma 

Approximately 3% of the adult population in Africa is already living with diabetes.

A recent survey revealed that 18.3% of COVID-19 deaths in the African region were among people living with diabetes. Approximately 3% of the adult population in Africa is already living with diabetes. The prevalence is projected to rise to 4.4% by 2025, health experts say.

Kenyan President Uhuru Kenyatta said he is pleased that one of the key objectives of the Compact is to enhance the capacity of health systems in lower-income countries to detect, diagnose, and manage diabetes. 

“We are realigning diabetes and other non communicable diseases, service delivery to make it easier for our people to access, quality health care based on need – and not the ability to pay,” said Kenyatta.

Image Credits: The Canadian Press/Adrian Wyld.

COVID-19 cases in India have skyrocketed by 70% in the past week

India has greenlighted Russia’s Sputnik V vaccine for emergency use following a severe shortage of vaccines against the coronavirus and a massive spike in cases, and is now poised to become one of the world’s largest manufacturing hubs for the vaccine with 50 million doses produced by July. 

India’s aproval of a third COVID vaccine comes as the country recorded over 185,000 new cases of COVID-19 on Tuesday – which is almost double that at the height of the first wave seen last September – and represents a 70% increase in cases over just the past week. 

So far, India has administered 100 million vaccine doses to its population of 1.4 billion people. These include Covishield, the lstraZeneca-Oxford vaccine being manufactured locally by the Serum Institute, as well as the indigenous Covaxin, developed by India’s Council for Medical Research, and manufactured by Hyderabad-based Bharat Biotech.

Sputnik V, produced by Moscow’s Gamaleya Institute and marketed abroad by the Russian Direct Investment Fund (RDIF), is a two-dose adenovirus vaccine that has boasted an efficacy of 91.6% in clinical trials  – nearly on par with the highest-performing mRNA vaccines produced by Moderna and Pfizer/BioNTech. It is priced at only $10 per dose, which is only a third of the cost of its mRNA counterparts, and rather requiring ultra-deep freeze, can be stored in conventional refrigerators for months.

Sputnik V costs $10 per dose and can be stored in conventional refrigerators, making it ideal for low-income settings

India Plans To Produce 50 Million Doses of Sputnik By July

Through new partnerships and “working capital” investments with five vaccine manufacturers, India should have the capacity to produce over 50 million doses of Sputnik by July, announced the CEO of the RDIF on Tuesday.

“We have announced partnerships with five of the largest production companies in India,” said Kirill Dmitriev, noting that improved manufacturing capacity will help speed up India’s vaccination drive. “We will be announcing a few more.”

The new partnerships, sealed with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, and Virchow Biotech, will help India become the world’s “largest production hub” of Sputnik, said Dmitriev, who called it a “Russian-Indian” vaccine.

“We believe Russia and India will be the largest production hubs [of Sputnik V] in the world,” said Dmitriev. “We actually think of this [Sputnik-V] as Russian-Indian vaccine because lots of production will be done in India,” said Dmitriev at a virtual press conference.

In recent months, the RDIF has partnered with a dozen countries to manufacture Sputnik, including China, Kazakhstan and South Korea. In total, it aims to produce 850 million doses of the vaccine a year.

Meanwhile, as India begins to ramp up domestic production of Sputnik V, the country may see its first deliveries of the vaccine from other RDIF production centers abroad within the next three weeks, Dmitriev told India Today. 

Dmitriev also said that RDIF is in negotiations with the Indian government to set a differential price for Sputnik V for the private and public health sectors.

India Will Fast-Track Approval of Foreign Vaccines 

In another effort to expedite the country’s massive vaccination drive, the Indian government also announced that it will fast-track foreign vaccines that have been approved by “credible” regulatory authorities – such as the US Food and Drug Administration, the European Medicines Agency, or the WHO’s Emergency Use Listing.

India’s health secretary Rajesh Bhushan said this will speed up India’s vaccination drive by overcoming the need for local clinical trials, the so-called “bridging trials”, which serve to ensure that foreign vaccines cater to the Indian context. 

“The pre-condition of having bridging clinical trials for a foreign vaccine before emergency use authorisation has been done away with and has been replaced with a parallel bridging trial post-approval,” he said in a press release.

“This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use,” said the press release.

Image Credits: RDIF, WHO.

The USA can do better to protect emerging global health threats for hundreds of millions of Americans and for billions of people around the world.

The Joe Biden-Kamala Harris administration and its allies in Congress have already posted an impressive track record of early efforts to revive and champion U.S. leadership in global health. The American Rescue Plan, proposed by President Biden in January and passed in March, includes significant emergency funding to support the international COVID-19 response through initiatives like the Global Fund to Fight AIDS, Tuberculosis and Malaria; a multilateral vaccine development partnership; the President’s Emergency Plan for AIDS Relief; and global health programs at the US Agency for International Development (USAID). 

America’s shift to tackle COVID-19 beyond our borders cannot happen fast enough. 

Every day, this depressingly unyielding pandemic serves up reminders of not only the power of biomedical research and development (R&D) to deliver amazing innovations—several vaccines developed and deployed in just over a year—but also of the shocking disparities in gaining access to them. Low- and middle-income countries, despite being home to 85% of the global adult population, account for only 49% of COVID-19 vaccine doses administered worldwide.

With awareness of the importance of global health R&D at an all-time high—and global health champions now aligning to pull levers of power at both ends of Pennsylvania Avenue—policymakers have an opportunity to provide investments and reforms that can help us emerge from the pandemic primed to conquer a number of stubborn global health foes. Seizing this moment will involve building on the successes of the last year and learning from the failures.

As Congress and the administration get to work on the FY2022 federal budget, here are six things they can do to provide much better protection from enduring and emerging global health threats for hundreds of millions of Americans and for billions of people around the world.

US Aid need to increase its funding for Research and Development.

1. Double Funding for Global Health Programs at USAID. From these increases, USAID should set minimum funding targets for the agency’s R&D work, establish a new chief science and product development officer position and create a $200 million USAID Grand Challenge for health security. USAID is the only U.S. agency with a mandate to focus on global health and development. Yet despite its track record of delivering high-impact health innovations, funding for global health R&D has waned in recent years and the agency’s unique capabilities have been underutilized and underfunded as part of the US government’s COVID-19 response. The American Rescue Plan includes funding that recognises USAID’s importance in combating COVID-19 and advancing global health. We need to build on this progress.

2. Increase Support for the Centre for Disease Control and Prevention – especially for its Centre for Global Health, the National Centre for Emerging and Zoonotic Infectious Diseases, and the Division of Tuberculosis Elimination and its Tuberculosis Trial Consortium. These programs have been operating on tight and relatively stagnant budgets even before COVID-19 diverted critical resources and expertise.

3. Provide Targeted Funding for Product Development and Translational Research Lacking Commercial Interest.

There is also a need for steady funding increases at the Fogarty International Center and sustained growth for the National Institute of Allergy and Infectious Diseases and the Office of AIDS Research. The National Institutes of Health’s high-profile work in confronting COVID-19 has highlighted the importance of past investments. But the pandemic also drained dollars and diverted talent from non-COVID priorities.

4. Establish a Permanent Funding Line at the Biomedical Advanced Research and Development Authority (BARDA) of at least $300 million annually to support work on emerging infectious diseases—a category of which COVID-19 is a high-profile, but not singular, example. Despite its proven value in dealing with a range of threats, BARDA has been overly reliant on “one-off” emergency supplemental appropriations for threats like Ebola and Zika, leading to dangerous gaps in its portfolio when limited funding runs dry. BARDA should also expand its research on antimicrobial resistance (AMR) to include drug-resistant tuberculosis (TB), which is a major health security threat to the United States. 

5. Protect Department of Defence Programs Focused on Malaria and Other Parasitic Diseases, TB and AMR. There have been internal proposals to potentially eliminate DoD’s malaria research programs, which would scuttle decades of progress achieved via research at the Walter Reed Army Institute of Research and the Naval Medical Research Center—despite malaria remaining a leading threat to U.S. troops deployed abroad. DoD’s efforts to develop new treatments for drug-resistant pathogens, which include dangerous strains of TB, are also essential to achieving global health security.

6. Increasing Support for Key Multilateral Initiatives, like the Coalition for Epidemic Preparedness Innovations (CEPI). Formalizing U.S. support for CEPI and committing at least $200 million annually would provide a much-needed boost to an initiative dedicated to developing vaccines against epidemic threats and making them globally accessible—but first, the U.S. should provide CEPI with $300 million of the global health funding just passed in the American Rescue Plan to boost its work on COVID-19. Also, Congress can support efforts at the Food and Drug Administration to provide technical support to under-resourced regulatory authorities around the world, which could accelerate access to a range of biomedical advances.

Together, these six recommendations can form the core of a broader effort to supercharge America’s global health R&D capabilities. Whether the motivation is to protect Americans from threats that have no respect for geography, to advance health equity around the world, or somewhere in between, the United States must take decisive action to resume its leadership in global health R&D.

Jamie Bay Nishi

Jamie Bay Nishi is director of the Global Health Technologies Coalition (GHTC), a coalition of more than 30 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics and other tools that bring healthy lives within reach for all people. For more information, read GHTC’s agency-by-agency blueprint for supercharging global health R&D: Meeting the moment, fueling the future: Policy recommendations for a new era of US leadership in global health R&D

 

Image Credits: Global Health Technologies Coalition.