How many epidemics should the world experience before decision makers realise that public health needs should dictate the research and development agenda and the price of resulting products? Despite public spending on medical research, price of medicines is still controlled by the monopoly of the companies that hold Intellectual Property Rights (IPR) on the product.
Since 2000, the world has seen waves of outbreaks and epidemics, bird flu, swine fever and SARS. That was when corona viruses started to be taken seriously. After the SARS crisis, the US National Institute of Health (NIH) spent approximately $700 million on corona research. However, the virus subsided and so funding decreased, and it became difficult for researchers to get grants to start or continue their research. Pharmaceutical companies did not find profit in a virus that did not cause long term health problems, so they deprioritised R&D on corona viruses.
MERS followed and despite its high mortality rate, it faded quickly and so did the interest in researching tests and remedies to prevent and treat it.
In 2014 the world was shocked again by a different virus: Ebola. This virus had previously been seen in few African countries and so funding for research was limited. Ebola virus claimed 11000 lives and was transmitted to some people from the US and Europe, attracting the attention of the Western media. Governments looked for vaccines or medicines for the disease but, unsurprisingly, found none. Again, interest in R&D increased and pharmaceutical companies searched their shelves to find potential molecules in order to develop vaccines and medicines. Now there is a vaccine being used in the current outbreak in Democratic Republic of Congo. A medicine was promising but failed to work in the outbreak.
Civil society raised concerns about the failure of the current global R&D system, which relies on monopoly, through intellectual property rights, to provide health products for epidemics. However, the world continued to rely on the intellectual property (IP) system that failed time and again at critical times.
We are now in the midst of the COVID-19 pandemic, a disease without vaccines or medicines. The response of most countries has been very sluggish at the beginning, with little evidence of preparedness for such a scenario, giving the virus ample opportunity to spread but consistently through communities. Yet some countries such as South Korea, Singapore and Germany immediately put into practice serious measures to contain the virus and decrease the death rates.
Medicines and vaccines for COVID 19
What has been impressive during this current pandemic is how scientists across many labs and research institutes have been working in partnership and sharing their discoveries, a real shift from the usual competitive approach. Public funding followed. For example, the UK committed £250 million to fund vaccine development.
Knowing that research for new molecules takes a long time, scientists have turned to already existing medicines that have antiviral properties and thus could work against the virus. Several medicines are under investigations, including anti-malaria, anti- HIV, anti- river blindness, anti- influenza, failed Ebola medicine and more. There are also around 76 vaccines being investigated.
While the world is eagerly following news about potential medicines and vaccines, there are fundamental questions that require urgent attention in order to guarantee that any medicines or vaccines are made available and affordable for all that need them all over the world. There are 3 main issues that need addressing: 1) how to set the price to make the medicines affordable to all; 2) how to make enough quantities for all and 3) how to distribute the products fairly between and within countries.
Some of the medicines that are currently being investigated have patents in some countries and not others. The patent rights have already expired on some medicines and therefore they are already being manufactured by generic companies. Pharmaceutical companies usually hold a monopoly on products secured by intellectual property rights and therefore can control the price. This monopoly has been damaging to people all over the world because prices have been too high to afford, even in wealthy countries. Europe woke up to the problem of unaffordable high prices after countries had to ration treatment of Hepatitis C as the price of the first antiviral medicines (sofosbuvir) was around $ 84,000/treatment course.
Given the scale of COVID-19, some countries have already decided to implement legal tools under the WTO Trade Related Aspects on Intellectual Property Rights (TRIPS) agreement. For example, Israel has already issued compulsory licensing on lopinavir/ritonavir while Chile, Ecuador, Canada and Germany amended their laws to approve compulsory licensing on medicines that prove effective. More countries could follow. In April, Costa Rica proposed establishing a voluntary mechanism under the auspices of the WHO to pull all intellectual property rights and other information related to diagnostics, medicines and vaccines together in order to make the products affordable to all countries. The EU ministers drafted a resolution for the World Health Assembly (WHA) to request the Director General of the WHO” to facilitate the equitable and affordable access of people to them, including through voluntarily pooling their intellectual property for all COVID-19-related medical interventions” . The proposal can help the world to avoid monopolized prices while allowing several companies to produce the same health product and therefore increasing the volume of production to serve all who need it.
Public pressure and governments’ actions obliged pharmaceutical companies to change their behaviour. For example, AbbVie gave up its intellectual property rights for Kaletra after Israel issued compulsory licensing. Roche agreed to share the method of its testing liquid with the Netherlands after it was accused it of rationing supply and significantly decreasing national testing capabilities. Gilead retracted from having “orphan status” on Remdesivir after public pressure accused the company of profiteering from the pandemic. The orphan status would have given Gilead benefits such as tax breaks and grants as well as 7 years exclusive monopoly on the medicine.
The scale of the pandemic prompted some enlightened investors issued a call to pharmaceutical companies that “right now financial considerations should take second place in the global challenge of getting the coronavirus under control as quickly as possible.collaborate and share relevant data in a timely manner with governments, the health sector, academia and your peers”. Such call can add incentive to avoid profiteering from the pandemic and instead pull all efforts to ensure access for all.
Making products affordable and available for all
The current actions by governments and international agencies illustrate options available to ensure affordable price through:
1. Automatic licensing for all health products relevant to COVID19. This will be more effective, practical and sustainable solution to ensure producing affordable products of adequate volume. This is better than compulsory licensing, which depends on individual countries’ action to secure medicine to their populations.
2. Pooled Intellectual Property Rights: As in the Costa Rican proposal for a Pooled IPRs. It will allow pooling from all companies and the MPP can negotiate the license details. The EU minsters drafted a resolution for the World Health Assembly to “facilitate the equitable and affordable access of people to them, including through voluntarily pooling their intellectual property for all COVID-19-related medical interventions.” The proposal has been supported by the ED of the WHO and several academics and NGOs. However, the proposal needs to be strengthened through:
Strengthening the resolution by making the pool obligatory, not only to secure affordability of products but also to enable several companies to produce the required volume of the health products so that there is enough supply given that no single company can produce for the whole world.
Calling on countries to use the flexibilities enshrined in the TRIPS agreement to ensure access to affordable health products relevant to COVID-19.
Requesting member states to support the WHO to enable its full functionality through political and financial means.
Calling on donors to support developing countries to purchase health products relevant to COVID-19, including protective equipment for health and care workers, tests and the forthcoming medicines and vaccines.
Calling on the WHO to work with member states to ensure fair distribution of health products between and within countries, so that all populations get the products needed.
4. All countries must increase public funding for medical research. Products that have public funding and old products should not be granted patents for new use for COVID-19.
5. The WHO should be supported to lead, in collaboration with other relevant multilateral agencies, to ensure fair distribution of health products between and within countries so that distribution depends on need not ability to pay or influence.
It is time that the world leaders re-think the global system of biomedical research and consider other ways to stimulate research, by delinking financing R&D from the price of resulting products. Pricing should not be left in the hands of pharmaceutical companies whose main driver is not public health, but profit. Instead, all governments should invest in funding research and thus have a greater say in deciding the research agenda and the price of health products.
https://www.gov.uk/government/news/pm-announces-record-funding-to-find-a-coronavirus-vaccine https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus-landscape-ncov.pdf World Trade Organisation https://www.keionline.org/32503 https://www.statnews.com/wp-content/uploads/2020/04/EU-Proposal-for-a-WHA73-Resolution-on-the-COVID-19-Response.pdf
 An antiretroviral medicine used for treatment of HIV. https://pharmaphorum.com/news/abbvie-wont-enforce-patents-for-covid-19-drug-candidate-kaletra/ https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-request-to-rescind-remdesivir-orphan-drug-designation https://news.achmea.nl/asset-managers-pension-funds-and-insurers-call-for-international--co-operation-within-the-pharmaceutical-industry-to-combat-coronavirus/ https://www.statnews.com/wp-content/uploads/2020/04/EU-Proposal-for-a-WHA73-Resolution-on-the-COVID-19-Response.pdf https://www.spotlightnsp.co.za/2020/04/20/covid-19-the-time-for-procrastination-over-patents-is-over/