Pharma and its critics agree government has a big role to play in ensuring fair access to Covid-19 remedies
As the EU launched efforts this week to raise €7.5bn from donors to accelerate access to coronavirus medicines worldwide, concerns remain that billions of the world’s poorest people will be left behind. Much effort from industry and political leaders alike has focused on funding the development of vaccines, diagnostics and drugs to prevent, test and treat Covid-19. Far less attention has been paid to how to scale up production, and how scarce supplies will be allocated.
In late April, international leaders gathered online to support the launch of the World Health Organization’s “accelerator” for “equitable global access to innovative tools for COVID-19 for all”. “We need to develop a vaccine, we need to produce it and to deploy it in every single corner of the world, and make it available at affordable prices,” said European Commission president Ursula von der Leyen, who was involved in launching this week’s fundraising meeting. Ursula von der Leyen, president of the European Commission. The EU is aiming to raise €7.5bn from international donors to assist the fight against coronavirus
Big Pharma steps up Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers and Associations, says coronavirus is a pivotal moment for his members. He argues that the sector is rising to the challenge with initiatives to develop the tools required and make them available affordably through unprecedented co-operation, donations and pledges on prices. “Everybody feels this is the moment when the industry needs to do the right thing,” he says. “It holds the keys to ending Covid-19. This is 1919 and 1929 combined: the Spanish flu with the Great Depression. I’m extremely pleased to see industry reacting as society would hope, without being coerced or forced.” Daniel O’Day, chief executive of Gilead, which has been donating supplies of remdesivir as a treatment that can accelerate recovery from the disease, concurs. “We understand the responsibility we have,” he says. “We are committed to making [remdesivir] accessible and affordable to patients around the world.” AstraZeneca has committed to supplying vaccines at cost. Bayer, Roche and other companies exploring the use of new medicines or “repurposed” existing ones to treat coronavirus have pledged “differential pricing” based on measures of countries’ ability to pay. As yet, none has revealed detailed figures.
Seth Berkley, Gavi’s chief executive, says: “In developing countries, we need some type of global access agreement. That will be very important, but tough in this political environment.” If the Global Fund and Gavi are able to help some of the poorest nations cope with coronavirus, the biggest gap may be for middle-income countries with substantial inequality, such as India……….. As Severin Schwan, chief executive of Roche, says: “We need to make distribution driven by objective criteria. Governments can really play a role.”
U.S. Representative Lloyd Doggett (D-TX), Chair of the House Ways and Means Health Subcommittee, and Rep. Rosa DeLauro (D-CT), Chair of the Labor, Health and Human Services, and Education Appropriations Subcommittee, urge Secretary Azar to release information about the extent of taxpayer investment in Remdesivir, government ownership of any Remdesivir patents, and any federal efforts to scale-up production.
Specifically the letter asks for information relating to:
1. Grants to academic institutions who conducted research on remdesivir, including the names, dates, and amounts of funding.
2. Research and development conducted directly by the NIH and other federal agencies, including the names, dates, and amounts of funding.
3. Clinical trials conducted by the federal government or that have received federal financial assistance, including the names, dates, and amounts of funding.
4. A list of patents and patent applications, with their numbers, that the federal government owns or has licensed for remdesivir. For any patents or patent applications that have been licensed, please provide to whom, the dates, and the terms of the license.
5. Any federal expenditures to retrofit or build new Gilead facilities to scale-up production capacity of remdesivir, including the amounts, dates, and specific uses of those funds.
Pharmaceutical company Roche announced Friday afternoon that it will release the recipe for its lysis buffer if Dutch laboratories ask for it. Earlier today Follow the Money revealed that the European Commission was exploring options for an intervention in pharmaceutical company Roche, instigated by the possible abuse by Roche of its position of power on the coronavirus test market. Below you find the article that prompted Roche to release its recipe.
Pharmaceutical company Roche has come under severe criticism due to the limited capability for coronavirus testing in the Netherlands. The majority of laboratories in the Netherlands depends on Roche test kits and machines, while the company is only able to supply 30 per cent of the outstanding orders. According to the Dutch National Institute for Public Health and the Environment (Rijksinstituut voor Volksgezondheid en Milieu – RIVM), the company has also refused to release the recipe for a solution – so-called lysis buffer – which is needed for the tests. An investigation by Follow the Money (FTM), which was published yesterday, revealed that Roche is withholding this recipe. With the recipe, labs would be able to quickly make their own solution and ramp up their testing capability.
Sparing use of testing capability
It is noteworthy that earlier this week Roche called on governments and health organisations to make sparing use of their testing capability. This is the only way to ensure the adequate supply of sufficient testing materials, according to the Swiss company. This appeal goes against the recommendations of the World Health Organization (WHO), which last week urged governments to test as widely as possible. It is the only way to curb the spread of the disease, according to the WHO.
‘Every man for itself’-mindset
A spokesperson of the Ministry of Health, Welfare and Sport revealed that the ministry and Roche will convene Friday afternoon to discuss the supply of testing materials. We have yet to receive a response to our question which steps Minister Hugo de Jonge is willing to take to ease the testing shortages.
Last week, the European competition authorities issued a joint statement in which they said to keep a sharp eye on companies that abuse their position of power. ‘It is of utmost importance to ensure that products considered essential to protect the health of consumers in the current situation remain available at competitive prices. The European competition authorities will therefore not hesitate to take action against companies taking advantage of the current situation.’
Global pandemics like Covid-19 require a coordinated global response. And yet what the world is witnessing is quite the opposite. The pandemic has provided new fuel to the US-China squabble, with the two sides engaged in endless mutual recrimination. President Donlad Trump’s reported attempt to secure exclusive rights to German biopharma major CureVac’s vaccine reflects a continuing preoccupation with his ‘America First’ approach. China’s authoritarian model and lack of transparency in handling the crisis have dented its global leadership credentials.
There are three dimensions of the concerted global action required: the free movement of medical supplies and services around the world; the development of necessary medical interventions involving diagnostics, drugs and vaccines; and their mass production and distribution around the world at affordable prices.
The pandemic has revealed that even the richest countries with sophisticated health systems are not immune to its depredations. As infection rates peak in the West in the coming weeks, the focus will shift to the much larger challenges faced by the poorer countries. The virus cannot be defeated unless it is defeated in all countries.
Given its large, vulnerable population, India has a huge stake in a unified global response to the crisis. It is also in a unique position to contribute to such an initiative. Its substantial R&D capabilities, large pool of skilled health workers and established role as the “pharmacy of the world” are acknowledged around the world. Indian leadership at this critical juncture will not only help in addressing the needs of its own population, but will also provide succour for the poor around the world.
South Centre Policy Brief by Dr. Dr. German Velasquez on Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock
The unprecedented global health crisis caused by the coronavirus COVID-19 pandemic, during the first quarter of 2020, brings back with particular urgency the discussion about the research and development (R&D) model for pharmaceuticals and other health technologies.
The COVID-19 crisis shows that there is an urgent need to re-design the global public health governance for health R&D. The adoption of a binding instrument ‘as allowed by Article 19 of the WHO Constitution’ on this matter was proposed many years ago. This brief argues that it is time to revive and materialize this initiative.
Big Pharma notched a regrettable victory in the early days of the COVID-19 response when it successfully blocked an enforceable reasonable-pricing clause from inclusion in the first $8.3 billion emergency spending bill. Although the bill contains a provision requiring “fair and reasonable pricing” for federal acquisitions and another authorizing the Secretary of Health and Human Services to take steps to ensure that coronavirus vaccine, treatments, and tests “will be affordable in the domestic market,” those provisions lack any meaningful enforcement mechanism. Moreover, drug companies inserted text that prevents the government from using lack of affordability as a reason to delay development of a medicine. As reported in Politico on March 5,
Industry lobbyists successfully blocked attempts this week to include language in the $8.3 billion emergency coronavirus spending bill that would have threatened intellectual property rights for any vaccines and treatments the government decides are priced unfairly. … The pharmaceutical industry not only killed the intellectual property provision in the coronavirus package, but it got language added into the bill that prevents the government from delaying a medicine’s development over concerns about its affordability.
Despite the legislation promising industry $3.1 billion to promote coronavirus research and development and to expand manufacturing capacity and another $300 million to pay for federal procurement, drug companies wanted the right to price gouge without restraint — and they got it.
What a difference two weeks have made.
Since then, Big Pharma and big medical technology companies have suffered one defeat after another as activists and progressive politicians have publicly challenged companies for their monopolistic behaviors. Most of these victories, outlined in Box 1 below, occurred in a matter of days—not weeks, months, or years. The most important lesson to learn from this wave of lock-step capitulation is that pharmaceutical and medical device companies are in a defensive rout, and thus that this is a precipitous time for even bolder campaigns to ensure widespread and affordable access to new COVID-19 technologies worldwide.
Box 1 – Companies Forced to Relinquish Exclusive Rights
A compulsory license issued by Israel compelled AbbVie to announce it would not assert any of its patents on lopinavir/ritonavir globally for any use or formulation (pediatric or adult), including potential approved use to treat COVID-19.
In a similar step, Mylan waived its exclusive right in the U.S. to sell and distribute generic lopinavir/ritonavir.
Gilead relinquished its orphan drug designation on remdesivir once activists and several members of Congress expressed outrage about Gilead having gamed the orphan drug legislation to gain 7-years of total market exclusivity, expedited and reduced-fee registration, and extra R&D tax credits on a medicine that might prove effective for millions, not the < 200,000 patients that the legislation was designed for.
Under pressure, Roche backpedaled and agreed to provide supplies of analysis buffer and its secret recipe for coronavirus testing to other Dutch laboratories.
Having reaped a well-earned reputation for price gouging over the past several years both for extortionate launch prices and double-digit annual increases, multinational pharmaceutical companies are especially vulnerable to charges that their aggressive assertion of intellectual property rights will prevent tests, medicines, and vaccines from reaching front-line health workers and the millions of people who might ultimately be infected with COVID-19.
However, Big Pharma will not stand by passively. Already, industry apologists are arguing that any constraints on pricing or intellectual property rights will kill incentive to invest in risky coronavirus research. (If this is true, it shows just how morally bankrupt this industry is in the face of the greater threat to public health in a century.) But, just as some industry spokespeople are spouting the same stale line about research incentives, other industry actors are seeing COVID-19 as an opportunity to burnish the industry’s sagging reputation. With great fanfare, fourteen of the largest drug companies, the Bill & Melinda Gates Foundation, and Wellcome Trust announced a collaborative consortium to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19. Although the only concrete action thus far appears to be the sharing of chemical libraries, we can expect a fair amount of positive publicity about industry’s openness to shared science and equitable access to new technologies. Industry will also tout the positive access moves described above in Box 1 as self-guided decisions made in the public interest.
Although we are unlikely to see any industry statements of support for compulsory licensing, there has also been a flurry of compulsory licensing activity in the past two weeks (see Box 2), and even the pro-business Financial Times has editorialized in favor of using compulsory licenses if needed to access COVID-19 products: “Another vital trade policy issue will arise in the near future: the licensing of drugs and vaccines effective against the virus. The world has an overwhelming interest in ensuring these will be universally and cheaply available. Fortunately, trade rules allow compulsory licensing. If necessary, it must be used.”
Box 2 – Compulsory Licenses
Israel issued a compulsory license when AbbVie could not supply adequate quantities of lopinavir/ritonavir, an existing antiretroviral being tested to treat COVID-19.
Chile and Ecuador have taken preliminary parliamentary steps to allow compulsory licenses on COVID-19 medicines and medical technologies.
Canada and Germany have amended national legislation to make it easier to issue government use licenses for COVID-19 medicines and medical technologies without having to first negotiate for voluntary licenses with patent holders.
The Spanish government has temporarily nationalized its health care industry and national health supply chain to ensure access to COVID-19 technologies and has further given the government power to take over pharmaceutical manufacturing facilities to make essential medicines.
There is also widespread support for a proposal by Costa Rica that the WHO coordinate the establishment and operation of a COVID-19 technology pool. This Pool would amass the broadest possible array of COVID-19 relevant intellectual property rights and data rights both to promote efficient, open-science research for new vaccines, medicines, diagnostics, and devices and to ensure universal, equitable access to such products across the globe. This campaign has echoes in the European Union, where 30 European Parliamentarians and 61 civil society groups petitioned to European Commission to guarantee open licensing for COVID-19 products financed through EU grants. Likewise, there are campaigns to lower the price of new COVID-19 testing cartridges sold by Cepheid from $20/cartridge to $5/cartridge and for Gilead to renounce all of its patent and data exclusivity rights on remdesivir globally.
Big Pharma is running scared, but we have to make them run faster. The only way to do this is to accelerate our demands against individual companies, for the COVID-19 Technology Pool, and for adoption and use of compulsory licensing measures at the same time that we point out the need for even more fundamental changes to how the world treats essential medical supplies. We now see that leaving the innovation and supply of priority medicines and medical technologies to monopoly-based industry is the path to viral perdition. Instead of treating vital vaccines, medicines, diagnostics, and medical devices like the global public goods that they are, governments and industry treat them like ordinary commercial goods – like the latest skateboard.
Government-granted monopolies to biopharmaceutical and medical devices companies are the most irresponsible barriers to erect in the middle of a global pandemic threatening millions of lives. These intellectual property monopolies not only impede open science needed to accelerate discovery of new medical technologies and therapies, but they also limit production to single suppliers that can in no sense meet urgent global demand, that might price gouge, and that will prioritize supply to rich and powerful countries. In the short run, we urgently need to pool IP rights on COVID-19-related medical technologies to allow mobilization of our best scientific efforts and to use all available global manufacturing capacity to speed newly approved medical responses across the globe. In the long run, we need a system that prioritizes research on neglected and emergent threats and that guarantees affordable access for all.
In light of the evolving coronavirus (COVID-19) pandemic, the governments are taking unprecedented infection prevention and control measures. One of the most important areas of work is providing people affected by COVID-19 with medical therapy, diagnostics devices and medical equipment.
Medicines the effectiveness of which in treating COVID-19 is proved by properly conducted clinical trials have not yet been registered in the global market. However, in the clinical practice all over the world several medicines that may potentially demonstrate the effectiveness in the COVID-19 treatment are being tested within the framework of studies and programs for early access to unregistered medicines. Some of them are under patent protection until 2031. According to expert estimates, the medicines for experimental therapy of COVID-19 may be profitably manufactured at prices ranging from $0.3 to $31 per treatment course.
Given the magnitude of the epidemic and serious consequences for the public health, the governments, among other measures, are considering measures limiting patent rights in the healthcare industry. Similar initiatives have already been taken in Brazil, Canada, Israel, Chile, and Ecuador. Recently, the mass media has reported that the German government is considering the possibility of amending the legislation to grant additional powers to the Ministry of Health regarding the use of medical patents, and these amendments have been approved by the Federal Council of Germany (Bundesrat).
All over the world, sufficient experience has already been gained in using medical inventions for the public health in accordance with the Agreement on Trade-Related Aspects of Intellectual Property Rights (1995), and the current epidemiological situation regarding COVID-19, unfortunately, again may require the adoption of such decisions.
In view of the foregoing, we request the Governments of EECA:
To assess the current legislation in the field of intellectual property and circulation of medicines for opportunities to use the inventions for the benefit of the public health and national security by the government and its authorized agencies;
If necessary, as soon as possible, to make amendments providing the government and/or its authorized agencies (including Ministries of Health) with the right to decide on the use of inventions for the benefit of the public health without the consent of the patent holder with adequate remuneration and/or, when applicable, expanding and clarifying this right, including providing for the possibility of non-use of the data exclusivity regime with regard to the registration dossier.
These measures will help to solve in more prompt manner the problems associated with the provision of medicines to patients with COVID-19, as well as other patients in the COVID-19 epidemic in the event of a threat of disruption in supplies of medicines. In addition, in the long run, these measures will expand the opportunities for improving access to medicines, diagnostic devices and equipment for treating other diseases, including HIV infection, viral hepatitis, tuberculosis and cancer.
List of organizations:
Association Partnership Network (Partnerskaya Set), Kyrgyz Republic
Belarusian Public Association Positive Movement (Positivnoe Dvizhenie)
Charitable Organization All-Ukrainian Network of People Living with HIV (100% Life)
Charitable Foundation Source of Hope (Istochnik Nadezhdy), Chelyabinsk, Russia
Charitable Foundation for Assistance to People Affected by HIV and Other Socially Significant Diseases Vector of Life (Vektor Zhizny), Russia
Charitable Organization Svitanok Club, Ukraine
All-Ukrainian Association of People with Drug Addiction WAVE (VOLNA)
Patient Control Movement, Russia
Eurasian Women`s Network on AIDS (EWNA)
Eurasian Coalition on Health, Rights, Gender and Sexual Diversity (ECOM)
Community Initiative Group PULS, Moldova
Non-Profit Public Organization Eurasian Harm Reduction Association (EHRA)
Non-Profit Partnership PharmActa. Quality and Standards
Public Association Support for People Living with HIV “Kuat”, Kazakhstan
Public Organization Initiativa Pozitiva, Moldova
Public Foundation AGEP’C (ANTIHEPATIT S), Republic of Kazakhstan
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