Bitter pill

In September 2021, the World Health Organisation’s Dr Michael Ryan, Chief Executive Director of the WHO Health Emergencies Programme, remarked that the COVID-19 virus is “here to stay with us” and will likely evolve, as have previous pandemic viruses, to be one of the many viruses that affect people’s health from year to year. Similarly, in a poll of 119 immunologists, infectious-disease researchers and virologists from 23 countries, 89 per cent responded that SARS-CoV-2, the virus that causes COVID-19, is likely or very likely to become endemic in populations across the globe.

Vaccination is a critical public health intervention that can help slow down the pandemic, protect people from serious illness and death, and relieve the burden on health systems across the globe. However, an inadequate global response and the inability of global leaders to ensure equitable access to vaccines has left many people at risk, including health workers, especially in poorer countries across the global south. Although rates of people fully vaccinated in high-income country are reaching and passing 80 per cent, only 2.3 per cent of people in low-income countries have received at least one dose, leaving hundreds of millions of people vulnerable to the severe and long-term complications of COVID-19.

Such a disparate and inequitable outcome has been due to a small number of pharmaceutical corporations retaining control over pricing and production of vaccines. Pharmaceutical corporations have a monopoly ownership of the intellectual property (the patents and the know-how) necessary to produce medicines. With that ownership comes the power to determine production, availability from country to country, and pricing. Pfizer, BioNTech, and Moderna are earning combined profits of over $1,000 (€880) every second by selling their COVID-19 vaccines to rich countries, according to new analysis, while the rest of the world still waits for vaccine access. During this pandemic, governments have acquiesced to the demands of pharmaceutical corporations, choosing to protect corporate intellectual property rights and profits instead of pursuing policies and actions that would increase access to these vaccines across the globe.

The COVID-19 crisis has demonstrated the true priorities of many governments as the call to solidarity through global sharing mechanisms or through ending intellectual property monopolies has been met with vaccine nationalism and corporate gamesmanship. The same challenges we’ve seen with vaccines, including affordability, production capacity, lack of transparency, unwillingness of pharmaceutical companies to share intellectual property, and government failure to enact laws and regulations that put people first, are set to be repeated with therapeutics.*

The growing need for therapeutics and the EU’s strategy

As vaccines remain inaccessible to many around the world, the need for therapeutics, and greater access to them, becomes ever more important. Vaccines work to prevent serious illness or death for someone who is exposed to the virus. Therapeutics are needed when people do not have the protection that vaccines offer or if they are already at high-risk of severe infection. Once a person who has not been vaccinated is exposed or tests positive for COVID-19, therapeutics should be administered as soon as possible in order to prevent hospitalisation and death.

Since the beginning of the pandemic scientists have investigated potential therapeutics for COVID-19. These have included the repurposing of existing medicines already in use for other illnesses, such as with Roche’s tocilizumab which is also used to treat many conditions including rheumatoid arthritis. Research is also being done to develop new medicines, results of which we’ve seen in the drugs from Merck and Pfizer, both of which promise to reduce hospitalisation or death in high-risk people infected with COVID-19. Finally, many clinical trials are being initiated as more medicines are found to have potential in clinical settings.

Early on in the pandemic, Gilead’s antiviral drug remdesivir seemed to be a promising therapeutic for hospitalised patients, and governments around the world quickly bought up the global supply, with Gilead licensing the drug to some generic manufacturers to distribute the drug in many low- and middle-income countries. Although much of the research at the time indicated little benefit of remdesivir for hospitalised COVID-19 patients, the European Commission, amid EU shortages, signed a €1billion joint procurement agreement to purchase 500,000 courses of treatment over six months in October of 2020. In November 2020, the WHO recommended against the use of remdesivir as more results from its own trial became available.

On 6 May 2021, the Commission launched its Strategy on COVID-19 Therapeutics as a complement to its 17 June 2020 vaccines strategy, calling it a “reinforced and strategic approach” to the development, manufacture, and procurement of safe and effective COVID-19 therapeutics at EU-level. In the strategy, the Commission lays out actions it will take on several fronts:

1. research, development and innovation;

2. access and swift approval of large-scale clinical trials in the EU;

3. scanning for candidate therapeutics;

4. securing supply chains and delivery of medicines;

5. ensuring that the regulatory process is rapid and flexible;

6. financing and procurement capacities;

7. international cooperation.

At each step, the Commission will coordinate and support processes to make sure the most promising therapeutics are identified early, go through the approval process swiftly, and are available to patients as quickly as possible with necessary resources for production, delivery, and procurement. For example, in line with the strategy the Commission will establish a COVID-19 ‘therapeutics innovation booster’ to gauge the state of therapeutics under development and to support those that are furthest along to get to the point of authorisation for use (by July 2021, but not established at the time of writing). It will also develop a mapping tool that analyses not only research and development but also production capacity and supply chains to make sure new drugs can actually get to people (second quarter 2022).

The strategy also includes earmarking funding to support safety assessment and data generation for clinical trials (€5 million under the EU4Health programme), providing funding to support national authorities in authorising clinical trials (€2 million under the EU4Health programme), and earmarking funding to support flexible manufacturing and access to COVID-19 therapeutics (€40 million under the EU Fab project). With regard to international cooperation and global access and availability of therapeutics, the Commission recommits to research, development, and regulatory initiatives already underway internationally, including the Access to COVID-19 Tools Accelerator.

Identifying the most promising therapeutics

In the search for promising drugs, the Commission put forth in the Therapeutics Strategy the goal of establishing a portfolio of ten potential COVID-19 therapeutics, identifying five of the most promising ones, by June 2021. Ultimately, the Commission aimed to have three new therapeutics available by October 2021, and possibly five in total by the end of 2021. In June 2021 the Commission announced the five promising therapeutics and then in October 2021 it announced the list of ten.

The Commission developed and tasked the European Expert Group on SARS-CoV-2 Variants with reviewing scientific evidence to support the Commission in developing a portfolio and making recommendations for the ten most promising therapeutics. The expert group is comprised of scientists with expert knowledge in infectious diseases, biology, public health, and clinical medicine from universities and institutions across the EU.

In the Therapeutics Strategy, the Commission acknowledged that medicines would be needed in the long-term for people having different levels of severity of COVID-19. Accordingly, the expert group worked with the intention of identifying promising therapeutics that would work to treat COVID-19 across the spectrum of the disease: people at risk of exposure to the virus needing preventative care; those who have asymptomatic infections or have mild cases of the virus; people who are hospitalised with moderate-to-severe and critical cases; and those who need treatment for the longer-lasting effects due to long COVID. The expert group also looked at the different ways the therapies in development work: antiviral, immunomodulator, or other types of treatments as appropriate for the different phases of the disease.

The expert group identified categories to cover the broad scope of therapeutics the Commission envisioned for the portfolio and established objective and science-based criteria. It evaluated 82 products that are in the later stages of the development process, from which three types of products emerged: antiviral monoclonal antibodies (mAbs), oral antivirals, and immunomodulators. Focusing on the scientific and medical merits of the therapeutics reviewed, and excluding any criteria concerning manufacturing, production, price, or access, the expert group was able to select the ten most promising therapeutic candidates. The drugs included on the final list of the expert group’s recommendations are based on the research available at the time of the review and will be revisited regularly.

These drugs work in different ways at different stages to prevent an infection from becoming a serious illness requiring hospitalisation or even leading to death. This includes people at risk of exposure to the virus and those who have tested positive but may have asymptomatic infections through people who have mild to moderate cases, are hospitalised, or are suffering from longer-lasting effects of the disease due to long COVID. The possibility of more medicines to treat COVID-19, especially as access to vaccines remains a major hurdle, is a hopeful development. However, the challenge of equitable access remains. These drugs, the research and development of which has been funded by public money, will be subject to patent and intellectual property rights held by pharmaceutical corporations. These corporations will have control over prices, supply, and availability of these crucial treatments around the world, and as we have seen with vaccines, can severely limit the possibilities of global need being met leading to unnecessary suffering and death.

The EU Therapeutics Strategy: no lessons learned

The support and coordination laid out in the EU Therapeutics Strategy has helped facilitate identification and potential approval of promising therapeutics for COVID-19. However, there is a gaping chasm in the strategy: it does not provide for any EU-level intervention in guaranteeing access to these medicines when prices or production capacity limit availability. When pharmaceutical corporations create such scarcity, governments must act to overcome the ensuing access challenges, such as by waiving intellectual property rights. The absence of such action has proven devastating for global vaccine equity and is absent in the Therapeutics Strategy.

Governments, multilateral organizations such as WHO, and philanthropic organizations such as the Gates Foundation, established international mechanisms, for example the Access to COVID-19 Tools Accelerator (ACT Accelerator) to ensure equity in access to vaccines, treatments, diagnostics, and to support health systems. Under the ACT Accelerator’s vaccine pillar the COVAX facility aims to ensure global vaccine equity. It was supposed to guarantee vaccine doses for at least 20 per cent of a country’s population by leveraging the negotiating power of all countries participating.

However, the EU and other rich countries took nationalist approaches to secure vaccines for people within their borders, severely undermining COVAX. Low-income countries have received delivery of only 9.3 vaccines for every 100 people, 7.1 of those through COVAX. On the other hand, rich countries, through making deals directly with pharmaceutical corporations, have acquired 155 vaccines for every 100 people. As a result low-income countries are heavily reliant on donations from other countries and from pharmaceutical corporations for vaccines which, while pledged, are often not delivered. These challenges persist for the vaccines pillar of the ACT Accelerator, COVAX, and the actions of governments and pharmaceutical companies continue to undermine its efforts. Rather than offer solutions for the likely identical challenges that lie ahead for international cooperation and equitable access to therapeutics, the Commission commits to “promoting cooperation between the EU-funded European platform trials and the [ACT Accelerator] partnerships…to facilitate the global roll-out and uptake of therapeutics”.

The Commission negotiated contracts for vaccines which heavily favoured pharmaceutical companies, with insufficient transparency leading to a lack of public scrutiny as to how public funds were being spent. When the European Parliament and the public demanded to see the contracts, the Commission belatedly made heavily redacted versions of some of the contracts available. Contractual provisions essentially removed any risk or liability from pharmaceutical companies, prioritising the companies’ interests over the public interest. For example, the EU’s contract with AstraZeneca allowed for the company to make “best reasonable efforts” to complete its contractual obligations, with no certainty around what might happen if it failed to do so. The contract with CureVac provides for the possibility that EU governments might have to pay for indemnification of the company for any side-effects of the vaccine. The CureVac contract also included provisions that gave pharmaceutical companies control over whether the EU can send doses to low- and middle-income countries.

The EU’s efforts to secure vaccines for the EU failed to approach anything that would pave the way for vaccines or any other COVID-19 health technologies to become a “global public good” as Ursula von der Leyen, President of the European Commission, and other EU leaders have said. Indeed, Investigate Europe spoke to former negotiators who conceded that, “The words ‘global public goods’ are an empty shell,” and access for all was never a priority. The EU Therapeutics Strategy fails to rectify those same missteps which proved so detrimental in the Commission’s approach to vaccines. To do so would require

• securing rights to any inventions and intellectual property, including patents, funded by public money;

  • retaining control over whether and to where these products can be exported;

  • full participation in global sharing mechanisms; and

  • full transparency in negotiations, including around pricing and capacity.

These steps will work to push back against actions of pharmaceutical companies that impede access and availability. However, the EU Therapeutics Strategy prioritises better coordination and facilitation of existing processes and initiatives rather than taking the necessary step of fundamentally changing the power that pharmaceutical companies exert over equitable access to medicines within the EU and globally.

Big pharma power and the continuing challenge of equitable access

Lobbying power to influence policy

From early on in the COVID-19 pandemic, pharma lobby groups such as Medicines for Europe, and the European Federation of Pharmaceutical Industries and Associations (EFPIA) were in close dialogue with the Commission about the supply of medicines, including supply chain challenges during the pandemic. This dialogue included information exchange about how the situation developed regarding the supply of medicines. However, pharma lobbying in the first phase of the pandemic mainly focused on EU’s vaccines strategy. The pharmaceutical industry succeeded in influencing the vaccine strategy and the negotiations about specific vaccine purchasing contracts, such that the outcome was virtually a corporate dream-come-true (see Box 2 below).

Documents obtained via freedom of information requests show that towards the end of 2020, COVID-19 therapeutics became a bigger focus. At a meeting attended by EU Health Commissioner Kyriakides (6 November 2020), the EFPIA “called on the Commission for an EU Strategy for Covid-19 therapeutics as the vaccines strategy has proved hugely beneficial.” The lobbying also targeted the EU’s powerful trade department, responsible for trade agreements with other countries (FTAs).

In a meeting with DG Trade on 17 November 2020, the EFPIA stated that their priority during COVID-19 was to continue supply of medicines “while undertaking research and development for therapeutic solutions to combat COVID-19”. During this meeting with the cabinet of Trade Commissioner Dombrovski, which was requested by the EFPIA, it insisted on the need for “upholding solid IP disciplines in EU FTAs and its enforcement”. It claimed that any attempt to curtail IP protection would be “detrimental on investments for the development of future innovative medicines”.

Pharmaceutical lobbies have the ear of the European Commission which readily accommodates their demands, even when those demands are detrimental to public health and are prolonging the pandemic. Marc Botenga MEP (The Left) noted in an interview for this article: “There is something very fundamental to the structure [of how the EU works]: The main objective is to further the interests of private companies, to champion their interests to the world. So, every policy has a red line: it must not harm what they call the competitiveness, meaning shareholder dividends, and the position of these multinational companies in the world.” In an environment in which the interests of pharmaceutical corporations drive law and policy, so much so that public interest is nearly an afterthought, equitable access to therapeutics is not likely to be achieved without strong action from the European Commission and governments around the world.

Not meeting goals

Companies have failed to produce sufficient vaccines, failed to deliver promised doses, and have rejected calls to price vaccines affordably for all countries. Even with mechanisms in place to facilitate sharing of technology and know-how, such as C-TAP and the Medicines Patent Pool, pharmaceutical companies have rejected all calls to fully share technology and know-how in order to increase global production and supply and save lives. As therapeutics become available, a similar pattern has become evident. This has been seen with Roche’s drug, tocilizumab, recommended by the WHO, and with Merck’s and Pfizer’s new drugs, both on the expert group’s list of ten most promising candidates.

The experience of Médecins Sans Frontières (MSF) in its efforts to procure tocilizumab for its projects clearly exemplifies the control pharmaceutical corporations can exert over global access and supply of medicines. Roche is the only maker of tocilizumab in the world and, although its patents expired in 2017, it holds secondary patents that prevent other companies from manufacturing a generic. However, the company itself announced that it is unable maintain sufficient supply, even expecting to be periodically out of stock of the drug globally due to the pandemic. Christa Cepuch of MSF’s Access Campaign explained, "Médecins Sans Frontières (MSF) has not been able to procure the forecasted 6000 vials that we will need for our projects… We have engaged many times with Roche and through the ACT-A consortium, Unitaid, and WHO, and still have hit a dead end with respect to actual procurement.” Cepuch also noted that “we don’t hear many high-income countries complaining, so we know where the shortages lie, and that is in low- and middle-income countries and low-resource settings where there is very little access to tocilizumab at a baseline.” MSF has also called out the prohibitively high prices Roche has set, including US$410 in Australia, $646 in India and $3,625 in the USA per 600mg dose, severely restricting access in many low-income countries. It was only after MSF publicly called on Roche to act that the company announced that it would not assert its patent rights against the use of its drug in low- and middle-income countries during the pandemic, allowing generics manufacturers to make the drug without legal repercussions. After this announcement, in September 2021 the Indian Government granted authorisation for a generic version of tocilizimab to the manufacturer Hetero.

Meanwhile Merck and Pfizer have granted voluntary licences for their novel oral antiviral therapies Molnupiravir, and Paxlovid, respectively, to the Medicines Patent Pool (MPP). Advocates for equitable access have been calling on pharmaceutical companies to share their intellectual property since the beginning of the pandemic. With a licence through the MPP, companies in other countries will be able to produce generic versions of these therapeutics without worry of repercussions for patent infringement. Merck’s voluntary licence will allow certain generic manufacturers, selected by MPP, to sell Molnupiravir in 105 countries, including 46 Least Developed Countries. Pfizer's voluntary licence for its drug Paxlovid will allow generic manufacturers worldwide to produce the drug to supply the medicine in 95 countries stipulated in the agreement. These countries include not only low and lower-middle income countries but also some upper-middle-income countries and countries that have transitioned from lower-middle to upper-middle-income countries in the past five years. Merck is set to sell a five-day course of treatment of Mulnopiravir for US$700 [€604] while a generic may cost as little as US$20 [€17]. A course of Pfizer’s Paxlovid is estimated at US$300-US$500 [€263-€440]. These voluntary licenses are an important step towards equity in access to these treatments, especially in middle- and low-income countries, but the shortcomings are glaring. Importantly, Merck’s voluntary license excludes almost half of the world’s population and "important upper-middle-income countries with robust manufacturing capacity”, such as Brazil and China. Pfizer’s voluntary license excludes countries such as Brazil, Cuba, Iraq, Libya, and Jamaica for the sale of generics, so these countries will have to buy the treatments directly from Pfizer at a price much higher than a generic.

The actions of these corporations, and the decisions they have made, give a preview of what’s to come with regard to access to COVID-19 therapeutics. Pharmaceutical corporations are not willing to fully share their intellectual property to make sure that everyone has access to treatments. Charity and donation models, such as COVAX and bilateral arrangements, have failed. Reinforcing existing structures, as the EU Therapeutics Strategy does, will not carve out a path toward global, equitable access to COVID-19 therapeutics or out of this pandemic.

Looking towards equitable, global access

In October 2020, South Africa and India proposed a waiver of the TRIPS agreement of the World Trade Organisation (WTO) (TRIPS waiver), which would set aside patent protections for COVID-19 vaccines and treatments for the duration of the pandemic. Nearly 160 low- and middle-income countries joined or supported the proposal, and some high-income countries eventually backed it, including US President Joe Biden who supported the waiver for vaccines. However, the European Union remains in full opposition of the waiver, asserting in its own counter-proposal that existing flexibilities in the TRIPS agreement and voluntary actions by pharmaceutical corporations are enough to address access concerns globally. In order to overcome the outsized influence pharmaceutical corporations have over who has access to treatments as they become available, the EU must change its position and support the waiver proposal.

The EU offers no alternative solution with its Therapeutics Strategy. The EU should be taking steps toward retaining rights to the intellectual property that it supported the research and development of with public funds, to ensure that research data, technology, and know-how is available to allow for adequate production, supply, and affordability globally. It must negotiate in full transparency so that public scrutiny may act as a counterweight to the power pharmaceutical companies wield at the negotiating table. The EU must also fully participate in international equitable allocation mechanisms so that they are not crippled by nationalistic priorities. Finally, where donations have been pledged, the EU and national governments must make every effort to see that their delivery is carried out.

If pharmaceutical corporations are to meaningfully contribute to equitable global access to COVID-19 therapeutics, they must commit to fully sharing their intellectual property with platforms such as the MPP, the Open COVID Pledge, or the WHO’s COVID-Technologies Access Pool (C-TAP). Companies should also be transparent about their production capacity, stock, and ability to meet demand, which would assist procurement agencies and organisations such as MSF better plan their responses across the globe, especially in middle- and low-income countries.

As this pandemic wears on, lives continue to be lost because pharmaceutical corporations have limited global access to vaccines. They’ve enjoyed soaring profits by holding on tightly to their intellectual property, and governments have simply not stood up to them. The same is set to happen with therapeutics.

In the EU, the Commission is satisfied with repeating the same mistakes that led to the current situation with vaccines as it undertakes its Therapeutics Strategy. In order to steer a different course, the European Commission and governments across the globe must take bold and concerted action now to challenge the power of pharmaceutical corporations and enact laws and policies that put the public interest and people’s lives first.

TAKE ACTION!

Public pressure has worked to sway both pharmaceutical companies, as with the example of Roche above, and governments, as with the US’s position change on the TRIPS waiver. We must continue to take action, to organise locally and with global coalitions, and demand that pharmaceutical companies share their intellectual property and that governments support the TRIPS waiver. We can:

• Join demonstrations in person, engage pharmaceutical company executives on social media, and write to local media outlets to raise the profile of the issue and increase pressure on companies and governments.

• Ask representatives in your national government to express their dissatisfaction at how this issue is being handled in order to push the issue up the national agenda.

• EU citizens should sign and share the Right to Cure/No Profit on Pandemic European Citizens Initiative that would require the EU to initiate a legislative process to make COVID-19 treatments a global public good.

NB: Our review of the situation with COVID-19 therapeutics is correct at time of publication. Please note that this is a fast-changing field with new therapetics entering the market and new announcements about licensing announced every few days.

Written by Leigh Kamore Haynes and edited by James O’Nions. Authorial contributions from Olivier Hoedeman and Katharine Ainger. With thanks to 
Dimitri Eynikel, Christa Cepuch, Marcio da Fonseca, Hu Yuan Qiong from MSF, Marc Botenga MEP (The Left)  and Gopa Kumar (TWN).