‘Vaccine equity is the challenge of our times – and we are failing’
Producers of lifesaving vaccines and therapeutics are of critical importance in the global effort to end the Covid-19 pandemic. Scientists and pharmaceutical companies moved at record speed to research and develop, then manufacture and market an estimated 11 billion vaccine doses by the end of 2021 [1]. Huge developments have been made in a short time thanks to the collaboration between science and industry.
However, the distribution of these medical products has been, and continues to be, unequal and unfair. The human right to health has been negatively impacted all over the world.
Title quote by Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO) at ‘A Vaccine for All’ Summit in April 2021.
Navigation
- Introduction
- Who we are: Pharmaceutical Accountability Foundation
- The Issue: Pharmaceutical Companies Only Partially Adhering to their Human Rights Responsibilities
- The Applicable Law and the Role of Human Rights
- PAF’s Response
- Methodology: How does the Fair Pharma scorecard work?
- Key Findings
- Policy recommendations
- Conclusion
Introduction: Who Will Judge These Jabs?
Using human rights to score the behaviour of pharmaceutical companies in their development and marketing of Covid-19 vaccines and therapeutics
Overall, 64% of the world population has received one dose of a Covid-19 vaccine, this is equivalent to 79% of populations in upper middle- and high-income countries (HICs) versus a meagre 15% in low-income countries. Vaccination programmes are at starkly different stages worldwide: according to Our World in Data, more booster doses were administered by high- and upper middle-income countries in 2021 than the total number of doses administered in low-income countries (LICs).
This disparity reflects the massive shortcomings in the distribution of COVID-19 medical products. Whereas the rollout of COVID-19 vaccines was ‘the fastest in global history’, taking just 11 months for scientists to develop effective vaccines, the world’s poorest populations are still significantly behind: in 2021, HICs had vaccinated 1 in 4 people, whereas LMICs had only reached 1 in 500 [2]. We are left with a huge imbalance between the incredible scientific advances of 2020 and the failure to move forward in matters of social equity.
by Albert Bourla (Harper Business, 22nd March 2022)
The current model of vaccine/therapeutic distribution is unacceptable from a human rights perspective, and raises serious questions as to the legal accountability of pharmaceutical companies for their disregard of international standards and principles. The UN Guiding Principles on Business and Human Rights, and the Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines make clear that the pharmaceutical industry has responsibilities to respect human rights.
The Pharmaceutical Accountability Foundation (PAF) has devised a strategy for assessing how pharmaceutical companies are doing in their adherence to human rights. The Fair Pharma Scorecard (previously Good Covid-19 Company Practices or GCCP) presents 19 criteria for monitoring whether pharmaceutical companies are acting in line with human rights principles and international standards for equitable access to medicines. They were developed by translating these standards and principles into concrete company behaviours.
The Fair Pharma scorecard can be used as an advocacy tool for NGOs, a policy tool for governments and health ministers, as a guide for how investors can act for the benefit of human rights, and as a tool for pharmaceutical companies to improve their practices (Covid-19 related, and beyond).
[2] Reliefweb, ‘Unequal vaccine distribution self-defeating, World Health Organisation chief tells Economic and Social Council’s special ministerial meeting’ (20 April 2021) https://reliefweb.int/report/world/unequal-vaccine-distribution-self-defeating-world-health-organization-chief-tells, accessed 21 October 2021.
Who we are:
The Pharmaceutical Accountability Foundation
The Issue:
Pharmaceutical Companies Only Partially Adhering to their Human Rights Responsibilities
The global Covid-19 vaccine rollout has involved huge logistical challenges, including limited production capacity, blocked supply chains, shipping bottlenecks and misinformation. For lower-income countries with weaker health systems and no national vaccine production, these hurdles are all the more demanding. High-income countries have exacerbated these existing challenges by stockpiling much of the world’s supply of vaccines, at the expense of poorer countries who couldn’t afford to compete for early doses. The grim result of this is the US, the UK and the Netherlands throwing away tens of thousands of doses due to expire in 2021. On top of this, many of the doses donated to low-income countries had very short shelf lives, which has resulted in further millions of doses being discarded in low-income countries. Nigeria, for example, destroyed 1 million expired doses of the AstraZeneca vaccine in December 2021, some of which had been donated with a shelf life of only 4 weeks.
Many different actors are therefore involved in ensuring fair access to Covid-19 medical products. However, it is crucial to address those that have enormous power to influence the outcomes of public health crises: the pharmaceutical companies themselves.
The Applicable Law and the Role of Human Rights
Finally, governments also have a duty to prevent private entities from violating human rights. This is known as indirect horizontal effect, and means that States must place direct obligations on private companies to prevent them from violating human rights law. Private companies therefore do have an obligation to ‘conduct themselves in a human rights-compliant manner’. The notion that they have serious responsibilities under human rights law needs to be reinforced to drive change in this sector and compel pharmaceutical companies to change their practices.
PAF’s Response
The Pharmaceutical Accountability Foundation (PAF) has designed the Fair Pharma Principles (previously: Good Covid-19 Company Practices or GCCP), to monitor corporate behaviour during the Covid-19 pandemic.
The Fair Pharma Principles are a practical application of human rights norms and international standards to the practices of pharmaceutical companies in their actions to manufacture and deliver COVID-19 vaccines and therapeutics. These assessment criteria are a realistic guide for companies to follow to better their practices.
States and civil society should also be able to hold pharmaceutical companies to account when they fail to respect their human rights responsibilities. The data collected in the Fair Pharma Scorecard and the overall score given to each company can provide leverage for NGOs, political groups and governments for driving change in the private sector.
The Fair Pharma Principles are also a recognition of the full potential of these companies to contribute to a more equitable distribution of vaccines and therapeutics. Most importantly, our scorecard results show that some companies do respect human rights, and therefore that this is a possible and viable approach that fits within the pharmaceutical business model.
The first version of the scorecard (then known as GCCP) was published in March 2021 and scores 9 vaccine producers (AstraZeneca, Pfizer, Moderna, Curevac, Novavax, Janssen, Sinopharm, Sinovac and Gamaleya) and 3 therapeutics providers (Eli Lilly, Regeneron and Gilead) according to Fair Pharma principles. The new scorecard, published in April 2022, scores 26 companies on a total of 30 products. This includes 10 companies producing a Covid-19 therapeutic, and 19 companies producing a Covid-19 vaccine.
PAF has also developed ‘Guidelines for Responsible Pharmaceutical Behaviour in Covid-19’, which present detailed actions that pharmaceutical companies can take in order to better their practices and receive a higher GCCP score. These are combined with policy recommendations for governments, the WHO, GAVI and CEPI.
Methodology: How does the Fair Pharma scorecard work?
The Fair Pharma Scorecard presents 19 criteria for monitoring whether pharmaceutical companies are acting in line with human rights principles and international standards for equitable access to medicines. The 19 practices were developed by translating human rights principles and international standards into concrete company behaviours.
The Pharmaceutical Accountability Foundation has identified four overarching human rights principles that should guide company action on their Covid-19 vaccines/ therapeutics:
- Commitments & accountability;
- Transparency;
- International Cooperation;
- Equality, non-discrimination & equity.
The Pharmaceutical Accountability Foundation’s first scorecard (then: Good Covid-19 Company Practices Scorecard or GCCP), published in January 2021, illustrates how four Covid-19 vaccine companies (AstraZeneca, Johnson & Johnson, Moderna and Pfizer) and three therapeutics companies (Regeneron, Eli Lilly and Gilead) performed on these good practices. Each company received a green, yellow, or red score on those company practices that can be judged based on information in the public domain.
| A Commitments and Accountability | C International Cooperation | E Equality, non-discrimination & equity | T Transparency |
|---|---|---|---|
| A1 The company publishes a global access plan for its product | C1 The company commits to C-TAP or MPP | E1 The company makes the active ingredient available on reasonable ground. [Only for therapeutics] | T1 The company publishes its R&D costs. |
| A2 The company commits to comply with human rights standards in relation to product development and marketing | C2 The company commits to not enforcing the exclusive rights of Covid-19 related patents | E2 The company commits to full technology transfer to other manufacturers | T2 The company publishes its profit margin. |
| C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator | E3 The company commits to non-profit, ‘fair’, or differential pricing | T3 The company publishes the average and/or marginal costs of production. | |
| C4 The company agrees to license its Covid-19 medical products to other companies | E4 The company equitably distributes supplies globally. [Only applies to vaccines] | T4 The company publishes its production capacity. | |
| E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable] | T5 The company publishes the public subsidies it received during product development and/or testing. | ||
| E6 The company agrees to waive exclusive rights in regulatory test data [where applicable]. | T7 The company registers its clinical trials in public repositories. |
Scoring criteria: all 19 principles are weighted equally, as per human rights principles. A good practice, which will obtain a green score, is worth one point, a bad practice will obtain a red score and is worth 0 points, and a ‘hazy’ practice will obtain a yellow score and is worth 0.5 points. In the scorecard, some of the criteria are greyed out, which means that no data was found/available, or that the criteria doesn’t apply (some apply only to therapeutics, and others only to vaccines). The companies are graded accordingly. The overall score is to give a general indication as to how these companies are doing in their efforts to perform well on all 19 points.
Key Findings
Our previous policy paper and scorecard found that vaccine companies performed best on transparency practices but have taken little action to make their products available on an equitable and non-discriminatory basis worldwide. See Annex 1 for more detail on how the individual companies scored. You can also check our 2021 GCCP scorecard.
Below is an outline of the Fair Pharma categories, with an overview of the number of compliant companies from our updated research:
| Good Company Practices | Number of compliant companies | |
|---|---|---|
| A Commitments and Accountability | A1 The company publishes a global access plan for its product | 5/26 |
| A2 The company commits to comply with human rights standards in relation to product development and marketing | 9/26 | |
| C International Cooperation | C1 The company commits to C-TAP or MPP | 2/26 |
| C2 The company commits to not enforcing the rights of Covid-19 related patents | 2/26 | |
| C3 The company supplies to, or signs agreements with, the vaccines or therapeutics pillar of the ACT Accelerator (COVAX) | 10/26 | |
| C4 The company agrees to license its Covid-19 products to other companies | 17/26 | |
| E Equality, non-discrimination and equity | E1 The company makes the active ingredient available on reasonable grounds [only for therapeutics] | 1/10 |
| E2 The company commits to full technology transfer to other manufacturers | 9/26 | |
| E3 The company commits to non-profit, ‘fair’, or differential pricing | 5/26 | |
| E4 The company equitably distributes supplies globally. [Only applies to vaccines] | 11/19 | |
| E5 The company does not seek protection beyond the minimum criteria in TRIPS, or enforces TRIPS+ measures [where applicable] | 2/26 | |
| E6 The company agrees to waive exclusive rights in regulatory test data [where applicable] | 0/26 | |
| T Transparency | T1 The company publishes its R&D costs. | 1/26 |
| T2 The company publishes its profit margin. | 3/26 | |
| T3 The company publishes the average and/or marginal costs of production. | 1/26 | |
| T4 The company publishes its production capacity. | 20/26 | |
| T5 The company publishes the public subsidies it received during product development and/or testing. | 8/26 | |
| T6 The company publishes the texts of licensing agreements. | 1/26 | |
| T7 The company registers its clinical trials in public repositories. | 25/26 | |
26 companies were scored on a total of 30 products. This includes 10 companies producing a Covid-19 therapeutic, and 19 companies producing a Covid-19 vaccine.
Information about company behaviour was scored on a 4-point scale (green-yellow-red) that was tailored to each of the 19 company practices. In general, the scale denoted: Green: Behaviour is compliant with Fair Pharma Principle; Yellow: Behaviour is partially compliant with Fair Pharma Principle; Red: Behaviour is not compliant with Fair Pharma Principle. Practices for which there is too little information in the public domain to score are indicated in grey. Please see our methodology report for more information: https://www.farmaterverantwoording.nl/wp-content/uploads/2021/12/Methodology-Update.pdf.
Policy
Recommendations
For companies developing/manufacturing Covid-19 medical products
- Follow PAF’s ‘Guidelines on responsible pharmaceutical behaviour in Covid-19’. Using these concrete and verifiable criteria, companies can publicise their commitments to international human rights standards and improve their public image.
- Reflect on the GCCP score given and use PAF’s recommendations on how to improve it.
For governments
- Use public funding to negotiate ‘fairer’ contracts. Governments have the power to negotiate conditions in their deals with vaccine and therapeutics providers. Governments can apply funding conditionalities to publicly funded developers of Covid-19 products. These terms could make government funding conditional on:
- The companies setting a fair price for the product.
- The companies committing to a responsible licensing mechanism such as WHO C-TAP or the MPP
- Data transparency in the event of public funding of Covid-19 vaccine/therapeutics clinical trials, licensing deals, costs and research.
- Provide funding for international licensing mechanisms such as CTAP and MPP
- Support the waiving of IP rights. More than 100 governments support the TRIPS waiver proposal, but a number of high-income countries are blocking it (The EU led by Germany, the UK, and Switzerland). The waiver would speed up worldwide access to Covid-19 medical products by removing legal barriers to their production.
- Stimulate companies to adhere to GCCP. Observance of our ‘guidelines for responsible pharmaceutical behaviour in Covid-19’ and scoring system could be included as a requirement in procurement contracts.
For WHO/GAVI/CEPI
- WHO in collaboration with the MPP should provide model licensing agreements for companies and governments to easily conform to international human rights standards in these deals
- WHO should provide regular updates on progress made with C-TAP. C-TAP can provide incentives for companies to support it, such as investing in new drugs.
- GAVI/CEPI should require companies contracted by the ACT Accelerator (vaccines and therapeutics) to adhere to GCCP.
For institutional investors
- Implement and follow the United Nations Principles for Responsible Investment (UNPRI), involving a 3-part responsibility to respect human rights:
- Adopt policy commitments to respect internationally recognised human rights
- Conduct due diligence processes to identify potential human rights implications of vaccine developers’ activities
- Enable or provide access to a remedy: both procedural and substantive, through national judicial or grievance mechanisms, or through non-judicial means that are legitimate, equitable, & transparent in accordance with the UN Guiding Principles on Business & Human Rights.
- Tie pharma CEO pay to equitable vaccine distribution: as a group of 65 asset managers have called for in January.
Conclusion
Many actors had roles to play in the research, development, manufacturing, marketing and distribution of Covid-19 medical products. Governments, international organisations, and institutional investors all participated in the global endeavour to vaccinate the population and treat severe cases of the virus, in a bid to fight the pandemic. Undeniably, pharmaceutical companies saved many lives with their valuable products. Our policy recommendations recognise that they were not alone in shouldering this responsibility. Furthermore, our engagement with the companies themselves shows that they are willing to be seen as committing to upholding their right-to-health responsibilities, to a certain extent.
However, pharmaceutical companies could have done more to make their products available to the global population. Much of our research shows that they shift the lion’s share of the right-to-health responsibility towards other actors. The Fair Pharma scorecard demonstrates that pharma urgently needs to be addressed to prevent another inequitable distribution of life-saving products such as we have witnessed during Covid-19. By showcasing good and the bad practices in a bid to stimulate pharma to ‘do better’, the scorecard shows that companies’ adherence to human rights principles is a mixed bag. Most importantly, it tells us that some companies do adhere to these principles; thus, that this is feasible, and fits within a viable business model. The Fair Pharma Principles, scorecard and Guidelines therefore act as a holistic model for industry change, providing the blueprint for a human rights-based approach to business during public health crises.