Fair Pharma Scorecard Methodology
Measuring Fair Pharma principles (previously: Good Covid-19 Company Practices or GCCP)
The Fair Pharma Scorecard measures the behaviour of pharmaceutical companies with regards to the development and manufacturing of Covid-19 vaccines/therapeutics against a matrix of 19 criteria. These criteria were developed by translating human rights principles and international standards into concrete company behaviours.
PAF collects information from the public domain regarding company behaviour and evaluates it using the Fair Pharma criteria to monitor how pharmaceutical companies are realising their human rights responsibilities, and how their behaviour is changing over time.
Below is an outline of the principles and methodology upon which this evaluation is made.
Human rights principles and international standards selection
The main legal basis for the Fair Pharma principles is the right to the highest attainable standard of physical and mental health and the right of everyone to enjoy the benefits of scientific progress and its applications in the International Covenant on Economic, Social, and Cultural Rights. The UN Committee on Economic, Social, and Cultural Rights (CESCR) has interpreted the Covenant rights as follows:
General Comment No. 14 on the right to health (article 12) in the International Covenant on Economic, Social, and Cultural Rights
45. For the avoidance of any doubt, the Committee wishes to emphasize that it is particularly incumbent on States parties and other actors in a position to assist, to provide “international assistance and cooperation, especially economic and technical” which enable developing countries to fulfil their core and other obligations indicated in paragraphs 43 [including provision of essential medicines] and 44 [including immunization against infectious diseases and the prevention, control, and treatment of epidemic and endemic diseases] above.
General Comment No. 24 on State obligations under the International Covenant on Economic, Social and Cultural Rights in the context of business activities
22. The Committee is particularly concerned that goods and services that are necessary for the enjoyment of basic economic, social and cultural rights may become less affordable as a result of such goods and services being provided by the private sector, or that quality may be sacrificed for the sake of increasing profits. The provision by private actors of goods and services essential for the enjoyment of Covenant rights should not lead the enjoyment of Covenant rights to be made conditional on the ability to pay, which would create new forms of socioeconomic segregation.
These Good Practices are further based on the human rights principles and international standards related to these rights, in particular The United Nations Guiding Principles on Business and Human Rights and Paul Hunt’s Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines (2008). In addition, the UN CESCR published the following statement in relation to pharmaceutical companies’ human rights responsibilities in the context of Covid-19:
Statement on universal and equitable access to vaccines for COVID-19
7. In line with international standards, business entities, including pharmaceutical companies, have the obligation, as a minimum, to respect Covenant rights. Thus, business entities should refrain from invoking intellectual property rights in a manner that is inconsistent with the right of every person to access a safe and effective vaccine for COVID-19 and with the obligation of States to guarantee, as expeditiously as possible, universal equitable access to vaccines for COVID-19.
Table 1. Human rights responsibilities underlying the Fair Pharma principles. From Paul Hunt’s Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines.
DEFINITION OF RESPONSIBLITY
25. The company should engage constructively with key international and other initiatives that are searching for new, sustainable, and effective approaches to accelerate and enhance research and development for neglected diseases.
30. As part of its access to medicines policy, the company should issue non-exclusive voluntary licences with a view to increasing access, in low-income and middle-income countries, to all medicines. The licences, which may be commercial or non-commercial, should include appropriate safeguards, for example, requiring that the medicines meet the standards on quality, safety and efficacy set out in Guideline 20 [on pharmaceutical regulatory requirements]. They should also include any necessary transfer of technology. The terms of the licences should be disclosed.
6. In relation to access to medicines, the company should be as transparent as possible. There is a presumption in favour of the disclosure of information, held by the company, which relates to access to medicines. This presumption may be rebutted on limited grounds, such as respect for the confidentiality of personal health data collected during clinical trials.
38. The company should disclose: i. as much information as possible about its pricing and discounting arrangements;
Equality, non-discrimination & equity
5. Whenever formulating and implementing its strategies, policies, programmes, projects, and activities that bear upon access to medicines, the company should give particular attention to the needs of disadvantaged individuals, communities, and populations, such as children, the elderly and those living in poverty. The company should also give particular attention to the very poorest in all markets, as well as gender-related issues.
33. When formulating and implementing its access to medicines policy, the company should consider all the arrangements at its disposal with a view to ensuring that its medicines are affordable to as many people as possible. In keeping with Guideline 5, the company should give particular attention to ensuring its medicines are accessible to disadvantaged individuals, communities, and populations, including those living in poverty and the very poorest in all markets. The arrangements should include, for example, differential pricing between countries, differential pricing within countries, commercial voluntary licences, not-for-profit voluntary licences, donation programmes, and Public Private Partnerships.
34. The arrangements should take into account a country’s stage of economic development, as well as the differential purchasing power of populations within a country. The same medicine, for example, may be priced and packaged differently for the private and public sectors within the same country.
Commitments and accountability
1. The company should adopt a human rights policy statement which expressly recognises the importance of human rights generally, and the right to the highest attainable standard of health in particular, in relation to the strategies, policies, programmes, projects and activities of the company.
2. The company should integrate human rights, including the right to the highest attainable standard of health, into the strategies, policies, programmes, projects, and activities of the company.
10. The company should have a publicly available policy on access to medicines setting out general and specific objectives, time frames, reporting procedures, and lines of accountability.
Some of the Fair Pharma principles are also related to standards in international law including the Trade-Related Aspects of Intellectual Property Rights (15 April 1994) and the Doha Declaration on the TRIPS Agreement and Public Health (2001).