Alejandro Luna Fandiño
Olivares, Mexico City
alejandro.luna@olivares.mx

Introduction

President López Obrador of Mexico stated that he would not oppose the commercialisation of the Covid-19 vaccine in the private sector as soon as the first regulatory approvals were made in the country. On 22 January 2021, he authorised the purchase of Covid-19 vaccines by both private companies and local governments.

The import of medicines, vaccines and regulated products must comply with corresponding import regulations and sanitary authorisations. In this case, the task of reviewing and approving such authorisations is the responsibility of the Commission for the Protection against Sanitary Risks (COFEPRIS), under the new leadership of Dr Alejandro Svarch.

There is also the greater issue of availability. In a global pandemic demand far exceeds production capacities, especially as vaccines have rigorous safety, efficacy and quality checks. Fair, equitable and global distribution of the vaccine is an enormous challenge. It requires the cooperation of all sectors involved – including governments, pharmaceutical companies, distributors, health professionals and hospitals – as well as responsible behaviour from the global population.

To date there are more than 15 Covid-19 vaccines in phase three of research and more than 237 in development; however, in the United States and Mexico, only three vaccines have been approved by regulatory authorities:

1. Pfizer – BioNtech’s BNT162b2;
2. Moderna’s mRNA-1273; and
3. Oxford AstraZéneca’s ChAdOx1 nCoV-19.

In countries such as Mexico, with a population of more than 120 million, it will not be easy to ensure fair, equitable and timely distribution of the vaccine. For this reason, the news issued by the President, indicating that he will authorise both the state and private sector to purchase the vaccines, is welcome. Though, it is important to point out that the right to vaccination in a timely manner, and access to it in the public and/or private sectors, is not a concession by the political party in power, or from any other government or party. Access to health care and immunisations is a right – a human right.

Access to healthcare as a human right

The Universal Declaration of Human Rights (UDHR), proclaimed by the General Assembly of the United Nations in Paris on 10 December 1948, is a common ideal for all peoples and nations. It established for the first time the liberties and freedoms that must be protected throughout the world, which every human has an inalienable right to. 

Human rights are intrinsic to all people, regardless of nationality, place of residence, gender, national or ethnic origin, colour, religion or language. They are intertwined with the principles of equality, universality and non-discrimination, and are interdependent and indivisible. Of all, the right to life is perhaps the original fundamental right, since many of the others depend on the guarantee and upholding of it. In this context, the right to health protection is much more than the absence of disease or having access to medical care: it touches all aspects of life, which is why it is so important to understand health in the broadest and most progressive manner possible. The right to health must be understood as a right to access a broad range of facilities, care, goods, services and conditions necessary to achieve the highest possible level of health.

The International Covenant on Economic, Social and Cultural Rights (ICESCR), the International Covenant on Civil and Political Rights (ICCPR) and their Optional Protocols are the instruments of the universal system for the protection of human rights. They regulate the protection of economic, social and cultural rights, and the protection of civil and political liberties, respectively. They expand on the content of the UDHR to encompass those rights that are considered foundational rights to meet people’s basic needs and the achieve the highest possible level of dignified life. Both the ICESCR and ICCPR were signed on 16 December 1966 by the General Assembly and came into effect in 1976. Mexico adhered to these instruments on 23 March 1981, with the agreement coming into force in the country on 12 May of that year.

The Additional Protocol to the American Convention on Human Rights in the Area of ​​Economic, Social and Cultural Rights (the ‘Protocol of San Salvador’) was established on 17 November 1988. It was ratified by Mexico on 8 March 1996 and came into force on 16 November 1999. Article 10 of the Additional Protocol specifically establishes ‘Universal immunization against the principle infectious diseases’ as a right.

In addition, the fourth article in Mexico’s Constitution guarantees the right to health protection for all people. Mexico’s General Health Law (the ‘Health Law’) also regulates the right to health protection, establishes the basis and methods of access to health services, and the agreement of the Federation and the federative entities regarding matters of general health. This is applicable to the entire Mexican Republic and its provisions are of public order and social interest. Article 27 of the Health Law states: ‘For the purposes of the right to health protection, basic health services are those referring to: VIII. The availability of medicines and other essential supplies for health.’

For vaccines in particular, these regulations recognise the importance of opportune inoculation and establish an efficient and prioritised routine for vaccination approvals and campaigns, as outlined in Article 157 bis.

In order to guarantee access to medicines and health protection, the general rule established by the Health Law and the Regulation of Health Supplies (the ‘Health Regulation’) is that authorised and available medicines are acquired and commercialised in Mexico. To meet the principle of access to health in an emergency, the Health Regulation provides an exception: if there is no product available in Mexico, it can be purchased abroad.

Conclusion

In conclusion, the government’s intention to provide free vaccines for all Mexicans is welcome, as is the President's initiative to encourage both public and private purchase of the vaccine, which enables greater accessibility.

However, in the short term and while the country deals with a complex and intense stage of the pandemic, the issue of vaccine shortages must be addressed as a priority. The government’s main responsibility is to ensure effective and timely import of vaccines. Corresponding authorisations for the import of vaccines should therefore be received, processed and resolved quickly and simply, in addition to addressing third-party rights – especially those related to safety, efficacy and quality. Concessions, proactivity and efficiency are expected from the Mexican government across the regulatory apparatus, as timely inoculation is a right, not a concession.