Introduction

In 2021, as well as in previous years, there was a profound transformation for public acquisitions in Mexico, in at least four ways:

• the transformation of the acquisition and logistics model of healthcare products for the Mexican government, eliminating distributors;
• modification of the health regulations for imported health products;
• the addition of a provision to the Public Sector Acquisitions, Leases and Services Act to permit, outside its framework, the contracting and acquisition of such products through international organisations; and
• public procurement of healthcare products through international organisations.

These changes have represented a challenge in terms of the acquisition of healthcare products in Mexico.

During 2021, acquisitions of healthcare products were made, to a large extent, through international organisations but there was also an unpredictable return back to consolidated public tenders implemented directly by Mexican healthcare institutions, such as the Mexican Health Institute for Welfare (INSABI). This is a confusing combination of procurement processes: one outside the Mexican legal framework, for certain healthcare products, following the mandates and manuals of international organisations; the other, at the same time, acquisitions through Mexican institutions, for other specific products. At the time of writing, those acquisitions are in the process of implementation. For the sake of the patients and the National Health System, it is hoped that they are successful; however, they deviate from the Mexican legal system in this area. Below is an analysis of this issue.

Current Framework and Context in Mexico

The position of the federal administration since 1 December 2018 was stated: “Profound corruption in the purchase of medicines”.

Measures were taken to prevent the participation of distributors in public acquisition processes, only permitting the holders of marketing authorisations to participate in them.

Resolution of the Ministry of Health

A resolution of the Ministry of Health was published on 28 January 2020 that permits the acquisition of medicines from abroad, even when they do not have a marketing authorisation in Mexico (a system of equivalency with other regulatory agencies and expedited approval of marketing authorisations).

The relevant points of the resolution are as follows.

• The resolution recognises as equivalents the requirements established in the RIS to obtain marketing authorisations of new molecules, generic medicines, biotechnological medicines, innovative, biocomparables, whether manufactured domestically or abroad, with the requirements requested and evaluation procedures carried out; as well as the importing of medicines with or without marketing authorisation in Mexico for any illness or disease, for the medicines prequalified by the WHO's prequalification programme for medicines and vaccines, or that are previously authorised by the respective regulatory authorities in Switzerland, the USA, Canada, Australia, the European Commission, and the WHO Regulatory Agencies of Reference Pan American Health Organization (PAHO)/WHO or regulatory agencies that are members of the Pharmaceutical Inspection Cooperation System (PIC/S).
• The resolution establishes the possibility of importing medicines for necessity (in order to guarantee supply for the correct and timely provision of services, it does not define what such concept refers to), through co-ordination between the Ministry of Health and the agencies related to the national supply and entry into national territory of health products (the Mexican Institute of Social Security, the Mexican Institute for Social Security and Services for State Workers, PEMEX, the Institute of Health for Welfare, the Mexican Secretariat of National Defence, the Mexican Secretary of the Navy and the Ministry of Health Coordination Center of the National Institutes of Health and High Speciality Hospital).

Other considerations of the resolution include the following.

• It determines that medicines that must be imported for necessity and that do not have a marketing authorisation in Mexico must be registered by regulatory authorities of reference (PAHO/WHO) or have a registration with regulatory agencies that are members of the PIC/S, and also regulatory authorities in Switzerland, the USA, Canada, Australia and the European Union.
• It establishes a period of five business days after the first importation to make the request for a marketing authorisation.
• It establishes that the marketing authorisation request will be rejected if there is evidence that the product to be registered has been reported by the WHO, by any regulatory agency that is a member of the ICH or the PIC/S, or by regulatory authorities in Switzerland, the USA, Canada, Australia or the European Union.
• It establishes a maximum period of 60 business days for a response on the granting of a marketing authorisation under the resolution; once that period expires, constructive denial will be presumed.
• The resolution mentions that, if necessary, the Federal Commission for the Protection against Sanitary Risk "will use its powers to avoid a possible risk to health with respect to medicines that do not have a marketing authorisation in Mexico", imposing the obligation on medical units that apply those medicines to implement intensive pharmacovigilance in terms of the applicable law.

The objectives are the following:

• the decision to acquire medicines abroad; and
• the decision to acquire medicines through international organisations.

Resolution of 18 November 2020: "RESOLUTION establishing administrative measures to ease the processing of the marketing authorisation of medicines and other health products from abroad"

This resolution determined the following:

• the possibility of obtaining marketing authorisations for medicines in a term of five business days from the date of their issuance; and
• the possibility that medicines can be imported without a marketing authorisation under the modification of the Public Sector Acquisitions, Leases and Services Act, through acquisition processes carried out by international bodies (such as the United Nations Office for Project Services, or UNOPS).

Public Sector Acquisitions, Leases and Services Act

For the purpose of implementing international purchases of health products, the Public Sector Acquisitions, Leases and Services Act was amended on 11 August 2020. The following paragraph was added to Article 1: “The acquisition of health goods or provision of health services contracted by the agencies and/or entities with international inter-governmental bodies, through mechanisms of collaboration previously established, are exempt from the application of this Act, provided the application of the principles established in the Political Constitution of the United Mexican States is shown.”

Indicating clearly that the terms of the Act will not apply in the case of acquisitions of health products implemented through international organisations, the road was left open for them.

International organisations from which Mexico has decided to purchase medicines

On 31 July 2020, Mexico announced the execution of an agreement with two international organisations for the purchase of medicines: UNOPS and PAHO.

UNOPS

UNOPS is an entity of the United Nations that provides project administration services in each area in which the UN has a mandate to meet objectives – from prevention of, and raising awareness on, the use of explosive mines to health sector reform; from IT solutions to the eradication of poverty.

It prepares development projects or provides specialised services, as may be necessary. Those services include:

• the selection and contracting of personnel for the project in question;
• the acquisition of goods;
• the organisation of training and education;
• the administration of financial resources; and
• the administration of credit.

UNOPS is the largest services provider of the United Nations system, and works on behalf of more than 30 departments and organisations of the UN.

The suppliers interested in working with UNOPS, or with any of the other 12 United Nations organisations, must be registered in the United Nations Common Supply Database.

UNOPS calls public tenders and locates suppliers through internet searches, contact with trade offices, business missions, chambers of commerce, professional associations, commercial archives and catalogues.

Its principles are:

• a better quality-price relationship;
• equity, integrity and transparency;
• effective competition; and
• the best interests of UNOPS and its partners.

The steps to follow to implement public acquisitions are:

• market research;
• procurement strategy;
• solicitation;
• request for quotation;
• invitation to tender;
• request for proposal;
• evaluation;
• contract award;
• review and approval;
• contract; and
• signature of contract.

UNOPS implements direct purchases itself without tenders when the nature of the goods or the particularities of the project require it; for example, in the case of medicines protected by patents.       

PAHO

PAHO is the international organisation specialised in the public health of the Americas and specialised in the health of the Inter-American System, and serves as the regional office for the Americas of the WHO.

The PAHO provides technical co-operation in health to its member countries, combats transmissible diseases and attacks chronic illnesses and their causes, strengthening health systems and responding to emergency and disaster situations.

All ministers of health and governmental institutions of the public health services network of the countries that are members of the PAHO can acquire medicines and supplies through a strategic fund. For that, it is only necessary to sign an agreement with the Organization.

It uses two funds for the purchase of products:

• a vaccines revolving fund; and
• another for the purchase of high-quality vaccines, needles and related supplies.

Strategic fund for medicines

The PAHO buys antiretroviral medicines and medicines for opportunistic infections associated with HIV/AIDS; anti-malaria and anti-tuberculosis of first and second line; anti-chagasic, anti-leishmaniasic, anti-viral and immunosuppressive medicines, and other essential medicines; laboratory reagents for rapid tests and confirmatory tests of HIV/AIDS, and reagents for measuring the viral load; and pesticides and products for malaria prevention.

Supplier requirements

The PAHO uses suppliers that have been evaluated and pre-qualified by the PAHO, that provide evidence that they meet the current requirements of best manufacturing practices and that apply appropriate warranty and quality control standards.

Registration is in the electronic tender system (In-Tend), where information on the company can be updated and changed, tenders responded to and the referenced documentation maintained in a safe place through the internet. Visit https://ungm.in-tend.co.uk/paho/aspx/Home to access the portal of In-Tend suppliers of the PAHO.

During 2021 and at the beginning of 2022, the Mexican government has been moving to return to the prior public procurement system, whereby Mexican healthcare institutions have been directly conducting public procurement of some medicines, based on the Public Sector Acquisitions, Leases and Services Act. Examples of this change are several tenders and direct purchases conducted by the Ministry of Health, as well as a consolidated public tender called and organised by INSABI. At the same time, the Mexican government is still using UNOPS' services to perform other public acquisitions. It is confusing that the Mexican government is returning to performing public procurement directly and executing government contracts, and, apparently, slowly standing back from using international public institutions to purchase healthcare products.

This is the new legal framework for making governmental health product purchases. A significant quantity of such products will be acquired through these procedures. As indicated previously, it is to be hoped that this effort is for the good of the protection of people’s health in terms of the Fourth Article of the Political Constitution of the United Mexican States.