Capacity building for the transfer of knowledge on Plasma-Derived Medicinal Products (PDMPs)

Partnership
Project

Background

The Republic of Cuba has more than 50 years of experience in the process of obtaining and using human plasma, when the blood donation service was officially organised throughout the island with the creation of blood banks at both municipal and provincial levels; all associated through a national network of blood banks. Human plasma donations in Cuba are voluntary and do not require a fee. The link between donor and patient, and between the donation and the product, is essentially the manufacturing process, which converts raw material (plasma) into useful treatments.

Cuba's Blood Derivatives Plant is part of the AICA Laboratories company and operates as a state-owned, non-profit company focused on the production of plasma-derived medicinal products (PDMPs), which are intended to meet the needs of the National Health System in the Republic of Cuba.

The anti-Rho (D) specific immunoglobulin is used to prevent haemolytic disease of the fetus and newborn (HDFN), also called erythroblastosis fetalis, a blood disorder in which a mother produces antibodies during pregnancy that attack the red blood cells of her own fetus. This occurs when the mother and baby have different blood types. In most of these cases, a difference in the Rh type (Rh incompatibility) causes the disease. This only occurs when the mother has Rh-negative blood and the fetus has Rh-positive blood, inherited from the father.

On the other hand, SARS (severe acute respiratory syndrome) is the severe stage of COVID-19 caused by massive alveolar damage and progressive respiratory failure, which is triggered by SARS-CoV-2. The spectrum of the disease is broad and ranges from mild and self-limited symptoms to severe and progressive atypical pneumonia, multi-organ failure and death.

Currently, several therapeutic alternatives have been proposed, although the results of population-based studies are inconclusive. This has prompted a growing number of studies advocating for the use of passive immunisation strategies, including intravenous immunoglobulins (IVIG), which have been used safely for decades to treat autoimmune diseases, immunodeficiencies, and certain bacterial and viral infections.

Entities and roles

Beneficiary entities

Ministerio de Salud de Panamá

Panama

Ministerio de Salud de Costa Rica

Costa Rica

Ministerio de Salud Pública y Asistencia Social de Guatemala

Guatemala

Secretaria de Salud de Honduras

Honduras

Secretaria de Salud de México

Mexico

Ministerio de Salud y Protección social de Colombia

Colombia

Ministerio de Salud

Argentina

Ministerio de Salud

El Salvador

Ministério da Saúde

Brazil

First provider entities

BioCubaFarma - Laboratorios AICA

Cuba

Second provider entities

International Plasma and Fractionation Association

Netherlands

Development challenges

It is estimated that 3.4 million high-risk births worldwide are not protected with anti-D immunoglobulin, which in turn is a serious social and health burden. According to figures from the Plasma Protein Therapeutics Association (PPTA), in 2010 this disease caused 114,000 newborn deaths, 55,000 brain injuries and 26,900 deaths in the womb.

Access to treatment for Rh-negative women who may be affected by haemolytic disease of the fetus and newborn in developing countries has long been limited. This situation has been exacerbated by COVID-19, which has led to further disadvantages and inequality among Rh-negative women. To this end, the project also promotes the rights of Rh-negative women.

Immunization with this product can occur at three different times: during gestation to ensure a safe pregnancy and delivery, after an abortion or miscarriage to avoid complications, or in the postpartum stage, which will allow for new pregnancies.

This project aims to bring attention to this issue, train medical staff and promote the immunization of women in this situation in the region, thanks to the active participation of specialists from IPFA; a leader in Europe on this topic.

The main objective of this Triangular Cooperation project is to promote training initiatives and the exchange of medical and scientific information with specialists from Mexico, Central America, Colombia and Cuba in two stages.

Triangular approach

The purpose of the project is to replicate the latest developments in the field of human plasma derivatives through professional training, in order to enrich the expertise of developing countries extending from Mexico to Central America and Colombia.

Sectoral approach - Contribution to the 2030 Agenda

Primary SDG

Goal 3.2 By 2030, end preventable deaths of newborns and children under 5 years of age, with all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births.

Goal 3.7 By 2030, ensure universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes.

Goal 3.8 Achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.

Secondary SDG

Goal 5.6 Ensure universal access to sexual and reproductive health and reproductive rights as agreed in accordance with the Programme of Action of the International Conference on Population and Development and the Beijing Platform for Action and the outcome documents of their review conferences

ADELANTE SDG

Goal 10.2 By 2030, empower and promote the social, economic and political inclusion of all, irrespective of age, sex, disability, race, ethnicity, origin, religion or economic or other status

Goal 10.3 Ensure equal opportunity and reduce inequalities of outcome, including by eliminating discriminatory laws, policies and practices and promoting appropriate legislation, policies and action in this regard

Goal 17.16 Enhance the global partnership for sustainable development, complemented by multi-stakeholder partnerships that mobilize and share knowledge, expertise, technology and financial resources, to support the achievement of the sustainable development goals in all countries, in particular developing countries

Territorial approach

Budget

EU contribution: 79,475.20 €

Co-financing - Triangular Cooperation Partnership: 20,000.00 €

Total budget: 99,475.20 €

Download PDF