The entities signing this letter publicly express their concern regarding the sustainability of the work carried out by Anvisa – the Brazilian Health Regulatory Agency – and thus alert the Federal Government and society to the urgent need to rebuild the workforce of this Agency, whose excellence is recognized worldwide.
According to Article 196 of the Federal Constitution, "health is a right of all and a duty of the State, guaranteed by social and economic policies aimed at reducing the risk of disease and other hazards and providing universal and equal access to actions and services for its promotion, protection, and recovery."
In this regard, Anvisa stands out as a state institution that, among other activities, has the authority to approve and regulate health technologies that will be made available to the Brazilian population, applying international best practices in regulation to the development, evaluation, and oversight of the regulatory framework under its jurisdiction, always based on technical and scientific principles.
For years, ANVISA has suffered from a lack of human resources to meet the social demands placed upon it, whether due to exponential growth in demand, retirement, staff turnover without replacement, or even migration to the private sector. Added to this critical scenario is the large number of employees about to retire and the need to enhance the careers of regulatory agencies in order to retain and qualify the remaining staff.
This looming crisis is causing concern and unease, especially in regulated sectors such as medical devices, medicines, and pharmaceutical supplies, which require predictability, legal certainty, and a stable business environment to guide the actions and investments necessary to supply products to the Brazilian market.
In a country whose industrial policy has the healthcare industry as one of its main pillars, it is not appropriate to treat the glaring need to rebuild the workforce of its sectoral regulatory agency in an indiscriminate manner. Both Nova Indústria Brasil (NIB), with regard to the healthcare industry, and the Economic-Industrial Healthcare Complex (CEIS) are public policies whose success depends on the soundness of Anvisa.
Currently, it is estimated that 20% to 30% of Brazil's Gross Domestic Product (GDP) is regulated by Anvisa, including medical devices, medicines, pharmaceutical inputs, blood products, sanitizers, food, cosmetics, tobacco products, pesticides, health services, and similar products.
In view of the above, the entities signing this document urge the authorities to take timely and effective action to remedy the staff shortage at ANVISA in order to safeguard the quality, safety, and effectiveness of health technologies and services offered to the Brazilian people.
ABIFINA – Brazilian Association of Fine Chemicals, Biotechnology, and Specialties Industries
ABIMED – Brazilian Association of Health Technology Industry
ABIMO – Brazilian Medical Devices Industry Association
ABIQUIFI – Brazilian Association of the Pharmaceutical Inputs Industry
ACESSA – Brazilian Association of the Self-Care Health Products Industry
ALANAC – Association of National Pharmaceutical Laboratories – São Paulo Office
ALFOB – Association of Official Laboratories of Brazil
ANBIOTEC – National Association of Biotechnology Companies
FARMABRASIL GROUP – Brazilian Association of the Pharmaceutical Research Industry and National Capital
INTERFARMA – Pharmaceutical Research Industry Association
PRÓGENÉRICOS – Brazilian Association of Generic and Biosimilar Medicines Industries
SINDUSFARMA – Pharmaceutical Industry Union