Pharmaceutical Regulations: A Comparative Study of US and Brazil

 

In-depth knowledge is necessary to navigate the intricate legal framework of the Brazilian pharmaceutical market

In order to manufacture, import, and sell pharmaceuticals in Brazil, companies must obtain specific licenses and sanitary permits from the National Health Regulatory Agency ("ANVISA") and local/regional health agencies in advance. Companies must acquire approval of the Price for specific categories of drugs from the Drug Market Regulation Chamber ("Chamber") after receiving a Marketing Authorisation ("Authorisation"). The country's drug price control model is characterized by government-imposed price ceilings. There is currently no public mechanism in place to reimburse drug development expenses and/or drug prices. The majority of individuals are able to access medications under the Brazilian health system ("System") at no cost, as it is public. The Brazilian Government ("Government") acquires medicines through public tendering from companies that, in certain circumstances, are required to provide price discounts on products sold to the Government. Health insurance companies are still subject to the specific regulations established by the National Agency of Supplementary Health Care ("Agency") in the private market. In general, health insurance companies are required to provide patients with treatments and products, including medicines, in accordance with a list of Agency-approved procedures.

The aforementioned is primarily the result of the country's universal public healthcare system, which provides local access to remedies and services through the System. The healthcare market in Brazil is separated into public and private tiers. The public tier, particularly the System, offers augmented pharmaceutical assistance by incorporating new medicines into its selection. Companies, patient associations, and patients alike have been drawn to this development. The System is relied upon by approximately 75% of Brazilians for treatments,[ii] and the number of medications purchased increased by 52.3% between 2017 and 2021.[III] Conversely, the private tier (which encompasses health plans) experienced a 114.2% increase in access to treatments during the same period. The pharmaceutical market is a critical component of the Brazilian economy and is currently experiencing double-digit growth. The pharmaceutical market expanded by approximately 14.21% in 2021, reaching a total of R$88.28 billion.[v] Pharmaceutical retail accounted for the majority of drug sales as an institutional market in 2021, with a 15.9% increase, resulting in a total of R$152.1 billion.[vi] There are numerous factors that contribute to the expansion of pharmaceutical retail, such as the potential for novel treatments and an aging population.

Simultaneously, Brazil frequently addresses critical concerns

including the inadequate investment in research and the accumulated demand for pharmaceuticals. It is estimated that there is a pent-up demand for drugs of up to 50%, despite the development. One explanation for this demand is the availability of drugs in the country. Factors such as high and non-competitive drug pricing, questionable public policy strategies, a fragile regulatory agenda, low R&D investments, and a tax burden considered among the highest in the world are all contributing to the difficulty in accessing pharmaceuticals. In contrast to the global market, Brazil has experienced minimal application of clinical research and the introduction of new treatments. One factor was the scarcity of initiatives to encourage innovation in the nation, such as the promotion of research. Although the public sector is responsible for the majority of research and development investments, recent governments have opted to reduce these expenditures. Investment in research by the private sector is still in the process of maturing. Brazil's heterogeneity, diverse climates, culture, and socioeconomic conditions continue to captivate numerous researchers. In order to effect significant change, specialists recommend that the government increase incentives, support scientific research, and simplify rules and regulations.

In Brazil, the COVID-19 pandemic has promoted the development and expansion of digital platforms and health start-ups. This type of medical assistance reduced the necessity for physical contact between physicians and patients, and telemedicine regulations were promptly updated. In addition to remote medical assistance, other branches have also expanded, including e-commerce solutions for medical products and equipment, psychological and emotional support tools, home-based physical exercise solutions, service platforms for daily activities, protection and safety of the elderly, and systems for enhancing hospital management. Between 2014 and 2020, Brazil invested approximately US$430 million in health technology, according to estimates. In general, the company must undertake prior clinical trials and, after confirming the product's safety, quality, and efficacy, apply for the granting of the Authorization from ANVISA. Specific evaluation and observation requirements are established by Brazilian legislation in accordance with the classification of drugs, including brand-name, generic, similar, biological, psychotherapeutic, notified, dynamised, and specific drugs. The generic drug's ceiling price must be at least 35% less expensive than the reference drug, as mandated by law.

At present, Chamber Resolution 2/2004 governs the pricing process

necessitating that the company submit economic data and price proposals to the Chamber in accordance with the Resolution's drug categories. Resolution 2/2004 categorizes medications into six categories in order to determine their price: Category I encompasses a "new product with a molecule patented in the country that provides a benefit to the treatment of drugs already used for the same therapeutic indication, with confirmation of one of the following requirements: a) greater efficacy of the existing drugs for the same therapeutic indication; b) same efficacy with a significant decrease in adverse effects; or c) same efficacy with a significant reduction in the global cost of treatment" (Article 2(I) of the Resolution). A "drug fitting one of the following situations: a) new pharmaceutical form in the country; or b) the new association of active ingredients already existing in the country" is described in Category V (Article 3(III) of the Resolution). A generic substance is classified as Category VI (Article 3(IV) of the Resolution). The company is required to adhere to the regulations of each category when proposing a price. Prices are adjusted annually in accordance with inflation. The Chamber has approved the utmost readjustment of prices by 5.60% for all drug levels in 2023, as outlined in Resolution 1/2023. Authorized readjustment percentages are frequently criticized for failing to keep pace with the industry's cost inflation. However, the actual product sales prices are typically significantly lower than the ceiling, particularly in markets where generic medicines are accessible to consumers.