Abstract
Transparency on drug costs and prices has been debated in the main areas of high-level governance in recent years. Brazil is one of the signatory countries to the Resolution of the World Health Organization on the transparency of the markets for medicines, vaccines, and other technologies and the transparency of the composition of the price of medicines can have an impact on the Brazilian health system. The aim of this scoping review was through documentary and literature analysis for definitions, characteristics, description, and theoretical grounding of Brazil’s attributes related to the voluntary commitments signed in the Resolution. Despite some limitations and barriers to achieving transparency in the composition of drug prices in Brazil, the country has a regulatory framework and successful experiences that can contribute towards improving price transparency. The Brazilian case indicates that transparency laws, policies, and institutional capacity could help provide some additional information for policymakers. Policymakers should also consider the use of health data interoperability standards to share information on the costs and pricing of medicines at all levels.
Introduction
Improving transparency is essential to determine what is fair; however, there is an absence of reliable data on costs of medicines. The prices charged by pharmaceutical companies for the same medicines vary widely, depending on who is the buyer (Ferrario et al., 2020; Morgan et al., 2020). Levels of price opacity are high and increasing. The disconnection between list prices and prices actually paid by purchasers has a number of drawbacks within and between countries (OECD, 2018).
Moon et al. (2020) claim that the paucity of public data on R&D costs, data on manufacturing and distribution costs are not usually made public, and there are no clear norms or guideposts on what is fair or for gauging the overall fairness of profits. There is no consensus on whether pricing should include market costs such as initial regulatory approval, administration, or post-approval surveillance for adverse effects. It is evident that all these categories require data transparency. In this context, transparency is a core value for access to medicines, as a human rights issue (Harvard, 2017; South Centre, 2020). As pointed out by Colbert et al. (2020), the ‘transparency could ensure that the right data are available to the right stakeholders so that practical solutions guaranteeing affordable access to medicines can be implemented’.
Convened by The United Nations Secretary-General, in 2015, a High-Level Panel on Access to Medicines was launched and clarified the discussion about requiring clear information on what it costs to innovate and bring a particular health technology to market (United Nations, 2017). This analysis may also have influenced the internalisation of this agenda by the WHO, culminating in the Resolution WHA72.8 about improving the transparency of markets for medicines, vaccines, and other health products (WHA, 2019).
In addition, in 2017 and 2019, the WHO convened the Fair Pricing Forum to allow stakeholders to discuss options for a fairer pricing system for pharmaceutical products (WHO, 2020a). These forums focused on price-related aspects that constitute barriers to access, in an attempt to find strategies for countries to address these barriers in the short and long term (WHO, 2020b). For the WHO, fair pricing is defined as ‘affordable for health systems and patients and that at the same time provides sufficient market incentive for industry to invest in innovation and the production of medicines’ (WHO, 2020c). However, for civil society representatives, the WHO’s definition of fairness does not prioritize affordability and transparency of R&D outlays, manufacturing costs, and pricing decisions. A medicine price can only be considered fair with full transparency of all R&D expenditures, manufacturing costs, and how the price is decided. This should be considered when setting prices to ensure that the public does not pay twice and receives a public return on public investments or benefits (MSF, 2020).
The Resolution WHA72.8 points to the support of the WHO director general in favor of transparency and monitoring the effect of transparency on the accessibility and availability of health products. Member states must, as of the adoption of the resolution, honor the voluntary commitments contained in the resolution and described in the results of this article. The adoption of the WHA resolution reflects the international debate on the transparency of medical costs and prices aimed at improving public sharing of information on real prices paid by governments and other buyers for health products, along the value chain from the laboratory to the patient. Resolution WHA72.8 is a strategic scenario for Brazil due to the responsibility and magnitude of accessing medicines, while Brazilian Unified Health System is one of the largest public systems for the purchase of medicines, although its budget limits this.
Considering that Brazil is a signatory country of Resolution WHA 72.8 adopted by the WHO, this study seeks to analyze the normative framework and operational conditions in Brazil in relation to this Resolution, as well as pointing out which questions are key to the sustainability of the Brazilian health system.
Health System and Pharmaceutical Market in Brazil
Brazil has the Unified Health System (SUS), a universal, comprehensive, and free public access system, with responsibilities decentralized among federal, state, and municipal governments and with complementary participation from the private sector. The SUS is structured on concepts and principles to promote the effective democratisation of health, which is a huge challenge. The National Medicines Policy and The National Pharmaceutical Policy establish the guidance to ensure the right to access medicines (Brazil, 1998, 2004). Research by the Brazilian Institute of Geography and Statistics (IBGE) shows that the proportion of spending on health in relation to the Gross Domestic Product (GDP) was 9.2%, in which 5.4% of GDP was spent on public health, equivalent to 3.9% of GDP in 2017 (Brazil, 2019b). Between 2008 and 2018, the Ministry of Health spending on medicines practically doubled, from R$ 9 billion in 2008 to R$ 17 billion in 2018 (Silva, 2019). Studies show that the access to prescription medicines for the main chronic non-communicable diseases in Brazil was 94.3% in the country, with 47.5% exclusively in the public health sector (Bermudez & de Azevedo Barros, 2016). Despite making great advances with the SUS, Brazil has failed to meet all the health needs of individuals, particularly as regards the supply of medicines, an important element to fulfill the integrality principle of the health system. The result is a growing demand by citizens, through the courts, for the provision of medicines and treatments that are not covered by the public health network. This phenomenon, known as judicialisation, has become relevant and controversial due to the different interests and actors involved (Vargas-Peláez et al., 2014). Only ten judicialised medications correspond to more than 90% of the total legal expenses in 2018, due to their high price. In which, in the period, some were not registered with the National Health Surveillance Agency (Anvisa) as a medicine Atalureno ‘Translarna’ or were not incorporated in SUS such as Eculizumab ‘Soliris’ and Nusinersen ‘Spinraza’ (Silva, 2019). Another example of excessive price is the case of Sofosbuvir in Brazil, which was launched at US$ 84,000 for 12 weeks of treatment and fell well below ‘access price’ levels set by Gilead and prices as low as are currently available between US$ 537.6 and US$ 10,735 in Brazil (Brazil, 2020a).
The main channels of access to medicines in Brazil are private health establishments, government (public bodies or entities at the federal, state, or municipal level), or other recipients. In this context, of the 6,154 registered products sold and commercialized in 2018, 34.7% are generic medicines, 35.2% are similar medicines and other types of products represent 30.1% of the total. In addition, generics and the like sold together more than 67% of pharmaceutical preparations. As for billing, biological medicines were the ones that showed the greatest growth: in 2016, they represented 19.1%; in 2017, they represented 22%; and in 2018, they accounted for 23% of total pharmaceutical revenues, representing, however, only 2% of total pharmaceutical preparations marketed in 2018 (Brazil, 2019c).
Most of the companies that hold medicine registration use distributors to sell their products on the Brazilian market, which can take place in both the private and public sectors (36). In 2018, sales through distributors accounted for 58.0% of sellers’ revenues and 73.0% of pharmaceutical preparations sold in the country. Direct sales to pharmacies and private drugstores together accounted for 19.0% of the market’s turnover and 18.0% of the quantity sold. The government, in turn, directly acquired 15.0% of the market’s revenue but only 4.0% of the amount sold (Brazil, 2019c).
Therefore, the impact that transparency in the composition of the price of medicines can represent for Brazil is evident.
Methods
This study is designed as a scope review, that is useful to describe broad topic and provide an overview of diverse literature, including different study designs and methodologies, both widely available, and gray scientific articles and reports. This exploratory study was carried out in two steps.
First step: The search for official documents related to the subject of the study was carried out on official websites: Chamber of Deputies; Federal Senate; Legislative and Legal Information Network; Brazilian Ministry of Health (MS); Federal Court of Justice; National Institute of Intellectual Property (INPI) and Anvisa. Institutional websites were searched in a structured manner using the site map and search functions (where available) as well as linked material. Data were collected independently by two researchers. There was no restriction on the date of publication. The initial screening was carried out by analyzing the title and the summary of the references, if any. Exclusion only occurred if the criteria were clear. In case of uncertainty, the reference was not excluded and was revised. Any disagreements were resolved by consensus reached by the two researchers. Table 1 provides a list of visited links.
Realms Considered in the Characterisation of the Information Available in Web Portal Access.
Second step: To complement the documentary analysis, eligible studies were first identified from a search of PubMed and Lilacs, a specific database for Latin American countries. The search was carried out using specific keywords for each voluntary commitment mentioned in Resolution WHA 72.8 with the following general MeSH terms strategy: ‘NET PRICE’, ‘DRUG’, ‘MEDICINES’, ‘COSTS’, ‘PRICE’, ‘PRICING’, ‘TRANSPARENCY’, ‘CLINICAL TRIALS’, ‘DELINKAGE’, ‘REPORT’, ‘INFORMATION’, ‘COMMERCE’, ‘PATENT’, ‘PATENT LANDSCAPE’, ‘HEALTH’, ‘HEALTH INDUSTRIAL COMPLEX’, ‘NATIONAL CAPACITIES’, and ‘BRAZIL’. To increase the sensitivity and specificity of the articles found, the MeSH terms and keywords were combined using the Boolean AND or OR operator, when appropriate. There was no restriction on language or date of publication (see Figure 1). Data extracted from each study included the authors and year of publication, definitions, characteristics, description, and theoretical ground. The two-step search took place between February and April 2020 and the analysis and discussion occur in 2021.
PRISMA Diagram of Literature Search.
Results
In the first step, 29 references, and in the second step, five references were included in this scoping review. Within the 34 references, we categorized the five voluntary commitments of Resolution WHA 72.8 to understand the issues underlying the national standards of global insertion (see Table 2).
Distribution of Included Reference by Categories.
Sharing Public Information About the Net Price
In Brazil, the medicine price registration process is regulated by the Pharmaceutical Market Regulation Chamber (CMED). CMED is a deliberative and executive body in which the Executive Board (SCMED) is exercised by Anvisa, which, since 2003, defines the economic regulation model in Brazil. For a medicine to be marketed in the country, it is necessary to obtain both the health registration at Anvisa and the setting of a maximum ‘ceiling’ price by CMED (Brazil, 2003a, 2003b).
The list of maximum prices allowed for the sale of medicines to retailers and consumers is updated and publicly available monthly for consultation. Pharmacies and drugstores, as well as laboratories, distributors, and importers, cannot charge a higher ex-factory price for medicines than that allowed by CMED. In addition to the list published on the Anvisa website, consumers can also consult magazines specializing in the publication of a maximum sale price to the consumer of medicines, which must be made available by pharmacies and drugstores (Brazil, 2003a, 2003b). The CMED also provides a statistical yearbook for the pharmaceutical market that presents data from the companies’ marketing reports, which companies operate in the national market, the degree of competitiveness in the sector, which groups of medicines were consumed by Brazilians and the volume of resources handled (Brazil, 2019c).
Brazil also provides a database for recording prices of drugs purchased by the federal, state, and municipal governments, the Health Price Database (BPS), which aims to record and make available online information on public and private purchases of medicines and health products (Brazil, 2020b). BPS is open access and any citizen, public, or private institution can access it to check the weighted average price of medicines and health products, weighted by reporting Municipality, unit price per concentration, and pharmaceutical form. In addition, attention is needed with risk-sharing agreements, which provide for payment based on clinical data. Brazil has a pilot project for a risk-sharing agreement for the incorporation of health technologies, to offer access to Nusinersen, a medicine for the treatment of Spinal Muscular Atrophy types II and III under the SUS (Brazil, 2019d).
In terms of publicizing the net price of medicines, that is the price excluded from fees and taxes, Brazil demonstrates that it has several sources of data available for consultation by the population. The question is whether these means are used. No data were found to demonstrate the effectiveness and/or the reach of these sources, in other words, if the citizen knows about his right to buy medicines for a price less than or equal to the maximum price defined in Brazil.
There is no transparency regarding the use of confidential discounts in Brazil and no evidence about any disconnection between list prices and prices paid. Public procurement publishes a summary of the contract or its amendments in the Diário Oficial da União, up to the fifth business day of the month following that of its signature, in accordance with rules for public tenders and contracts.
The MS has a National Database of Actions and Pharmaceutical Assistance Services, which consolidates data from the list of the National Essential Medicines (Rename) and the Program ‘Farmácia Popular do Brasil’, sent by states, municipalities, and federal institutions, such as, for example, the price of each pharmaceutical unit purchased or distributed (Brazil, 2017a, 2019e). However, this structured database is limited to data from public health services or a public–private partnership.
Clinical Trial Cost Data
To follow up the steps of clinical research with medicines and health products in the country, study protocols must be previously approved by the National Commission on Ethics in Research (CONEP) and the Local Ethics Committee (CEP) (Brazil, 2015). CEP must analyze the projects received, in addition to forwarding them to CONEP and Anvisa to issue the special statement and import license. Anvisa is responsible for the evaluation of clinical protocols regarding methodological aspects, health risk, and the correct addressing of questions relevant to future evaluations of the registration of products under investigation. Human clinical trials are regulated in Brazil through a resolution that aims to define the procedures and requirements for conducting clinical trials with medicines in the country (Brazil, 2011). It is important to stress that there is a special procedure for registering clinical trials for rare diseases in which approval for these trials can be granted without the presence of a substantiated opinion from the CEP (Brazil, 2017b, 2017c).
The recent regulatory changes on clinical trials in Brazil also do not deal with clinical trial cost data. In the special procedure for registering clinical trials for rare diseases, it is not guaranteed that the research sponsor will provide detailed data on clinical trial costs. As the number of patients involved is necessarily much lower, the cost of clinical trials for medicines for rare diseases is reduced compared to medicines for other diseases and conditions, and investments in advertising are lower, adding the advantage related to lack of competition (Villardi et al., 2020). As stated above, it appears that there is a normative and regimental framework for the development of clinical research in Brazil, but it still does not consider the availability and access to post-study data and the costs of human clinical trials. No measures were identified that progressively disconnect R&D financing from prices, which would benefit the appropriate Health Technology Assessment, decision-making, combining technological innovation with access to medicines, and consequently promoting the rational use of medicines.
Information About Rebates, Discounts, or Other Transactions Between the Sellers, Sponsors, and Payers/Buyers
CMED is responsible for publishing information on sales revenues, prices, and units sold in Brazil. Annually, CMED discloses the behavior of the pharmaceutical market and data from the marketing reports of these companies, through a document named ‘Statistical Yearbook of the Pharmaceutical Market’ (Brazil, 2019c). Regarding the costs of subsidies and incentives, Brazil has a medicines tax relief and exemption policy, through Law 10147/2000, which provides a special regime for the use of presumed credit for the Contribution to the Social Integration Programs and for the Formation of the Civil Servant’s Assets (PIS/Pasep) and the Contribution for the Financing of Social Security (Cofins), intended for legal entities that proceed with the industrialisation or the import of specific products (Brazil, 2000). Approximately 65% of the products sold are exempt from PIS/Pasep and represent almost 70% of annual sales (Silva, 2019).
It is important to point out that Cofins is the main source of revenue of the MS. It is a tax benefit granted to companies, with the objective of reducing prices and expanding the population’s access to medicines, essential to guarantee the right to health. Thus, it constitutes an important instrument of the National Pharmaceutical Policy, which proposes a wide range of actions with the objective of guaranteeing access and the rational use of medicines for the promotion, protection, and recovery of individual and collective health. However, it is important to demonstrate the efficiency on these tax exemptions to be reversed in economic and social benefits (Brazil, 2004). The granting of tax benefits is subject to a system established by CMED, which specifies, at the federal level, the taxation of medicines according to a tax classification defined in a positive, negative, or neutral list, to try to guarantee an impact on prices due to the reduction of the tax burden on medicines. In addition, CMED is responsible for establishing criteria for price setting and re-pricing, which occurs annually, based on a model for setting ‘ceiling’ prices (Brazil, 2003a, 2003b). According to a bulletin prepared by the Ministry of Economy, which analyzes the policy of exemption from medicines, in 2018, R$ 11.8 billion was spent on this tax subsidy, equivalent to 4% of the total federal tax expense, an amount close to the direct expense of the provision of medicines via SUS, which registered R$ 13.9 billion (Brazil, 2020c).
Another instrument used in Brazil to give greater efficiency to the resources used in health is the Price Adequacy Coefficient (CAP), which is the mandatory minimum discount percentage levied on the ex-factory price, resulting in the maximum price for public procurement. The CAP value is updated annually by CMED. The discount applies in two situations: purchases of medicines on the list of medicines subject to the CAP or purchase of any medicine due to a court decision.
In Brazil, the number of units of medicines sold, as well as the price of medicines purchased by the government are public, as are the reports with maximum selling prices, published by CMED monthly. However, there is still a big gap regarding the availability of a disaggregated database with prices in all Brazilian municipalities and states. While annual sales data are available for top-selling products, having more complete reports allow policymakers and researchers to perform the required analyzes. Brazil does not have a policy for detailed disclosure of public subsidies in the form of donations, research, R&D contracts, low-interest loans, tax credits, or other government grants for the pharmaceutical industry.
For Brazil to collaborate to improve the reporting of information from suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives, robust, and standardized database has the potential to support the monitoring and evaluation of prices and new strategies to reduce barriers to access to medicines, taking into consideration the economic and geographical diversity of Brazil, SUS principles and its modalities for access to medicines and standards health data interoperability (Brazil, 2017d, 2020d)
It is noteworthy that the consumption of medicines is influenced, among other factors, by the low elasticity of demand at the price, considering that it is an essential good to guarantee the maintenance of medicine therapy and mitigation of suffering (Américo, 2017; Brazil, 2020c). Therefore, people may be compelled to acquire them even if market prices are high, compromising a high percentage of household income, especially for those with lower incomes (Brazil, 2020c; Soares et al., 2019).
Patent Landscape
The analysis of patent applications in the country is carried out by INPI, which provides a database of patents. In a report by the Institute for Applied Economic Research (IPEA), it was recommended that the INPI ‘participate more actively in the definition of the list, for example, through consultations and reports on expiration of patents, technology prospecting through patents and possibility of second use of medicines’ (Varrichio, 2017).
Within the scope of the Legislative, the Interministerial Group on Intellectual Property (Gipi) was created through Decree 9931/2019, with the purpose of proposing actions and coordinating the Federal Government’s performance in the area of intellectual property. The role of this group is to propose recommendations to improve public reporting of patent status (Brazil, 2019f). In addition, through Ordinance Joint Anvisa and INPI 01/2017, and Ordinance 168/2017, an administrative procedure was regulated regarding the prior consent of Anvisa for the granting of patents for pharmaceutical products and processes, after analysis to public health and of interest to SUS (Brazil, 2017e, 2017f). In addition, bill 1462/2020 is in progress at the National Congress, which provides for flexibility in the rules for the compulsory licensing of medicines, supplies, and health equipment (Brazil, 2020e).
Access to patent applications filed in Brazil can be done in the INPI database, which must be strengthened by improving information on patent status and marketing approval status for health products. However, an international database standardized with patent status and market entry status in each country can have a positive impact on monitoring the technological horizon and the transparency of the pharmaceutical market in Brazil. In this context, Brazil has the technical and regulatory potential to achieve this commitment with enhanced public reporting of information on patent status, health product marketing approval status, and situations in which data exclusivity has been applied in free trade agreements (Brazil, 2020d).
National Capacities
In the field of consolidation of the regulatory framework on the national production of medicines, Decree 9245/2017 stands out, which institutes the National Policy for Technological Innovation in Health (PNITS) with objective to promote the technological and economic sustainability of SUS, defining the structural conditions to increase the productivity and innovation capacity of Brazil. It has a view to contribute to expanding access to health, in addition to encouraging innovation and scientific research and technology in the productive environment and promote technological training, reach of technological autonomy, and the development of the national and regional productive system in the area of health (Brazil, 2017g).
This policy can assist in building national capacity for rapid response to public health incidents and emergencies. Brazil has more than 20 public laboratories capable of providing treatments for various diseases and has potential to work together in an R&D platform for open innovation. It should be noted that with the advent of the pandemic caused by the COVID-19 virus, the National Health Council published Recommendation 27/2020, which recommends actions to confront COVID-19 to the executive, legislative, and judicial branches. Among the recommendations is the ‘stimulation of a policy of industrial conversion of the industrial park to meet the demand for health equipment’ and approval of ‘credit lines for the expansion of the technological and productive capacity of the national laboratories of medicines and supplies to face the pandemic’ (Brazil, 2020f).
With the new statute of the current federal government, the Department of the Industrial Complex and Innovation in Health (DECIIS), responsible for the implementation of public policies to strengthen the industrial complex and monitor the PNITS, was extinguished (Brazil, 2019g, 2019h). Policies, guidelines, strategies, and goals related to the health industrial complex have been weakened and; therefore, it is necessary to assess whether this fragmentation can have potential or harmful effects in strengthening national drug production capacities.
The policy that encourages Public–Private Development Partnerships (PDP), which take place between two or more public institutions or between public institutions and private companies, towards a gradual reduction in prices, economics, economic sustainability, and advantages through national public production of medicines, needs to be better evaluated and publicized. Silva and Elias (2019) propose the elaboration of price studies of the products object of these partnerships. Varrichio (2017) says ‘there is an enormous difficulty in the survey and in the systematisation of data related to the purchases of the MS that can demonstrate savings of these public purchases, because this data is found dispersed in several bases’. An annual list of strategic products for SUS is published with a view to forming PDP; however, the last list was only published in 2017, which may be indicative of disinterest in the use of PDP since the huge political changes Brazil has experienced this time. The guarantee of access to medicines as a fundamental human right presupposes, among other issues, the mastery of knowledge for local production of strategic products and the health and economic regulation of the pharmaceutical market (Brazil, 2017h; Vieira, 2019).
As a strategy to strengthen the health industrial complex in Brazil, the PDP expanded the national technological density. However, according to Guimarães et al. (2019), they have emphasized partnerships involving the transfer of technologies that are no longer under patents or even in the phase of declining their life cycle, but there is a gap in the scope of original technology development projects, which is reflected in the persistent dependence on pharmaceutical products, as pointed out by the trade deficit of R$ 5.8 billion in 2018 (Associação da Indústria Farmacêutica de Pesquisa, 2019). As for the costs of advertising drugs, public laboratories cannot exceed certain percentages, due to their public nature. This can be used to contrast the difference between public and private laboratories with this argument for establishing the total cost. Recently, Anvisa published initiatives that could impact national drug development: exemption from the criteria for establishing or adjusting ex-factory price, with PMC regulated by CMED for certain drugs and the institution of a Working Group with the objective to propose criteria for pricing medicines that bring incremental innovation to CMED (Brazil, 2019i, 2019j). To date, there are no results on these initiatives in the innovation of medicines by Brazilian pharmaceutical companies.
Discussion
Some Progress After the Publication of the Resolution WHA 72.8. Around the World
The related transparency in the cost of R&D and clinical trials mentioned in Resolution WHA 72.8 is only voluntary when the information is available to the public, different from the initial draft resolution (KEI, 2019). Furthermore, it was found that the version of this resolution, dated April/2019, required that the pharmaceutical industries, when requesting the registration of medicines, had the obligation to submit information related to the delinkage of R&D costs in the entire production chain, including the costs of clinical trials and information on public subsidies received for health product development. Despite this, Resolution WHA72.8 represents an important achievement for health. Since then, important progress has been highlighted in this field, in which no direct relationship between progress and resolution has been investigated.
The Declaration of the Health Ministers of Malta, Cyprus, France, Italy, Greece, Portugal, and Spain (2019) expressed concern about the drug price disparities presented by the pharmaceutical industry and affirmed that it is a shared challenge. The importance of carrying out joint and transparent negotiations for the purchase of medicines was highlighted, as well as the need to send the declaration to the European Parliament. South Africa delivered a statement at the WTO TRIPS Council on transparency of R&D Costs and Pricing of Medicines and Health Technology in October/2019. This presents questions related to the experiences and actions of member states regarding the transparency of costs and prices of medicines (KEI, 2020a).
The Pan American Health Organization (PAHO) and the Ministry of Health of Costa Rica organized the Meeting of the Regional Initiative for Information Exchange on Prices, Coverage and Economic Regulation of Health Technologies, with participation of representatives from Argentina, Brazil, Bermuda, Chile, Costa Rica, Ecuador, El Salvador, Honduras, Paraguay, Uruguay, and an international expert from South Korea attended. Among other topics, the meeting debated the negative implications of the lack of transparency on the prices of medicines and medical devices and highlighted the importance of transparency in Regional actions (PAHO, 2020).
The Regulations Amending the Patented Medicines Regulations in Canada were published. The amendments include adding new price regulatory factors, so value for money and affordability can be taken into consideration, requiring patentees to report price and revenue information that is net of all price adjustments such as direct or indirect third-party discounts or rebates and greater transparency, including elaboration of cost impact modelling assumptions and calculations. The new draft of Patented Medicine Prices Review Board Guidelines is available for public consultation in Canada (2020a, 2020b).
Furthermore, the Committee on Finance, Senate Report for a bill on the Prescription Drug Pricing Reduction Act, to ‘lower prescription drug prices in the Medicare and Medicaid programs, to improve transparency related to pharmaceutical prices and transactions, to lower patients’ out-of-pocket costs, and to ensure accountability to taxpayers, and for other purposes’ (United States, 2020). There are also other bills introduced in the US Congress that include drug price or R&D transparency provisions (KEI, 2020b).
Transparency provisions were inserted in the French Social Security Budget Bill for 2020, which was expected to make public the amount of public investment in R&D from which pharmaceutical companies benefited for the development of medicines. The amendments were subsequently rejected; however, they are expected to be regulated in the form of a Decree (France, 2020; Mediapart, 2020). Meanwhile, Italy is about to publish a Decree that introduces updated and appropriate criteria for transparency of prices and costs of medicines, which has already been signed by the Health and Finance Ministers, and only needs to be published in the Official National Gazette (Italy, 2020).
Within the scope of data sharing standards, the report was published, issued by the European Medicines Agency (EMA), ‘HMA-EMA Joint Big Data Taskforce Phase II report: Evolving Data-Driven Regulation’, containing medicine (safety and efficacy) data sharing initiatives to help industry and regulators develop and oversee medicines (EMA, 2020). These initiatives could also be extended to share data on prices, costs, and other financial data on medicines. Brazil already has regulations for the definition and adoption of health information interoperability standards through the ‘National Health Data Network (RNDS) that allows the receipt, storage, availability, access and analysis of data and health information’ among public and private health establishments and health management bodies. This may pave the way for specific regulations regarding data on medicines (Brazil, 2017a, 2020a).
Finally, in March/2020, the government of Costa Rica submitted a letter to the WHO in which it proposes that the WHO make feasible mechanisms for the exchange and use of information and requesting that the Global Observatory on Health Research and Development create a database on R&D activities related to COVID-19, including estimates of the costs of clinical trials and subsidies (Costa Rica, 2020).
These are some possibilities whose example can collaborate with Brazil. It is worth considering that it is the responsibility of the Brazilian State, in addition to the implementation of relevant public policies at the national level, to have the capacity to act on the international stage in favor of national public health interests and the primacy of the right to health over commercial interests as state policy, especially in the face of the constant pressure exerted, both in multilateral forums and bilaterally, by developed countries, whose realities and interests are often different from those of Brazilians (Brazil, 2019a).
A Step Towards Improving Price Transparency in Brazil
The high prices associated with the launch of new products, especially for hepatitis C, oncological medicines and biotechnology products, certainly effective, presents new and greater challenges to guarantee universal access to health care at costs and prices accessible in Brazil (Bermudez, Auxiliadora, & Costa, 2016). The implementation of transparency of prices and costs of medicines in Brazil takes place amidst the current crisis surrounding the Brazilian scenario of budgetary, economic and federative beings, and application of fiscal austerity policies, which has further aggravated the health situation of Brazilians (Castro et al., 2019; Doniec et al., 2016).
Approximately 77.7% of the Brazilian population, around 164.4 million people, use only SUS to have access to health services and most health insurance does not even cover most essential care measures in health (Brazil, 2020g). In this scenario, newly incorporated drugs (especially high-priced ones) may be ‘competing’ for the same budget with more essential medicines. The sustainability of the provision of health technologies in SUS is also challenged by the strong growth of ‘judicialisation’ for access to medicines and other high-priced technologies (Massuda et al., 2018; Vargas-Peláez et al., 2014). It is important to note that Brazil has a National Health Council, an institutional instance of policy control and social participation, in which it represents sectors of civil society, scientific entities, workers, and government, have inter-sectoral commissions that monitor and supervise the actions and services of the SUS. Among them, we highlight the inter-sectoral Commission on Science, Technology, and Pharmaceutical Care (Brazil, 2008).
In Brazil, medicines remain an important component of the budget for low-income families. The deficit in access to medicines was analyzed by the Ministry of Economy, which ‘found that the expenditure of families with medicines affects about 6.5 million people and that its incidence is quite unequal, 42% of people in this situation are among the poorest 10% of the population’ (Brazil, 2020c). With austerity policies and profound impoverishment of a large part of the population, this scenario can be aggravated.
In this sense, the implementation of Resolution WHA72.8 has the potential to strengthen international cooperation between member countries and influence current regulatory and purchasing policies for medicines and contribute to measures to address the abuse of applied prices and dependence on international medicines. Furthermore, it is urgent that the WHO encourages the strengthening of the national capacities on medicine production of the member states, with open collaboration and exchange of information that reduces the cost of developing the desired innovations, leading to more accessible prices for all peoples, where public health interests prevail over commercial interests (Suleman et al., 2020).
This deeper knowledge of the terms of Resolution WHA72.8 may provide further studies. With this information, it will be possible to present paths in the light of material, economic, and political adversities and also failures and successes to guarantee the realisation of the right to health, especially in the context of the global South. Transparency laws, policies, and institutional capacity could help provide some additional information for Brazilian policymakers, to make more medicines available at more affordable prices and collaborate with better outcomes in health.
Conclusion
The results show Brazil has an important regulatory framework and successful experiences that can contribute towards improving price transparency. However, the future of transparency in public policy issues is currently uncertain in Brazil, as evidenced by the example of the authorities’ intention to hide health data during the COVID-19 pandemic. The main gaps in the Brazilian regulatory framework regarding the five topics underlined by the Resolution WHA72.8 are as follows: lack of transparency about the use of confidential discounts, insufficiency on investment in R&D with disclosure of unlinked cost, there is no database with voluntary information on medicines costs and absence of regulation that includes actions, competence, and duties to reach transparency of the pharmaceutical market in Brazil.
Footnotes
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Funding
The authors received no financial support for the research, authorship and/or publication of this article.