Outlook for 2022 - Health

INTRODUCTION

With the advent of the Covid-19 pandemic, health has consolidated itself as one of the central themes and, eventually, a priority on the political and economic agenda of the government, in the national and international contexts.

The outbreak of an unprecedented health crisis led to a large-scale increase in demand for pharmaceutical ingredients, protective equipment and health products, putting pressure on the political class to articulate actions to increase production capacity, acquisition and distribution of strategic inputs. Furthermore, initiatives aimed at conducting clinical studies with vaccines, the development of the Brazilian industrial complex and innovation in access to health services have also gained notoriety over the last few years.

In 2022, the third year after the start of the pandemic, discussions on the adoption of measures restricting the movement of people in public spaces and borders, as well as on vaccine coverage, industrial property, health regulation and private assistance should continue to be in evidence. In this context, the dialogue between the Three Powers must remain one of the main challenges for the government of President Jair Bolsonaro.

Even so, with the reduction in the number of hospitalizations and deaths from Covid-19, due to the advance of vaccine coverage, and the approach of the 2022 general elections, the tendency is for the political class to seek to establish alliances to make possible a possible reelection. In addition, relevant changes are expected in strategic positions in the Ministry of Health (MS) and the National Health Surveillance Agencies (Anvisa) and Supplementary Health (ANS).

In this way, strategies to optimize dialogue with other government entities and resume agendas that were previously stagnant or secondary should gain more and more space on the government's agenda. However, it is important to note that variables such as new mutations of the coronavirus and new waves of contamination have the potential to bring untimely impacts to the plans of the Three Powers this year.

EXECUTIVE POWER

Palácio do Planalto and the most aligned entities of the Federal Government have maintained their position in relation to most health issues, especially the Covid-19 pandemic. President Bolsonaro remains resistant to encouraging vaccination for adults and children, as well as adopting measures restricting the transit of people and products in public spaces and borders.

This orientation led to friction with entities of the Three Powers in the last year, especially with Anvisa, the Federal Supreme Court (STF) and opposition parliamentarians in the National Congress. In this context, the tendency is for the President to seek to strengthen alliances already established with Centrão parties in the Legislature, in order to make possible the advancement of priority agendas, such as the reformist agenda, and strategic results for the government in deliberations of Vetos and Provisional Measures ( MPVs).

Furthermore, with the approach of this year's general elections, more than 10 ministers are expected to leave their positions in order to run for elective positions, among them the current Minister of Health, Marcelo Queiroga. Such initiatives have also been articulated by the President, with the aim of strengthening his base of support in Congress if he is reelected.

Furthermore, with the advancement of political configurations for the Elections, the pre-candidates for the presidency intensify the articulations to define the future responsible for the health area in their teams. Until then, only Sérgio Moro has officially announced his choice for the position in his future campaign, which will be assumed by Denizar Vianna, who was secretary of the SCTIE/MS during the administrations of the former ministers of Health, Henrique Mandetta and Nelson Teich, in under the Bolsonaro government. In this context, the name of former Minister of Health and current federal deputy Alexandre Padilha (PT/SP) has been quoted to coordinate the area of health in the future political campaign of former President Lula.

Queiroga's appointment to the MS was initially well received by both the medical profession, for his technical profile as a cardiologist, and politics, for having experience in leading institutions such as the Brazilian Society of Cardiology (SBC), of which he was president.

However, the same alignment with the Planalto that allowed him to avoid friction with the President also earned him criticism from the medical and social classes, who consider the Minister's stance ambiguous and, at times, misaligned with science. As a result, professionals in the field made an attempt this year to revoke the honorary vice president position held by Queiroga at the National Academy of Medicine (ANM), considered the most relevant institution in the sector in Brazil, which did not prosper.

In this context, there was a cooling off of the Minister's speech in relation to his participation in the elections. Even so, there is a possibility that he will be replaced in April, an opportunity in which Bolsonaro should seek to allocate a personality even more aligned with the government and with a more incisive stance, which could help to consolidate his electoral base this year, to the detriment of the loss in the potential for dialogue with technical and/or opposition groups, something in which Queiroga has a relative advantage.

At the state level, the main axis of dialogue must remain in the context of the Tripartite Intermanager Commission (CIT), which brings together the three managing entities of the Unified Health System (SUS): MS, the National Council of Health Secretaries (Conass) and National Council of Municipal Health Departments (Conasems). The CIT is focused on public policy discussions and the incorporation of treatments and services into the SUS. As a result, it has functioned as a channel for greater dialogue with the states compared to direct contact with state/municipal governments or their representative associations.

PUBLIC POLICY

Earlier this year, MS articulated the update of the National Covid-19 Testing Expansion Plan (PNE-Teste), with the objective of promoting self-testing as a complementary instrument of the national strategy for testing against the disease. The formalization of the initiative as a public policy was carried out so that Anvisa could proceed with the release of self-tests for lay users, in order to optimize screening and isolation of positive cases.

However, it is important to point out that the release by Anvisa of the self-tests will only allow the submission of applications for registration of these products by companies regularized at the Agency, which will depend on technical approval for commercialization in pharmacies and drugstores. Until then, Anvisa approved 2 self-test registration requests, the “Novel Coronavirus (Covid-19) Autotest Antigen” and the “COVID Ag Detect”, whose marketing is authorized. Despite this, no type of self-test will be made available free of charge by MS through SUS.

Currently, the ministry is working on running a campaign against the coronavirus, aimed at disseminating and providing guidance on the stages of childhood vaccination, testing and application of the 2nd dose and the booster dose against the virus, aiming to increase prevention actions, especially in regions with low vaccination coverage. The topic will also be addressed within the scope of the Technical Advisory Board on Immunization of Covid-19 and the Brazil Genome Project, aimed at mapping and sequencing genomes to facilitate drug and vaccine research.

Innovation in vaccines should also be the protagonist of discussions and measures carried out within the scope of the Virus Network Specialist Committee, established within the scope of the Ministry of Science, Technology and Innovation (MCTI). As announced by the ministry this month, the agency played a relevant role in articulating with academic and research institutions in scientific projects related to the pandemic.

One of the institutions that are part of the Committee, Fundação Oswaldo Cruz (Fiocruz) made available this month the first doses of the vaccine against Covid-19 with an API of entirely national production. This year, the Virus Network is expected to promote articulations aimed at advancing projects in favor of the genetic sequencing of the coronavirus, the production of national technologies for medical/hospital use and, mainly, testing against Covid-19.

Throughout 2022, the MS will also promote campaigns related to the prevention of early pregnancy, leprosy and acute myocardial infarction. The latter had the closest involvement of the Minister, due to its area of medical specialty. In addition, the portfolio provides for the implementation of a public policy aimed at reducing maternal mortality and infant mortality, which is being developed within the scope of the Secretariat of Primary Health Care (SAPS) and aims to combat the increase in registered maternal mortality rates. especially after the start of the pandemic.

Also noteworthy are the institutional discussions regarding the incorporation of new treatments for health, developed within the scope of the National Commission for the Incorporation of Technologies in the SUS (Conitec). The agency has a strategic role for the portfolio and should remain in evidence mainly due to the outcome of the decision not to accept chapters of the agency's guidelines for the treatment of Covid-19, which rejected the use of the so-called Covid Kit.

The incorporation of treatments both in the SUS and in private health is in evidence in all spheres of government, which should be maintained throughout the year. The repercussion of the theme and the approach of the General Elections should increasingly drive other movements of authorities in the MS and related bodies, a perspective evidenced by the recent departure of Mayra Pinheiro, known as "Captain Chloroquine" from the portfolio to assume a position in the Ministry of Labor and Social Security (MTP) and, later, to compete in Congress for the state of Ceará, as well as for the nominations: i. career servant Sandra Barros for the Secretariat of Science, Technology, Innovation and Strategic Health Inputs (SCTIE); ii. from nurse Maíra Botelho to the Department of Specialized Health Care (SAES); and iii. from the ex-secretary of SCTIE, Hélio Angotti, to the Secretary of Management of Work and Education in Health (SGTES). In the future, other changes can be expected in the Cabinet of the Minister and in units of the Executive Secretariat.

HEALTH SURVEILLANCE

The prospects for Anvisa's performance this year are related to the Regulatory Agenda (AR) 2021-2023, which establishes regulatory projects on products subject to health surveillance, which must be deliberated by the Agency's Collegiate Board between this year and the next.

The initial version of the AR published in May 2021 had a list of 146 regulatory projects, which is reviewed annually in order to keep it aligned with the agency's priorities and strategic objectives. After this year's update process, AR now has 158 regulatory projects, divided into 16 macro themes.

The increase in the number of projects is the result of the review and simplification processes of normative acts, due to the Covid-19 pandemic. For this year, the main expectation is that measures related to the food registration process, the review of the regulatory framework on over-the-counter medicines, the expansion of health services and the sanitary criteria for the operation of vaccination rooms in the country will be deliberated. .

Despite this, Anvisa also evaluates, on an extraordinary basis, proposals not included in the AR. Currently, the total number of proposals evaluated by the Agency is segmented as follows:

Source: Anvisa Portal.

It is worth mentioning that Anvisa is the Executive Secretary of the Medicines Market Regulation Chamber (SCMED), an interministerial body responsible for establishing the factors used in the annual calculation of the maximum value of medication readjustments. Negotiations on the topic are in progress and the expectation is that they will be concluded in the first half of the year. Regarding the pricing of medicines, new moves are also expected around the proposed tax burden for the category, in the case of progress of the Income Tax Reform in the National Congress.

Other topics in evidence are the approval of: i. innovative treatments for rare diseases, including gene therapy with T cells of chimeric antigen receptors, known as “CAR-T” and other technologies in the field of cells, blood and tissues, which recently became part of the scope of the Second Directorate; ii. drugs developed with cannabis; iii. drug and medical device coding and serialization standards; iv. toxicological evaluation of pesticides; v. revisions and consolidations of standards; international regulatory convergence in food, medicine, cosmetics and sanitizing products; saw. waste management of health services and transport of dangerous products; vii. combating piracy of products subject to sanitary surveillance; and remote inspection of imported products.

Finally, it is worth noting that, unlike the 2019 scenario, Anvisa has 5 full members on the Collegiate Board, ensuring the deliberative quorum for the coming years. Among the current terms, only that of the director of the Third Board, Cristiane Jourdan, ends this year, on July 24th. Despite the President's interest in making a nomination more aligned with the government, the reappointment of the Director remains a viable alternative.

SUPPLEMENTARY HEALTH

At the beginning of this year, the regulation of supplementary health within the scope of the ANS occupied a prominent position in the National Congress, with the approval of the Conversion Bill (PLV) 29/2021, coming from Provisional Measure (MPV) 1067/2021, which deals with the updating of supplementary health coverage.

The matter amends the Health Plans Law (Law 9656/1998), to establish a new process for updating the list of procedures and events in health, within the scope of the Agency, as well as creating the Commission for the Update of the List of Procedures and Events in Supplementary Health (Cosaúde), which is already in operation.

From the sanction of the matter by President Bolsonaro, the ANS will have a period of 180 days, extendable for another 90 days to analyze administrative processes for updating the list, a period equal to that of Conitec, with the exception of cancer drugs.

ANS actions in 2022 will be governed by the Annual Management Plan (PGA), which includes 29 actions and projects, which are divided into Institutional Results, Internal Processes and Infrastructure and Learning.

Furthermore, the validity of Regulatory Agenda 2019-2021 will be extended to 2022, with the aim of enabling the conclusion of regulatory projects that were not completed by the end of the last year. In this sense, the ANS still has to deliberate on matters of 16 topics related to the axes of balance of supplementary health, improvement of the regulatory environment, institutional articulation and strengthening of institutional governance.

After the regulation of Cosaúde and the implementation of the requirements arising from the sanction of PLV 29/2021, the most awaited decision in Supplementary Health is the annual readjustment factor of the values of individual health plans. In 2021, for the first time in the historical series, the ANS defined a negative factor for the adjustment in the category, which was set at -8.19%, mainly due to the drop in private assistance services.

While experts consider the event as an indication of a drop in demand for private assistance services, with an emphasis on individual plans, the Agency argues that the outbreak of the pandemic and the consequent measures of social isolation and postponement of elective surgeries and procedures, or that is, non-emergency, culminated in the negative character of the factor, to function as a form of compensation for the deficit in assistance in relation to the amount paid by consumers.

It is noteworthy that the ANS must define the new adjustment factor for health plans by April, which must be applied between May 2022 and April 2023. In the current context, the definition by CMED of the annual price adjustment factors of medicines, the progress of discussions on Tax Reform, regarding the tax burden on medicines, and the pressure from Congress and Civil Society for mandatory coverage of expensive treatments, such as those for cancer, genetic disorders and rare diseases, may significantly impact the demand for private assistance throughout the year. In this sense, initiatives in favor of digital health and telehealth services can progressively evolve, with the aim of balancing the provision of care and providing a greater degree of sustainability to the supplementary health market.

Finally, there is an expectation of holding hearings and voting for nominees to assume positions on the Collegiate Board of Directors of ANS. the names of Maurício Nunes da Silva and Eliane Aparecida de Castro Medeiros have already been approved in the Senate, while the names of Daniel Meirelles Fernandes Pereira it's from Jorge Antonio Aquino Lopes are still waiting for Sabbath at the House.

INTERNATIONAL

At the international level, Brazil's recent approval to represent the Americas in the World Health Organization's (INB/WHO) Intergovernmental Negotiating Group stands out, aimed at discussing a draft international instrument on pandemics. The INB meetings will begin in February and will be attended by delegations from South Africa, Egypt, the Netherlands, Japan and Thailand.

The group expects to create, by the end of 2024, an international instrument to help the global capacity to face possible new health emergencies. The Brazilian delegation will be formed by the Ministries of Health and Foreign Affairs.

In addition, with the intensification of international meetings that were previously secondary to the pandemic, Anvisa is expected to increase participation in international forums of regulatory convergence, such as the International Council for Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (ICH, in acronym in English, as well as progress in discussions on harmonized standards within the Southern Common Market (Mercosur).

Another topic that has been gaining notoriety within Anvisa is the pilot project developed in partnership with the United Nations Development Program (UNDP/UN) for the inspection of irregular products. This month, the Agency presented the first results of the initiative, which began in 2021 and will remain in effect until October 2023. Thus, new initiatives of cooperation and international convergence are expected to optimize the fight against piracy of products subject to health surveillance.

LEGISLATIVE POWER

Within the scope of the Legislature, the expectation is that the legislative proposals listed by the Federal Government within the scope of the Priority Legislative Agenda for 2022. In the context of health, the following matters were listed:

PLS 589/2021Provides for measures to control the quality of medicines in the post-registration period.Chamber of Deputies
PL 2552/2021Amends Law No. 11,903, of January 14, 2009, which “provides for the tracking of the production and consumption of medicines through technology of capture, storage and electronic transmission of data”, to extend the deadline for implementation of the National System of Drug Control.Chamber of Deputies
PL 1613/2021Amends Law No. 8080, of September 19, 1990 (Organic Health Law), to provide for the processes of incorporation of technologies into the Unified Health System (SUS) and on the use, by SUS, of medicines whose indication of use is different from that approved in the registration of the National Health Surveillance Agency (Anvisa).Presidential Sanction

It should also be highlighted the Bill (PL) 2583/2020, which aims to establish a National Health Strategy, focusing on the development of the industrial complex of the sector in Brazil. The matter should be part of the priority agenda of the Social Security and Family Commission (CSSF) for this year, along with the other projects listed above.

Additionally, the Social Affairs Commission (CAS) and the Senate Plenary are expected to hold prominent discussions regarding the pandemic, especially regarding labor legislation and industrial property, as well as votes by authorities for Anvisa and ANS. Due to the approach of the elections, a greater protagonism of the Parliamentary Fronts in Congress is also expected.

Also, topics related to industrial property, technology transfer and patent granting should remain in evidence in the first half of this year. There is expectation of deliberation, in March, on the Veto 48/2021, which deals with the breach of patents for vaccines and medicines for Covid-19. In addition, progress is expected in discussions regarding possible revisions to the criteria for the production, labeling and marketing of food in general and products for infants and children.

FORJUDICIAL ORDER

In the Judiciary, discussions should mainly focus on STF decisions on maintaining the requirement for a health passport for travelers to enter the country. The judgments of actions related to the possibility of requiring proof of vaccination to maintain jobs should also be highlighted and, possibly, intensify the points of friction that already exist with the Planalto. In addition, the Supreme Court must remain vigilant in relation to possible new episodes of cyber-attacks on the Ministry of Health's data systems, due to the possible risks to the consolidation and transparency of SUS data.

Contrary to what was expected, the Supreme Court did not complete the assessment of the Allegation of Noncompliance with Fundamental Precept (ADPF) 913/2021 until mid-February. Given the prioritization of themes related to party federations, budget guidelines for this year, among others, the tendency is for the issue to be pacified only after Carnival.

Additionally, the Superior Court of Justice (STJ) is currently judging 2 appeals whose central theme is the definition of the exhaustive or exemplary nature of the ANS Role. Although the vote of the rapporteur, Justice Luis Felipe Salomão, is due to the exhaustive nature of the list, Justice Nancy Andrighi presented, on February 23, a vote due to its exemplary nature. As a result, the collegiate decided to postpone the vote on the matter to grant a joint view to the ministers. The expectation is that the topic, which is already the subject of discussion in Congress in favor of Minister Andrighi's vote, will have its deliberation concluded only between March and April.

Bulletin updated on 02/24/2022

Wrote by Umbelino Lôbo Team: Juliana Oliveira, Analyst.

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