Life Sciences 2024 Comparisons

Pharmaceuticals and medical devices in Brazil are regulated by Federal Laws and Resolutions (known as “Resoluções” or RDCs) issued by ANVISA, the National Health Regulatory Agency.

Key legislation for pharmaceuticals includes:

• Law 5,991/1973, known as the Law of Sanitary Control of the Distribution and Sale of Medicines, which regulates the distribution, sale and control of medicines and related products.
• Law 6,360/1976, the primary statute for pharmaceutical products, covering production, commercialisation, advertising, labelling, quality control and penalties.
• Law 6,437/1977, which outlines penalties for violating federal sanitary statutes and regulations.
• Law 9,294/1996, which imposes restrictions on the use and advertising of specific products.

Key legislation for medical devices includes:

• RDC 751/2022, amended by RDC 810/2023, which establishes rules for risk assessment, notification procedures, registration, labelling and use of medical devices.
• RDC 830/2023, which sets the validity term for medical device marketing approvals.
• RDC 36/2015, amended by RDC 549/2021, which establishes rules for in vitro diagnostic devices.
• RDC 657/2022, which regulates software as a medical device (SaMD).
• Normative Instruction 290/2024, under the terms of RDC 741/2022, which establishes a procedure for analysing medical device registration petitions, utilising analyses by an Equivalent Foreign Regulatory Authority (AREE).

ANVISA operates independently within the Ministry of Health as the primary regulatory authority. It oversees the production, marketing and utilisation of health-related products and services, as well as supervising ports, airports and borders. ANVISA functions as a semi-autonomous agency, with administrative and financial autonomy but linked to the federal government (Ministry of Health). Oversight and budgetary control are provided by the Ministry, while ANVISA’s board of directors, composed of technical experts, makes science-based decisions regarding regulations and approvals.

Regulatory decisions in the pharmaceutical and medical field can be contested through administrative appeals, either directly to the relevant regulatory authority or via lawsuits in federal courts.

The process for filing administrative appeals against ANVISA’s decisions is governed by Law 9,784/1999, which regulates administrative procedures within the Federal Public Administration, and RDC 266/2019. ANVISA’s decisions undergo a maximum of three instances:

• First instance – decisions by Organisational Units
• Second instance – Appeals Division (“Gerência-Geral de Recursos” or GGREC)
• Final instance – Collegiate Board of Directors (“Diretoria Colegiada” or DICOL)

First instance appeals are directed against decisions issued by ANVISA’s Organisational Units and must be addressed to the authority responsible. If unresolved initially, appeals are reviewed by the General Appeals Management at the second stage and, if necessary, escalated to the Appeals Division (GGREC) and ultimately to the Collegiate Board of Directors (DICOL).

Appeals must adhere to formal requirements outlined in RDC 266/2019, Article 4 onwards, and must be submitted in writing. The deadline for appealing an ANVISA decision is 30 days from the notification date.

Similar challenges can be applied to other regulatory matters under ANVISA’s jurisdiction, such as food, cosmetics, sanitisers and tobacco derivatives.

ANVISA categorises pharmaceutical products based on their active pharmaceutical ingredient (API) and innovative characteristics as outlined in RDC 753/2022, as can be seen below:

Pharmaceutical Categorisation (RDC 753/2022)

• Reference drug: An original, rigorously tested drug approved by ANVISA.
• Generic drug: A cost-effective alternative drug with the same ingredients, form and effect.
• Innovative drug: A drug that features new molecules, combinations or delivery methods.
• New drug: A drug that contains previously unapproved molecules.
• Similar drug: A drug that is similar to a reference drug with minor variations.

Medical Device Categorisation (RDC 751/2022)

Categorised by use and risk:

• Active medical device: Operates with external energy, alters density of gravity or converts energy.
• Diagnostic and monitoring device: Provides information on health states.
• Therapeutic device: Modifies, replaces or restores biological functions.
• Single-use device: Used once per procedure.
• Implantable device: Fully or partially inserted into the body.
• Invasive device: Partially or fully penetrates the body.
• In vitro diagnostic device: Analyses samples for diagnostic purposes.

Risk Classification

• Class I: low risk
• Class II: medium risk
• Class III: high risk
• Class IV: maximum risk

Clinical Trials for Pharmaceuticals

• RDC 9/2015 (amended by RDC 205/2017) sets procedures and requirements for pharmaceutical clinical trials, aligning with international standards.
• CNS Resolution 251/1997 defines regulatory and bioethical guidelines.
• CNS Resolution 466/2012 establishes general rules for clinical trials.
• RDC 506/2021 (amended by Normative Instruction 270/2023) governs clinical trials for advanced therapy medicinal products.

Clinical Trials for Medical Devices

• On 28 May 2024, the Brazilian president approved Law 14,874/2024. This law establishes rules for research involving human subjects and creates the National System of Ethics in Research with Human Beings. With its publication, a 30-day window began for a joint session of the Senate and the Chamber of Deputies to deliberate on any presidential vetoes.

• RDC 837/2023 regulates medical device trials.
• RDC 751/2022 defines risk classification, notification, labelling and use instructions.
• Normative Instruction 21/2017 (amended by RDC 557/2021 and RDC 702/2022) regulates Good Clinical Practice inspections.

Pharmaceuticals

For ANVISA approval of pharmaceutical trials, sponsors must submit a Drug Clinical Development Dossier (DDCM) as per RDC 9/2015. ANVISA’s Co-ordination of Research and Clinical Trials department (COPEC) assesses the DDCM for sanitary risks before approval. ANVISA aims to complete its analysis within 180 days for Phase I or II studies involving biologics or conducted solely in Brazil, and 90 days for Phase III studies with synthetic drugs conducted partly abroad. Sponsors must also provide detailed protocols to the Research Ethics Committee (CEP) before trials commence. Imported products for human research must also obtain ANVISA approval, with sponsors maintaining responsibility for data integrity and quality, even if functions are delegated to a Clinical Research Organisation (CRO).

It is worth noting that Law 14,874/2024 establishes a new deadline of 90 days for ANVISA’s analysis of primary petitions for clinical trials with human beings.

Medical Devices

RDC 837/2023 simplified medical device clinical trials in Brazil, aligning with international standards and clarifying ANVISA approval requirements. This regulation eliminates the need for Clinical Research Process Consent and expedites approvals by consolidating documentation under a single Medical Devices Clinical Research Dossier (DICD) process. This streamlining removes the necessity for CEP opinions, simplifying paperwork. Only trials with results that could support Class III and IV medical device registration in Brazil necessitate ANVISA submission.

ReBEC (Registro Brasileiro de Ensaios Clínicos) is the official Brazilian Registry of Clinical Trials, operated by ANVISA. It is a public platform where anyone can find details about clinical trials conducted in Brazil, including study design, participant criteria and contact information.

The database contains information such as trial title, sponsor, investigational product, phase, primary and secondary endpoints, inclusion/exclusion criteria and participating research centres.

Health data is considered sensitive under National Research Ethics Committee (CONEP) Resolution 466/2012 and Law 13,709/2018, also known as the General Data Protection Law (Lei Geral de Proteção de Dados Pessoais or LGPD), mandating confidentiality for trial participants’ data in both public and private institutions.

Sponsors must document and report adverse events, especially fatal or life-threatening ones, to ANVISA electronically within seven days of becoming aware of them (RDC 9/2015).

Chapters III and IV of RDC 9/2015, amended by RDC 790/2023, specify that sponsors must submit annual monitoring reports on the trial drug’s progress, detailing all adverse events using subject codes. They also require a final report after the trial’s completion across all participating countries, including information on withdrawn subjects and verified adverse events.

These reports, exclusive to Brazilian centres, must meet the minimum requirements outlined in Article 68 for annual reports and Article 69 for final reports. The annual report should be submitted within 60 days of the annual reference date (the trial’s start date in Brazil), while the final report is due within 12 months of the trial’s conclusion.

The new normative text (Law 14,874/2024) also establishes that the researcher is responsible for submitting the research documentation, including any amendments, to the CEP for approval, but the reporting of adverse events continues to be ANVISA’s responsibility.

There are no specific regulations in Brazil that explicitly restrict the use of online tools for supporting clinical trials, such as for recruitment or monitoring purposes.

However, it is essential to ensure that any online tools used comply with CONEP Resolution 466/2012 and the LGPD, which clearly states that health data is considered sensitive, and confidentiality of trial participants’ data is mandatory for both private and public institutions.

Building on the discussion above, health data is considered sensitive, necessitating strict confidentiality safeguards in both private and public institutions. According to Article 5, Item II of the LGPD, sensitive personal information includes details regarding a natural person’s racial or ethnic origin, religious beliefs, political views, union or other organisational memberships, health or sex life, and genetic or biometric data.

Transferring personal data from clinical trials to a third party or affiliate is possible but subject to stricter conditions outlined in Article 11 of the LGPD:

• Specific consent: Explicit and informed consent from the data subject is mandatory, clearly explaining the recipient and purpose of the data transfer.
• Limited exceptions: The LGPD permits transferring sensitive data without consent in limited circumstances, such as legal compliance or protecting the data subject’s life or safety. However, these exceptions are interpreted narrowly.

Following on from 2.5 Use of Data Resulting From Clinical Trials, data from clinical trials in Brazil faces strict data protection regulations due to its personal and sensitive nature. Before transferring such data to third parties or affiliates, explicit consent from participants, contractual agreements outlining data security protocols and potential data residency restrictions must all be considered.

Regarding medical devices, RDC 751/2022 regulates their classification in Article 4 as any instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article, intended by the manufacturer to be used, alone or in combination, in human beings, for some specific medical purpose, and whose principal intended action is not achieved by pharmacological, immunological or metabolic means in the human body, but which may be aided in its intended action.

For a product to be classified as a pharmaceutical (regarding Law 10,742/2003), it should be any pharmaceutical product, technically obtained or prepared, for prophylactic, curative, palliative or diagnostic purposes.

Biologic products often involve complex manufacturing processes and unique safety considerations compared to traditional chemical drugs. Therefore, obtaining marketing authorisation for biologics in Brazil typically involves additional requirements beyond those for chemical drugs:

• Comprehensive dossier: Detailed information about the biologic product must be submitted to ANVISA. This dossier typically includes:
1. Product characteristics
2. Manufacturing information
3. Non-clinical studies: Data from pre-clinical studies (in vitro and in vivo) assessing the product’s safety and potential efficacy.
4. Clinical studies: Data from well-designed and controlled clinical trials in humans to demonstrate the product’s safety and efficacy for the intended use.
5. Risk management plan: A comprehensive plan outlining potential risks associated with the product and strategies to mitigate those risks.
• Comparability studies: For biosimilars (biologics that are similar to an already approved reference product), additional comparability studies demonstrating similarity to the reference product in terms of quality, safety and efficacy are often required.
• Stricter regulatory requirements: Compared to chemical drugs, biologics might face stricter regulatory requirements related to manufacturing process controls, product characterisation and ongoing monitoring of safety post-marketing.

Additional Considerations

• Foreign clinical trials: Clinical trials conducted outside Brazil might be accepted by ANVISA under certain conditions. However, specific requirements regarding data integrity and compliance with Good Clinical Practices must be met.
• Post-marketing surveillance: Marketing authorisation holders are typically required to conduct post-marketing surveillance to monitor the safety and efficacy of their biologic product in the real-world setting.

The following are some of the main resolutions that relate to biological products:

• RDC 55/2010 (in force but with amendments) regulates the registration of new biological products and biological products.
• RDC 413/2020 (in force but with amendments) regulates post-registration changes and cancellation of registration of biological products.
• RDC 412/2020 establishes the requirements and conditions for conducting stability studies for the purposes of registration and post-registration changes to biological products.

Marketing authorisations for pharmaceuticals and medical devices are valid for ten years from the date of their publication in the Brazilian Official Gazette (DOU). They can be renewed for successive ten-year periods.

Certain requirements must be met for renewal, for example, for medicines, the product must have been marketed for at least 80 months (two-thirds) of the ten-year period (120 months).

For medical devices, for example, revalidation of the registration must be requested no more than 12 months and no less than six months before the registration expires.

The registration of a product which is subject to health surveillance may be cancelled in the following situations:

• When the renewal of the product’s registration has not been requested within the period specified by ANVISA.
• When it is proven that the product or manufacturing process may present a risk to the health of the consumer, patient, operator or third parties involved.
• When a request from the holding company is made when it no longer has any interest in marketing the product.
• When a request from the holding company is made when the registration is to be transferred to another company.

In addition, ANVISA can take preventive measures to protect public health during a health risk assessment. These measures, authorised by Law 6,360/1976, Law 9,782/1999 and Law 9,784/1999, include inspection actions such as seizure, recall, prohibition and suspension of activities relating to the product or service in question (storage, marketing, distribution, manufacture, import, advertising and/or use).

Furthermore, ANVISA can utilise precautionary measures, which are also proactive administrative actions based on the terms of Law 6,437/1977. These measures aim to safeguard public health in situations of imminent risk, even before a formal hearing with the party involved. For example, a precautionary interdiction can be applied when there is clear evidence of product alteration or adulteration.

Once a health investigation is completed and an infraction is confirmed, ANVISA initiates the process of charging the responsible party. Penalties for sanitary infractions, as defined in Law 6,437/1977, can be applied individually or in combination.

The process for obtaining marketing authorisation for pharmaceuticals and medical devices in Brazil is overseen by ANVISA.

Here is a summary of the steps:

1. Pre-application:

• Compile all necessary data and documentation.
• Evaluate risk classification and seek pre-submission consultations with ANVISA.

2. Formal application:

• Submit a comprehensive dossier electronically through ANVISA’s online platform.

3. Technical evaluation:

• ANVISA experts assess safety, efficacy and quality.
• Inspections of manufacturing facilities or clinical trial sites may be conducted.

4. Decision and issuance:

• ANVISA issues a final decision approving or rejecting. It is also possible that it may request further information for making such decision.
• If approved, ANVISA issues a marketing authorisation document.

Variations to marketing authorisation:

• Similar process, but typically less extensive.
• Complexity depends on the nature of the change: minor, moderate or major.

Transfer of marketing authorisation:

• Eligibility is limited to specific corporate operations such as mergers or successions.
• Procedures are outlined in RDC 102/2016.
• Deadlines vary by product category.
• No other changes are permitted in the transfer petition.

Steps for submitting a registration transfer request:

1. Company registration

2. Company size change (optional)

3. Petitioning

4. Fees

5. Protocol

6. Monitoring

Important points:

• The registration number follows a specific formation process.
• The validity of the registration remains the same regardless of the transfer publication date.

In Brazil, patient access to pharmaceuticals and medical devices typically requires ANVISA’s marketing authorisation. However, exceptions exist:

• Clinical trials: Patients can join strictly regulated trials for new products. This requires informed consent.
• Compassionate use programmes: Eligible patients with life-threatening conditions and no alternatives may access unapproved products under strict criteria:

1. Eligibility: Determined on a case-by-case basis.
2. Physician request: Detailed justification submitted to ANVISA.
3. ANVISA approval: Evaluation based on risks and benefits.
4. Limited availability: Access granted from a limited supply, often from the manufacturer.

Compassionate use is not guaranteed, and ANVISA holds final approval authority.

The regulations concerning the obligation on the marketing authorisation for pharmaceuticals and medical devices are summarised below:

Pharmaceuticals (Medicinal Products)

Marketing authorisation (MA) process

• RDC 31/2014 (in force with amendments) defines procedures for obtaining an MA in Brazil, including documentation requirements and evaluation timelines.
• ANVISA (National Health Surveillance Agency) oversees the process.
• Phases include pre-clinical studies, clinical trials (Phases I-III) and post-marketing (Phase IV) studies.

Pharmacovigilance obligations (medicinal products)

RDC 658/2022 establishes General Guidelines for Good Manufacturing Practices for Medicines.

Post-marketing obligations

Phase IV trials may be imposed to monitor real-world safety and efficacy.

Medical Devices

RDC 751/2022 (in force and with amendments) regulates the risk classification, notification and registration regimes, labelling requirements and instructions for use of medical devices.

• Technovigilance obligations: Manufacturers must actively participate in technovigilance.
• Post-marketing obligations: Similar to pharmaceuticals, ongoing safety assessment is crucial.

The following are some resolutions regarding the control, inspection and monitoring of products and services:

• RDC 67/2009 (in force with amendments): Technovigilance standards applicable to health product registration holders in Brazil.
• RDC 551/2021: Obligation for registration holders to carry out and report field actions, meaning actions of a health product with the aim of reducing the risk of an adverse event related to the use of the health product already on the market of health products in Brazil.
• RDC 665/2022: Good Manufacturing Practices for Medical Products and Diagnostic Products for In Vitro Use.

In the realm of third-party access to pharmaceutical and medical device authorisations, regulation is governed by the Information Access Law (Law 12,527/2011). Despite the sensitivity and confidentiality of health products, interested third parties can request access to registration information under this Law.

Article 7 states that access to information includes obtaining data from records or documents produced by relevant bodies or entities, whether stored publicly or not, as well as information concerning public asset administration, resource usage, bidding and administrative contracts.

However, it is important to note that while all information regarding a registered health product may be requested, it may not always be provided by regulatory agencies such as ANVISA or the Chamber for the Regulation of the Medical Market (CMED).

The primary regulation safeguarding commercially confidential and individual-related information is the “secrecy law” (Lei do Sigilo). Additionally, trade secrets benefit from specific legislation protection, crucial for preserving proprietary knowledge and fostering competitiveness and innovation.

To safeguard trade secrets effectively, companies should implement practical measures:

• Identification and classification: Recognise and appropriately classify information deemed as trade secrets.
• Access control: Limit access to authorised personnel only.
• Contracts and agreements: Incorporate confidentiality clauses in contracts with partners, suppliers and employees.
• Physical and digital security: Implement measures to protect electronic documents and data physically.
• Training and awareness: Educate employees on the significance of confidentiality and trade secret protection.

Several laws and regulations in Brazil address the falsification and distribution of counterfeit medicines and medical devices:

• Law 6,360/1976 establishes health surveillance norms, defining counterfeit medicines and medical devices and stipulating penalties for their production, distribution and trade.
• Brazilian Criminal Law (Law 2,848/1940), Article 273, prescribes severe penalties for those who falsify, corrupt, adulterate or alter products for therapeutic or medical purposes, including a ten to 15-year sentence.
• RDC ANVISA/DC 430/2020 regulates Good Drug Distribution, Storage and Transportation Practices (BPDA), setting requirements for companies in the medicine production chain to ensure product quality and prevent counterfeit, rejected, stolen or adulterated medicines. It aims to maintain medicine quality and safety throughout distribution, storage and transportation.
• Law 9,695/1998 defines falsification, corruption, adulteration or alteration of products intended for therapeutic or medicinal purposes as a heinous crime.

As stated on ANVISA’s website, reporting irregular and illegal medicines involves the following steps:

• Contact the manufacturer’s customer service centre for clarification.
• Inform the local Health Department and report the incident to the Health Surveillance Centre.
• If irregular or counterfeit products are confirmed, report to ANVISA via the Ombudsman’s Office.

Several laws and regulations in Brazil address the falsification and distribution of counterfeit medicines and medical devices:

• Law 6,360/1976 establishes health surveillance norms, defining counterfeit medicines and medical devices and imposing penalties for their production, distribution and trade.
• RDC ANVISA/DC 430/2020 regulates Good Drug Distribution, Storage and Transportation Practices (BPDA), setting requirements for companies in the medicine production chain to ensure product quality and prevent counterfeit, rejected, stolen or adulterated medicines. It aims to maintain medicine quality and safety throughout distribution, storage and transportation.
• Law 9,695/1998 defines the falsification, corruption, adulteration or alteration of products for therapeutic or medicinal purposes as a heinous crime.

As stated on ANVISA’s website, reporting irregular and illegal medicines involves the following steps:

• Contact the manufacturer’s customer service centre for clarification.
• Inform the local Health Department and report the incident to the Health Surveillance Centre.
• If irregular or counterfeit products are confirmed, report to ANVISA via the Ombudsman’s Office.

Both pharmaceutical and medical device manufacturing facilities in Brazil need a licence to operate, known as an “Autorização de Funcionamento” (AFE), issued by ANVISA.

The procedure for obtaining an AFE is outlined in RDC 336/2020:

• Registration: The company and product must be registered with ANVISA.
• Documentation: Detailed documentation should be submitted describing manufacturing processes, quality control measures and plant layout, complying with Good Manufacturing Practices (GMP) regulations (RDC 658/2022 for pharmaceuticals and specific RDCs for medical devices).
• Inspection: ANVISA conducts a facility inspection to verify compliance.
• Approval: If compliant, ANVISA issues the AFE.

Activities authorised by the AFE include manufacturing, storage of raw materials and finished products, and quality control procedures.

The AFE has no expiry date.

Additional notes:

• While a GMP certificate is not mandatory for the AFE, facilities must adhere to ANVISA’s Good Manufacturing Practices.
• Documentation requirements and inspections may vary based on product complexity and risk classification.
• For certain products such as electrical medical devices, breast implants, rubber gloves and sterile disposable syringes, an INMETRO certificate confirming compliance with Brazilian standards is necessary.

Wholesale distributors of pharmaceuticals and medical devices in Brazil must be licensed by ANVISA. The Authorisation to Operate Pharmacies and Drug Stores (AFE) permits the sale of industrialised medicines, including those under special control per Regulation SVS/MS 344/1998 and updates.

The application process, outlined in RDC 16/2014, Article 28, requires the submission of technical and formal documentation.

Once granted, the AFE for Wholesale allows commercialisation of various products such as medicines, pharmaceutical inputs, health products, cosmetics, personal hygiene items, perfumes and disinfectants between legal entities or to professionals.

The AFE has no expiry date.

As mentioned in 1.3 Different Categories of Pharmaceuticals and Medical Devices, ANVISA categorises pharmaceutical products based on their API and innovative characteristics, as outlined in RDC 753/2022.

Law 6,360/1976 is the primary pharmaceutical law, governing production, marketing, advertising, labelling, inspection, quality control, penalties, importation and marketing authorisation of medicines, drugs, active ingredients and medical devices. Decree 8,077/2013 regulates it.

To secure marketing authorisation for medicinal products, the applicant must be an authorised manufacturer or importer. ANVISA authorisation is mandatory for manufacturing/selling pharmaceuticals and/or importing them before market entry.

Various government agencies enforce import regulations for pharmaceuticals and medical devices:

1. National Health Regulatory Agency (ANVISA):

• Oversees health product import/export.
• Sets specific technical requirements/procedures via resolutions/directives.

2. Federal Revenue Department (Secretaria da Receita Federal do Brasil):

• Manages customs control at Brazilian borders.
• Collaborates with ANVISA to verify import documents, classify goods and collect duties/taxes.

3. Ministry of Agriculture, Livestock and Supply (MAPA):

• Participates in importing specific agricultural/veterinary medical devices.
• Collaborates with ANVISA on import procedures for these products.

4. National Institute of Metrology, Standardisation and Industrial Quality (INMETRO):

• Involved in importing certain medical devices meeting technical standards.
• May require additional certifications/conformity assessments to meet Brazilian specifications.

In Brazil, only a local legal entity can serve as the importer of record for pharmaceuticals and medical devices. Specific requirements must be met:

Eligible importer of record:

• Brazilian legal entity: Registered with the relevant commercial registry. This includes subsidiaries of foreign companies or wholly Brazilian-owned companies.
• Foreign company with a branch office: A foreign company can be the importer if it has a duly established and registered branch office in Brazil.

Importer of record requirements:

• Valid CNPJ (National Registry of Legal Entities): The company must possess a valid CNPJ, a unique identification number for Brazilian legal entities.
• Qualified technical professional: The importer must employ a qualified technical professional responsible for the imported products, possessing relevant qualifications.
• Permanent establishment: Maintaining a physical establishment in Brazil with proper infrastructure for storage and distribution to ensure supply chain traceability.
• ANVISA registration: The importer must be registered with ANVISA, allowing verification of regulatory compliance and import management capacity.

In Brazil, importing pharmaceuticals and medical devices requires prior authorisation from ANVISA.

Key regulations, including RDC 810/2023 amending RDC 751/2022, cover risk classification, notification, registration regimes, labelling requirements and usage instructions for medical devices. Additionally, RDC 18/2014 regulates communication to ANVISA regarding temporary or permanent discontinuation or reactivation of medicine manufacture or import.

Import Authorisation (AI) requirement:

• Commercial imports typically require an AI from ANVISA.
• Importers must apply for the AI before the shipment reaches Brazil.
• ANVISA assesses applications and supporting documents to ensure product registration, technical compliance and adherence to GMP.

Exemptions may apply in certain cases:

• Donations: Importing for public health programmes as donations may be exempt from AI, subject to specific ANVISA procedures and documentation.
• Emergency situations: Temporary authorisations may be granted during public health emergencies.
• Clinical trials: Authorised trials have specific import procedures for investigational drugs and medical devices.
• Personal use: Limited exemptions may exist for small quantities for personal use, but travellers should verify guidelines with ANVISA or Brazilian customs to avoid penalties.

Brazil’s non-tariff regulations and restrictions (NTRs) for imports, including pharmaceuticals and medical devices, ensure product safety, quality and compliance.

Basis for imposing NTRs:

• Harmonised System (HS) Tariff Code: Determines NTR requirements based on product classification.
• Technical description: Product characteristics can dictate NTRs; eg, medical devices may need extra certifications.
• Regulatory category: ANVISA’s classification influences NTRs, with high-risk products facing stricter regulations.

Laws and regulations listing products subject to NTRs:

• Law 13,097/2015: Governs import/export of health products, outlining ANVISA’s role.
• ANVISA resolutions and directives: Specify technical requirements, registration and import processes for different product categories.
• Other legislation: Additional regulations from ministries such as MAPA or INMETRO may apply.

Brazil engages in trade agreements with provisions for trade and regulatory facilitation. Some include:

Trade Bloc

Mercosur: Formed in 1991 with Argentina, Uruguay, Paraguay and associate members such as Bolivia, Chile, Peru, Suriname and Guyana. Mercosur promotes trade integration via tariff reductions and regulatory harmonisation.

Free Trade Agreements (FTAs)

Brazil has FTAs with various countries:

• Uruguay and Paraguay (Mercosur)
• Argentina (Mercosur)
• Bolivia (Mercosur)
• Chile
• Paraguay (bilateral)
• Israel
• Palestine
• Egypt
• South Africa

Trade/Regulatory Facilitation Provisions

FTAs often include:

• Mutual Recognition Agreements (MRAs): Recognising each other’s testing and certification procedures to reduce redundant testing.
• Harmonisation of technical standards: Aligning regulations and standards to simplify compliance.
• Streamlined customs procedures: Speeding up customs clearance and reducing paperwork.
• Transparency and information sharing: Enhancing regulatory transparency and information exchange for smoother trade in regulated goods.

Brazil imposes price controls on pharmaceuticals and medical devices through CMED, regulating prices, fostering competition and setting price ceilings.

Key laws include:

• Law 10,742/2003: Establishes CMED and modifies previous legislation.
• Decree 4,937/2003: Defines criteria for drug price adjustments.

Medical devices undergo economic monitoring per RDC 478/2021, with Normative Instructions 84/2021 and 119/2022 outlining monitoring details.

Drug Price Approval

The process involves submitting economic data and proposed prices based on drug categories outlined in RDC 2/2004.

CMED’s decision is subject to appeals, with final decisions potentially reviewed by federal courts.

Drug Price Categories (Resolution 2/2004)

Categories I-VI: Classify drugs based on novelty and therapeutic benefit, each with specific pricing rules.

Omissive category: For drugs not fitting established categories.

Appealing Price Decisions

Companies can challenge CMED decisions internally and through federal courts if legal grounds exist.

Drug Price Classification

CMED classifies approved drug prices into three categories:

• Factory price (PF): Maximum price for companies selling drugs to pharmacies and the government.
• Maximum consumer price: Highest price pharmacies can charge consumers.
• Maximum selling price to the government: Price resulting from applying a mandatory discount (PAC) to the PF. The PAC is adjusted annually.

Price Adjustments and Industry Concerns

Annual price adjustments, criticised for lagging behind inflation, affect drug pricing, though actual market prices often fall below set ceilings, especially for generics.

International reference prices indirectly influence drug pricing in Brazil, particularly in Category I, where they play a significant role. Resolution 2/2004 establishes a price basket comprising nine countries, serving as a benchmark for evaluating manufacturer prices, excluding taxes.

Category I, for new patented drugs offering substantial benefits, is directly influenced by international prices. The proposed PF cannot exceed the lowest PF practised for the same product in the basket of countries, ensuring competitive market entry.

However, drug pricing in Brazil is influenced by factors beyond international prices:

• Product characteristics: Novelty, therapeutic benefit and patent status influence pricing.
• Cost-effectiveness analysis: Companies must demonstrate the drug’s cost-effectiveness compared to existing treatments.
• Public health needs: CMED may prioritise public health considerations, setting prices below international levels.

Brazil’s healthcare system blends public and private financing for drugs.

Public System (SUS)

• SUS prioritises essential healthcare and medication access for citizens.
• SUS is government-funded to ensure universal health access (Article 196 of the Constitution).

Drug acquisition:

• Public bidding: Transparent, cost-effective drug procurement via public bidding.
• Government may purchase patented drugs without bidding.
• Productive development partnerships: Strategic drug partnerships with private firms ensure reliable supply at set prices.
• Technology incorporation (CONITEC):
1. Evaluates new technology inclusion into SUS based on evidence and cost-effectiveness.
2. Stakeholder submissions undergo CONITEC review and final recommendation.
3. Law 14,313/2022 allows SUS reimbursement for off-label drug uses upon CONITEC approval.

Private System (Health Insurance)

Health insurance coverage:

• ANS oversees private health insurance, defining mandatory coverage.

• ANS’s List of Procedures mandates drug coverage based on contracted plans.

List of Procedures:

• ANVISA authorisation: Only ANVISA-approved drugs are included.
• The list is updated every two years to include new technologies.

Judicialisation:

• Lawsuits ensure access to drugs not covered by SUS or private plans.
• Constitutional guarantee (Article 196) supports patient access, especially for rare diseases or cannabis-based products.
• Supreme Court guidelines consider ANVISA approval, alternative treatments and unreasonable delays in drug evaluation.

Brazil employs cost-benefit analysis (CBA) within Health Technology Assessment (HTA) processes for pharmaceuticals and medical devices, though its direct influence on pricing and reimbursement decisions varies.

HTA process and CBA:

• CONITEC manages Brazil’s HTA process, considering factors such as clinical effectiveness, safety, budgetary impact, ethics and societal/public health effects.
• CBA evaluates technology costs against expected health benefits.

Impact on pricing:

• While CBA informs negotiations for essential drugs on the RENAME list, it is not decisive.
• Government considers affordability, production costs, R&D expenses and reasonable profit margins, with international prices as negotiation benchmarks.

Impact on reimbursement:

• CBA heavily influences reimbursement decisions by SUS.
• SUS prioritises interventions with favourable cost-benefit ratios, ensuring significant health benefits at justifiable costs.
• High-cost, low-benefit technologies may not be reimbursed by SUS.

Limitations of CBA:

• CBA complexities and uncertainties arise in calculating long-term health benefits and costs.
• Quantifying ethical considerations and improved quality of life in economic terms can be challenging.

Brazil has implemented regulations to oversee physician prescribing and pharmacy dispensing, aiming to ensure rational medication use and control pharmaceutical spending.

The Federal Council of Medicine and ANVISA provide guidance:

• The Federal Council of Medicine offers guides for medical prescriptions.
• ANVISA’s RDC 44/2009 outlines Good Pharmaceutical Practices for pharmacies.

Prescription regulations:

• Only licensed physicians and dentists may prescribe medications.
• Prescriptions must adhere to a standard format set by the Ministry of Health.
• Stricter rules govern controlled substances prescriptions.
• Electronic prescriptions, while not yet mandatory, are increasingly being utilised.

Pharmacy regulations:

• Only licensed pharmacists may dispense medications, ensuring proper prescription verification.
• Pharmacists may substitute generics for brand-name drugs with patient consent.
• Pharmacies must retain dispensed prescriptions for record-keeping.
• Some medications are available over the counter, with pharmacists providing guidance on usage and interactions.

In Brazil, ANVISA regulates medical devices, including software, determining their classification based on intended use per RDC 657/2022.

Criteria for medical device classification:

• Intended use: Diagnosis, prevention, monitoring, treatment, rehabilitation or medical information provision.
• Mechanism of action: Interaction with the human body or control of medical devices.

Apps not classified as medical devices:

• General wellness and lifestyle apps
• ANVISA-exempt apps
• Healthcare management apps
• Data processing apps
• Embedded apps

Additional regulatory framework:

• Guide 38: Principles and Practices of Cybersecurity in Medical Devices.
• RDC 751/2022: Risk classification, notification, registration, labelling and usage instructions.

Specific regulations in Brazil govern telemedicine as distinct from traditional medical practice. Law 14,510/2022 establishes a nationwide legal framework, replacing temporary measures from the COVID-19 pandemic.

Physicians and Mobile Devices

Brazilian physicians may provide medical services via mobile devices, adhering to telemedicine regulations. This encompasses consultations, diagnoses (within limits) and remote patient monitoring.

Regulatory Considerations

Key factors for telemedicine in Brazil include:

• Informed consent: Patients must consent to telemedicine consultations and retain the option for in-person visits.
• Doctor-patient relationship: Generally, an existing relationship is required, except for emergencies or initial consultations.
• Technical standards: Secure platforms ensure patient privacy and data security.
• Record-keeping: Telemedicine consultations require proper documentation and storage per regulations.

Brazil has specific regulations governing the promotion of medicines and medical devices online, including through websites and social media. These rules aim to ensure ethical advertising and protect public health.

Here is an overview of the regulatory framework:

• RDC 96/2008 (with amendments): Governs advertising, publicity and information related to medicines.
• Brazilian Consumer Protection Code: Applicable to all marketing endeavours, including those for medical products.
• CONAR Code of Conduct: Established by the National Council of Self-Regulation of Advertising (CONAR), this covers advertising activities, including healthcare products.
• CEM (Code of Ethics for Physicians): Issued by the Federal Council of Medicine, guiding physicians’ behaviour, including advertising practices.

Electronic prescriptions are regulated and permitted in Brazil under the Telemedicine Law (Law 14,510/2022), which provides a legal framework for telemedicine.

Various entities are involved in regulating electronic prescriptions:

• Ministry of Health: Establishes general rules.
• Federal Council of Medicine: Defines parameters for doctors’ practices, including electronic prescriptions.
• ANVISA: Ensures technical compliance.
• ANS: Addresses coverage by health insurance plans.

Requirements:

• ANVISA RDCs 344/1998 and 6/1999 specify technical standards, including the use of the doctor’s electronic signature meeting ICP-Brasil standards.
• A pre-existing doctor-patient relationship is typically necessary for issuing electronic prescriptions.

In summary, electronic prescriptions in Brazil are lawful and regulated but must adhere to guidelines from the Ministry of Health, the Federal Council of Medicine, ANVISA and ANS.

The marketing of medicines by telephone, fax and internet can only be carried out by pharmacies and drugstores open to the public, with a pharmacist in charge present during all opening hours, and must follow the instructions contained in RDC 44/2009 (in force with amendments).

Therefore, remote selling is regulated by RDC 44/2009, specifically Articles 52 to 59, which set out requirements that must be met fully by establishments wishing to provide medicines by remote means.

In Brazil, Electronic Health Records (EHRs) and health-related data are regulated to safeguard patient privacy.

Regulation of EHRs

The Brazilian Ministry of Health oversees EHR regulation, prioritising data security, patient confidentiality and interoperability.

Health Information as Sensitive Data

Under Brazil’s General Data Protection Law (LGPD), health data is considered sensitive, attracting stricter regulations.

Stricter Health Data Rules

The LGPD imposes additional obligations, such as:

• Explicit consent for data handling
• Patient access rights
• Robust security measures

Cloud Platforms and Health Data

Storing health data on cloud platforms follows specific rules:

• Cloud providers must ensure data security.
• Contracts between controllers and cloud providers must outline security measures.
• Data residency requirements may limit data storage outside Brazil, depending on regulations.

In Brazil, the BRPTO (INPI) offers protection for second-use inventions, granting patents for novel applications of known substances. However, for a second-use claim to be accepted, the treated disease must be novel, meaning the compound has not been previously described as useful for treating the claimed disease. Factors such as treatment schedule, patient group or dosage do not confer novelty or inventive step for a use claim.

Applicants are required to draft their patent claims in the Swiss-style format, stating: “The use of (relevant substance) in the manufacture of a medicament for the therapeutic treatment of (medical condition).”

Until recently, Brazilian law prohibited generic drug labels from excluding patented indications. However, in late 2023, ANVISA revised its 2009 labelling regulation, allowing generics to exclude patented indications.

The introduction of skinny labelling is expected to lead to increased patent litigation, as brand-name drug manufacturers may seek to prevent generic manufacturers from bypassing patent rights. Determinations of infringement regarding the removal of patented indications from labels will be made on a case-by-case basis.

Brazilian courts are likely to examine alleged infringers’ actions, including efforts to encourage off-label usage of products for still-patented indications, even if such uses are not explicitly listed on the label.

In Brazil, the BRPTO (INPI) grants protection for second-use inventions, recognising patents that propose new applications for known substances. It is important to note that for a second-use claim to be accepted, the treated disease must be novel, meaning the compound has not been previously described for treating that disease. Details like treatment schedule, patient group, or dosage don’t confer novelty or inventive step for a use claim.

Applicants are required to draft their patent claims in the Swiss-style format, stating: “The use of (relevant substance) in the manufacture of a medicament for the therapeutic treatment of (medical condition).”

Until recently, Brazilian law prohibited excluding patented indications from generic drug labels. Generics had to replicate the entire brand-name drug label, including all approved indications.

However, in late 2023, ANVISA revised its 2009 labelling regulation, allowing generics to omit patented indications.

The introduction of skinny labelling in Brazil is expected to lead to increased patent litigation, as brand-name drug manufacturers may try to stop generic manufacturers from bypassing patent rights. Determinations on whether removing patented indications constitutes infringement will be made case by case.

Drawing from legal precedents elsewhere, Brazilian courts are likely to consider the alleged infringer’s actions, including efforts to promote off-label usage for still-patented indications, even if not explicitly listed on the label.

Article 40 of Law 9,279/1996 (Brazilian Patent Statute – BPS) stipulates a 20-year patent term from the filing date. Previously, a minimum ten-year term from grant protected applicants from BRPTO delays. However, this provision was deemed unconstitutional by the Supreme Court in 2021.

Following the removal of the automatic ten-year protection, many patent holders have filed lawsuits seeking compensation for lost term due to BRPTO delays. Despite no official judiciary stance on Patent Term Adjustment actions, recent court decisions suggest an uphill battle for plaintiffs.

A definitive higher court ruling is awaited to clarify whether term adjustments will be encouraged or discouraged.

Pharmaceutical or medical device patent infringement can occur in three primary forms:

• Literal infringement: When a product precisely embodies each element of a patent’s claims.
• Doctrine of equivalents: Protects the inventive essence of the patent, allowing for minor deviations if the accused product achieves substantially the same outcome in substantially the same manner.
• Contributory infringement: When someone knowingly supplies a component or material intended for use in a product that infringes a patent, lacking a substantial non-infringing purpose.

Engaging in registration or pricing procedures may provide grounds for a patent infringement lawsuit, but it does not necessarily amount to actual infringement.

Exceptions to patent infringement, as outlined in the BPS, include:

• Experimental purposes related to studies or scientific and technological research.
• Acts exclusively for generating information, data and test results for commercialisation registration in Brazil or abroad, after the patent’s expiration.

Although the law does not expressly predict the threat of infringement, it is observed in case law, particularly in pharmaceuticals.

Specific steps indicating potential future commercialisation of a medication include obtaining GMP Certificates, obtaining marketing approval and completing pricing procedures. Key regulatory aspects in pharmaceutical cases include marketing approval and pricing procedures before CMED.

The pharmaceutical must be commercialised during at least two-thirds of the ten-year period, ie, 80 months; otherwise, the right to renew the registration is lost. Therefore, it is possible that the holder may have to wait up 40 months to engage in any commercial act related to the registration drug and, consequently, not infringe any patents.   

Given that many infringement cases involve requests for preliminary injunctions, potential defendants can initially appeal against such decisions. The judge may also require the patentee to post a bond, although the amount is at the judge’s discretion. Under the Brazilian Civil Procedure Code, the party seeking the injunction is responsible for any damages caused to the other party by its enforcement.

Alternatively, potential opponents can:

• seek a declaratory judgment of non-infringement, asserting that there is no infringement; and/or
• file a separate patent invalidity action with federal courts to declare the patent invalid or suspend its effects, at least between the parties.

Common defences to patent infringement include prior use, experimental use and patent invalidity.

Compulsory licensing, regulated by Articles 68 to 74 of the BPS, allows the use of patent rights without the owner’s consent under certain conditions. Situations leading to compulsory licensing include non-use of the patented subject matter in Brazil, inadequate commercialisation, dependency on another patent, and national emergency/public interest. However, a compulsory licence may be denied if the patentee can demonstrate legitimate reasons for lack of use, efforts to prepare for exploitation, or legal obstacles preventing production or marketing.

In Brazil, patent infringement proceedings are typically initiated by the patent holder. If the patent holder has granted an exclusive licence, the licensee may also have the right to pursue infringement action based on the terms of the licence agreement.

Remedies for Patent Infringement

Criminal proceedings

While patentees can pursue criminal action, civil lawsuits are more common in Brazil due to the limited impact of criminal penalties.

Civil lawsuits

Civil actions are the primary remedy for patent infringement, often seeking damages, cessation of use and preliminary injunctions.

Preliminary injunctions

These can be granted ex parte, based on Article 209 of the BPS, which allows judges to prevent irreparable harm from infringement pending a final decision.

Requirements for preliminary injunctions:

• clear evidence of infringement and likelihood of success; and
• demonstration of irreparable harm.

Challenges with ex parte injunctions

Unilateral reports are uncommon due to the complexity of patent cases, making ex parte injunctions rare.

Judicial process

Single judges without technical backgrounds oversee infringement and invalidity actions. An unbiased expert is appointed to provide technical reports, critical for court decisions.

Expert nomination

Parties can agree or challenge the appointed expert. If dissatisfaction persists, interlocutory appeals can be filed.

Technical assistance

Parties can appoint technical assistants and submit queries to the expert for guidance.

Code of Civil Procedure

Parties can mutually select experts to conduct the evidence phase, promoting procedural efficiency.

Multiple experts

In complex cases involving various technical fields, the judge may appoint multiple experts, increasing costs but ensuring comprehensive analysis.

Validity challenges

Patent validity can be argued as a defence in infringement cases. However, validity challenges are often litigated separately in federal courts to ensure comprehensive review.

Summary

In summary, patent infringement proceedings in Brazil involve civil lawsuits, preliminary injunctions, and technical expert assessments, with the option for parties to select experts and challenge nominations. Validity challenges are typically addressed separately in federal courts to ensure thorough examination.

Brazil lacks a formal pre-entry patent declaration akin to the US declaratory judgment. However, potential generic entrants have several mechanisms to assess the patent landscape before market entry:

• Patent invalidation proceedings: Seeking invalidation of the reference product’s patent through the BRPTO can pave the way for generic entry, although this can be a time-consuming process.
• Analysis of patent exemptions: Assessing whether the reference product’s patent falls under exemption categories such as compulsory licensing or experimental use for generic development could allow entry without infringement.
• Freedom to Operate (FTO) opinion: Obtaining an FTO opinion evaluates patent risk associated with the proposed generic product, offering guidance despite lacking legal binding.

While not obligatory, obtaining clearance through invalidation or exemption is advisable to mitigate infringement risks and potential lawsuits from the patent holder.

In terms of pharmaceutical and medical device approval processes, Brazil lacks a patent-linked system. Regulatory approval focuses on safety, efficacy and adherence to standards rather than patent status.

In nullity actions, the trial court judge’s decision hinges on careful analysis of parties’ arguments, complemented by input from the BRPTO and expert opinions. The judge considers the case’s nuances and parties’ submissions before issuing a final decision.

Brazil’s legal framework robustly tackles pharmaceutical and medical device counterfeiting through various intellectual property (IP) rights:

• Patent infringement: If a company’s patented pharmaceutical or medical device is imitated or directly copied, it violates patent rights.
• Trade mark infringement: Selling counterfeit products with identical or confusingly similar trade marks infringes trade mark rights.
• Copyright protection: While less common, copyright safeguards certain aspects of medical devices, such as software or user interfaces.
• Industrial design rights: Registered industrial designs protect unique shapes or appearances of medical devices.
• Unfair competition: Unregistered trade dress, such as distinctive store layouts, receives protection under unfair competition laws.

Enforcement procedures:

• Civil lawsuits: IP holders can file civil lawsuits seeking injunctions to stop counterfeiting and monetary damages to recover losses.
• Criminal prosecution: Counterfeiting is a criminal offence, leading to imprisonment and fines.
• Customs enforcement: ANVISA collaborates with customs officials to seize counterfeit goods at borders.

In Brazil, trade marks for pharmaceuticals and medical devices face stringent regulations aimed at protecting public health and safety:

• Prohibition of misleading marks: Trade marks that deceive consumers regarding the nature, quality or origin of pharmaceuticals or medical devices, including false claims about effectiveness, safety or regulatory approval, are prohibited.
• Prohibition of confusingly similar marks: Trade marks resembling existing ones for pharmaceuticals or medical devices are typically prohibited to prevent consumer confusion and maintain brand integrity.
• Compliance with regulatory requirements: Trade marks must adhere to regulatory standards established by agencies such as ANVISA, ensuring compliance with specific labelling and packaging norms for safety and efficacy.

Regarding the import and distribution of genuine pharmaceutical or medical device products from other markets:

• Parallel imports: Brazilian law permits the parallel importation of authentic products from other countries, provided there is no trade mark infringement and there is compliance with regulatory standards.
• Exhaustion of rights: Once a trade mark owner consents to selling their products in a country, they may relinquish control over subsequent sales, impacting their ability to restrict imports and distribution from other markets.

While trade mark law imposes restrictions, it also allows for the import and distribution of genuine products from other markets under specific conditions and regulations, including those outlined in regulations such as RDC 59/2014, Law 6,360/1976 and ANVISA Service Guidance 43/2017.

While there are no specific legal mechanisms for trade dress protection in Brazil, the BPS provides some recourse.

Article 195 of the BPS prohibits the use of deceptive practices to mislead customers and classifies such acts as unfair competition, subject to civil and criminal penalties.

Prior to 2016, Brazilian case law on trade dress was fragmented. However, the Superior Court of Justice (STJ) has since established a more consistent approach. The STJ now uses a case-by-case analysis to determine trade dress protection.

This analysis is based on three key elements:

• Distinctiveness: The trade dress must be unique and readily distinguishable from competing products in the marketplace.
• Non-functionality: The protected elements must not be essential to the functionality of the product (eg, the shape of a pill for safe consumption).
• Likelihood of consumer confusion: There must be a significant risk that consumers will be misled into believing that the product comes from a different source.

To assess the likelihood of confusion, the courts have considered several factors, including consumer habits and market dynamics.

There is no data exclusivity for pharmaceuticals or medical devices in Brazil.

It is worth noting that Brazil applies different standards in different sectors.

While there are data package protection periods for veterinary products, fertilisers and agrochemicals under Law 10,603/2002, there are no such provisions for human medicines. Initially, the judicial measure included data package protection for human pharmaceuticals, but these provisions were later removed.

To expedite access to essential medical supplies during the COVID-19 pandemic, ANVISA implemented RDC 346/2020.

This temporary framework facilitated quicker registration and post-registration changes for active pharmaceutical ingredients, medicines and medical devices.

Key Measures of RDC 346/2020

Leveraging foreign expertise: ANVISA allowed the use of data from pre-approved foreign regulatory bodies to partially fulfil GMP certification requirements. This streamlined the process without sacrificing quality standards.

Foreign regulatory body recognition: Eligible foreign agencies had to participate in recognised international programmes demonstrating robust regulatory oversight, such as:

• The Pharmaceutical Inspection Cooperation Scheme (PIC/S);
• The Medical Device Single Audit Program (MDSAP); and
• The Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substance manufacturers.

Remote inspections: Instead of traditional on-site inspections for GMP certification, ANVISA permitted remote inspection mechanisms, involving video conferencing and data transmission to verify adherence to GMP standards.

It is important to note that RDC 346/2020 is no longer in effect.

ANVISA has implemented measures concerning clinical trials and COVID-19 treatment vaccines in Brazil:

• RDC 573/2021: This amendment to RDC 9/2015 accelerates the approval process for clinical trials of medicinal products by accepting analyses from foreign authorities within the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
• During the pandemic, ANVISA’s Clinical Research Technical Unit prioritised COVID-19 research to align with global efforts for safe and effective therapeutic options.
• RDC 387/2020: Introduced during the pandemic, this increases the maximum quantities of medicines under special control allowed in prescriptions and permits remote and home delivery of such medicines.
• RDC 475/2021 (now repealed): Outlined procedures for requesting temporary authorisation for emergency use of COVID-19 medicines and vaccines.
• RDC 379/2020: Temporarily updated requirements for manufacturing, importing and procuring priority medical devices for health services during the pandemic. Temporary exemptions from certain ANVISA approvals and notifications are granted to manufacturers and importers, though compliance with other standards remains mandatory.

Specific regulatory pathways exist for emergency approvals of pharmaceutical products and medical devices, including those for COVID-19.

Pharmaceutical products:

• RDC 44/2009 sets standards for Good Pharmaceutical Practices, controlling the operation, dispensing and marketing of products in pharmacies.
• RDC 483/2021 (now revoked) outlined temporary requirements for importing priority medical devices and medicines during the COVID-19 emergency.

Medical devices:

• RDC 751/2022 (as amended by RDC 810/2023) addresses risk classification, notification, registration, labelling and instructions for use.
• RDC 423/2020 transitions medical devices from registration to notification for low-risk products.

These pathways ensure the safety and efficacy of products, particularly during health emergencies like COVID-19. They involve rigorous assessment, documentation and approval processes for safe usage.

ANVISA adapted existing pathways and streamlined processes to expedite access to critical COVID-19 treatments and diagnostics. However, essential safety and efficacy data remain necessary.

The COVID-19 pandemic has brought significant healthcare challenges, impacting the import and export of medical devices and medicines. ANVISA has responded with measures to streamline procedures and provide more flexible certification to ensure access to essential products.

RDC 483/2021 permits the temporary importation of new medical devices and priority medicines for COVID-19-related healthcare. Products in the first annex are exempt from ANVISA’s sanitary regulation, with importers responsible for ensuring quality and safety. This accelerates the import process due to the urgent nature of the pandemic.

Another important resolution, RDC 518/2021, amends RDC 67/2016, which regulates accreditation applications and changes for pharmaceutical equivalence centres.

Additionally, RDC 384/2020 introduces a temporary procedure for health certificate issuance via document analysis, following regulations outlined in RDC 72/2009.

Recognising diverse global needs, the World Health Organization stresses the importance of flexible digital certificate systems.

In conclusion, ANVISA’s initiatives aim to simplify import procedures, offer more flexible certifications, and ensure access to medical devices and medicines during the COVID-19 crisis.

The COVID-19 pandemic has presented significant healthcare challenges, impacting the import and export of medical devices and medicines. ANVISA has responded with measures to streamline procedures and provide more flexible certification to ensure access to essential products.

RDC 483/2021 permits the temporary importation of new medical devices and priority medicines for COVID-19-related healthcare. Products listed in the first annex are exempt from ANVISA’s sanitary regulation, with importers responsible for ensuring quality and safety. This accelerates the import process due to the urgent nature of the pandemic.

Another important resolution, RDC 518/2021, amends RDC 67/2016, which regulates accreditation applications and changes for pharmaceutical equivalence centres.

Additionally, RDC 384/2020 temporarily includes a procedure for health certificate issuance via document analysis, following regulations outlined in RDC 72/2009.

Recognising diverse global needs, the World Health Organization stresses the importance of flexible digital certificate systems.

In conclusion, ANVISA’s initiatives aim to simplify import procedures, offer more flexible certifications, and ensure access to medical devices and medicines during the COVID-19 crisis.

In 2020, amidst the COVID-19 pandemic, telemedicine emerged as a vital tool for hospitals, enabling remote care. This year, the Federal Council of Medicine formalised and regulated its usage.

Telehealth initiatives are integrated into various projects of the Programme to Support the Institutional Development of the Unified Health System (PROADI-SUS), with investments exceeding BRL91.3 million. This collaborative effort involves six reference hospitals and the Ministry of Health.

Law 14,510/2022 nationally regulates telehealth, covering remote services across all health professions regulated by the Federal Executive Power.

This innovative regulation permits a wide range of services, including pre-clinical care, consultation, monitoring, diagnosis and post-surgery follow-up, ensuring comprehensive patient support.

The ordinance governing telehealth in Brazil establishes stringent criteria and standards aligned with guidelines from competent bodies such as ANVISA and ANS, emphasising adherence to ethical standards and quality requirements equivalent to traditional in-person care, and prioritising patient well-being.

Specific compulsory licences for COVID-19 treatments or vaccines do not exist in Brazil; however, discussions during the pandemic prompted adjustments before the BRPTO.

Law 14,200/2021 amended the BPS to address compulsory licensing in cases of national or international emergencies, declarations of public interest, or nationwide states of public calamity.

This amendment expands compulsory licensing scenarios to include national public calamities, building upon existing provisions in the IP Law.

The law introduces procedural changes, such as setting patentees’ remuneration at 1.5% of the net sale price, subject to case-specific adjustments.

Moreover, it enhances transparency by requiring the executive branch to compile a list of patents potentially subject to compulsory licensing.

Brazil has implemented exemptions specifically for agreements between public entities and developers. On 6 January 2021, a legislative measure introduced provisions for vaccine supply agreements, including negotiating clauses limiting liability for breach of contract related to the vaccine. This measure became Law 14,124 in March 2021.

Law 14,125, enacted in the same month, addresses civil liability for adverse events following COVID-19 vaccination. It allows the government and local authorities to assume financial responsibility for certain vaccine-related injuries if the vaccine is approved by ANVISA or granted emergency use authorisation during the declared public health emergency.

However, this assumption of liability by the government applies only to vaccines directly procured by them.

During the COVID-19 pandemic, specific provisions relating to the requisition or conversion of manufacturing facilities were implemented.

One relevant resolution is RDC 330/2019, which established sanitary requirements for the organisation and operation of diagnostic or interventional radiology services, as well as regulating the control of medical, occupational and public exposures resulting from the use of radiological technologies.

Additionally, RDC 579/2021 addressed issues relating to the import, commercialisation and donation of equipment, including the sale of used equipment, provided they meet the established requirements.

During the COVID-19 pandemic, Brazil’s public procurement system for medicines and medical devices was temporarily modified through Provisional Measure 951, introduced in April 2020. This measure facilitated faster acquisition by allowing joint purchases between public entities and suspending the requirement for competitive bidding for healthcare materials and equipment needed to combat the pandemic. These changes streamlined the process, enabling quicker purchases to address urgent needs during the crisis.

However, it is essential to mention that Provisional Measure 951 is no longer in effect.