Life Sciences 2021

Last Updated March 22, 2021

Argentina

Law and Practice

Authors



Baker McKenzie has a Buenos Aires office that is an established centre of the firm's healthcare industry group. More generally, Argentina is a leading centre for life sciences development in Latin America, from its early 2000s creation of the Ministry of Science, Technology and Innovative Production (MSTI) to its current involvement in manufacturing of the AstraZeneca COVID-19 vaccine and other pandemic-related equipment for domestic and overseas distribution. Since 2006, the office has provided a range of legal services to a significant number of international clients in this space, taking a holistic, efficient approach. The firm was an early adopter of an industry approach to healthcare. The firm would like to thank Esteban Rópolo, Bernard Malone, Felipe Graham, Candelaria Munilla and Mercedes de la Fuente for their contributions to this chapter.

There is a range of legislation and regulation governing the pharmaceutical field in Argentina.

Pharmaceuticals

Law No 16,463 (as amended and complemented)

This sets general rules regarding technical and economic control of medicines, drugs and all other products of use and application in human medicine. According to such law, import, export, production, manufacturing, fractioning, commercialisation, and storage of any product for use or application of medicine on human beings may only be conducted with prior authorisation of the National Ministry of Health (MoH) or the National Agency of Medicines, Food and Medical Technology (the ANMAT and, jointly with the MoH, the "Health Authority"), in the premises authorised by the Health Authority and under the direction of the technical director.

Executive Decree No 150/1992 (complemented by Disposition ANMAT No 5,755/1996)

This provides rules for the registration, manufacturing, import, export and sale of drugs. A local marketing authorisation (Registro de Especialidad Medicinal) is required to sell any drug in the local market. The commercialisation or free delivery of drugs without a marketing authorisation is prohibited throughout the national territory, except as otherwise authorised by the Health Authority.

Resolution 627/07 enacted by the MoH

This sets out the good practices applicable to the promotion of pharmaceuticals under prescription, regulating the relationship between pharmaceutical companies and healthcare professionals (HCPs). Under the resolution:

  • the promotion of drugs without a marketing authorisation is forbidden;
  • the contents of the promotion of a medicinal product shall be aligned with the claims under which the marketing authorisation was approved; and
  • the promotion of drugs should be aimed at products' rational use and based on objective criteria.

Executive Decree No 1,299/97

provides rules for the commercialisation of drugs and indicates that drugs may only be marketed through pharmaceutical wholesalers, pharmacies, healthcare or sanitary premises, whether public or private that are duly authorised by the Health Authority.

Special and ancillary regulations

These are passed by the Health Authority regarding registration requirements and procedures applicable to specific and more complex medicines, including but not limited to:

  • biological medicines and medical specialties of biological origin for human use and/or monoclonal antibodies obtained from recombinant DNA methods (Disposition ANMAT No 7,075/2011 and Disposition ANMAT No 3,397/2012);
  • biosimilars (Disposition ANMAT No 7,729/2011); and
  • rare diseases and orphan drugs (Law No 26,689, Disposition ANMAT No 4,622/2012).

Medical Devices

Laws relevant to medical devices include:

  • Law No 16,463 also sets rules for the different stages of commercialisation of medical devices in the local market;
  • Disposition ANMAT No 2,318/2002 provides a classification by medical device types (classes I through IV);
  • pursuant to Disposition ANMAT No 2,319/2002, Argentina has incorporated into its national legal framework the Technical Regulations for the Registration of Medical Devices approved by Mercosur – Disposition No 40/00;
  • Disposition ANMAT No 1285/2004 defines a medical device as any equipment, device, material, product or system of medical, dental or laboratory use or application intended for prevention, diagnosis, treatment, rehabilitation or contraception that does not use pharmacological, immunological or metabolic means to perform its main purpose; and
  • ANMAT Disposition No 9,688/2019 regulates the process of registration, revalidation, modification, transfer and cancellation of medical devices. It also organises, unifies and clarifies all the documentation required for such processes.

Industry Codes

The Argentine Chamber of Medicinal Specialties (CAEME) is the local chamber that gathers most of the foreign pharmaceutical companies and the Argentine Chamber of Consumable Goods, Implantables and Medical Equipment (CADIEM) have, as members, many medical device companies. CAEME and CADIEM members are subject to the guidelines stated in their respective Codes of Ethics and ancillary regulations and contractual obligations. Industry chambers are important players in the industry since they establish guidelines and rules that are followed by their members, setting the market tone.

Chambers codes of ethics or regulations do not override or supersede applicable law.

Local Health Authorities

National MoH

The MOH is the main local sanitary authority managing the administrative issues related to the public health service, including but not limited to epidemiology issues, vaccination campaigns, border health controls and registration of health professionals. It is part of the centralised Public Administration and, among other duties, the MoH shall:

  • execute the plans, programs and projects in the area of its competence prepared in accordance with the directives issued by the National Executive Power;
  • control of the operation of services, health establishments and/or institutions;
  • carry out the global planning of the health sector and the coordination with the health authorities of the provincial jurisdictions and the Government of the Autonomous City of Buenos Aires, in order to implement a Federal Health System;
  • pass laws and regulations to regulate the scope and responsibilities for the practice of medicine, dentistry and related professions, guaranteeing the accessibility and quality of medical attention; and
  • control products, technology, equipment, instruments and procedures related to health.

Provincial ministries of health work in conjunction with the MOH. However, there could be province specific regulations applicable to provincial territories (eg, certain regulations applicable to clinical trials).

ANMAT

ANMAT is a decentralised body of the National Public Administration, dependent of the MOH. It was created by Executive Decree No 1,490/1992 (as amended). As regulatory authority, it grants import and manufacturing licences, controls adherence to GMP and grants marketing authorisations and controls  the efficacy, safety and quality of drugs, medical devices, cosmetics and food products (among others).

The Superintendence of Health Services (SSS)

The SSS has monitoring, control, and enforcement capacities over healthcare insurers of the National Health Insurance System and has authority over the national healthcare insurance companies and the National Institute of Social Security for Retired Persons and Pensioners.

The National Comprehensive Drug Policy Department (Secretaría de Políticas Integrales sobre Drogas de la Nación Argentina or SEDRONAR)

SEDRONAR is a secretary of State dependent of the Office of the President and aims to coordinate national policies against drugs and other addictions. SEDRONAR controls all operations with certain chemical substances capable of being used in the illicit manufacture of narcotic drugs and psychotropic substances.

Under Executive Decree No 1,095/1996, legal entities or individuals that produce, manufacture, prepare, elaborate, repackage, distribute, market wholesale and/r retail, store, import, export, transport or carry out any other type of transaction, national or international, involving substances included in lists I and II of its Annex I, must first be registered with the National Registry of Chemical Precursors under the Secretariat of Programming for the Prevention of Drug Addiction and the Fight Against Drug Trafficking of the Office of the President.

The National Commission for Evaluation of Health Technologies (Comisión Nacional de Evaluación de Tecnologías de Salud or CONETEC)

CONETEC was recently created for the purpose of evaluating health technologies and making recommendations to the MoH with regard to its inclusion, use, financing and coverage policies (pharmacoeconomics type assessment).

As a general rule, adverse decisions of regulatory bodies can be challenged by the affected party (eg, the manufacturer or importer) by an administrative appeal to be decided by the same regulatory body or by its superior overseeing administrative authority. Once administrative appeals are decided, the affected party can initiate a judicial review lawsuit before the federal courts with jurisdiction on administrative law matters.

Generally speaking, an administrative or legal challenge must be based on factual or legal grounds that sufficiently demonstrate that the decision was invalidly issued (eg, having insufficient legal or factual background; having no jurisdiction on the matter; violating due process). These procedures, which arise from the National Administrative Procedure Law, apply usually for other regulated products.

Pharmaceuticals

There are two categories of pharmaceutical products as stated by Law No 16,463, considering their dispense condition: Over the Counter (OTC) and Under Prescription.

Medical Devices

For registration purposes, medical devices are classified in different classes (I, II, III, and IV), depending on the degree of risk they represent for human health.

ANMAT has published 18 rules that guide the classification of medical devices depending on the intended purpose(s) of each medical device. The criteria used to determine the classification of a device will depend on:

The degree of invasiveness of the medical device:

  • the contact with the body;
  • the body part affected by the use of the medical device;
  • if the device is surgical or active;
  • if it administers or exchanges energy;
  • if it is potentially dangerous;
  • if it controls or monitors the therapeutic devices categorised as Class III; or
  • if it is specifically intended for the monitoring of vital physiological parameters, among others.

Disposition No 1480/2011 (Guidelines for Investigations on Human Beings) passed by the MoH, provides guidelines to investigators, sponsors, members of research ethics committees, regulatory and health authorities, who conduct or participate in investigations or clinical trials involving humans beings. Such investigations:

  • are defined as any scientific activity for the systematic collection or data analysis to develop new knowledge, by exposing human beings to observation, intervention or other type of interaction with investigators, either directly or through the alteration of the environment or collection or use of biological material or personal data or other types of records;
  • shall be authorised by the ANMAT; and
  • are subject to requirements set forth by the local regulatory authorities that may be appointed in each jurisdiction.

Research ethics committees have the authority to reject approvals, suspend or definitively cancel an investigation that does not comply with ethical standards, and must inform the health authorities about any serious or persistent ethical breach in the development of previously approved clinical researches.

On the one hand, clinical trials protocol requirements of pharmaceuticals are set forth by MoH.

Regulation No 1,480/2011 and ANMAT Disposition No 6,677/2010. The protocols must be approved by ANMAT and by the intervening Ethics Committee. Each local health authority has jurisdiction to appoint a local agency to regulate and supervise these investigations, so it is a matter that must be analysed on a case by case basis.

Conversely, ANMAT Disposition No 969/97 provides the applicable regime to clinical trials of medical devices. Moreover, ANMAT Disposition No 4457/2006 refers to the modifications to the clinical studies already authorised (under Disposition No 969/97), which are signed by the Evaluator Commission and Permanent Advisor of Clinical Trials of Medical Technology Products of the Medical Technology Directorate.

There are no regulatory requirements for a clinical trial to be listed in a publicly available database, or make its results publicly available.

There are no specific regulatory restrictions for using online tools to support clinical trials. However, implementation of an online methodology will still require compliance with applicable regulations on, for example, security and consent. Written consent by participants may include requiring an actual signature on a consent form.

The resulting data from clinical trials is both personal and sensitive data. The resulting data can be transferred to a third party or an affiliate provided certain requirements are met.

Patient Rights

Law No 16,529 regarding the Rights of the Patient in their Relationship with Health Professionals and Institutions states that patients have the right to privacy concerning the obtaining, classification, use, administration, custody and transmission of his clinical information. This right includes the confidentiality of Patient's personal data according to Data Protection Law No 25,326. In this sense, Patient's personal data shall not be disclosed by anyone that intervene in its elaboration or manipulation except when the patient expressly authorises it. Health data shall be understood as the information on their health condition, analysis, studies, treatments that should be done to the patient and their health evolution, risks, complications or effects of his/her illness.

In addition, Disposition No 1,480/11 contains provisions referring to confidentiality and security obligations intending to protect patients’ data including Health Data. Use of medical data for a purpose that differs from patient’s consent presents an ethical problem, even if it implies no risk for the data owner. Prior consent indicating specific use/purpose is required and preservation and the confidentiality of personal data, including health data, must be ensured.

Prior Consent

Patients' prior written consent is a procedure that permits to ensure that a patient undertakes voluntarily the decision of participating in a clinical trial themselves or by means of their legal representative. For the above purposes, in a clinical investigation, only a physician can provide the patient with the information with respect to its treatment. Consent form shall follow specific contain and format, depending on the jurisdiction in which it is signed (eg, in the City of Buenos Aires, Law No 3301/09 states certain formalities for consent forms).

Disposition No 1,480/11 expressly provides that in the case of genetic research, the patient has the right to decide whether or not they will be informed of the results of his/her studies, as long as they are of clinical relevance and there is a course of action to modify the patient's evolution.

Finally, Disposition No 12/2010 provides that if confidential information is to be published, rigourous and effective disassociation and protection procedures should be followed in order to avoid the identification of the owner of the data.

The creation of databases containing sensitive data is forbidden, expect when created and operated as indicated in Sections 7 and 8 of Data Protection Law No 25,326. Regarding health data, which is considered sensitive data, such database can only be created or maintained by public or private health institutions and professionals linked to the health sciences.

In order to determine if a product should be classified as a pharmaceutical or as a medical device, the following definitions stated by Law shall be considered.

Pharmaceuticals

According to Executive Decree No 150/92, "Medicine" is defined as any pharmaceutical preparation or product used for the prevention, diagnosis and/or treatment of a disease or pathological state, or to modify physiological systems for the benefit of the person to whom it is administered. Moreover, "medicinal or pharmaceutical specialty" is defined as any medicine, designated by a conventional name, whether or not a trademark or trademark, or by the generic name that corresponds to its composition and content, prepared and packaged uniformly for distribution and sale, of quantitative composition defined, declared and verifiable, of stable pharmaceutical form and of verifiable therapeutic action.

Medical Devices

ANMAT Disposition No 2,318/2002 refers to "medical product" as a health product such as equipment, apparatus, material, device or system of use or medical, dental or laboratory application, aimed at prevention, diagnosis, treatment, rehabilitation or contraception and that does not use pharmacological means, immunological or metabolic to perform its main function in humans, being able to meanwhile be assisted in their function, by such means.

There are specific requirements for registration of medicinal specialties of biological origin for human use, manufactured industrially or in the manufacture of which an industrial process intervenes. Disposition MoH No 7,075/11 provides rules the above medicinal specialties, namely:

  • blood products;
  • products obtained by a recombinant DNA route;
  • monoclonal antibodies;
  • biological drugs obtained from biological fluids or tissues of animal origin; and
  • other biological products.

Pursuant to ANMAT Disposition No 9688/2019, the marketing authorisation granted by ANMAT for pharmaceutical products (medicines) or medical devices has a valid period of five years. Marketing authorisations are renewable. In case of orphan drugs or other drugs in special conditions, the validity term is defined on a case-by-case basis by ANMAT according to scientific criteria (eg, marketing authorisation for drugs in special conditions has a valid period of one year).

Marketing authorisation for medical devices are also valid for five years, renewable, according to ANMAT Disposition 2318/2002.

ANMAT may require modifications or observe any inconsistencies in the documentation or information provided by the holder of a marketing authorisation for a given pharmaceutical product or object to any modification of the formula, components or any other changes that may endanger public health.

ANMAT may revoke the marketing authorisation at any time based on technical or scientific reasons, on a case-by-case-basis. ANMAT has broad powers to order the modification, suspension, or withdrawal of a marketing authorisation for a pharmaceutical or medical device.

The procedures, legal regimes and even authorities within ANMAT vary depending on whether the authorisation is required for drugs or for medical devices. Generally speaking, however, in order to obtain the marketing authorisation for pharmaceuticals and medical devices, pharmaceutical companies ("Marketing Authorisation") – importers or manufacturers – shall file the request with ANMAT. ANMAT will act through different divisions depending on whether the product is a drug (Instituto Nacional de Medicamentos or INAME) or a device (Instituto Nacional de Productos Médicos).

The relevant division will analyse all the documentation and information provided by the interested party and decide whether to grant the Marketing Authorisation or not. If any inconsistency or irregularity in the information and/or documentation filed arises from the evaluation carried out by ANMAT, the interested party will be notified only once of all the inconsistencies or irregularities in order to correct them within an stipulated term. If the inconsistencies are not corrected, ANMAT may reject the registration of the pharmaceutical product or medical device.

Registering and Modifying Medicines

ANMAT Disposition No 5,755/1996 (as amended) complements Executive Decree No 150/1992 and regulates the proceedings to register medicines before the ANMAT. ANMAT Disposition 2318/2002 provides rules for medical devices registration process with the ANMAT. ANMAT Disposition 2319/2002 refers to the authorisation process for manufacturers and/or importers of medical devices.

Any modification made to any of the characteristics of a medical product or medical devices authorised by ANMAT or to the information provided as registration requirements once the Marketing Authorisation has been granted by ANMAT, must be communicated to ANMAT. If ANMAT finds that said modification was not communicated, ANMAT has the power to suspend, cancel, prohibit the commercialisation and request withdrawal from the market of said product, initiate an investigation and apply sanctions.

With the same criteria applied to any modification on the product that is required when a pharmaceutical or medical technology product is assigned from the importer or manufacturer to a third party, the transfer of the Marketing Authorisation shall be duly registered with ANMAT.

Pharmaceuticals

Pharmaceuticals that lack local marketing authorisation approval can be supplied to patients only in specific cases, such as:

  • “compassionate use” (eg, when the pharmaceutical has received approval abroad but not yet locally), under the exceptional regime to import and commercialise them (ANMAT Disposition 4616/2019);
  • expanded access programs upon the laboratory’s request (ANMAT Disposition 828/2017);
  • clinical trials (ANMAT Disposition 6677/2010); and
  • post-trial access by patients that participated in the trial (ANMAT Disposition 12,792/2016 and Civil and Commercial Code).

Finally, Disposition No 654/2021 passed by the MOH on 12 February 2021 (complementing Law No 27,350 and Executive Decree No 883/2020) approved an Exception Access Regime (Régimen de Acceso de Excepción) for products containing cannabinoids or its derivatives, exclusively for medicinal use, for individual patient treatment or in the context of a scientific investigation.

This exception regime applies (for a limited period of time) when:

  • there are no marketing authorisations issued in Argentina for pharmaceuticals products that contain cannabinoids or its derivatives; or
  • such products are under clinical investigation for medical conditions approved by the MOH.

This provision approves the exceptional pathway to import pharmaceuticals with the referred characteristics with ANMAT's authorisation under this regime, as long as they are prescribed by physicians duly authorised with the Health Authorities. Physicians shall by exclusively liable for such pharmaceuticals quality, security, and effectiveness, according to the local regulations.

Medical Devices

The exceptions for the commercialisation of medical devices without a Marketing Authorisation are stated in the ANMAT Disposition No 2318/2002 as follows:

  • medical products intended for clinical research, complying with the legal requirements from the Health Authority to carry out these activities, being the commercialisation and/or use for other purposes prohibited;
  • new presentations resulting from a group of registered medical products, which shall contain label and claims; and
  • the accessories exclusively aimed to integrate another medical product of the same manufacturer that has been already registered. The product's technical report (pertaining to its registry) shall contain information on the referred accessory.

"Guidelines to Good Manufacturing Practices for Manufacturers, Importers /Exporters of Medicines for Human Use", approved by ANMAT Disposition No 3827/2018, stipulate rules to be followed during the manufacturing process of pharmaceutical products, such as quality control obligations, stability studies and inspections. In addition, ANMAT Disposition No 5358/2012 approved the "Guidelines to Good Pharmacovigilance" for the holders of Marketing Authorisation of pharmaceutical products, including but not limiting to reporting obligations in case of adverse reactions, risk management obligations, audits, permanent evaluation of benefit-risk relation and reporting to the Health Authority any change in such relation.

Regarding medical devices, the Argentine system of medical devices audit by the Health Authority is based on three pillars:

  • control of manufacturers and importers, which shall demonstrate compliance with the Good Practices of Manufacture of Medical Products and implement quality management system according to their activities;
  • approval of the medical product, considering safety and efficacy as essentials; and
  • market control and surveillance. It consists of Technovigilance actions that prevent the spread of quality failures or adverse events.

In that sense, ANMAT Disposition 8054/10 created the "Technovigilance Program", which main functions are to collect, evaluate and organise information on adverse events of medical products after the approval of their Marketing Authorisation and during their commercialisation.

As a general rule under the Administrative Procedure Law and the Access to Public Information Law, any party having a legitimate interest can access the public docket of a governmental authority. However, the authority can limit such access based on commercial confidentiality, patient’s personal data protection or other public interest reasons. In general, and on grounds such as those, ANMAT does not allow public access to such filings. Additionally, several regulations may provide additional confidentiality due to their legal protections on commercial secrets and know-how (even in absence of a patent), such as Law 24,766 on Commercial Confidentiality and the Criminal Code.

According to Law No 16,463, the commercialisation and distribution of medicines and/or medical devices shall be carried out by those who are duly licensed as a pharmaceutical and/or medical devices company by ANMAT and then obtain the Marketing Authorisation to commercialise and/or distribute the corresponding medical products or medical devices. The Health Authority has the power to determine the conditions and requirements to obtain the corresponding licence and MA, to estipulate the restrictions.

In the same way, the Health Authority is entitled to apply sanctions in case of illegal or unauthorised distribution of medicinal products and/or medical devices, including falsification of such products which Marketing Authorisation is held by a third party. These practices can entail administrative liabilities towards the applicable municipal, provincial and/or national authorities, including civil and criminal liabilities.

ANMAT and other enforcing authorities, including judicial courts, can monitor, investigate, impose sanctions and prohibit commercialisation of pharmaceuticals lacking legally required approvals. While administrative authorities can act sua sponde, judicial courts need to have a specific petition by an interested party.

To import a pharmaceutical product ANMAT shall grant a Marketing Authorisation to the interested party. Therefore, unauthorised medicinal products cannot be commercialised and/or distributed within the country. The Argentine Customs Authority verifies that all licences and authorisations of any pharmaceuticals and medical devices are in rule when the import occurs.

Manufacturing Plants of pharmaceutical products and medical devices shall obtain authorisation by ANMAT to operate. The manufacturer or owner of the manufacturing site shall file with ANMAT certain documents and information regarding including blue prints and GMP.

Authorisation is granted by ANMAT on a Federal Level and by the Provincial Ministries of Health on a provincial level. To determine what authorisations will be required for a given plant a case by case analysis considering location and type of activity is required. All plant will require (in addition to the foregoing) a municipal permit issued by the corresponding City Hall.

ANMAT considers the guidelines of Good Manufacturing Practices and Good Quality Control Practices issued by the World Health Assembly (in May, 1992) that have been adopted by ANMAT Disposition No 2,819/2004, as amended and complemented by ANMAT Dispositions No 3,602/2018, No 3,827/2018 and No 1,281/2019. Upon receiving all the documentation stated above by the interested party, ANMAT analyses it and confirms the authorisation. The conditions and validity term of each Marketing Authorisation are determined on a case-by-case basis. When products are manufactured abroad, ANMAT has the right but not the obligation, to conduct an inspection. Costs resulting from or required for any such inspection will be borne by the entity seeking plant approval.

Manufacture and Distribution

Decree No 1299/97 states the critical stages of pharmaceuticals' supply chain, and states, among other matters, that licensed pharmaceutical companies authorised by the Health Authority shall commercialise medicinal specialties manufactured and/or imported by them exclusively in pharmaceutical wholesaler, pharmacies and public or private healthcare and/or healthcare centres, authorised by the MoH or by the respective provincial health authorities.

Likewise, manufacturers, pharmaceutical distribution companies, pharmaceutical wholesalers and pharmacies authorised by provincial health authorities must be also registered with ANMAT to carry out commercial transactions involving pharmaceuticals that imply transit between provinces and/or the different jurisdictions within the Country.

Pharmacies

Pharmacies may only purchase medicinal specialties from pharmaceutical wholesalers, pharmaceutical companies and/or from the aforementioned pharmaceutical distribution companies, legally authorised by MoH and/or by the respective jurisdictional health authorities, as appropriate. At the same time, pharmacies may sell medicinal specialties only to the public and/or to public or private healthcare and/or health centres.

Moreover, the dispense and sale of medicines to the general public, throughout the Country, may only be carried out in pharmacies (according to Laws No 17,565 and No 26,567).

The Mercosur Technical Regulation on Good Practices for the Distribution of Pharmaceutical Products (incorporated by Disp. ANMAT No 3475/05) sets the same criteria, stating that it its expressly forbidden to distributors the delivery – even without cost – of pharmaceutical products to establishments that are not authorised by the Health Authority.

The authorised establishments to intervene in the pharmaceuticals supply chain and the way in which they can do so are specifically determined in the applicable regulations. In all cases they must obtain the corresponding jurisdictional and/or national health authorisations.The delivery of medicinal specialties directly to patients by laboratories, distributors and/or pharmaceuticals wholesalers is prohibited.

Healthcare centres/medical insurance companies

Also, in those cases in which pharmaceutical products are commercialised to healthcare centres (eg, clinics or hospitals) or to medical insurance companies that acquire them for delivery to their patients, they must be delivered solely and exclusively to duly authorised companies. Restrictions also apply to deposits at the healthcare centers that shall be duly authorised for the storage of medicines, being strictly prohibited the delivery of medicines to anyone that has not obtain all sanitary authorisations.

Breaches of Rules

Any breach to the aforementioned rules constitutes a very serious offense under the terms of Dispositions ANMAT No 5037/09 and No 1710/08. There are legal consequences and penalties -such as suspension of authorisation, inhibition of medicines and fines- to the involved companies and their technical director, which are jointly and severally liable for the referred acts (Disposition ANMAT No 5054/09).

Legal Requirements

Pursuant to Law No 16,463, any company or establishment which  that carries out the wholesale of medical devices (including import, export, manufacture, fraction, commercialisation or deposit in national jurisdiction or interprovincial trade of drugs, chemical products, reagents, pharmaceutical forms, medicines, diagnostic elements and all other products of use and application in human medicine) must be registered and controlled by the ANMAT (particularly the Instituto Nacional de Dispositivos Médicos) and must have professionals authorised by their respective professional associations and registrations in the ANMAT that guarantee the safety and efficacy of the import and commercialisation of medical devices.

ANMAT Disposition No 191/99 states the legal requirements for the manufacturing of medical devices, which must be registered following the parameters according to the above disposition.

Moreover, through its Disposition 4303/99, ANMAT requires that the medical devices shall follow the highest standards of current technology.

The general classification is over-the-counter or available on prescription only. The latter offers subcategories depending on product indication or components (eg, psycho tropics will require specific type of prescriptions)

Importation is regulated by the Customs Code (Law No 22,415) and the several rules and regulations issued by the Customs Department and by ANMAT (as far as pharmaceuticals and medical devices are concerned). Customs is the agency in charge of enforcing these rules and regulations at the point of entry. Afterwards, once they are released in the market, ANMAT is the agency in charge.

Only companies with a local presence and duly registered with the Federal Tax Authority may act as importer of record and, in the case of pharmaceuticals and medical devices, importers of record have to comply with the specific requirements set forth by ANMAT, including having a valid marketing authorisation. ANMAT has to approve each import declaration on a case-by-case basis.

Also, exceptions have been enacted in emergency situations to authorise certain healthcare centres and not for profit associations to import medical equipment for their own use.

In addition, under specific COVID-19 emergency legislation enacted by Congress, the MoH was exceptionally authorised to approve the use and purchase of COVID-19 vaccines lacking ANMAT MA.

In general, importation of pharmaceuticals and medical devices are subject to prior authorisation by ANMAT. Exemptions are very limited and subject to ANMAT's regulations.

Non-tariff barriers are imposed based on the specific HTS Code of the goods. Such HTS Code specifically lists all licences, permits, etc required for the importation of the products.

Argentina is a member of the Mercosur Agreement together with Brazil, Uruguay and Paraguay. Mercosur has agreements in place with other countries such as Chile, Bolivia, Peru and Mexico. The extent and scope of these agreements vary on a case by case basis.

In practice, the exemption would work as follows.

  • Accuray would execute a services agreement with a local entity that already has a registration to operate as importer of this type medical devices (requirement described under a) above) (the “Local Host”). This services agreement must establish, among other things, that the Local Host shall file the necessary RPM requests but shall not be an agent or distributor of Accuray, who will directly close transactions with customers and ship equipment to customers.
  • The Local Host will file for and obtain all relevant RPMs.
  • Upon each transaction closed by Accuray, the Local Host will issue an authorisation to Accuray’s customers (who must qualify as a healthcare centre or non-for-profit organisation in the terms of the sanitary emergency regime described above) indicating that that customer is authorised to import a given piece of equipment (indicating equipment type, serial number, etc) under the Local Host’s RPM.

This structure will have to be analysed more in depth, when the client identifies the Local Host in Argentina and before signing any agreements with the Local Host.

In general, marketing authorisation holders have the right to set the price for the pharmaceutical, being only required to inform such price to ANMAT’s registry (“vademecum”). Such right only has generic limitations arising out of:

  • the Civil and Commercial Code (ie, rights cannot be exercised abusively);
  • the Antitrust Law (ie, prices cannot be set in abuse of substantial market power);
  • the Commercial Loyalty Decree (ie, prices cannot be set in violation of commercial loyalty);
  • the Consumer Protection Law (ie, consumer rights to proper information and proper treatment cannot be violated);
  • the Supply Law (ie, prices cannot be abusive or generate disproportionate and unjustified profits); and
  • the Patent Law (ie, prices cannot be set disproportionately or restricting access by the local market).

However, there is currently some case law and experience of authorities actually enforcing these limits on specific pharmaceuticals, and it may occur that in the coming years certain orphan drugs may be subject to some of these limits.

In addition, recently, in specific exceptional cases, and using the generic powers of economic regulation granted by the Supply Law, the authorities have directly regulated the prices of a specific orphan drug and frozen prices of specific pharmaceuticals so as to prevent their from increasing due to inflation.

There is no general rule in this regard, since authorities generally do not fix prices. However, price level in other countries is a relevant item that has been increasingly reviewed by authorities when deciding, eg, to fix the price of an orphan drug.

There are specific public funds to reimburse public medical insurers (obras sociales) and also, in certain cases, private medical insurers. There are extensive rules regulating the cases, conditions, extent and procedures to obtain such reimbursement. Argentina's population is basically insured by the referred obras sociales funded through social security contributions and affiliates co-payments and government subsidies, private medical insurers and the PAMI. All three generally offer some degree of reimbursement for their affiliates and must cover the Mandatory Coverage Program (Plan Medico Obligatorio).

For a drug or a device to be included under the Mandatory Coverage Program, a specific procedure needs to be complied with by the MA holder, and the MoH must issue a specific resolution doing so, which must be published in the official gazette. Exceptionally, and upon patients’ requests, courts may also include in the Mandatory Coverage Program drugs or devices not explicitly included by the MoH, insofar as it is properly demonstrated in court that such drug or device is necessary to ensure proper quality of life in the patient.

In the last three years, the National Government has taken active measures to evaluate the cost-benefit of specific high-cost and low-prevalence pharmaceuticals, as a condition prior to including it in mandatory coverage programs and approving its reimbursement. This evaluation is done on a case by case basis by specific commissions (such as CONETEC), and only exceptionally for specific drugs, but it is likely to extend in the future and be conducted more regularly.

In the public and private market, health providers and medical insurers have developed different procedures to audit and verify that the pharmaceuticals are dispensed correctly. The aim of such audits is to verify that pharmaceutical products have been dispensed in a legitimate way and discounts have been applied correctly. The most common measure is the audit carried out by companies specialised in the administration and audit of the dispensing of ambulatory drugs in pharmacies, such as Farmalink.

There are no specific rules in Argentina for medical apps. Under the local regulations, medical apps in and of themselves would not fit in the definition of medical devices provided by the legal framework. Software associated to a given medical device or apps connected with a given device will be reviewed within the medical device marketing authorisation application.

Law of Electronic and Digital Prescription No 27,553 passed on August 2020 authorised the use of telemedicine platforms within the national territory, as long as such use is in accordance with Law No 25,326 of Personal Data Protection and Law No 26,529 regarding Patients' rights. By virtue of the foregoing, physicians may practice of medicine, dental and other related activities by providing attention by means of telemedicine platforms, including a mobile device. There are no specific provisions for mobile devices as of the date hereof.

Pursuant to Law No 27,553, the practice of medicine by means of telemedicine has been included in the provisions of Law No 17,132 the regulates dentistry, the medical profession and ancillary activities.

Resolution of the MoH No 20/05 and No 627/07, Disposition ANMAT 4980/05, Decree 1490/92 and Disposition ANMAT 6516/15, as amended, set forth that all ads directed to the public of certain products (eg, over-the-counter medicinal specialty; cosmetic products, for personal hygiene and perfumes; and dietary supplements), will be subject to ANMAT control after its diffusion. Advertising of OTC pharmaceuticals and medical devices is permitted if it follows ANMAT's rules.

According to Disposition ANMAT 4980/05, medical device advertising to the general population is allowed only for devices that, due to their intrinsic nature and proposed use, may be used or indicated for their direct use by the patient and/or non-professional user (the class of the medical device is not relevant for purposes of this regulation although it can be assumed that devices over class III always require HCP intervention).

Prescription drugs and devices that are not for patient direct use can only be promoted to HCPs and, therefore, massive advertising in online platforms is not permitted except when such communications must be published in mass media for health or safety reasons.

Since Law No 27,553, throughout the national territory the prescription of pharmaceutical products is allowed through electronic or digital prescriptions, signed in a holographic, electronic or digital way. Pharmacies and health establishments must supply the prescribed drugs in electronic or digital prescriptions.

Online sales of medicines is not allowed in Argentina. The delivery and sale of drugs, medicines and pharmaceutical products to the public can only be carried out in duly licensed pharmacies. Law No 17,565 on the Exercise of Pharmacy, updated by Law 26,567 in 2009 regarding the preparation of prescriptions, the dispensing of drugs, medicines – including those called over-the-counter and pharmaceutical specialties, whatever their condition of dispensing – provides and maintains the criteria providing that the dispensation can only be made in the entire territory of the country, in authorised pharmacies. Thus, sale of medicines outside the authorised establishments and delivery of medicines to the general public, in any manner different to the one stated above is expressly forbidden and is deemed an illegal practice of pharmacy.

As regards medical devices, there is no specific regulation for their commercialisation. A specific permit issued by ANMAT is, however, required for inter-jurisdictional distributors who are not the Marketing Authorisation Holders.

There are no regulations specifically addressing electronic health records; however, several laws and regulations will apply to the implementation of health electronic records (eg, Data Protection Law, Digital Signature regulations, etc). As already explained, health-related information is considered sensitive data, subject to specific limitations and stricter regulations; for example, formation of databases with health related information is limited to public or private health institutions and healthcare professionals. As regards cloud platforms and transfer and store of sensible data, there are no specific regulations on patients data, and therefore general regulations on sensitive data and data transfer will apply.

Patents are mainly regulated by Law No 24,481, Executive Decree No 590, as amended, and regulations issued from time to time by the Industrial Property National Institute (INPI). Additional requirements may result from ANMAT's regulations. Standard patentability requirements such as novelty, inventive step and industrial application apply to pharmaceuticals or medical devices. The most common issues in obtaining patents for Pharmaceutical Compositions are related to delays in registration resulting from the Patent Office's restrictive criteria.

Second and subsequent medical uses of a known product are not patentable, as provided in specific regulations (eg, Circular 008/2002 INPI). This criteria is considered to be against the TRIPS Agreement and the same Patent Law. Principles under these regulations may extend to restrict dosage or selected patient populations. Infringement in turn will be construe upon the non-authorised use of the whole or a portion of a patented product, according to the acting judge scrutiny.

The term of grant of a patent application is in the range of three to four years. Term of patent validity is of 20 years as of application date and cannot be extended. Patent extension may be intended through innovation in existing patents, in which case a new patent application may be filed, and should go through the registration process which will surely be treated with a very strict scrutiny. A third party may challenge the new patent application for not complying with the patentability requirements and, if necessary, seeking filing an invalidation action before a court of law.

An infringement will result from using a product, device or process already registered, without the authorisation of the owner of such registry.  Applying for a marketing authorisation will not imply an infringement per se, but probably a reasonable threat that the actual infringement will take place. A reasonable threat of infringement is actionable. If an injunction is requested, the requirements are:

  • to evidence before the acting judge the potential infringement;
  • to demonstrate that the delay in granting the requested measure will affect the right of the plaintiff; and
  • to file a security bond.

Defences against patent infringement should be aligned to demonstrate that there is no overlapping between the actual use and the protected patent. Bolar defence will also be available; in this regard, Section 8 of Law 24,766, provides that any third party may use the information protected by a patent, before the expiration of the patent, for experimental purposes and to gather the information required for the approval of a product or procedure to be commercialised after the expiration of the patent. Compulsory licences are available under Section 44 – and related provisions – in Law No 24,481.

Proceedings for patent infringement can be initiated by the owner of the patent affected by the infringement, or any other party holding such right (eg, licensee). Against infringement both, injunctions and standard legal proceeding will be available. A typical procedure for a patent infringement action will involve a cease and desist requirement, pre-trial mediation hearing, filing of a lawsuit before a court of law, evidence stage and final pleading. Invalidity is available defence that has to be invoked as counterclaim.

A potential generic entrant should first conduct an investigation to determine if what it proposes to do is lawful under patent law (Freedom to Operate). Argentina has granted very few pharmaceutical patents in the recent past, so there are no specific procedures for generic entrants. There is no patent linkage mechanism available in Argentina.

Patent Law 24.481 modified by Law No 24.572 provides for sanctions resulting from violations to patent rights and grants judges the authority to order protective and preventive measures. In addition to injunctions, actions for damages are available. The law also provided for criminal sanctions for counterfeiting.

The are no specific restrictions, and therefore the general limitations for trademark registration resulting from Sections 2 and 3 of Law No 22,362, will apply. These limitations relate to generic denominations, forms, already used trademarks and the like. Import regulations on importation of pharmaceutical and medical devices shall also apply.

Under applicable regulations, IP protection is available for the trade dress or design in general, with no specific provisions for pharmaceuticals and medical devices.

According to Confidentiality Law No 24,766, the information regarding pharmaceuticals that is filed with the Health Authority in order to obtain the approval of their Marketing Authorisation is protected against any dishonest commercial use as defined by such law and may not be disclosed. Although biologicals are subject to a specific regime, there are no regulations for these specialties referring to data exclusivity.

In accordance with Decree No 260/20, the Argentine government granted powers to the MoH to carry out the direct purchase (contrary to the bids or more complex procedures usually carried out before the COVID emergency) of goods, services and necessary equipment to deal with the sanitary emergency.

In addition, Joint Resolution No 1/2020 of the MoH and the Ministry of Productive Development established a list of critical health supplies necessary to mitigate the spread of COVID-19, which are subject to the aforementioned regime. The list is dynamic; it has been supplemented or modified according to the requirements of the supervening circumstances.

The purpose of said resolution was also to encourage companies that participate in the critical health supplies manufacturing chain to increase the manufacture, distribution and marketing of said supplies to the maximum of their capacity and to determine the means to ensure their distribution and supply to the population, and health entities.

Supplies

Companies involved in the manufacture, distribution and commercialisation of the key supplies have been compelled to increase production to their maximum capacity and report to the Sanitary Regulatory Authority and the Ministry of Production, production plans as well as the amount of goods produced and sold and identify the buyers. Health institutions will have priority to acquire key supplies.

Supply Law No 20,680 will apply to any deviations. This law gives the government broad powers to intervene in economic processes (eg, manufacturing of products) to protect essential needs of the population. The Supply Law sets forth fines (among other sanctions).

Subsequently, Decree 297/2020 was issued, in which the essential activities against the COVID-19 pandemic were defined, and were somehow exempted, depending on the case, from the lockdown dictated by the government.

Federal Government Intervention

Likewise, the Federal Government, through the Secretariat of Inner Commerce, intervened more strongly on pricing and production of specific medicines and medical devices. For instance, such Secretariat prohibited increases on the prices of sanitiser and liquid oxygen, and mandated their production at maximum capacity. These regulations were enacted not only on a general basis (ie, for all market players) but were also directed to single market players considered to bear substantial market power. In addition, and given the economic impact of the pandemic and the predicted impact of health spent on the public budget, the government been issued price controls and maximum price regulations on orphan drugs not specifically related to the pandemic.

Finally, the National government granted certain tax and pension benefits, including but not limited to the payment of employer contributions to the Argentine Integrated Pension System to employers who are providers of services, establishments and institutions related to health.

There have been major impacts on the management of clinical trials. The main issue is in connection with the on-site clinical trials and the isolation measures, which makes the recruitment and the development of the trials more challenging. ANMAT has issued guidelines tending to ensure that trials in progress are not interrupted.

Regarding regulatory pathways applicable to emergency approvals, the Argentine Federal Government imposed certain actions to reduce the manage costs of the health care system. In addition, several resolutions have been issued in connection with a specific orphan drug, including pricing controls and the exclusion of the mandatory reimbursement plan. This is an important precedent that should be monitored by manufacturing ad importers of high cost drugs.

In response to the health emergency and within the framework of the joint Resolution No 1/2020 (“Resolution”) of the MoH and the Productive Development Ministry, which provides the list products devices that are essential to face the COVID-19 crisis ("Key Supplies"), ANMAT published a simplified mechanism for those companies that import or manufacture medical devices listed in the Resolution and its subsequent amendments, and diagnostic reagents for in vitro use for COVID-19 and must carry out the expansion of the expertise area and/or the provisional authorisation of the company.

In the case of imported devices, regardless their origin, the following documentation will be exceptionally accepted:

  • a certificate of free sale (CFS) of a country of high sanitary surveillance, which may be submitted with simple translation at all, without apostille and legalisation; or
  • the valid registration certificate issued by the competent Health Authority and/or with the European Conformity (EC) mark. 

In these cases, the following text must appear in the indication of use of the device: “Device registered in the context of the COVID-19 health emergency.”

Third-Party Manufacturing Capacity

Notwithstanding the foregoing, in the context of the health emergency and for the purpose of supplying society with safe products, those who have the operational capacity to manufacture critical medical devices in this context may do so (as third parties) to companies authorised by ANMAT through the National Institute of Medical Devices. Said authorised companies will be the holders of the device registration and responsible for their manufacture and commercialisation.

The Federal Government reduced formalities for Governmental purchase of medicines, medical devices and medical supplies.

On 18 May 2020, ANMAT issued a press release informing that filings made on hard copy, which are related to medical devices, can now be reconverted and filed electronically through ANMAT's online system, HELENA.

In addition, ANMAT incorporated two new rates for in vitro medical devices were incorporated for agile modification through the ANMAT online system, HELENA. It is applicable only for requests that do not modify the in vitro medical device itself, nor its basic methodology, nor its performance characteristics.

The exportation of certain materials deemed critical during the COVID-19 emergency was subject to prior authorisation (eg, face masks, alcohol, ventilators, etc). Likewise, import duties applicable to these materials have been waived during the duration of the emergency.

Several regulations have been issued allowing physicians to prescribe via email or WhatsApp. HMOs will reimburse pharmacies accepting these virtual prescriptions.

HMOs started to accept telephone or video doctor visits and physicians have been authorised to charge for remote appointments.

On 13 April 2020, the ANMAT officially published the telehealth and public distance communication (telemedicine services) platform "TeleCOVID" that reaches the patients' home for the first time. The service is intended for people with suspected or mild symptoms of COVID-19 and for those who need medical assistance to monitor chronic diseases.

In addition, Law No 27,553 on Electronic or Digital Prescriptions, entered into force on August 2020. This law provides that the prescription and dispensation of medicines, as well as any other medical or dental prescriptions or prescriptions from other legally authorised healthcare professionals may be electronic or digital. Law No 27,553 also establishes the possibility of using healthcare tele-assistance platforms throughout the Argentine territory, as long as the provisions of Data Protection Law No 25,326 and Patients' Rights Law No 26,529 are observed.

The Argentine Patents and Utility Models Law No 24.481 (Section 45), as well as the TRIPs Agreement and Paris Convention – treaties for which Argentina is a party to – establish the possibility of granting compulsory licences in case of Sanitary Emergency or National Security.

Up to this date, we are not aware of any compulsory licence having been requested to/granted by relevant authorities.

The Argentine Patents and Utility Models Act establishes the conditions under which compulsory licences can be granted by the State:

  • the licence to use the patent shall be granted by the Argentine PTO;
  • it shall be non-exclusive;
  • such licence cannot be assigned to third parties;
  • on general basis, the authorisation only enables the licensee to supply the internal market;
  • fair compensation shall be granted to the owner of the patent, the amount of which shall be established by the circumstances of the case;
  • the use of the licensed patent outside the scope of authorisation as well as compensation shall be reviewed by a court; and
  • the party requesting the compulsory license shall have the economic capacity to efficiently exploit the patent and shall possess an authorised venue by competent authority.

In addition, note that under Section 70 of Law 27,541 (the Social Support and Reactivation of Manufacture Act of 21 December 2019) and as a general provision, the government has authorised the Health Ministry to grant compulsory and mandatory licences in the health sector, should the need arise.

Pursuant liability exemptions regarding COVID-19 vaccines, Law No 27,573 granted broad and exceptional powers to the National Executive Power (the "Executive") to negotiate the expedited purchase of COVID-19 vaccines. The law authorises to extend jurisdiction in favour of foreign judicial and arbitration tribunals and to agree to indemnities in favour of the entities that have developed or that sell the vaccines to the Executive. In addition, an exceptional procedure for the emergency regulatory approval of such vaccines was enacted. The powers and authorisations under the law will be in effect for the duration of the health emergency caused by COVID-19.

Accelerated Purchasing Regimes

In effect, the Executive is authorised to purchase the COVID-19 vaccines through the accelerated purchasing regime approved during the pandemic (Executive Order 260/2020 and related regulations), and is expressly allowed to include various exceptional clauses in the contracts. These clauses are:

  • extension of jurisdiction in favour of judicial and arbitration courts abroad;
  • waivers of the defence of sovereign immunity;
  • indemnity (except for fraud, malice or negligence) regarding monetary claims related to and in favour of those who participate in the research, development, manufacture, provision and supply of Vaccines;
  • confidentiality; and
  • other clauses according to the international market.

These clauses may pose multiple legal and commercial challenges related to implementation and enforceability, in particular due to the existence of other legal regimes and case law with which they will coexist and which could result in claims or challenges (for example, legislation and jurisprudence regarding access to public information, transparency, patient rights, competition, commercial loyalty, supply and consumer protection).

In addition, the law exempts from the payment of import duties and any other tax, levy or contribution, of any nature or origin, Vaccines and disposables imported by the MoH or on behalf and order of the MoH, the provinces and the City of Buenos Aires.

Emergency Vaccine Approval

Finally, ANMAT is authorised to carry out the emergency approval of the COVID-19 vaccines through a summary procedure if certain requirements are met. Also, Law No 27,573 has exceptionally, during the Health Emergency as declared by Law 27,541 and Executive Decree 260/20 by virtue of the COVID-19 Pandemic, authorised the National Executive through the MoH to carry out the emergency approval of the COVID-19 vaccines with the due support of the scientific and bioethical evidence that allows to verify their safety and efficacy.

By virtue of the above, the MoH authorised through Resolution No 2784/2020 the Sputnik V vaccine, with the recommendations of ANMAT.

During the pandemic, authorities have not requested the requisition or conversion of manufacturing sites due to COVID-19, but they have requested manufacturers of certain strategic drugs and devices to operate at full capacity to ensure production and to give the public sector a preference for their acquisition. Further, authorities have approached certain industry players to reconvert some of their facilities (warehouses and the like) to ensure vaccine conservation logistics. In addition, local companies had to prepare and file before the relevant labour authorities of their security and safety protocols, to confirm they were sufficient and included all necessary protective measures.

There have been no changes to the system of public procurement of medicines and medical devices due to COVID-19. However, the Federal Government reduced formalities for governmental purchase of medicines, medical devices and medical supplies.

Companies involved in the manufacture, distribution and commercialisation of the key supplies were required to increase production to their maximum capacity and report to the Sanitary Regulatory Authority and the Ministry of Production, production plans as well as the amount of goods produced and sold and identify the buyers. In addition, certain key industry players in the manufacturing of certain equipment (ventilators) were indirectly intervened by the authorities, which required them to operate at full capacity and give preference to the sales to the public sector.

Baker McKenzie

Cecilia Grierson 255
6th Floor, C1107
Ciudad Autónoma de Buenos Aires
Argentina

+54 11 4310 2200

+54 11 4310 2200

Vanina.Caniza@bakermckenzie.com www.bakermckenzie.com
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Law and Practice

Authors



Baker McKenzie has a Buenos Aires office that is an established centre of the firm's healthcare industry group. More generally, Argentina is a leading centre for life sciences development in Latin America, from its early 2000s creation of the Ministry of Science, Technology and Innovative Production (MSTI) to its current involvement in manufacturing of the AstraZeneca COVID-19 vaccine and other pandemic-related equipment for domestic and overseas distribution. Since 2006, the office has provided a range of legal services to a significant number of international clients in this space, taking a holistic, efficient approach. The firm was an early adopter of an industry approach to healthcare. The firm would like to thank Esteban Rópolo, Bernard Malone, Felipe Graham, Candelaria Munilla and Mercedes de la Fuente for their contributions to this chapter.

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