The Life Sciences Law Review: Argentina

Introduction

The pharmaceutical industry continues to be a highly regulated sector that has a very important presence in Argentina. Its financial results are highly affected by the influence of agreements entered into with social security organisations – mainly the social security organisation that covers retired people – and private health insurance companies. These organisations agree on coverage that favours its affiliates regarding prices from laboratories, wholesalers and pharmacies. Despite the fact that these kinds of agreements continue to be in place, there have been changes in the financial politics these organisations have, owing to the fact that they are now calling for bids and joint purchases of certain products – mainly those related to oncologic and special treatment prognosis, which are usually the most expensive products.

An important change in the commercialisation of pharmaceutical products in the social organisation that covers retired and challenged people (it includes the higher percentage of sales in the market) is the fact that this organisation decided to terminate agreements with the whole industry, switching to agreements company by company, in an additional effort to reduce the impact of the price of products. We cannot assure that this effort has been successful.

Due to the covid-19 pandemic, 2020 has been, worldwide, an exceptional year and Argentina has not been the exception. Although a main character in this pandemic scenario, as any other industry, the pharmaceutical industry had to rapidly adapt to the circumstances imposed by the pandemic. As in other parts of the world, Argentina was and currently is the stage for some clinical trials related not only to vaccines for covid-19 but also for other products related to this disease, such as hyperimmune equine serum products. On the regulatory side, because of the pandemic situation, the government has issued many regulations related to this situation, some of which directly relate to the pharmaceutical industry and life science sector, including a covid-19 Vaccine Law for the direct purchase by the government of these type of vaccines and the granting of immunity to laboratories related thereto. Also, it has been a year in which some important laws and other regulations have been passed, such as a law regulating electronic prescriptions, the Cystic Fibrosis Law, and a new regulation on the medicinal use of cannabis, among others.

Changes also occurred in the public administration. With the change of government in December 2019, Carlos Chiale resigned as head of the National Administration of Drugs, Food and Medical Devices (ANMAT) and was replaced by a former head of the institution, Manuel Limeres.

During 2020, Mr Ginés González García, who previously acted as Minister of Health during the 2002–2007 period, has continued to act as Minister.

The patentability of pharmaceuticals continues to be the main issue affecting the industry and is a source of never-ending discussions related to the extension of the novelty requirement that a product or procedure should have to determine its eligibility for a patent. The 2012 joint resolutions of the Ministry of Industry 118/2012, the Ministry of Health 546/2012 and the Patent Office 107/2012 add requirements to obtain the patentability of pharmaceutical products. Said regulation is still being challenged through the lawsuit triggered by several companies, which has been ongoing since August 2013. This major lawsuit has not even reached the stage in which evidence has been produced, given the fact that it was always a window to carry on negotiations related to patentability being allowed to state that the mentioned joint resolution was never consented.

The protection of research and consequent patentability of products has, however, created broad divisions between the different types of laboratories that operate in the country. These are:

  1. laboratories that have products based on previous research, mainly subsidiaries of foreign laboratories;
  2. local capital laboratories that work through licences negotiated with research laboratories;
  3. laboratories that sell branded generic products that are not patented in the country; and
  4. laboratories that sell generic products.

The differences between these laboratories are apparent at an intellectual property level. The primary means of commercialisation of pharmaceutical products is the same in all cases and follows the course of laboratory–wholesaler–pharmacy. Product distribution is carried out through specialised companies that usually act on behalf of the different laboratories that constitute their clientele. Another means of commercialisation is through participation in specific bids issued by the public administration or by different hospitals. In these bids, the laboratories participate directly and do not follow the usual commercialisation channel. Social security entities are highly involved in calculating discounts to their affiliates working through the regular commercialisation channel mentioned above. Nevertheless, in some cases, bids are called by either public or private social security entities, but these are specific to certain products, such as orphan drugs or vaccines.

Generic products – excluding branded generic products – have very little market relevance.

As well as providing a broad description of the pharmaceutical market, it should be added that the regulation of the commercialisation of pharmaceutical products, medical devices and dietary supplements is controlled and regulated by the Ministry of Health through ANMAT. ANMAT has published on its website a vade mecum of all products registered with it and being commercialised, indicating not only their active principles, but also commercial names and prices.

The regulatory regime

The principal piece of legislation is Law No. 16,463, the Law of Medicines, issued by Congress, which has been in force since 1964. Law No. 16,463 is further complemented by decrees issued by the Executive Power. These decrees are subject to more specific regulation by means of resolutions issued by ministries, mainly the Ministry of Health. Finally, ANMAT also establishes multiple specific regulations.

ANMAT, consisting of a decentralised controlling entity on matters related to pharmaceutical products, food and medical devices, was created in 1992, through the enactment of Decree No. 1490/92. ANMAT is dependent upon the Ministry of Health, usually through the intervention of the Secretary of Health. As mentioned, with the change of government in December 2019, former Director of ANMAT Carlos Chiale was replaced by Manuel Limeres who had been the head of the Administration during 2002 and 2008.

The faculties granted to ANMAT in connection with the pharmaceutical industry not only relate to the approval of laboratories, storehouses and products, but also enable it to act as the controlling public office with respect to the industrialisation and commercialisation of pharmaceutical products.

As a general principle, importers, exporters, manufacturers and distributors of pharmaceutical products must be qualified by ANMAT to develop their activities within the pharmaceutical industry. This authorisation, once granted, is valid throughout the country. Nevertheless, provincial laboratories (authorised to act only at a provincial level) may also be qualified.

ANMAT also plays an important role in the approval and control of clinical trials that take place in the country.

Law No. 16,463 originally established that, in order to be authorised, laboratories must manufacture their own products. Considering scientific, economic and political environments, laboratories have been authorised to import and commercialise pharmaceutical products without the obligation to manufacture them. There are rules by which ANMAT authorises the referral to third-party laboratories for specific stages of manufacturing. As minimum requirements, when not manufacturing their own products, laboratories are required to have their own quality control laboratory that should be in accordance with the products commercialised by the laboratory, a storehouse and a technical director. Licensing to authorised laboratories is a common way to enter the market when the laboratory is not registered in Argentina. Another way is related to import through exceptional channels as named patients programmes, although this way implies a use of such imports for a different purpose from the one the regulation was issued for.

Owing to the industry's development, ANMAT has issued certain specific regulations that apply to clinical trials, traceability of products and other matters. Additionally, some specific laws that deal with the pharmaceutical industry have been enacted, such as Law No. 26,529, which relates to the patient's rights, and Law No. 26,689, which relates to orphan diseases.

As mentioned above, in 2020 the Argentine Congress passed Law No. 27,552, on Cystic Fibrosis of the Pancreas or Mucoviscidosis and Law No. 27,553, on Electronic or Digital Prescriptions. Also, the Executive Branch issued Decree No. 883/2020, by means of which the prior regulation of Law 27,350 (which set the regulatory framework for the medical and scientific research on the medicinal, therapeutic or palliative use of the cannabis plant and its derivatives) was repealed and a new regulation of this law was established.

i Classification

The regulatory regime is broad and covers regulations that apply to the commercialisation of all products of its incumbency.

The principal regulations that deal with pharmaceutical products are:

  1. Decree No. 150/92 and Resolution No. 233/1996, which establish requirements to register pharmaceutical products and qualify as a laboratory (including manufacturer, importer and distributor laboratories);
  2. Decree No. 1299/97, which regulates the commercialisation of products;
  3. Disposition 3602/2018, No. 3287/2018 and others, which establish the good manufacturing practice (GMP) to be followed classifying all different product alternatives;
  4. Disposition No. 4616/2019 which regulates the exceptional access regimen for the import of pharmaceutical products on a patient's name basis;
  5. Disposition No. 4622/2012, which regulates the registration (under special conditions) of pharmaceutical products destined to treat rare diseases;
  6. Disposition No. 7075/2011 and No. 7729/2011, which regulate the registry of biological products and biosimilar products;
  7. Resolution No. 627/2007, which regulates the promotion of ethical products; and
  8. Disposition No. 4980/2005, which regulates the advertising to the general public of free-sale pharmaceutical products (over-the-counter (OTC)), medical devices including those that apply to dentistry, cosmetic products, food, dietary supplements, household cleaning products, and in vitro and self-testing diagnostic products.

As mentioned above, for pharmaceutical products to be authorised for their commercialisation, they must be registered with ANMAT. For such registration, the following information must be provided:

  1. product information;
  2. technical information;
  3. label information; and
  4. leaflet information for patients.

In cases where the product to be registered is imported from the countries listed in a specific annex to Decree No. 150/92 (these are countries that have highly developed methods of health control), the certificate of commercialisation of the health authority of the corresponding country shall also be provided. Marketing authorisations are granted for a five-year term (except in the case of registration of products under special conditions (i.e., products to treat rare diseases) in which case the term of determined on a case-by-case basis) and can be renewed as many times as required by the holder.

ii Biological products

Regulations Nos. 3397, 7075 and 7729 have been issued by ANMAT to establish specific requirements for approving biological products and biosimilar products.

Biological products listed in Regulation No. 7075 include hemoderivatives, products obtained with recombinant DNA techniques, monoclonal antibodies and biological medicines produced from animal tissues.

To register biological products, strict requirements must be met, including providing detailed information regarding the active principle and the manufacturing process of the active principle. Requirements vary in the case of monoclonal antibodies.

The approval of biological products continues to be a matter subject to claims made by laboratories – mainly those that develop innovative products. The fact that triggered such claims was that the regulations issued to approve biological products included the obligation for the authorities (mainly ANMAT) to issue specific guidelines to be complied with to obtain the approval of such products.

These guidelines were listed during the last quarter of 2018. They appeared on ANMAT's website on 12 October but were not published with any detail as to when they would have to come into force. In addition, these guidelines have not been identified with any regulation number.

The guidelines refer to biological products establishing the need to file a guide, the requirements to register biological products related to the plants, a location of the plants, a report of the clinical aspects, etc. They also refer to vaccines, radiopharmaceutical products, medicines for advanced therapies, blood banks and related products.

Unfortunately, such guidelines are only listed and not described. It is not clear if the purpose of complying with them is for internal purposes only, if they would contribute to a final report or how the information compiled would be kept.

iii Non-clinical studies

No specific legislation refers to the welfare of animals in clinical trials carried out in Argentina. However, there are several references to how these kinds of trials should take place in Regulation No. 6677/2010 issued by ANMAT and related to the performance of clinical trials. Several articles written on this topic relate to bioethical concerns about clinical trials and, moreover, it has been stated that, if possible, this kind of trial should be replaced according to the circumstances of the matter under investigation.2

iv Clinical trials

Requirements to perform clinical trials are regulated by Resolution No. 1480/2011 issued by the Ministry of Health, complemented by Regulation No. 6677/2010 issued by ANMAT (the regulatory authority in charge of authorisation and control of any clinical trials to be performed). Additionally, ANMAT has created the National Registry in Health Investigations.

A clinical trial is an area that has shown a constant increase in activity in the past few years and with the covid-19 pandemic, a series of clinical trials in Argentina have been opened. There are currently five for vaccines related to covid-19 and 16 for other pharmaceutical products related to covid-19 treatments.

ANMAT must grant prior authorisation for any clinical trial. The sponsor, which must be a locally domiciled company or a foreign company's representative in Argentina, must request authorisation from ANMAT. Information about the sponsor is required, not only for legal purposes, but also for financial purposes to substantiate that it will be able to afford any eventual damages. In addition, a guarantee may be required.

Information related to the clinical trial is also required, such as:

  1. the name of the study;
  2. the phases of the trial;
  3. the product involved;
  4. the number of subject participants;
  5. consent forms that are required from subjects participating in the trial;
  6. information about the principal investigator; and
  7. information about the site.

The informed consent of the participating subject is required and the wording of the form should prove that the subject clearly understood the implications of participating in the trial. It is the principal investigator's duty to obtain and keep the consent forms. Certain requirements apply to subjects who are vulnerable owing to educational disadvantage. The informed consent form must be approved by ANMAT, the ethics committee appointed in connection with the trial and the Data Protection Registry.

v Named-patient and compassionate use procedures

Regarding orphan drugs, closely related to the named-patient situation, ANMAT issued Disposition No. 4616/2019 to rule over compassionate use of drugs. This resolution regulates the mechanism for the import of products that are not commercialised in the country and in the instance that a patient requires a specific treatment duly prescribed by his or her physician. The import of such drugs has to be requested in each case by the patient or their legal representative. Patients must file a declaration by the manufacturer of the drug, the prescription of such drug by the physician and the informed consent of the patient to be treated with such drug. The total amount of drugs to be imported shall be for a treatment that does not exceed 90 days. For long treatments, the authorisation is granted for up to 180 days. If the treatment is longer, a new and different request shall be made in each case.

According to Resolutions Nos. 942 and 426 of 2001, the import of these drugs is exempted from the payment of custom taxes and fees.

Disposition No. 4616/2019 establishes that the import of these products is allowed from high standard pharmaceutical developed countries listed in Annex I of Decree 150/1992, when requested by public authorities to attend a sanitary crisis and medicines that are not in the country at a certain moment or are not accessible to patients for justified reasons.

Law No. 26,689 could be defined more as a list of intentions and 'to dos' rather than a specific regulation on the matter. In practice, these cases assume the presence of the patient before ANMAT and compliance with specific steps to obtain the import of the necessary drugs, which is usually granted. Specific organisations, such as associations of patients or foundations, usually help to support the psychological state of the patient and family during the procedure.

It is worth mentioning that Disposition No. 4616/2019 expressly excludes from the exceptional access regimen it provides for non-registered products the import of products that contain cannabis derivates for medicinal use.

vi Pre-market clearance

No pharmaceutical product or medical device can be commercialised without having the approval of the Board of Health, with the exception of products included in clinical trials duly authorised or the ones imported by the exceptional access regimen mentioned above.

The approval of pharmaceutical products by ANMAT should be required by a laboratory duly qualified as such before the Argentine authorities. Laboratories that are not qualified are not allowed to register pharmaceutical products. Nevertheless, it is possible for such laboratories to appoint a local laboratory (either a local subsidiary of a foreign laboratory or a national laboratory) as its representative to obtain the marketing authorisation issued by ANMAT in the name of the local laboratory acting on behalf of the foreign laboratory that is not qualified in the country.

General aspects of the procedures have been described in Section II.i; however, it is important to highlight that products registered in highly sanitary developed countries can be locally registered through a fast-track procedure that implies local recognition of the foreign marketing authorisation. Once a product is registered, similar products may be registered through a fast-track procedure to be carried out before ANMAT.

Once the product is registered, it is necessary for ANMAT to conduct a technical verification of the information related to the control methods, elaboration, pharmaceutical tests, stability studies, operational capacity to elaborate or control included in the applications for registration of the products in order for ANMAT to issue a commercialisation authorisation in accordance with Disposition No. 9707/2019 that regulates the procedure for requesting such authorisation. Without such authorisation, although the product is registered, it is not possible to start commercialisation of it.

vii Regulatory incentives

There are no regulatory incentives that would grant an extension of the patent term in cases in which a specific product has been subject to a patent application.

Nevertheless, a law that deals with confidentiality issues was enacted on 18 December 1966 (Law No. 24,766). This law establishes that during the process to authorise a new product, the confidentiality of the file related to that process should not be made public.3 Nevertheless, the same law establishes that if a patent has been granted for a product, it is possible to perform trials with it, but commercialisation should be kept on standby until the patent expires.4

In contrast, Law No. 25,649 (enacted on 18 September 2002) favours the use of generic drugs and obliges doctors to prescribe pharmaceutical products using the name of the active principle of products. Law No. 25,649, however, does not prohibit use of the trademark in the packaging of the product, nor does it prohibit prescribing the use of the commercial name. The concrete application of the Law has not been clearly effective to date.

viii Post-approval controls

Post-approval controls are managed by ANMAT, principally by means of reports made by parties on infringements to current regulations. Nevertheless, ANMAT is authorised to carry out inspections and to review products already authorised for commercialisation. Technical directors, being jointly and severally liable with the laboratory for any damage that a product may cause, are also keen to review batches of products during the manufacturing process and once finalised.

Additionally, laboratories usually carry out pharmacovigilance of their products, and agreements specifically related to such issues are commonly executed between laboratories that license their products to third parties.

In connection with this aspect of the business, the Ministry of Health issued Resolution No. 435 in April 2011, concerning traceability of pharmaceutical products that follow a specific product from its manufacture or importing stage, to the time it is exhibited for sale.

ix Manufacturing control

Disposition No. 3602/2018, issued by ANMAT and including GMP, is the main rule that regulates the manufacture of pharmaceutical products. This regulation was drafted in line with the international requirements on GMP such as the ones approved by World Health Organization in 2015, reports of the Pharmaceutical Inspection Corporation Scheme (PE 009–2015 and Annexes 2017) by norms of the International Council and ISO (International Organization for Standardization).

For the purpose of verifying the compliance of GMP, ANMAT is empowered to supervise the manufacturing laboratory as well as the sites in which commercial companies and importers develop their business. ANMAT may carry out technical inspections that cover the functioning conditions and quality control used in such places. Additionally, the manufacturing sites should also be approved by the municipality in which they are located and specific approvals on certain aspects, such as disposal of residues and other environmental issues, also apply. Some of these approvals are incorporated at a municipal level.

x Advertising and promotion

Section 19 of Law No. 16,463 prohibits any form of public announcement of products that require an authorised prescribed delivery. The Supreme Court of Justice has supported this rule in several judgments by stating that the mere release of prescription medicines to the public without professional control may endanger public health.

The Ministry of Health Resolution No. 627/2007 regulates permissible practices for the promotion of pharmaceutical products requiring a medical prescription. Importantly, the resolution forbids pharmaceutical companies from, directly or indirectly, granting, offering or promising healthcare professionals (HCPs) any kind of incentive, such as bonuses or financial perks.

The promotion of medicinal products can only be addressed to practitioners authorised to prescribe or deliver medicines. The promotion should provide sufficient information, both technical and scientific, to allow practitioners to learn about therapeutic properties of the product. Promotion should be accompanied by informational material supporting the specification data of the approved product. Information should include the generic name and trade name of the pharmaceutical product and its quantitative and qualitative composition, form, counter-indications, adverse effects, warnings and doses. The only possibility of mentioning non-approved medicinal products is in the frame of specific congresses addressed to medical practitioners, and even in this case products should be identified by their active principal denomination, not being allowed to use the commercial brand.

Only the holder of a marketing authorisation may promote a product. While the holder of a marketing authorisation may entrust promotion to a third party, it maintains responsibility for all promotional communications and materials. The holder of the marketing authorisation must ensure that its agents or visiting practitioners receive the necessary guidance and comply with the requirements of Resolution No. 627/2007.

The aforementioned regime for promotion does not apply to OTC products or medical devices. Subject to control, advertising of OTC products is permitted. The advertising of OTC products should not act as an incentive to use the products. The inclusion of a disclaimer recommending a consultation with a physician is mandatory.

xi Distributors and wholesalers

The work of distributors and wholesalers is also under the supervision of ANMAT. Two clear distinctive functions are differentiated: one is the physical storage and distribution of the products, and the other relates to the collection of purchase orders and invoicing of the products. Storage facilities are subject to the approval and control of ANMAT.

The latter are companies that represent several laboratories and, acting on their behalf, invoice the products to be sold to wholesalers or pharmacies. These companies later render accounts and are compensated through a commission.

xii Classification of products

The classification of products is outlined in Section II.i. All products (both ethical and OTC) are considered to be pharmaceutical products and should be sold only in pharmacies.

Some years ago, it was possible to find OTC products sold outside pharmacies (e.g., kiosks); however, settled jurisprudence has established that OTC products should only be sold in pharmacies and kept behind the counter.

Products for hospital use are usually sold through bids and can be delivered without following the usual commercialisation chain directly to hospitals, both private and public, and without needing to comply with all packaging and labelling requirements that need to be followed for the sale of these products through pharmacies.

In cases in which products are delivered as free samples, the products must include the generic name and brand name in accordance with Article 6 of Law No. 25.649, which requires both names to be of the same size and be given the same emphasis. Samples should also state: 'Free sample – sale forbidden'. Free samples can only be delivered to practitioners authorised to prescribe or deliver medicines.

xiii Imports and exports

Imports of pharmaceutical products are only authorised after following the regular procedures before the customs authorities, and a prior authorisation granted by ANMAT. These procedures usually include a visit and clearance of the plant in which the product to be imported is manufactured. The only entity authorised to import a pharmaceutical product is the laboratory that holds the marketing authority granted by ANMAT. The import is subject to clearance before going to marketing by means of a control held by the technical director of the laboratory intervening in the import of the product. The import of products to be used in clinical trials, which are not authorised for marketing, is subject to prior authorisation by the health authorities.

The export of products is authorised in cases in which the marketing authorisation, or a specific document, states that the product is available to be exported.

The donation of pharmaceutical products and medical devices from abroad is also subject to the control of ANMAT, as well as the customs authorities, and is subject to specific guidance. For example, products to be donated should be individually described and are subject to control; simply providing a general description of the products is not adequate.

xiv Controlled substances

Psychotropics are subject to a strict, specific regulation that is continuously updated, with strict control carried out by ANMAT. Manufacture, import and use of psychotropics in products is subject to specific procedures and requirements, such as keeping an inventory, which helps to control which psychotropics and precursor chemicals are used in the manufacture of legitimate products.

In addition to measures strictly related to the pharmaceutical industry, a specific public entity – the Planning Secretariat for the Prevention of Drug Addiction and the Fight against Drug Trafficking – has been created to control and take action against the illegal use of such products. Laboratories are also obliged to register before the entity and to comply with its regulations.

xv Enforcement

ANMAT is authorised to carry out inspections on working plants and raise any kind of observations it may deem appropriate. In these cases, ANMAT issues a deed that includes all objections and then serves notice to the company to file its defence. After reviewing any evidence that might have been provided, ANMAT issues a resolution. Eventual penalties are a call for attention, fines, closure of the facility and the suspension or even annulment of the authorisation to function.

Depending on the case, the imposition of penalties can also include a penalty for the technical director of the laboratory.

The decision issued by ANMAT is subject to appeal before the federal courts.

Pricing and reimbursement

The general principle is that each laboratory may set the prices for the sale of its products. So far, the new government put in place at the end of 2019 did not issue any general measures regarding pricing of products nor have there been any formal agreements between the industry and the government to prevent prices increases. As a matter of fact, at the end of 2020 it was announced that the price of pharmaceutical products increased by 46 per cent during 2020, above the inflation index for the year. The government issued, in November 2020, a Joint Resolution (between the Ministry of Health and the Secretariat of Domestic Trade) which establishes maximum prices for institutional sales to the health entities of the public, private and social security subsystems of certain medicines in the context of the health emergency declaration issued by the National Congress and extended by the National Executive Power amid the covid-19 pandemic. The products at stake are Atracurium (50mg × 5ml ampoule), Pancuronium Bromide (4mg × 2ml ampoule), Fentanyl (0.25mg × 5ml ampoule), Midazolam (15mg × 3ml ampoule) and Propofol (200mg × 20ml ampoule).

Since 1997 there has been an agreement in place between all the laboratories that integrate the pharmaceutical industry and social security entities, some public, some controlled by unions and some private (also known as medical insurance companies). This agreement was terminated in 2019. The agreement was executed by the three major industry chambers (the Argentine Chamber of Medical Specialities, the Industrial Chamber of Argentine Pharmaceutical Laboratories and the Business Chamber of Argentine Pharmaceutical Laboratories) acting as representatives of their member laboratories. In late 2019, it was the intention of the major social security organisations to enter into agreements with each laboratory, either through bids or contracts.

In addition to these agreements, the above-mentioned chambers entered into others with wholesalers and pharmacies to ensure the provision of products to affiliates throughout the country at the same price and with the same discounts.

Around the year 2000, the chambers also created a local company in which no chamber has a majority equity control (the auditing company), the purpose of which is to manage and audit the agreements entered. The creation of this company was authorised by the local antitrust agency.

Regarding the agreements, their purpose is not to supply products to social security entities, but rather to benefit the affiliates of the different entities with discounts on products prescribed by their doctors and sold by pharmacies that adhered to the agreement mentioned. Some entities have closed lists of doctors, or products or pharmacies, but in general the lists are very broad. Discounts vary according to the products involved. An important purpose of these agreements is to ensure the provision of products throughout the whole country at the same price, without prejudice to the chain of commercialisation or to the affiliates.

These discounts are made in each pharmacy on products sold from its own stock and, once audited, later compensated by the social security entity. This means that at the time the products are sold by each laboratory through the regular chain of commercialisation, it is impossible for them to know if the final destination of the products will be an affiliate to any social security entity or not.

No industry chamber negotiates prices of products on behalf of any laboratory. Prices are fixed by the laboratory and are published in specialised magazines. Discounts are calculated based on the published price (i.e., the price of the product for any person not belonging to any social security entity).

The real parties to the agreements are each laboratory and the social security entity. The chambers represent the laboratories for practical reasons. Laboratories must each ratify the agreement. If a laboratory does not want to enter into such an agreement, it may refuse to do so.

The following example illustrates how the system works. A product is prescribed by a qualified doctor to an affiliate. The affiliate goes to his or her usual pharmacy and acquires the product. The pharmacist will sell the product to the affiliate with discounts and inform the social security entity of the sale to obtain its approval. Assuming the prescription is approved, the entity will reimburse the pharmacy through the auditing company, which will check the amount received and pay the amount of the discount afforded by the social security entity to the laboratories, which will then issue credit notes in favour of the wholesaler and, further, from the wholesaler to the pharmacy to compensate the full amount invoiced and paid by the pharmacy and the wholesaler at the time the product was sold by the laboratory. This is a summarised explanation. Much of the system is currently managed technologically (e.g., affiliates have carnets, pharmacies use online systems) and, usually, reimbursements by social security entities are made every two weeks covering various sales, so in practice the system is a bit more complicated; however, the general principles work as explained.

Some products are not subject to discounts.

Wholesalers and pharmacies are also joined in chambers that are very active in the protection of their associates (the Argentine Pharmaceutical Confederation, the Argentine Federation of Pharmacy Chambers, the Association of Mutual and Union Pharmacies of the Republic of Argentina, the Association of Distributors of Medical Specialities, and others).

Administrative and judicial remedies

The administrative remedies are the responsibility of ANMAT and are described in Section II.xiv. Similar procedures apply in the case of faulty products and infringements of the commercialisation regulations.

Additionally, Sections 200 and onwards of the Criminal Code penalise with imprisonment and fines any person who modifies or falsifies medicinal products and compromises public health.

There continues to be a slow increase in judicial summary actions being brought to courts by patients with the aim of getting their social security organisation, their medical insurance company or the state to allow or afford the provision of products. This is mainly related to cases in which expensive pharmaceutical treatments apply, despite whether or not said product can be imported or locally acquired. Sometimes it is the conduct of the social security organisation or medical insurance that triggers the response of a claimant through courts, especially in cases in which a change of treatment (usually for a cheaper one) is suggested or tried to be put into force by the financer.

Financial relationships with prescribers and payers

Most of the financial aspects of the pharmaceutical industry and its relationships with prescribers and patients, including those affiliated with social security entities and medical insurance companies, are described in Sections II.iv, vi and ix, and Section III.

In addition, there are special regimes in which public aid for the acquisition of certain products has been established by law, such as in the case of AIDS patients. Other programmes in place are the Health Programme, the Haemophilia National Programme and the Newborn Programme. Most recently, the Cystic Fibrosis Law established the free coverage of all products and treatments related to that disease.

Medical attention is publicly supported through municipal, provincial or national hospitals. Medical assistance in public hospitals is free of charge. Private medical insurance companies have special agreements with private hospitals or have health institutions on their own.

Resolution No. 500/2004 manages specific programmes to help patients afford medical treatments that are very expensive. The programme consists of total or partial subsidies or reimbursement for medical treatments, medical devices and medicinal products. It is not mandatory for the Public Health Administration to grant the aid.

The Ministry of Health Resolution No. 627/2007 regulates permissible practices for the promotion of pharmaceutical products requiring a medical prescription. This resolution forbids pharmaceutical companies from, directly or indirectly, granting, offering or promising HCPs any kind of incentive, such as bonuses or financial perks.

Doctors and other HCPs are also regulated by Law No. 17,132, which prohibits them from obtaining benefits from pharmaceutical companies.

Special liability and compensation issues

Product liability is based on general principles included in the Argentine Civil and Commercial Code and in the Consumer Protection Law No. 24,240 (CDL), as amended by Law No. 26,361. In general, in cases that are related to claims concerning whether certain trials or products should be covered by the social security organisations to which the claimant subscribes, both public and private, the courts tend to favour the consumer (in this case, the patient). To this extent, the patient is considered to be a consumer, which means that the CDL is also applicable. Nevertheless, all cases are different and should be analysed individually.5

The general practice according to the civil law obliges the affected party to prove that the product caused the damage suffered. If the party's statement is supported with evidence, a specific indemnification is fixed by the courts according to the circumstances of the case (e.g., age, disability, expenses incurred, moral damage).

The CDL incorporates a certain type of class action and allows consumer organisations to initiate actions when collective interests are affected or threatened. Section 52 bis of the CDL allows a request for punitive damages, a clear contrast to the civil law.

The CDL was enacted in September 1993. The first cases have related to newly produced pharmaceutical products and it is not yet possible to define a trend regarding application of the CDL to such products.

There are no special compensation issues in place.

Transactional and competition issues

i Competition law

The competition regulations in place have been applied by public entities to control prices on pharmaceutical products. Legal actions have been initiated but, to date, no decisions have been issued.

The government has tried to reduce the cost of medical products, principally by enacting Law No. 25,649 on 18 September 2002, which favours the use of generic drugs, obliges doctors to prescribe pharmaceutical products using the generic and non-proprietary name of the product, and requires the inclusion of the generic name in the packaging of the product.

ii Transactional issues

There are no special transactions (other than those available in all countries) that are worth mentioning in this chapter. The pharmaceutical industry has, in general, adapted the commercialisation of products to the method described in Section III, which maintains a level of commercial competition with similar products.

Commercial discounts are common practice, as well as distribution agreements or co-marketing agreements that allow the promotion of products by laboratory representatives who are not the owners of the product being promoted.

Current developments

According to the latest information available and that it is being publicly discussed, it appears that the current government has the intention to reorganise the Argentine Health System that we described above. The intention would be to combine both public and private health systems to maximise their resources. However, so far, no bill to modify this is being discussed at the Congress level. Up to now, no restrictive rules on commerce in general have been announced, except for some specific rules related to the covid-19 pandemic.

Regulations enacted by previous administrations that made difficult or impeded the possibility of patenting pharmaceutical products in Argentina are still in place and we expect they will remain in effect. The pharmaceutical research industry reacted by filing an administrative and judicial action that has not been resolved.

Clinical trials have increased and continue to grow in the country, especially amid the covid-19 pandemic.

Discussions on the regulatory area are centred on the regulations needed to qualify biological products in the country.

Covid-19-related regulations

At the end of 2019, the National Congress passed the Social Solidarity and Productive Reactivation Law in the Public Emergency Framework which declared, among other emergencies, the sanitary emergency and under the scope of such sanitary emergency, Title X of the law, set some new parameters, directions and rules. Amid the covid-19 pandemic, in March 2020, the National Executive Branch issued Decree 260/2020 by means of which extended the term of the sanitary emergency declared by Law 27,541 for one year as of the publication of this Decree in the Official Gazette.

After isolation measures were taken by the government, to avoid the contravening of those isolation measures by patients gathering in waiting rooms of hospitals or private offices and to avoid viral circulation, the government issued a series of regulations for this situation. By Resolution 696/2020, modifications were authorised in the prescription and dispensation of psychotropic medications or others for the care of chronic and eventually severe pathologies during the sanitary emergency. In line with this, the Superintendence of Health Services issued the Resolution 282/2020, by means of which it recommended that for as long as the isolation measures were in place, Health Insurance Entities should implement and encourage the use of teleassistance or teleconsultation platforms to guarantee essential demand benefits.

Later on, the Congress passed Law No. 27,553, on Electronic or Digital Prescriptions, which has two main purposes: (1) it is established that the prescription and dispensing of medicines, as well as any other prescription may be written and signed through handwritten, electronic or digital signatures, in electronic or digital prescriptions in the national territory; and (2) it is established that health teleassistance platforms may be used throughout the national territory, in accordance with the personal data protection law and the patient rights law.

As per clinical trials, the Ministry of Health issued the Resolution 908/2020, by means of which the ethical and operational guidelines for the accelerated ethical evaluation of research in human beings related to covid-19 are approved. Under these guidelines, research ethics committees (RECs) should formulate procedures for a rigorous evaluation of research in human beings that, in turn, ensures the existence of quick and flexible mechanisms to respond efficiently to the times and needs of a sanitary emergency. These recommendations seek to guide the RECs in developing operational procedures for an accelerated evaluation of research projects related to covid-19.

In October 2020, the Congress passed Law No. 27,573, which declared of public interest the research, development, manufacturing and acquisition of the vaccines destined to generate acquired immunity against covid-19 within the scope of the sanitary emergency established by Law 27,541 (extended by Decree 260/2020 as a result of the covid pandemic declared by the WHO).

The main points of the law are that, when executing agreements for the acquisition of these vaccines, the Ministry of Health may agree on: (1) the extension of the jurisdiction in favour of arbitral and judicial tribunals located abroad; (2) a waiver to invoke the sovereign immunity defence; (3) conditions of patrimonial indemnity regarding compensation and other pecuniary claims related to and in favour of those who participate in the research, development, manufacturing, provision and supply of the vaccines; and (4) confidentiality in accordance with the international market for vaccines and in accordance with Law 27,275 on Access to Public Information, Law 26,529 on Patient Rights and complementary regulations.

This law also provides for an emergency and exceptional approval mechanism of the vaccines directly by the Ministry of Health (and not by ANMAT, which is the entity that usually registers and approves vaccines).

Footnotes

1 Emilio N Vogelius is a partner and Ana Andrés is a senior associate at Estudio Beccar Varela.

2 See 'Animal welfare and the use of laboratory animals in scientific research' by Ana M Jar in Argentina Journal of Microbiology, volume 46, No. 2, Buenos Aires, June 2014, also available online at
www.scielo.org.ar/pdf/ram/v46n2/v46n2a01.pdf.

3 Article 4, Law No. 24,766.

4 Article 8, Law No. 24,766.

5 Case included in AR/JUR/33790/2016.

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