Spotlight: medicine and medical device pricing and reimbursement in Argentina
por Ana Andrés
Áreas de práctica relacionadas: Derecho de la Salud – Life Sciences
LEXOLOGY
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 and 2023 has been no exception to this. These organisations agree on covering a part of the price fixed for the sale of products in pharmacies. On their side, all pharmacies agree on selling the products with the agreed discounts. Despite the fact that these kinds of agreements continue to be in place, due to continuing renegotiations, there have been changes in the financial politics because public social security organisations 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.
One of the most important of these organisations, in terms of the quantity of people they provide coverage to and the higher percentage of sales in the market, is the social organisation that covers retired people and those with disabilities.
With the exception of a new law passed to provide a regulatory framework for the development of the medicinal cannabis and industrial hemp industry, not many changes occurred during 2022 regarding the issuance of regulations in the healthcare sector. Manuel Limeres continued as head of the National Administration of Drugs, Food and Medical Devices (ANMAT). Carla Vizzoti continues as Minister of Health.
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.
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.
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Spotlight: medicine and medical device pricing and reimbursement in Argentina
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