The Protection of Personal Data is a fundamental right of citizens of inexcusable application by any type of organization, both public and private. In this sense, companies, professionals or any type of organization collect and process data from natural persons (clients, patients, employees, etc.) and, therefore, they are responsible for the security and protection of such data.
In this sense, after the approval of the New General Regulation of Data Protection (RGPD) – 2016 / 679- in the European Union in 2016, with its corresponding entry into force on May 25, 2018, which has repealed Directive 95/46 / EC, the rules of the game have changed not only for the EU countries and their institutions, both public and private, but the wave of updating of the national regulations on this issue has reached Latin America, specifically we refer to countries such as Argentina, Uruguay, Chile and Brazil.
In the case of Argentina, it recently submitted a bill to Congress that would replace the Personal Data Protection Law No. 25,326, which has been in force since 2000, in an attempt to align the country’s data protection standards. with the GDPR. The bill includes the requirements for notification of mandatory non-compliance, the appointment of a DPO in certain circumstances, the right to data portability and the right to be forgotten, as well as the new liability standards. Likewise, through Resolution 159/2018, published in the Official Gazette dated December 5, 2018, the modification of the authority for the protection of personal data was ordered, and so far it has been the NATIONAL DIRECTORATE FOR THE PROTECTION OF PERSONAL DATA. With the entry into force of this resolution this year, the new Argentine authority will be ACCESS TO PUBLIC INFORMATION AGENCY.
In this matter of Chile, it has a law dedicated to data protection, Law No. 19.628 on Protection of Privacy, which was published in the Official Gazette on August 28, 1999 (the Law). Currently there is a bill in the Senate, which is about to be approved and would significantly modify Law No. 19,628 on Protection of Personal Data, in order to increase the protection of privacy to comply with international processing standards. of data and the guidelines of the Organization for Economic Cooperation and Development (OECD). It is important to highlight the fact that the Chilean data protection authority was created relatively recently in the year 2017.
With regard to Uruguay, in August of the year 2018, it has adopted a decree that demands that the majority of data controllers register their databases with the Protection and Supervision and Data Supervision Authority.
Finally, Brazil is the Latin-American country that has carried out the most radical change on this matter. On August 14, 2018, Brazil enacted the law “Lei Geral de Proteção de Dados Pessoais (LGPD)”, the first general privacy law in the history of the nation. The aforementioned law, which will become effective on February 16, 2020, is very similar to the GDPR, even in its expansive definition of personal data and its strong emphasis on both the rights of interested parties and the requirement of legal bases for processing. of personal data. This marks a very important milestone in this matter for Brazil, since previously it did not have an appropriate law to regulate the protection of personal data.
In conclusion, and as we mentioned at the beginning of this article, this legislative activity in South America follows a wave of efforts to modernize data protection laws worldwide, which includes other latitudes such as Israel, Japan and South Africa. Therefore, it is to be expected that during the course of 2019 new countries will adhere to this data protection movement.
“Doubt, of whatever kind, can be ended by action alone.” (Thomas Carlyle, 1795-1881)
Manufacturers of healthcare products, mainly those located outside Latin America often doubt about how their products will be considered in this Region. This question is also frequently asked by manufacturers of medical devices, especially by the time a regional business strategy is being discussed. In this article, Moeller IP Advisors highlights some actions that will give an answer to this question.
Regional Background: The Regulation of Medical Devices in Latin America
The regulation of medical devices started in the Region in the mid 90âs as a result of reforms that were carried out in the Health Sector. It was at that time that the role of the state with regards to the regulation and protection of the health of the population became more relevant in comparison with former decades.
It is also important to keep in mind that, Latin America countries including the Caribbean area are essentially medical device importing countries. It is within this context, that the health authorities of each state must guarantee the quality, safety and efficacy of products for its population, notwithstanding if the products are manufactured locally or mostly imported into their countries.
Additionally to these two regional factors, there is a third one, which takes place at an international level and that is the constantly evolving technology, where research and development enable the creation of increasingly sophisticated products.
It is this permanent evolution of new technologies that requires the continuous updating of the regulation criteria concerning these new technologies, to determine which products are safer from a quality point of view as well as the most effective for the diagnosis and / or treatment for which they have been designed and developed.
According to data provided by PAHO2, in Latin America, the countries may adopt the guidelines for a Medical Device Regulation Program based on some of the following options:
- global experience on the GHTF3 Group Guidelines or
- on the countryâs own experience where ultimately, each country will develop the guidelines in a specific way.
Should the countries follow either option to establish the guidelines for local regulation, each one must inevitably define the scope of what is a medical device as well as the classification according to its level of risk.
Clearly, health regulation is not limited by the definition or scope on what is a medical device and how it should be classified. For the purpose of this article, we will base our analysis on these two issues to explore the possible actions a foreign manufacturer can take and that will help to define a regional business strategy.
Current Medical Device Regulation in force in Latin American countries
Although almost all countries of the Region have nowadays a regulation in force making reference to what is considered a medical device, it is possible that according to the nature and use of a health product, it could be considered as a âNon Classified Productâ that falls into a “grey area” or a so called “borderline” category.
For those products that clearly fall into the definition and scope specified in the regulation of each country, the manufacturer will need to consider the risk class in which the product will be included by the time of registration as a previous step to enter in the country or market of interest.
On the contrary, those products that are within the limits of the definition of a medical device and therefore categorized as âUnclassifiedâ present some uncertainty and it will be necessary to find out if there is any way to know whether or not the health authority will have any intervention with regards to the products involved before being launched on the market.
In some countries, the health authority, specially the Medical Technology Departments which are responsible for the evaluation and approval of medical devices, accept a written query on, what is commonly referred to as, a “Non Classified Product Queryâ.
In Argentina, for example, ANMAT4 proposes the “Consultation concerning a Non Classified Product”, whose instructions can be found on its website.
Procedure for “Consultation concerning a Non Classified Product” in Argentina
In order to assess whether a product falls within the statutory definition of a medical product set out in Annex I of Resolution GMC No. 40/00, the health authority requests that the company interested in this assessment should initiate a query by enclosing the following documentation in a file :
- Intended use declared by the manufacturer of the product and clinical application
- Form and / or route of use
- Information on how the product would be supplied
- Qualitative and quantitative composition, if applicable
- Labels, instruction manuals or catalogs
- Any other information that may be deemed advisable
- Certificate of approval of the product from the county of origin (if this document is written in a foreign language a translation into Spanish must be provided)
The documentation must be signed by the legal representative of the company.
Once the evaluation process has been completed by the health authority, the Department of Medical Technology will issue a note making reference to the intervention / or no intervention with the product.
This Statement issued by the health authority to the manufacturer or the importer will be used at the time the product is imported to the country in case Argentine Customs requires the intervention of the health authority to clear Customs.
Similar procedures in other countries in Latin America
Currently the health authorities of Colombia and Venezuela apply a similar procedure, issuing a document called the âNon Intervention Letterâ that states that there is no intervention of the health authority prior to the importation of the product into the markets of these countries.
In Brazil, it is possible to perform a query via email to ANVISA5 through a company representative based in the same country.
In Mexico, COFEPRIS6 has recently reclassified 1669 products which are not considered medical devices according to the Agreement on Deregulation of Medical Devices of December 31, 2011. For this reason, the products included in this list do no longer require registration by the health authority. Also, the agreement specifies that 96 products are considered low-risk medical devices.
The regulation of health products as the result of the stateÂ´s regulatory role and its responsibility in protecting the health of the population, the low level of medical device manufacturers within the region and the permanent technological evolution of research and development on an international level are the three factors that define the current scenario of medical devices in Latin America. In this context, the uncertainty of foreign manufacturers, on how their product will be considered by the health authority is usually one of the most important issues to overcome at the time to decide a business strategy in these markets. Therefore, the chance to submit a formal query to the health authority requesting its position concerning a product in particular to find out if the manufacturer will need to proceed with the registration of a certain product in the market of interest, is a viable option that can, on the one hand, dispel this doubt and on the other hand , obtain a document that will be necessary to submit to Customs in the case, where it is required, when you have to proceed with the importation into the country.
1Authors: Marta Pentz (Head of the Regulatory Affairs Department).
2Pan American Health Organization
3Global Harmonized Task Force
4Argentine National Food & Drug Administration
5National Agency of Sanitary Surveillance
6Federal Commission for Protection against Health Risks