On February 2nd, the European Data Protection Board published a series of responses related to inquiries prepared by the European Commission (justice and consumer section). These consultations are aimed at the EDPB solving questions about the protection of personal data used in clinical research.
European Data Protection Board
The document is divided into six different sections that are developed in various paragraphs and contain answers to questions ranging from ethical issues, informed consent to anonymization processes, and the collection and processing of personal data obtained in medical research.
Regarding informed consent and data processing, special focus is placed on its legal basis and on the distinction between informed consent and the legal basis of consent required under the standards of the General Data Protection Regulation, both terms being, complementary to such protection; and the need to have a special consent from the patient when there is no other way out than to resort to the treatment that the research is developing, to improve the quality of life of the subject.
The same happens when data controllers conduct clinical trials in different State Members of the EU, and it is necessary to homogenize the legal basis of all of them -when conducting the project- to comply with the GDPR standards and their own localisms.
An interesting topic that the document tries to elucidate, although it will be left to a later consultation, is the possibility of extending the consent of the owner of the data – the subject of the trial – extracted in one trial, for other trials of the same nature.
Related questions about the Data Protection document
Regarding obtaining broad consent in terms of clinical trials, the EDPB refers in a certain way to recital 33 of the GDPR, in order to minimize the requirements of specific consent when the purpose of the data processing cannot be determined at an initial stage of harvest.
Finally, the document refers to relative issues such as:
1) The use of the information obtained directly from the owner of the data for other purposes than those originally reported and if necessary and in which cases -and how-, must comply with the requirement of transparency.
2) The application of processes of pseudonymization and anonymization of personal data in clinical trials.
3) The processing of specific categories of data and their treatment on a large scale during clinical trials.
For further information or professional advice regarding clinical trials, legal requirements, compliance, and data protection, you can contact our Moeller’s Legal Department Members in charge of this area through our Relationship Managers Vivien Racy and/or Vivianne Cardoso, following this link.
In view of the worldwide aspect that Protection of Personal Data has acquired, and its category of Human Right in many laws around the world, it is necessary to have an adequate protection framework, which is not only limited to the laws that regulate its treatment and safeguarding, but also must extend to the relationships that are managed between the data controllers, data processors, third companies and the owners of said data.
From the incursion of personal data in all possible areas of interaction, the Law is not foreign at all, much less in the contractual field, as one more link in the chain of measures aimed at providing all current or current information accumulation, potentially related to a specific or determinable natural person. Therefore, it is unavoidable to make a list of the contracts that are used in this type of situation both in the field of cyberspace and in the relationships that are developed between the owner of the data with the person in charge of treatment, and of the latter with the data processor.
It could be taken into consideration that the privacy policies that abound in the websites have a contractual legal nature, with a predisposed content and the possibility for the user to select the browsing preferences to determine what data is available to share or allow them to be collected and which ones not.
- What information will be collected (names, emails, phone numbers, etc.).
- How the information will be used (for statistics, to improve the shopping or browsing experience, promotions, Email Marketing, etc.).
- What will be done with the collected data.
- The possibility of modifying the policy in the future.
- Contract form (for modifications, updates, or cancellations).
- Cookies policy.
- It offers relevant information about the way in which the data is protected.
Terms and conditions
It is an unnamed, on-line, electronic contract for adhesion to pre-arranged clauses.
Terms and conditions are established between the user of a certain website and the owner of said site and is mainly intended to inform the user of issues related to the content of the page and the services offered through it, as well as information appropriate to the user about what is done with the collection and processing of their personal data, and the type of data that is transferred to the person in charge through the site.
Also, within the terms and conditions are established the duties and responsibilities of the user and the correct use of the site, intellectual property issues, legal framework, among others.
Privacy policies can be found separately from the terms and conditions, or in a single identified body.
The outsourcing contract, in general terms, is mainly intended to delegate to a company, or a specialized natural person, a portion of the business process that is the responsibility of another company, which the latter considers that it is more suited to carry out that portion of the process involved. It is the outsourcing of activities.
With regard to the field of data in general and personal data in particular, a company that develops an activity in the process of which requires or feeds on said data hires another for the management and processing of personal data. The owner of the database is the data controller and the data processor is the third party that provides the outsourcing service.
Points to consider in the data outsourcing contract
- The data controller should include in the contract a clause by which it obliges the data processor, to fulfill and respect the purpose for which the database or registry was created, not being able to carry out acts tending to undermine said purpose, taking reservation of the data obtained and applying a treatment that serves said purposes.
- As the data processor is acting on behalf and order of the owner of the database, it is necessary that he respects the instructions given by the latter, having to abide by them and the framework of the contract and its purpose and also the contract and –if applicable- criminal law that govern the matter. Especially for the responsibility that entails the person responsible for the data, the election of the person in charge of personal data processing, and the development of the work of this one in front of third parties.
- The person in charge of the processing of personal data has to abstain from transferring the data that is subject to treatment to third parties. Data Processor does not have the authorization to obtain from the owner the consent to carry out the assignment -as he is not the owner or person in charge of the database.
- Once the objective or the purpose for which the data were collected and processed has been fulfilled, Data Processor must return all that information to the Data Controller, not being able to store or keep the data in their possession, unless there are subsequent situations expressly established, which determine the maintenance of these data in the possession of the data processor.
- There must be a duty of confidentiality on the part of the person in charge of the treatment, which consists primarily of not disclosing or using for purposes contrary to the contract, the law, public order or the rights of the owners and third parties, the personal data whose treatment was entrusted. Even this duty must be maintained after the ending of the contractual relationship between both parties.
- Both Data Processor and Controller have a security duty regarding not only the treatment of the data in general but also regarding the fact that databases where these data are stored, comply with, or have a level of security appropriate to the protection of the information stored there.
Transfer of data
The transfer of personal data is a contract that is established between Data Controller and third parties or companies. It inevitably requires the consent of the owner of the personal data and the cause of the transfer must be explained, which must be related to the legitimate and legal activity carried out by the person responsible for the database, file, registry, or archive or be related to the activity of the assignee.
The object of the data transfer contract must be circumscribed to those data contained in the databases, registers, files, and which are those collected by the person responsible for the treatment.
At Moeller IP Advisors we have a specialized worldwide work team with the ability to advise on drafting contracts and certain clauses that involve personal data, both in corporate and digital environments. Contact us!Read More
1. Introduction: MERCOSUR-EU Agreement and the legislation on Data Protection
As is well known, last year, after several rounds of negotiations, the agreement between Mercosur and the European Union on economic matters emerged. Said agreement included matters related to customs duties, exchange of goods and services, sanitary measures, intellectual and industrial property rights, SMEs, dispute resolution, among other issues of relevance to both blocks.
Among these issues, although not as an integral part of the text of the agreement, discussions related to the Protection of Personal Data were also included. Currently, the States of the European Union are governed by the General Data Protection Regulation, or by its acronym, the GDPR, which is mandatory since May 25, 2018. During her visit to Argentina, in July of last year, the European Commissioner for Justice, Consumers and Gender Equality Vera Jourova, spoke about the benefits that the regulation and harmonization of data protection legislation would bring to both blocs.
For sure the EU is at the forefront in this matter, and in order to enable the advancement of this agreement for both blocs and above all, for the MERCOSUR countries, it is necessary that their laws harmonize with the provisions and principles of the GDPR, as which would bring about a quantitative and qualitative leap towards respect for the individual rights of people, the self-determination of the person regarding the processing of their data on the internet and in files, the final recognition of data protection as a fundamental human right, among other conquests.
Nowadays, in the current global situation of the coronavirus pandemic that hits the whole world, the negotiations have stalled, since there are urgent issues to address regarding the countries that make up each block. However, it is noteworthy that the will to move forward is intact.
That is why is necessary to carry out a review of the situation in which the laws of the MERCOSUR countries are in relation to the Protection of Personal Data, and why it is almost mandatory to use this time to be able to adapt them to the required standards by the EU in order to finally reach the conclusion of the negotiations carried out at the time of carrying out the revision of the Agreement between the two trade blocs.
2. Country by Country: MERCOSUR-EU Agreement and the legislation on Data Protection
The law that regulates the protection of personal data in Argentina is Law 25326, enacted on October 4, 2000, and is currently in force.
This law regulates what pertains to the treatment of personal data, its classification, the principles that should govern its treatment, international transfer of data, the rights of its owners, and the resources and actions that they have both administrative as well as judicially to obtain the deletion, rectification, modification, addition and correction of the data found in files or databases, both public and private, and the obligations of the owners of said files or databases when collecting and processing personal data.
In Argentina, the enforcement authority regarding Personal Data and Access to Public Information is the National Agency of Access to Public Information, which has a secretariat that is in charge of regulating and supervising everything related to personal data and the compliance of the Personal Data Protection law, which is the National Office of Protection of Personal Data.
In 2018 a Bill was presented to amend the Data Protection law and bring it as closely as possible to the GDPR standards, but unfortunately, the bill lost parliamentary status this year.
In 2018 it was sanctioned the new Law on Personal Data Protection – No. 13,709 LGPD-. On August 26 the Brazilian Parliament decided that the suspension of its enforceability would not be extended, so it is the law that is currently in force in Brazil to regulate everything related to the protection of the personal data of natural persons, processed both within the borders of the country, and by foreign companies that process data of persons located in Brazil.
This law has many points in common with the European General Data Protection Regulation, establishing an adequate legal framework regarding the collection, processing, and storage of personal data in general and sensitive data in particular, as well as the obligations and responsibilities of those –processors and controllers- who collect, process, select and store personal data, and may be liable –in case of non-compliance with the provisions of the law-, to be sanctioned administratively, civilly and criminally.
Likewise, it establishes the rights of the holders of personal data to grant informed consent for the collection and processing of their data and to control access, correction, rectification, updating, anonymization, and deletion of their data that are contained in databases both public and private.
For this law, it is mandatory -in certain cases- the need to have a Data Protection Delegate, and the enforcement authority is the National Data Protection Agency of Brazil.
In Paraguay, the Protection of Personal Data is regulated not only in the country’s Constitution but is also based on Laws No. 1682/2001, 1969/2002, which amends the first one and Law 5542 / 2015.
This set of laws regulate, among other issues: the processing and treatment of personal data contained in files, records, and public and private databases. The collection, processing, and treatment of personal data is only allowed for scientific, economic, statistical, or marketing purposes.
However, the current legislation establishes nothing regarding the figures of the database administrator; but it does regulate obligations pertaining to those responsible for said bases. Nor does it make a distinction between processors and controllers. Nor does it establish any obligation to report data breaches or incidents that occur with personal data.
The international transfer of data and its regulatory framework is not established in the legislation of Paraguay.
Likewise, there is no authority in Paraguay that regulates matters relating to the Protection of Personal Data and compliance with the law.
Finally, although the law does not establish anything regarding the possibility of making claims before administrative or judicial entities for violation of Personal Data, the penalties are established by other regulations, which allow those whose data have suffered any violation the right to claim before civil or criminal justice the pursue of a compensation.
There is a bill presented to the Paraguayan Parliament in 2019.
In Uruguay, personal data is ruled by Law No. 18,331, amended by Law No. 19,670, whose regulatory decree 64/020 modified certain articles of the first-mentioned law.
The law regulates the following aspects: a) it establishes a sort of glossary with definitions pertaining to personal data and the principles applicable; b) it also regulates the registration of the databases of the entities that collect and process personal data, whether they are located in Uruguay or process personal data of persons residing in Uruguay -under certain circumstances-; c) Establishes for public and private entities the need to have a Data Protection Officer and its obligations and responsibilities thereof; d) the need to have the informed consent of the owner of the data to collect, process and treat said data; e) the international transfer of data, the cases in which it proceeds and the requirements to transfer data to third parties; f) the obligations of the person in charge and the administrator of the databases; g) In the event of personal data breached or incidents that occur with them, the collectors, processors and responsible of the databases has to give notice and take the necessary measures to minimize risks; h) administrative sanctions concerning non-compliance with the rules contained in the law, ranging from warning to imposition of fines.
The application authority in the field of Data Protection in Uruguay is the Regulatory and Control Unit of Personal Data.
In February 2020, Law 19,670 was regulated, which among other issues complements Law 18,331 in terms of: 1) the adoption by the person responsible for the treatment of technical and/or organizational security measures to avoid and/or minimize incidents and breaches that may occur with personal data; 2) the promotion of national and international standards on cybersecurity; 3) the documentation of such measures and the planning and impact assessment regarding Personal Data.
3. Conclusion: MERCOSUR-EU Agreement and the legislation on Data Protection
After having made a brief reference to the Agreement between the European Union and Mercosur and the current state of the negotiations, reviewing the legislative situation of some of the countries that make up this last regional bloc, the truth is that it is essential to have an adequate level of protection of personal data, especially due to the extraterritoriality principle generated by compliance with the provisions of the GDPR and the cross-border flow of data.
Today we are witnessing a new era in human rights, where digital self-determination is no stranger. Where the right to digital existence of people cannot be overwhelmed over other issues such as those of an economic nature. That existence must be protected against any kind of violation.
Likewise, it is necessary to harmonize the laws of both economic blocs, which pushes MERCOSUR to take all the necessary steps to adapt its laws and regulate this new human right as an imperative, in order to achieve safer agreements in pursuit of a conciliatory and protective globalization of this new right that appears today.
Finally, it is worth highlighting the position that countries such as Argentina and Uruguay have in terms of recognition by the European Union regarding the adequate level of protection that these countries ensure to Personal Data, which places them at the forefront in the region.
However, it is mandatory for Argentina to update its law in order to continue maintaining that position in the face of the constant requirements of a globalized world both materially and digitally.
As announced by the Argentine authorities, the country has been chosen by some international laboratories, in order to test the effectiveness of vaccines against the coronavirus, which causes the disease known as COVID-19, by carrying out a series of tests on a sample of people, taking as parameters issues such as age, sex, previous disease conditions, among other factors.
In Argentina, there is a specific regulatory framework for conducting tests on the human body, which includes not only common law – civil law – but also specific rules and even provisions of public bodies that regulate issues related to said tests.
The main rules applicable to the development of this type of activities – going from the most general to the most specific – will be succinctly developed, in which are immersed questions about the disposition of the body itself, informed consent, transfer of personal data, sensitive data processing
a) Law 26,994. Civil and Commercial Code.
The civil and commercial code is applicable to the case of informed consent, regulating the acts of disposition that a person can carry out on the body itself, including investigations in human beings.
Article 58 establishes the requirements that need to be carried out when a person is a study subject or participant in medical research in humans through interventions, such as treatments, prevention methods, diagnostic or predictive tests, whose efficacy or safety are not scientifically proven.
Article 59 for its part, regulates informed consent regarding medical acts and health research.
b) Law 25326. Protection of Personal Data.
The conduct of clinical trials also involves sensitive personal data, by relating such trials to very personal and fundamental issues related to the dignity of the person, which have the status of human rights.
In Argentina, the law that regulates the protection of personal data in general, and sensitive data in particular is Law 25326.
This law establishes that sensitive data is “… Personal data that reveals the racial and ethnic origin, political opinions, religious, philosophical or moral convictions, affiliation, and information regarding health or sexual life.”
Likewise, in its article 7, when dealing with the category of data, and when referring to sensitive data, the law prescribes the following: “ARTICLE 7 – (Category of data). 1. No person can be forced to provide sensitive data. 2. Sensitive data can only be collected and processed when there are reasons of general interest authorized by law. They may also be treated for statistical or scientific purposes when their holders cannot be identified. ”
In section 2, the law refers to the process of data anonymization that consists of dissociating the data itself in relation to the determined or determinable person, holder of that data, through a certain process.
Article 8 of the law also mandates that, regarding health-related data, “Public or private healthcare establishments and professionals linked to the health sciences may collect and process personal data related to the physical or mental health of patients who come to them or who are or have been under treatment by them, respecting the principles of professional secrecy. “
Regarding the consent of the owner of personal data, Article 5 of the Data Protection Law prescribes that “(…) the free, express and informed consent will be required, which must be in writing, or by any other means that allows match it, according to the circumstances. The aforementioned consent given with other declarations must appear expressly and prominently, prior notification to the requested data, of the information described in article 6 of this law. “
Specifically speaking of international personal data transfer –sensitive data in particular-, article 12 exceptionally authorizes the transfer of said type of data only in an epidemiological investigation, as long as it is carried out under the terms of subsection e) of Article 6 –only when an anonymization procedure is applicable to the data collected-.
c) Resolution 1480/2011 and Disposition 6677/2010 from the Health Regulatory Authority –ANMAT-
c.1) Res. 1480/2011, Point A3. provides a definition of what informed consent has to be considered when a clinical trial is being carried out. The rule establishes that “As a general principle, consent must be obtained for all research involving human beings or carried out with biological samples or personal data.” In connection with this, the test subject will have to be informed the measures that will be taken to protect the confidentiality of personal data.
Regarding the confidentiality of the information obtained from the test subjects, point A6 prescribes that personally identifiable data should not be used when a study can be done without it. When it is necessary to record personal identification data, researchers must justify that need. For this purpose the consent has to be obtained. Furthermore, point A8. Regarding the management of the data and the results, prescribes the obligation for the researches to secure the personal data.
c.2) Disposition 6677/2010 from the Argentinean Health Regulatory Authority. Regime of Good Clinical Practices for Clinical Pharmacology Studies.
This provision states:
- a) That researchers must ensure the confidentiality of the information in the stages of preparation, execution and completion of the study, as well as the identity of the people incorporated into it;
- b) That the protocols contain confidentiality considerations;
- c) That it is an indispensable requirement for the approval of a clinical trial, the presentation of an informed consent form in which the person is informed: objectives, methods, advantages, therapeutic alternatives and possible risks inherent in the study and that it is free to withdraw their consent to participate, at any time, without explaining the causes.
As a corollary of this report, in order to carry out clinical trials in Argentina on people, the following aspects must be taken into account:
a) Minimum consent requirements.
- The confidential nature of the information related to the study, and the personal data of the patient.
- The objectives, methods, and potential benefits provided in the study.
- Therapeutic alternatives.
- The possible risks inherent in the trial, and the damages that may be caused to the patient.
- The freedom of the participant to withdraw their consent at any time, without explaining the causes or resulting in harm to them.
- That the researcher will provide the medication free of charge in the study.
- That if the patient / healthy volunteer cannot provide consent on their own, it must be obtained from their legal representative.
- That the researcher will bear the costs arising from the clinical investigation, both the expenses of the procedures used for the study and the damages caused to the patient as a consequence of their participation.
- That the signing of the informed consent does not imply the resignation of the patient to any of the rights provided in the current legal regulations.
b) Data Protection Principles that have to be complied with during Clinical Trials:
- The obtention of the informed consent;
- The rights that the subject has regarding his personal and sensitive data;
- The informed consent has to include the right of professional secrecy;
- Indicate the pseudonymization and anonymization procedures;
- The right of the person to access, control, rectify and erase their personal data from the database;
- Respect the principle of data quality and the purpose of its collection