Argentina

Argentina: News regarding the National Regulation of Clinical Trials

24 Jun 2013

For the last few years, the number of clinical trials performed in Argentina has exponentially increased1; that is why the recent events, which will have consequences in the quality and quantity of the trials to be performed, should not be surprising.

Resolution HM 1490/2007 of November 14, 2007.

This Resolution of the National Health Ministry states, at a national level, the standards of GOOD CLINICAL RESEARCH PRACTICE IN HUMAN BEINGS, including the recommendations comprised in the Document of the Americas of March 4th, 2005 elaborated by the Pan American Health Organization (PAHO/WHO). Moreover, it complements and modifies Dispositions 4854/1996 and 5330/1997 (still in force), issued by the National Administration of Medicine, Food and Medical Technology (ANMAT in Spanish).

This resolution applies to clinical trials authorized by ANMAT, trials performed in hospitals and national institutions depending on the National Health Ministry, on the National System of Social Security and on other federal organisms. The most relevant aspects of the new regimen are the following:

  1. It obliges the sponsor to purchase civil liability insurance or any other form of warranty that fully covers the possible damages suffered by those persons involved in the trial.
  2. It regulates the legal requirements and obligations of the Clinical Research Organization (CRO), in particular the transfer of liabilities and trial tasks.
  3. It states a special compensation regime for damages suffered by participants thus aggravating the civil liability of the sponsor, but in a confusing way.
  4. It regulates in detail the informed consent.
  5. It incorporates the requirement of “assent” for children of 7 years and older.
  6. It obliges the sponsor, researcher, and institutions/centers to disclose and document (by means of written contracts) remunerative and funding agreements of the trials.
  7. It regulates the power and liabilities of the Independent Research Ethics Committee (IEC).
  8. It does not regulate the protection of personal data, which is governed by another pertinent law.
  9. It does not determine the applicable legislation in the case of infringements or sanctions.

Existing projects of federal legislation regulating clinical trials

The serious adverse event resulting in the death of a patient that took place in January, 2007, during a clinical trial carried out in a public hospital of Buenos Aires City, where the patient was receiving treatment, put in the public agenda the discussion of how to regulate such trials. Currently, different national bills are being discussed in the Congress for such purpose.

One of these bills, File N� 1159-D-2007, drafted by legislators of the official party, already counts with the approval of the Chamber of Deputies (November 21, 2007) and it includes many of the aspects tackled by the above-mentioned HM Disposition 1490/07. However, if it becomes a law, such bill will modify many of the aspects that are currently exclusively regulated by the ANMAT or by the provincial legislation and their respective regulatory entities.
In summary, there are many relevant points for the performance of clinical trials that have been modified or that may be modified in a near future, therefore, it will be necessary to follow closely the news regarding this matter.

If you are interested and wish to receive periodic updates regarding this matter, please send us an e-mail to mail@moellerip.com. Our staff of the Regional Department of Regulatory Affairs is looking forward to assisting you.

Notes:
1 Different official and private sources were recently mentioned in a local newspaper pointing out that the budget of pharmaceutical companies (mostly foreigner) to perform clinical trials in Argentina is twice the one they had in 2002. Likewise, it is reported that nowadays 28.000 patients are participating in clinical trials.




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