Protection of test data is very relevant to quality protection and, therefore, health protection. In this regard, regulations securing the quality of pharmaceutical products have not evolved in Argentina as they have done in countries with better sanitary vigilance.
Argentine Law 24,766 regulating the protection of test data does not offer effective data protection and its literal interpretation is inconsistent with TRIPs. Article 5 of said law and Articles 3 and 4 of executive order No 150/92 set forth a summary proceeding of approval of similar medicaments already registered in selected countries or in Argentina, which does not require own trials or tests.
According to these rules, similarity is evidenced by "bioequivalence or bioavailability".
Bioequivalence requires "in vivo" trials, but due to the sanitary authority's decision, these "in vivo" trials are only required for high-risk products, and not for low- or medium-risk products; therefore, they are not carried out for most of the similar medicaments.
The only tests that are carried out are "in vitro" lab trials which are of a very limited nature because they only verify the dissolution rate.
Therefore, the adopted concept of similar medicament – which does not require in vivo trials – is that it is a pharmaceutical equivalent of the original or referenced one: it has the same active substance formula, the same pharmaceutical form, the same prescription and dosage regime, but may have a different size, shape, expiration date, impurity, and inert matter, among others.
However, pharmaceutical equivalence is not the same as therapeutic equivalence. A medicinal product is therapeutically equivalent to another one when it can be clinically proved that it has the same safety and efficacy, using the same pharmaceutical forms, administration routes and doses. A patient is interested in the therapeutic effect, and not in the pharmaceutical name.
As a result of the adopted system, for example, in the case of reports for lack of efficacy of certain medicaments, the usual answer provided by the sanitary authorities has been to affirm that despite these reports, the samples provided by the complainant comply with the product specifications. This is so because there are only data about the product formula, and not about its therapeutic effect.
When analysing the similarity regime in force it must be concluded that such a regime does not properly protect the general interest regarding the verification and assurance of the product quality, and that access to pharmaceutical products cannot be solved by ignoring the fulfillment of the quality requirements.
 |
| Daniel R Zuccherino |
Obligado & Cia
Paraguay 610, 17th Floor
C1057AAH, Buenos Aires, Argentina
Tel: +54 11 4114 1100
Fax: +54 11 4311 5675
admin@obligado.com.ar
www.obligado.com