mardi, mars 08, 2011

Argentina: 'Similarity-based approval' system ineffective for test data protection

Introduction

Test data protection (or data exclusivity) is one of the most interesting topics in the debate about IP rights.

Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) establishes that test data required as a condition to approve the marketing of pharmaceutical or agricultural chemical products which use new chemical entities - the origination of which involves a considerable effort - is protected against unfair commercial use.

However, Argentine Law 24,766 regulating this issue does not offer effective data protection and, consequently, its literal interpretation is inconsistent with TRIPs.

Those against test data protection argue that the information publicly disclosed and submitted in order to obtain marketing authorisation is not protected under Article 39.3 of TRIPs.

Health authorities have established a 'similarity-based' approval system for pharmaceutical products.

Similares

In countries providing effective test data protection, no third party is allowed to obtain the health authorities' marketing approval during the data protection term by using the test data submitted by the rights holder.

The principle governing this situation should be that every company requesting marketing authorisation must perform its own clinical trials evidencing the efficacy and safety of the product for which approval is sought.

In spite of this, Article 5 of Law 24,766 sets forth a similarity-based approval mechanism by means of a summary proceeding which does not require the submission of own trials or tests.

The information required by Article 5, which must be submitted in order to obtain approval by similarity, can be easily accessed by copying the information from the original drug used as a reference.

Similares - as allowed according to Article 5 under a similarity-based approval mechanism - are a class of pharmaceutical product approved by health authorities which are copies of innovative original drugs. This practice is prevalent in Latin America and some African and Asian countries.

Health authorities generally approve similares without requiring safety and efficacy data of the similar product itself, and as such, similares should not be confused with generics.

Also, due to the fact that similares are manufactured, packaged, marketed with their own brand names and distinct packaging (and are not designed to look like the innovator product), and are legally approved for marketing and use, they should not be confused with counterfeits.

Lack of enforcement

Among the main reasons for the lack of enforcement of test data protection at the health authority level is the fact that health authorities consider test data protection as an IP right that benefits only the private holder, not taking into account that such protection acts as a unique incentive to promote research and development, as well as to improve quality.

Intellectual property protects the results of innovative research as a means for promoting research in all fields. In general, it legally protects economic and scientific research efforts for innovations in different fields and, in particular, it protects test data in the pharmaceutical and chemical fields.

Access to medicines

Several issues must be considered when analysing access to pharmaceutical products and their quality. Access to pharmaceutical products cannot be solved by disregarding the fulfilment of quality requirements.

Pharmaceutical equivalence is different from therapeutic equivalence, since a pharmaceutical product can be considered therapeutically equivalent only when it clinically demonstrates the same efficacy and safety.

Therefore, Article 39.3 of TRIPs on test data protection is very important in the matter of health protection, since in accordance with its provisions, health authorities can require the submission of test data to prove the safety and efficacy of pharmaceutical products, while ensuring that the test data will not be subject to unfair commercial use.

For further information on this topic please contact
Daniel R Zuccherino at Obligado & Cia by telephone (+54 11 4114 1100), fax (+54 11 4311 5675) or email (dzuccherino@obligado.com.ar).

Contributed by Obligado & Cia