Argentina - What are the most recent developments affecting the biologic sector in Argentina?

The most recent developments include new production capabilities in the public sector, and a licence agreement between GTC and Bio Sidus in the private sector.

Pharmaceutical R&D activities in the public sector are focused on biotechnology. Historically, investments have been low, concentrated on basic science and developed by public institutions which do not co-operate with the private sector. Recent developments affecting the biologic sector, however, include the plan to create the Pilar Biotechnology Park; the installation of a plant for the production of vaccines against seasonal influenza and influenza A (H1N1), in co-operation with the private sector; and technology transference for the local production of the yellow fever vaccine in Argentina.

In the private sector, GTC Biotherapeutics and the Argentine Bio Sidus, part of the Sidus Group, entered into a registration licence agreement in May 2010 under which Bio Sidus will perform all necessary actions to obtain sales authorisations for GTC's lead product, the recombinant human antithrombin ATryn. A product licence agreement for the supply of material and marketing rights will be negotiated separately. It is anticipated that the review process in Argentina will be completed within a fast-tracked period of no less than six months from the filing of the dossier with the regulatory authorities.

Further reading - A detailed analysis of the Argentinian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Argentina (published May 2010)

Argentina - Why were new drug regulatory measures implemented in Argentina in QIV 2009?

Argentina aims to tackle drug counterfeiting, fight against the “medicine mafia” and control drug prices.

The distribution of counterfeited drugs in the public sector has been a difficult pill to swallow, but the government has responded with new, and more aggressive, regulatory measures to tackle drug counterfeiting and fight against the “medicine mafia”. Additionally, the government aims to reduce drug prices and has indeed formalised an agreement with drug producers valid until 2010. Below follow the main regulatory measures implemented in QIV 2009:

• Under Law 26,524, issued in November 2009, the penal code was reformed, incorporating drug counterfeiting.
• In November 2009, Article 1 of the Pharmacy Law No. 17,565 was modified, therefore OTC medicines can only be sold by pharmacists or authorised dispensers in pharmacies.
• The Chamber of Deputies approved a drug traceability regulatory draft in October 2009, which is now pending in the Senate.
• Additionally, a formal price-cut regulation was introduced in November 2009 to reduce the price of 600 medicaments by 30.0% until 1st July 2010.

Further reading - An in-depth review of the Argentinian pharmaceutical market is available from Espicom: The Pharmaceutical Market: Argentina (published January 2010)