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04/08/2005 | Argentina: Drug-Registration Wrangle (Economist Intelligence Unit - Business Latin America)

De Nuestra Redacción

With their patents now better protected, foreign pharmaceutical firms say other propery rights are at risk

 

Multinational pharmaceutical companies and their domestic competitors roughly split Argentina’s US$2bn-a-year prescription drugs market between themselves. Demand for prescription medicines, including generic substitutes, will continue to grow strongly after several years of slumping sales, presenting new business opportunities. However, as the market has revived, disputes have emerged over regulations governing the registration of new products.

In the 1990s the battle between foreign and local drugmakers was over patent protection. In September 1995 Argentinian lawmakers, pressured for years by the US, finally passed a law that specifically afforded patent protection to pharmaceutical products. Then in 1996 Congress passed a new patents law that broadened the scope of protection for intellectual property owners. Argentina also subscribed that year to the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). However, effective lobbying by local drug manufacturers persuaded the government to postpone the implementation of the new legislation to October 2000.

Since then, Argentina’s domestic drug manufacturers have managed to hold on to their half-share of the market. Multinational companies attribute this in part to the fact that the local authorities have slowed down the approval process for new patents under the law, to reduce the pressures on the domestic manufacturers. Indeed, since October 2000 the Instituto Nacional de la Propiedad Industrial (INPI) has granted just eight product patents and 180 process patents. These new entries represent less than 5% of the total number of medications now on the market.

Argentina’s pharmaceutical business contracted sharply in the early 2000s, when several years of recession took their toll. Officials devalued the peso in January 2002, and annual sales fell to an historic low of US$1bn (at wholesale prices) that year. At that point manufacturers were more interested in surviving than in fighting each other.

Two years later, local makers’ market prospects had recovered. According to IMS, a UK-based pharmaceuticals research firm, Argentinian drug sales totalled US$1.8bn (wholesale) in 2004 for an 80% increase year on year. Rising revenues have since refuelled manufacturers’ desire to compete aggressively for market share.

Tripped up

Some multinational companies are counting on the TRIPS agreement to give them an advantage. Earlier this year, a local court agreed to hear a case filed by MSP Singapore, a joint venture of Merck and Schering-Plough (both US), claiming that local pharmaceutical regulations are unconstitutional because they force foreign drugmakers to divulge trade secrets in order to register new products.

In June, Judge Francisco Soto issued a precautionary measure ordering the local regulatory authority, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), to recall from the local market all treatments containing the anticholesterol drug ezetimibe and the anticancer drug imatinib mesylate until the case is resolved. However, the judge’s ruling was subsequently appealed by the affected parties, four domestic drug manufacturers—Phoenix, Elea, Gador and Casasco—and one foreign producer, Ivax (US), all of which were making and selling generic treatments containing ezetimibe.

The judge’s initial ruling accepted MSP’s claim that its competitors were violating Article 39 of the TRIPS agreement, which requires member countries to protect confidential information from unfair commercial use. Essentially, the foreign claimants accuse their local counterparts of copying their preclinical and clinical research studies, which are presented before ANMAT in order to register a new treatment and are taken into account before the launch of a new drug.

The sale of pharmaceutical products in the Argentinian market is subject to previous authorisation by the health authorities and is regulated by Decree 150 (1992). Articles 3 and 4 of the decree allow local laboratories to import or produce a given drug, provided it has been previously approved in an industrialised country.

In its legal filing, MSP said that Articles 3 and 4 of Decree 150 are unconstitutional because they conflict with Article 39 of the TRIPS agreement, which was incorporated into the Argentinian constitution in 1996. Local drugmakers’ two lobbying groups countered that MSP was trying to set up a monopoly to benefit its products.

The local laboratories argue that the information regarding the two drugs is not a trade secret, as it is in the public domain and thus replicating it does not violate any confidentiality.

Predictably, the administration of President Néstor Kirchner, which has often taken a hostile stance towards foreign investors, has sided with local industry. The health minister, Ginés González García, has instructed officials to appeal any judicial ruling questioning Decree 150. The minister confronted all drugmakers in Argentina in 2002 when he persuaded Congress to pass a law mandating doctors to prescribe generic as well as brand-name medications.

Argentina's top laboratories

2004 sales (US$ m)

Roemmers (Argentina) 152.6

Bagó (Argentina) 98.0

Bayer (Germany) 86.0

Pfizer (US) 81.5

Ivax (US) 80.0

SanofiAventis (France) 77.4

Gador (Argentina) 75.4

Elea (Argentina) 73.5

Roche (Switzerland) 70.0

Phoenix (Argentina) 61.0

Source: IMS.

Offnews.info (Argentina)

 



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29/12/2005|
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25/12/2005|
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29/11/2005|
27/11/2005|
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18/11/2005|
08/11/2005|
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31/10/2005|
31/10/2005|
28/10/2005|
25/10/2005|
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30/03/2005|
27/03/2005|
27/03/2005|
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18/03/2005|
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28/02/2005|
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29/01/2005|
29/01/2005|
27/01/2005|
27/01/2005|
27/01/2005|
27/01/2005|
26/01/2005|
26/01/2005|
15/01/2005|
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15/01/2005|
12/01/2005|
12/01/2005|
09/01/2005|
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09/01/2005|
09/01/2005|
07/01/2005|
07/01/2005|
05/01/2005|
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04/01/2005|
04/01/2005|
27/12/2004|
27/12/2004|
27/12/2004|
27/12/2004|
27/12/2004|
25/12/2004|
25/12/2004|
19/12/2004|
19/12/2004|
19/12/2004|
19/12/2004|
19/12/2004|
18/12/2004|
18/12/2004|
13/12/2004|
13/12/2004|
12/12/2004|
12/12/2004|
08/12/2004|
08/12/2004|
06/12/2004|
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02/12/2004|
02/12/2004|
29/11/2004|
28/11/2004|
28/11/2004|
28/11/2004|
28/11/2004|
28/11/2004|
19/11/2004|
19/11/2004|
18/11/2004|
18/11/2004|
12/10/2004|
10/10/2004|
10/10/2004|
03/10/2004|
24/08/2004|
24/08/2004|
14/08/2004|
14/08/2004|
26/04/2004|
26/04/2004|
11/04/2004|
11/04/2004|
04/02/2004|
04/02/2004|
10/12/2003|
10/12/2003|
05/11/2003|
05/11/2003|
10/10/2003|
06/10/2003|
01/08/2003|
01/08/2003|
28/07/2003|
28/07/2003|
28/07/2003|
28/07/2003|
23/07/2003|
09/07/2003|
24/06/2003|
24/06/2003|
18/06/2003|
18/06/2003|
03/06/2003|
01/06/2003|
17/03/2003|
17/03/2003|
22/02/2003|
22/02/2003|
23/01/2003|
23/01/2003|
15/01/2003|
01/01/2003|
01/01/2003|
01/01/2003|
01/01/2003|
01/08/2002|
01/08/2002|
01/08/2002|
01/08/2002|
19/07/2002|
19/07/2002|

ver + notas
 
Center for the Study of the Presidency
Freedom House