A brave decision: data package exclusivity in Brazil

A leading decision rendered by a Brazilian federal judge enforcing data package exclusivity for pharmaceuticals for human use demonstrates the Brazilian government’s attitude towards eight private companies and reveals the positive impact of enforcing the rule of law on widening access to medicine in Brazil.

When Federal Trial Judge Jose Marcio da Silveira e Silva issued his ruling on the enforcement of Lundbeck’s data package exclusivity for its Lexapro drug against two powerful family-owned Brazilian companies and ANVISA, both parties and the association of generics industries immediately voiced concerns that the Brazilian population would suffer from lack of affordable medicine.

Their arguments can be summarised as follows: Silva’s decision will spark thousands of new lawsuits, with negative impacts on public health, public order, the national treasury and the national budget, and will also impair national pharmaceutical policy, as well as resulting in negative consequences for access to drugs in Brazil.

ANVISA’s political appointees threatened to blame the Brazilian judiciary with damaging Brazilian patients and taking government programmes to bankruptcy, by extrapolating the immediate impact of the decision, which was the first to uphold the 1994 implementation of Article 39.3 of the TRIPS Agreement and the 1996 TRIPS-plus statutory crime of infringing data package exclusivity.

Both statutes have specific language protecting the IP owners of data package exclusivity. However, until Silva’s May decision, the legislation was only upheld and enforced for agrochemicals and veterinarian products. The main reason is that both statutes do not have a statutory term limitation.

In the absence of such a limitation, the Brazilian administration failed to enforce the legislation effectively; several companies benefitted from this situation. Jose Marcio da Silveira e Silva was the first federal judge to challenge the arrangement in favour of the rule of law, by establishing by analogy a limitation of 10 years for new chemical entities and five years for active ingredients already approved for human use in Brazil.

Such limitation is found in a 2002 law that only applies to agrochemicals and veterinary products, limiting the term and establishing compulsory licences. The use of analogy as an instrument of jurisprudence and legal analysis by the courts in the absence of specific legislation is certainly not new in the legal systems based on those of continental European civil law countries.

This is not a big issue in terms of its interpretation, construction and enforcement, but will have a big impact on the status quo.

Right after the decision, while the Brazilian government found supporting voices in the association of private industries selling generic products and a few family-owned large corporations in the country, a group of leading scientists, all with tenure in public institutions, issued the results of a large research project on the potential impact of Jose Marcio da Silveira e Silva´s decision on the Brazilian government’s public programmes on distribution of free drugs, as well as the impact on the 300 products that sell the most according to IMS-Health data.

"Both parties and the association of generics industries immediately voiced concerns that the Brazilian population would suffer from lack of affordable medicine."

The multicentre study, subject to peer review, was conducted by Professor Dr Vitor Francisco Ferreira, member of the National Academy of Science (UFF); Professor Dr Wilson da Costa Santos, dean of the Pharmacy School (UFF); Professor Dr Lúcio Cabral, dean of the Pharmacy School (UFRJ) and member of ANVISA’s board of advisors; Professor Dr Luis Eduardo Menezes Quintas (UFRJ); Professor Dr Almir Gonçalves Wanderley, member of ANVISA’s board of advisors (UFPE); Professor Dr Rodrigo Alvaro Brandão Lopes Martins (USP); and Professor Dr Ronaldo Guimarães Fonseca, member of the Brazilian Academy of Neurology and Medical School, and the Universidade Estadual Paulista.

The results reveal that the information being broadcast by ANVISA, the association of generics and the local family-owned companies is inaccurate. The impact of the decision on the big sellers was so irrelevant that the names of the eight companies benefitting from the status quo became evident.

Out of 1,640 drugs researched by the Brazilian academia, only 15 would benefit from data package exclusivity. All 15 had their price established and controlled by the Brazilian government and several competitors in the same therapeutic indications.

Companies that invest in safety, quality and efficacy, and comply with Brazilian legislation are Lundbeck; Roche; Genzyme; Chiesi; Bayer; Wyeth; GlaxoSmithKline; Eli Lilly and Biogen-Idec. They will lose money if Brazil returns to the policy of not enforcing the law.

On the other hand, there are eight companies that may prefer the old system: Torrent, Ache/Biosintetica; EMS/Germed/Legrand; Biolab Sanus; Teva; Eurofarma; Medley and Farmoquímica.