Brazil reaches 11th hour deal on drug patent

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The Brazilian government has reached a deal with Abbott Laboratories that will ensure cheaper supplies of lopinavir/ritonavir (Kaletra) without beginning the production of a generic version of the drug in Brazil, the country’s health minister announced on Friday.

Brazil had threatened Abbott Laboratories with the prospect of issuing a compulsory license for Kaletra if an agreement that would reduce the cost of the drug could not be reached. The Brazilian government argued that the differential price offered to Brazil, which Abbott stated to be the lowest offered to any country outside sub-Saharan Africa, did not take account of the growing volume of patients who needed the drug.

Brazil asked for a 50% reduction in the price of Kaletra, and in a statement issued on Friday, reported that Kaletra would be supplied by Abbott at a price comparable to generic versions of the drug manufactured in India. However Abbott Laboratories said that a per pill price had not been agreed, and that what was on offer was a volume discount that would reduce the price of the drug as more patients began to take it. The Brazilian government expects the number of patients needing Kaletra to triple over the next six years, and projects that the deal will save up to $259 million over the same period

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

A crucial, if overlooked aspect of the deal is an agreement that the Brazilian government will be able to obtain a new formulation of Kaletra that is stable at high temperatures as soon as it is approved by the US Food and Drug Administration, and at a discounted price. Given the Brazilian climate, this is an important concession.