Brazilian_Patent_Reform

37
In fact, a detailed analysis of hundreds of new drugs approved by the FDA between
1989 and 2000 revealed that 75% do not show therapeutic benefits against other existing
products. Only 153 (15%) out of 1,035 new drugs approved by the FDA in that period
were framed as highly innovative – drugs with new active principles that also induced
significant clinical improvements. 37
Between 2000 and 2004, the situation was much the same; only 11% of new drugs
were highly innovative (49 out of 427) 38 . Following that pattern, the scientific magazine
British Medical Journal published a study demonstrating that only 68 (5.9%) out of
1,147 new patented drugs analyzed between 1990 and 2003 by the Canadian agency
for price revision of patented drugs were labeled breakthrough drugs – that is, the first
pharmaceutical product that effectively treats a given disease or promotes considerable
treatment gains in comparison with existing drugs 39 .
More recently, a study developed by Professor Carlos Correa reveals the drop in FDA
approval of new chemical entities for pharmaceutical use over the last few years, as
demonstrated by the following chart. 40
Chart 1
New chemical entities for pharmaceutical use
approved by the FDA, U.S. (1994-2010)
Source: FDA apud CORREA, 2011.
37 See James Love. Evidence Regarding Research and Development Investments in Innovative and
Non-Innovative Medicines. September 2003. Available at http://www.cptech.org/ip/health/rnd/
evidenceregardingrnd.pdf.
38 United States Food and Drug Administration – CDER NDAs Approved in Calendar Years 1990-2004 by
Therapeutic Potential and Chemical Type. Available at http://www.fda.gov/cder/rdmt/pstable.htm.
39 Breakthrough drugs and growth in expenditure on prescription drugs. In Canada, Morris L. Barer, Patricia
A. Caetano and Charlyn D. Black, Steven G. Morgan, Kenneth L. Bassett, James M. Wright, Robert G.
Evans, British Medical Journal, 2nd September 2005, 331:815-6. Apud MÉDICOS SEM FRONTEIRAS.
As negociações na OMS sobre Saúde Pública, Inovação e Propriedade Intelectual (IGWG): o que vem
acontecendo e quais são os desafios? (in Portuguese).
40 Correa, Carlos. Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing. Geneva,
South Center, 2011.