The Chilean parliament is due to examine legislation setting up a national medicines agency, a move which is seen as good news for drugmakers, especially multinationals.
Health Minister Jaime Manalich has said he is sending legislative proposals to parliament to create the new Agencia Nacional de Medicamentos (Anamed), which will take over drug regulatory responsibilities from the National Institute of Public Health (ISPCH). An important responsibility of the new agency will be enforcement of bioequivalence requirements, the current lack of which has enabled local drugmakers to manufacture and market “me-too” drugs in the guise of generics.
Therefore, the establishment of Anamed will be particularly positive for international drugmakers, “which have been involved in long judicial battles against local manufacturers of ‘me-too’ drugs without bioequivalence accreditation,” note analysts at IHS Global Insight.
Chile’s current lack of effective patent enforcement and failure to adequately implement data protection continue to be major issues for US drugmakers, who recently requested the US Trade Representative (USTR) that Chile should remain on the US Priority Watch List of intellectual property rights (IPR) transgressors. Chile does again appear on the Priority Watch List in the USTR’s newly-published 2011 Special 301 Report on IPR, which says that “the US urges Chile to provide adequate protection against unfair commercial use, as well as unauthorised disclosure, of undisclosed test and other data generated to obtain marketing approvals for pharmaceutical products.”
Anamed’s proposed other areas of responsibility include: – oversight of Good Manufacturing Practices (GMP), with a goal of accrediting at least 50% of manufacturers operating in the country; – establishing an average 152 days for the registration of new drug products and 125 days for similar products; – improving pharmacovigilance; – creating a framework for drug trials in humans; – strengthening cooperation with other Latin American drug regulators such as Argentina’s Anmat and Brazil’s Anvisa; – and developing international partnerships in both the public and private sectors.
Business Monitor International (BMI) recently forecast that the Chilean pharmaceutical market will increase from a value of US$2.86 billion in 2010 to $3.41 billion this year, which is growth of 7% in local currency terms and a rise of 19.4% when expressed in US$. These growth rates are similar to BMI’s forecasts for the nation’s levels of health care spending overall, which are for an increase from $15.14 billion in 2010 to $18.21 billion this year.
