IHS Global Insight Perspective | |
Significance | The Chilean subsidiary of the vaccine division of Sanofi-Aventis has announced it will replace 140,000 doses of its flu vaccine, due to problems in the cold chain. The company stated that the decision must be seen as a precautionary measure, given the fact that risks were not detected in the vaccines in the preliminary analysis. |
Implications | The setback is likely to delay the distribution of the flu vaccine across the country. However this is not the first controversy related to the process. Indeed the public tender also was delayed due to odd reasons that might have played a role in the decision of the Vice Minister of Health to step down. |
Outlook | Delays in the public tender, overpricing and logistical problems have marked the flu vaccine process in 2011. Even though there was no risk for the population because vaccines were not delivered yet, the general controversy is threatening the political capital of the Health Minister. In addition, it raises the need to modernise the tender process and increase transparency about public health decisions. |
Two weeks before of the beginning of the Chilean influenza vaccination campaign designed to cope with the high prevalence of flu during the southern hemisphere winter, 140,000 doses designated to children between six months and two years old have suffered an important drawback and will be replaced. The information, along with the statements from the French headquartered pharmaceutical company and the Ministry of Health, were reported by the local La Tercera. This is new setback in a process that has been immersed in controversy, after the delay in the public tender and the likely inflated price that the government is paying for influenza vaccines.
According to the report, technicians from Sanofi Pasteur (France) detected failures in the cold chain process within a lot of vaccines, affecting approximately 140,000 doses out of 550,000 that the Ministry of Health acquired through direct purchasing. Representatives from Sanofi Pasteur pointed out that the company informed the Ministry of Health of the situation and, even though initial checks have not reported alterations in terms of efficacy, the company has decided to replace the alleged damaged vaccines with new products. The Medical Director of Sanofi Pasteur Chile, Alejandra Massoc, stated that "It is true that a small proportion of pediatric vaccines that came to our country, scheduled for this season, showed deviations in temperature during transport. Our head company, through its Quality Department, determined as a measure of extreme caution that these doses will not be used and our company is already handling their replacement". On their side, the Ministry of Health has stated that this drawback will not represent a delay in the vaccination schedule, which is due to start in two more weeks. However, experts from the local health sector have raised doubts regarding whether the plan can be carried on without delays, considering that the new lot of vaccines must pass through the importation bureaucracy and receive technical certification from the National Institute of Public Health (Instituto de Salud Publica, ISP).
Controversial Public Tender
The cold chain problem has not been the only issue that authorities and pharmaceutical companies have faced through this process. Indeed, the public tender initiated on 24 November 2010 was declared void with no winners being awarded the government contract to supply influenza vaccines (see Chile: 4 January 2011: No Winner Declared in Chile's Flu Vaccine Public Tender), which was branded a very odd situation by the industry and health experts. According to the government, the decision was taken because of improper requirements set by the regulator, due to the lack of specifications in terms of serotypes of influenza virus that vaccines should contain. On that occasion, this reason raised by the Health Minister himself, was challenged by the Deputy Minister of Public Health, who remarked that the kinds of the virus were already known and the problems related to the public tender were related to managerial problems within the ministry. This fact caused a delay in the public tender and subsequently the distribution process. In addition, the Deputy Minister of Health resigned a few weeks later due to personal reasons (see Chile: 25 January 2011: Chile's Vice-Minister of Public Health Resigns After Disagreement over Flu Vaccine Tender).
Outlook and Implications
The 2011 influenza vaccination process in Chile has been exceptionally controversial. When neighbouring countries such as Argentina and Brazil have vaccination schemes running smoothly and on time, the Ministry of Health has been involved in a bitter controversy around the entire process which might damage the always limited popularity of the Chilean Minister' of Health. The delay, first caused by problems in the public tender in the context of waiting for the serotype notification, and secondly due to logistical problems such as with the cold chain, is creating the perception of inefficiency in the Ministry of Health. Moreover, now MPs have ordered an inquiry around the process, because they claim that due to the delay in the public tender, the government is paying USD18 million more than it should, due to purchasing the vaccines at the last minute. Depending on the results of this inquiry, and whether the delay is perceivable by the population during the winter, this controversy could cost the government of Chile dear. In addition, this situation once again raises the alert in terms of the necessity to modernise the governmental process and mechanisms of transparency, especially in big public tenders related to such diseases.