Cervical Cancer and Latin America, an story of inequality

Data coming from the project Globocan (2008), drawn up by the International Agency for Research on Cancer (IARC) based on information from each country, confirms the suspects that cervical cancer it is the second-most common type of cancer in women in Latin America, after breast cancer. The information is highlighted in a report published by IPS News, flagging that unlike other regions such as US and Europe, a preventable cancer such as cervical still has a high incidence within the region, creating a favourable context for the introduction of Human Papiloma Virus (HPV) vaccine. According to the information provided by IARC, cervical cancer is the most frequent type of cancer in countries with the poorest populations, such as Bolivia, Guatemala, Honduras, Nicaragua and Peru, but also has a high burden in supposedly well off countries such as Argentina, Brazil, Colombia, Costa Rica, Ecuador, Mexico, Paraguay and Venezuela.

According to PAHO, 40 percent of cancer cases diagnosed in the region could be prevented by regular check-ups and physical exercise, a healthy diet, and avoiding smoking and excessive drinking. However, the main prevention strategy, pap smears, has been incapable of bring down the number of new cases especially in poorer countries, mainly due to the lack of appropriate coverage and extension of health services, especially primary care access. HPV vaccines, such as Gardasil (Merck/US) and Cervarix (GSK/UK) might have a major impact in curving down these trend in case governments or PAHO decided to invest in programme aiming to reduce cervical cancer, as well as the economic burden that they cause to the health systems.

CHILE: Government propose new Drug Regulator Agency

The new drug regulator agency will be in charge of ensuring the quality, efficacy and safet of drugs distributed in the country, amongst other functions. Bioequivalence requirements, as part of the legislation, are the flagship of the new public entity.

The MoH has announced it is about to send to parliament for discussion the creation of the new Drug Regulator Agency (Anamed) in Chile, setting out drug regulation as a priority in the country. Amongst its different functions, the main impact is going to be seen in the generic drug market, as bioequivalence requirements will come up. Clinical research and developing local and international partnerships are also among the main objectives. This is positive news for the pharmaceutical sector, especially international pharmaceutical companies, which have been involved in long judicial battles against local manufacturers of “me-too” drugs without bioequivalence accreditation. In addition, the presence of a Chilean counterpart for Anvisa, Anmat and other Latin American agencies can foster co-operation within a regional framework.

Read the complete story published on the website of IHS Global Insight (here) and the quotes in Pharma Times (here)

Peru: Humala calls Int Pharma Companies “monopolistic” and pledges strengthen local industry

The Peruvian presidential contester, Ollanta Humana, who might win the second run-off in a tight presidential election, has stated he will support local pharmaceutical companies against what he has described as “monopolistic” attitudes from international pharmaceutical companies.

In a visit to the plant of the local Laboratorios Induquimica, he pledge that Peruvians will have access to drugs with good quality and fair prices if he is elected, as part of a populist strategy. In addition, Adifan, the Peruvian Pharmaceutical Association, has endorsed Humana’s statement, after he pointed out that the local industry is “battling fiercely” against the pressure exerted by multinational companies, in a language that recalls his alleged link with Venezuelan president Hugo Chàvez. Apart from this aggressive attitude, he did not reveal further details about possible measures against pharmaceutical companies; however, price caps are one possible alternative.

The remarks, published in the local La Republica, mark a break from the moderate image he has been creating since the results of the first round brought him and the far-right candidate Keiko Fujimori to an uncertain second and final election round. His comments have spread concern among markets, including the pharmaceutical sector, regarding the nationalist approach that Humana could take if he wins the election by 5 June. The latest poll published in the Peruvian media shows that both candidates are neck and neck ahead of the second-round run-off election, sowing doubts about the future of one of Latin America’s strongest economic performers, and a key player in the common front that Pacific countries, such as Chile, Colombia and Mexico, want to offer to Asia-Pacific economies.

Spain: AEMPS Releases 2010 Annual Report, 72% of Authorisations for Generic Drugs

The Spanish drug regulator agency, AEMPS, has released its latest inform regarding the activities conducted during 2010. Apart of the increase in the absolute number of approval, the press has widely highlighted the fact that out of the total percentage of drug approvals, generics drugs represent 72%. Even though is a high figure, this must be examined cautionsly, given the fact that it is strickly correlated with the high volume of generic drug application, especially compared with innovative drug.

The complete post is published in the internal service of IHS Global Insight:

The Spanish Drug Regulator has unveiled the results of its performance during 2010, highlighting a 17% increase in drug authorisations and the consolidation of generic drugs, with almost three-quarters of the share in terms of new marketing approval. Complete report click here)

Health Has No Price program in Brazil

During the first part of the year, the Brazilian government announced that hypertension and diabetes drugs will be provided to the entire population free of charge. In this post, published in Eye For Pharma Website, I explore why this measure is important for the most vulnerable population in Brazil.

In March, the Brazilian Health Minister, Alexandre Padilha, officially launched one of the most important initiatives in terms of access to drugs since the negotiations under the TRIPS agreement to bring down prices of HIV/AIDS drugs were carried out at the beginning of the past decade.

The initiative, an extension of the successful state program Farmacia Popular do Brasil (Popular Pharmacies), consisted of a national campaign for the free distribution of medicines for hypertensive and diabetic patients, called Saúde Não Tem Preço (Health Has No Price).

Keep reading this article in Eye For Pharma Blog (click here)

Interview for International Medical Device Regulatory Monitor

This is part of the my interview with the International Medical Device Regulatory Monitor published yesterday. Because it is only available for subscribers, I will reproduce some parts of it. Basically what the medical devices industry is interested is in the recent changes of the Brazilian regulation in terms of patents, and which are going to be, under the new scenario, the roles of the local drug regulator ANVISA and the National Institute of Intellectual Property.

Recent regulatory shakeups in Brazil, focusing on patents and standards, mean major changes for the country’s medical device approval processes. The patent system changes include the legal restriction of the National Agency for Sanitary Vigilance’s (ANVISA) power to examine applications of intellectual property rights on drugs.

Brazil Attorney-General of the Union Louis Adams transferred that power to the National Institute of Industrial Property (INPI), and ANVISA’s role is now reduced to the scope of health risks on the product seeking patenting, Ruben Gennero, Latin America and Spain analyst for IHS Global Insight, says. He notes ANVISA can no longer reject or supervise the patent process.

In the past, ANVISA was a large part of the patent approval process. Before a product could be patented, the agency reviewed each submitted product’s novelty, inventiveness and intellectual property.

But Gennero says there has been a decade of controversy about ANVISA’s role in the patent process and, “throughout the last seven years, out of 1,596 applications approved by INPI, 145 were disapproved by ANVISA afterward.”

Although ANVISA’s patent powers were restricted, it did not keep the agency from recently passing new product registration and quality standards for Brazilian suppliers of needles, syringes and catheters.

ANVISA modified the requirements for manufacturers and importers of materials used in medical procedures and hospitals based on national technical standards and international resolutions RDC 3/2011, DRC 4/2011 and DRC 5/2011.

The resolutions establish minimum requirements for identity and quality for the products.

Now, to obtain registration of these materials, suppliers must obtain a certificate of good manufacturing practices and a certification of compliance, both issued by ANVISA.

The agency is giving suppliers until early January 2012 to meet the new requirements. Molly Cohen

The complete interview can be found here

Latin America as a Key Emerging Market

Today it has been my debut in PharmaPhorum.org , in collaboration with my friend Valentina Jaramillo. We have written together what i trully believe is a prove that Latin America should be regarded as a key emerging market and secondly, Latam is much further than Brazil and Mexico.

Latin America is more than a southern continent populated by 577 million people. Indeed, it is more than a group of countries playing good football or enjoying carnivals and colourful traditions. Once called ‘the new world in old times’, there is a group of us who strongly believe our region continues to represent an interesting opportunity for the rest of the world, in particular in terms of healthcare and the pharmaceutical sector.

“…clinical research and likely changes in policy regulations are driving the attractiveness of Latin America as a market open for innovation and development…”

Keep reading here