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

Health Ministers from Andean Region meeting in Chile assess Centralised Purchase of Drugs

The Health Ministers of Chile, Bolivia, Colombia, Ecuador, Peru and Venezuela, gathered in the XXXII Meeting of Health Ministers of the Andean Region in Santiago, reinforced their commitment with the improvement of health conditions on their respective countries and their willingness to work out a common framework, integrating health policies throughout the region. In such context, one of the main announcements issued in the end of the meeting was the intention to assess the feasibility of a joint purchase of drugs, using the Strategic Fund of the Pan American Health Organisation (PAHO).  In this regard, the Minister of Health of Chile, Jaime Mañalich, pointed out that “as the Andean countries, is a must grow and work in order to improve the quality of health and access to good drugs in the road to become developed countries”.

The announcement came up within the context of the annual meeting of the Health Minister of the Andean Region. This group, throughout several agreements, has been working out different projects since forty years aiming to integrate the health policies of the region. However, since the last decade, it real value has not been relevant, given the fact that governments have had other priorities,, which have weakened such kind of agreement. The Health Ministers have committed themselves in order to assess whether a joint framework supported by PAHO can facilitate and speed up the access of drugs in the region. Coupled with that, the aim is to take advantage of possible economies of scale, in order to bring down prices of drugs. Strengthening collaboration among South American countries is a must, however, different policies and approaches amongst the subscribers countries could make unviable the proposal, which is currently in an exploratory phase.

El Cartel del Hospital Sotero del Rio

Hace algun tiempo, escribí un post sobre un cartel aparecido en la puerta del recuperador en la unidad de emergencia del hospital Sotero del Rio, uno de los hospitales mas grandes y que atiende a la poblacion del sector sur-oriente de Santiago.

El post, publicado en Matasanos.org , trataba de la hostilidad a la que tienen que hacer frente los equipos de emergencia, públicos o privados, que traen pacientes a las urgencias en estados críticos. Gritos, cuestionamientos y malos tratos son tema habitual y me toco vivirlo en persona durante los tres años que trabaje en rescate prehospitalario.

Después de difundir el post, y su desafortunado y estupido cartel, hemos visto una evolución del mismo:

Como ustedes pueden ver, lejos de cambiar, ahora se explícita la medida - de manera digna de país OECD por supuesto - directamente contra las ambulancias particulares. Que se pretende? Cual es la intención del jefe de servicio? de las enfermeras? del personal que trabaja ahí? En todos los casos, ya sea paciente critico o un paciente que espera una cama por estudio, la presencia del personal que realizo la intervención es necesaria.

Para mi esto es indignante, y da cuenta del bajo nivel que tenemos.

Que dira el Ministro de Salud? El Director del SS Sur Oriente? El Director del Hospital? El jefe de Urgencia?

Actualización: Me cuentan que el cartel fue retirado de la entrada del recuperador, y en su lugar aparece un cartel formal que dice “No entrar sin autorización” , lo que es en mi opinión un aviso razonable dentro del contexto del Servicio de Urgencia.