Chile: Government is due to send white paper with changes in the insurance market

The Chilean Health Minister, Jaime Manalich, has commented to the local media La Segunda in an interview that before the next March 15^th, the government will send to the parliament the white paper proposing modifications in the private insurance market.

The changes comes after the High Court (Tribunal Constitucional) ruled in favour of patients who were subject of rises on their private insurance premiums, due to discriminative factors such as age and gender. After several of similar cases, the Government pledged to send a white paper to the parliament, in order to be discussed. The main input of the proposed changes are based on the work (Spanish) of the Expert Panel called by the President, in order to receive advise about modifications.

The proposal is expected to include two main changes: the freeze in the insurance premiums for customers over 65 years  of age and the estimation of the premium prices based on the inflation of the health sector. The Association of private insurance companies have endorsed the prospective changes, giving the fact that they are supposed  to increase the attractiveness of private insurance in sectors where the public insurance option is predominant, especially  for elderly people. Further details and the definitive proposal will be released during the first days of March.

Interview: Chile’s Bono Auge Subsidy and Its Impact in Medical Devices Market

I would like to share here part the interview I have given to FDA News Bulletin and International Medical Device Regulatory Monitor Service about the likely impact of Bono Auge, the new subsidy to the demand announced by the Government of Chile (which was a pledge of the presidential campaign), in the health devices market.

The device industry in Chile is keeping up with increased demands for equipment following the start of a new healthcare system, Bono Auge, which gives patients quicker access to medical services.

Under Bono Auge, which went into effect Jan. 1, patients insured by the Fonasa, the public insurance fund, can access health services at public or private treatment centers if they are not treated by their usual provider within a time frame specified by the Regime of Explicit Health Guarantees, or Auge.

Bono Auge, if successful, may be an improvement for patients, but it could mean supply shortages if the device industry cannot keep up with the demand for products.

“Any type of impact in the medical devices industry, either increase indemand for equipment or likely problems of the industry trying to meet a great demand for more devices, could be possible in the context of the increase in the demand for private medical services in certain pathologies,” IHS Global Insight’s Latin American healthcare analyst, Ruben Gennero, told IMDRM.

The first phase of Bono Auge went into effect for patients waiting for cataract procedures, making ophthalmologists and equipment for cataract surgery, a large portion of Auge, a model for ensuring the new system runs smoothly.

“Because there is a public tender offer as part of the process, from the point of view of the providers, it is relatively easy to estimate the demand that they will have to face. Once the demand is projected, they will have the information necessary to acquire more medical devices as part of a planned schedule and that fact might avoid any rush or even a shortage,” Gennero said.

“At the moment, there are no reports of shortage in private medical services,” he added.

Overall, Gennero sees Bono Auge as an opportunity for the device industry. “The demand for health services that was neglected now must be met. Therefore, an increase in the capacity of service provision, including medical devices, will be required,” he said.

Information on the Bono Auge is accessible in Spanish at www.gobiernodechile.cl/especiales/bono-automatico-auge/. — Molly Cohen

Brazil: Sanofi Pasteur dengue vaccine might be marketed first in Brazil

Brazil might be the first country receiving the dengue vaccine manufactured by Sanofi-Pasteur, the vaccines division of French pharma giant Sanofi-Aventis, reported the Brazilian local press. According to the source, executives from the French pharmaceutical company have met with Brazilian health authorities in order to find out ways to speed up the authorisation process of the vaccine in the country, which is currently undergoing Phase III clinical studies after having demonstrated a balanced immune response against all four serotypes after three doses in Phase II.

The announcement came after the agreement signed by Sanofi-Aventis with the International Vaccine Institute (IVI) to support the recently launched Dengue Vaccine Initiative. Brazil offers a good opportunity to launch the vaccine first, because Dengue is endemic and  on the other hand, Brazilian health authorities  would have the resources and the will to launch  the vaccine as soon as possible.  Currently, there are two other vaccines in competition to Sanofi. This includes GSK and Fiocruz’s dengue vaccine as well as one developed by Instituto Butanta. However, the endeavours between GSK and the local Institute Fiocruz to develop  a similar vaccine  which is to be locally produced, in addition  to Instituto Butantã ’s product,  may prove to be difficult  for the aspirations of Sanofi-Aventis, which would be to launch the vaccine in Brazil before 2015.

Latin America: Neglected Diseases Could be Eliminated in the Americas, PAHO says

The Pan American Health Organization (PAHO) have unveiled a study concluding  that some neglected diseases that primarily affect poor or marginalized populations in the Americas could be eliminated or reduced  if regarded as public health problems  and through increased administration of medicines and vaccination. In the research the authors analyze the presence of lymphatic filariasis, onchocerciasis, schistosomiasis, human rabies transmitted by dogs, trachoma, and soil-transmitted parasites in “hotspots” of Latin America, identifying critical areas for intervention. As a main conclusion, they suggest that the goal of elimination as a public health problem or drastic reduction of the selected neglected diseases is achievable in the region through a defined strategy in order to increase the access of drugs and vaccine within Latin American countries.

Even though Latin America has not the severity in terms of tropical disease burden that Africa can exhibit, these diseases still represent an issue especially in the most disadvantage countries of the region. In fact, countries from Central America like Haiti and deprived zones of Brazil still face important prevalence of such diseases. According to the study, increase in the control of these pathologies can be achieved, however, Health Ministers from the Americas have urged PAHO to mobilize resources and provide technical cooperation to eliminate these diseases. The prevalence rate of tropical diseases in Latin America represent an opportunity for pharmaceutical companies in order to design partnerships strategies with either PAHO or local government aiming to increase the access of drugs that can resolve such conditions, and in parallel open mechanism of communication with those markets.  A link to the study can be found here.

Spain Central Government decided to Challenge Galicia’s drug catalogue

The Spanish Council of Minister, representing the Minister of Health, finally has decided to challenge in court the controversial decision about a prioritised list of drugs, implemented by the autonomous community of Galicia, several local media reported. The decision came after the Minister of Health announced a period of investigation within her organisation, basically oriented to determine if the federal government or in this case, the Minister of Health, would have jurisdiction over the measure, considering that the decision was taken by a autonomous community. But in parallel, other autonomous communities, such as Andalucía, have expressed their interest in to move to a sort of similar policy, which could have accelerated the willingness of the MoH in terms to challenge in court the drug catalogue, in order to avoid a massive movement towards drug restriction.

MoH: Constitutional Trial

The decision of the federal government was announced in the beginning of the week and resolves the speculations during the past days, about whether the MoH would present legal actions against the measure or not. The Government has contested the Xunta of Galicia decision and presented a law suit in the Constitutional Trial, which is the entity which oversees that every law or public policy meets the fundamental rights in the country.   According to the local media, there are no memories about such a confrontation in the health field. The Council of Ministers suggests that the drug catalogue is restricting the access of drugs in the Galician healthcare and therefore, establishing a discriminatory separation between the citizen of Galicia and the citizens in the rest of the country. In addition, after it assessment process, the MoH regards the pharmaceutical policy as a State policy, pointing out that autonomous communities are not entitled to restrict the offers of drugs, just for their population.

Industry and Government of Galicia reactions

The industrial association of pharmaceutical companies, Farmaindustria, has expressed its satisfaction with the decision of the Council of Ministers. In a press statement,  the asociation pointed out that now the federal government is sharing the same thoughts expressed by several health stakeholders, regarding the drug catalogue as a  “clear invasion of the State powers’ from the Autonomous Community of Galicia’ and “a violation of the current legislation”. They concluded that the catalogue “reduces Galician patients’ rights and undermines their equal access to available treatments and their right to access to medicines in terms of equality with citizens of other communities, breaking the cohesion of the National Health System and threatens the unity of Spain”.   In addition, the Federation of Pharmaceutical Distributors (Fedifar), has coincided with Farmaindustria agreeing with the Government’s decision.

On the contrary, the Government of Galicia has expressed its concerns about the legal action in the Constitutional Trial. Furthermore, they have branded the decision as a “political” considering that there is no drug restriction at all from their point of view, because the catalogue includes all the active components of drugs that are distributed and reimbursed in a national level. According to their remarks, the main feature of the catalogue is to prioritise products which have the same active components, but are cheaper than the average. In addition, they said that with this measure the community of Galicia will lose the opportunity to save more than € 110 million (USD 150 million).

What’s going to happen?

Spain has been immersed in a tough campaign in order to bring down its health expenditure since the global economic crisis started. Indeed, amongst across the communities there was a 2.36% of reduction in the pharmaceutical bill during 2010, thanks to several measures such as the reduction in 30% of the prices of generics and 7.5% in the prices of branded drugs outside the reference price system. The argument of the Galician authorities is that they are addressing the same intention of the federal government, so there would be no reason to regard the catalogue as a controversial policy. However, according to the MoH, 427 drugs that are being already reimbursed by the National Health System are excluded from the catalogue of Galicia, which mean Spanish citizen from Galicia will not have access for these drugs through the public health system. This problem of equity, coupled with the fact that a measure such the catalogue could have deleterious impact in the consistency of the Spanish public healthcare across the communities, are enough reason for the Council of Ministers to present a complain to the Constitutional Trail. This court will have five months to rule whether the catalogue can continue or not. As long as the court declares admissible the legal resource, Galicia will have to stop its application.

Brazil: Free Hypertension and Diabetes Drugs through Farmacia Popular

Yesterday the President of Brazil, Dilma Rousseff, launched the national programme Saúde Não Tem Preço ( translated as ` Health has no price ’ ) which mean pharmaceutical products to treat hypertension and diabetes are going to be distributed for free in the pharmacies that are part of the network Aqui Tem Farmácia Popular (“Popular” Pharmacies). The initiative will enter in force from the next February 14th and it was one of the promises made by the actual President during the presidential campaign, as part of the wide strategy focused on tackle extreme poverty in Brazil. However, since 2004, 107 drugs included hypertension and diabetes treatments are heavily subsidized by the government through this network of pharmacies, with a 90% of discount in the price, which mean in practical terms that vulnerable patients had to pay only 10% of the price of the drug.  Under the new measure, only hypertension and diabetes treatments will be provided free of cost and there will be a list of drugs available on each pharmacy specifying which are the drugs that can be obtained without cost on each of them, mainly generics.

Free medicines will be available to all Brazilians who have a doctor’s prescription, but the authorities say they expect the offer to be taken up mainly by poorer people who use the public health system. Throughout Brazil, the government said there are 15,000 pharmacies that are part of this agreement which mean to sell drugs under the government subsidy scheme. The official figures released outlined that the programme benefits 1,3 million people, of whom about 660,000 suffers from high blood pressure and 300,000 are diabetics. Besides patients with those illnesses, the Pharmacia Popular scheme offers drugs for treatment such as asthma, rhinitis, Parkinson’s disease, osteoporosis and glaucoma. The government’s budget for the Health Has No Price programme is US $ 280 million annually.

Free HIV drugs first and now Diabetes and Hypertension

Since 1996, Brazil has provided free anti-retroviral drugs to patients with HIV/Aids, an approach that has been widely praised. Following the same strategy the government wants to tackle the increase on the figures of Brazilian who have metabolic problems. Currently, about 33 million of Brazilians have high blood pressure, and more than seven million have diabetes. The Health Minister has pointed out that high blood pressure and diabetes caused 34% of deaths in Brazil in 2009 and these epidemiological facts were the main reason to take the decision of liberalise the provision of treatments.

What it does suppose to mean?

This is the first major health announcement from the President Dilma Rousseff, who came in to office supported by the tremendous popularity of her predecessor Lula da Silva, providing an insight into potential principal aspects of her government’s policy measures with respect to the sector. The announcement regarding metabolic treatments such as diabetes and hypertension is part of her intention, first because it was a pledge in the presidential campaign and secondly, indirectly supporting her main commitment, which is to reduce extreme poverty in Brazil. Even though patients had to pay a small quantity in order to get access of those drugs, the abolition of the 10% co-payment in such drugs will have a positive impact in the vulnerable population. The measure has been granted as universal because every Brazilian registered in the public health system can obtain the benefit showing a prescription issued by a doctor. However, the 100% discount will only be available in certain pharmacies and for a reduced list of drugs, mainly generics produced locally, which are part of the programme called “Popular Pharmacies”. Having said that, and considering the geographic distribution of these pharmacies, is highly likely that this initiative will have a bigger impact in vulnerable population, rather than well off Brazilians. From the point of view of the industry, despite of the decrease on the sale profit, especially in the retailer sector, the increase in the volume of sales and the fact that more people will be attracted to come in stores and purchase products will mean an opportunity for the industry to recover the profits and even increase the revenues in sales.

Vacuna Neumococo y Latinoamérica: Es posible avanzar?

A raíz de la reciente incorporación efectiva de la vacuna anti neumococo (Synflorix/GSK) al Plan Nacional de Inmunización chileno, lo cual es un tremendo avance, vale la pena preguntarse cómo estamos en Latinoamérica en cuando a esquemas de vacunación comparados entre nosotros como región y con el resto del mundo.

Es absolutamente establecido que las vacunas son una de las estrategias más costo-efectivas y que tienen mayor equidad en términos de salud pública. Gracias a las vacunas y su implementación de carácter obligatorio, algo que siempre ha sido cuestionado por los sectores más liberales, es que ya podemos decir que ciertas enfermedades que antes provocaban estragos y diezmaban poblaciones ya se encuentran erradicadas, como es el caso de la viruela y poliomielitis, al menos en la región (todavía hay focos en India y Afganistán).

La reciente incorporación de la vacuna neumococica decavalente de GSK es un tremendo avance en Chile, en la medida de poder disminuir las enfermedades graves causadas por esta bacteria tales como neumonía y meningitis, con una disminución de la incidencia de casos graves – incluso muerte – en el segmento de menores de cinco años. Pero como están las cosas si uno compara los distintos países de la región?

En una rápida revisión, de acuerdo a los datos que uno puede obtener por Internet, haciendo un barrido por los distintos países de la región uno se encuentra con la vacuna en cuestión esta solamente presente en Brasil, Nicaragua y Peru, además de Chile, siendo  solamente disponible en el sector privado para Argentina, Bolivia, Colombia y México. La pregunta es…que hace que una vacuna catalogada como “esencial” por la OMS y base de los programas de inmunización europeos no esté ampliamente disponible en nuestra región?

Muchos dirán… el precio y las inefables ambiciones despiadadas de las transnacionales farmacéuticas, en este caso la británica GSK (Synflorix Decavalente) y la americana Pfizer/Wyeth (Prevnar 7 y 13). Es cierto que el costo es alto, alcanzando los 100 dolares promedio en la región, a través del sector privado. Si consideramos que son tres dosis las recomendadas, eso significa 300 dolares por proceso-vacuna que son muy difíciles de implementar a gran escala en los países de desarrollo medio y bajo de la región.

Como lo hizo Chile y como lo hizo Brasil entonces….?

Ambos países siguieron estrategias distintas y bien pueden orientar al resto de la región respecto del futuro. Como todo existe un camino largo y uno corto, uno fácil y uno difícil. Si a eso sumamos las realidades locales y las voluntades políticas, podemos ver que la decisión pasa por factores que van mas allá de las necesidades especificas, en este caso de vacuna de neumococo.

Chile tiene 17 millones de habitantes, el GDP/ per capita mas alto de la región y una industria local de biológicos bastante débil en general. Su estrategia ha sido depender de la importación de productos tales como vacunas, ya que no existe el interés (cuestionable en mi opinión) de impulsar la industria nacional tanto para, satisfacer las necesidades locales de la población, como también de exportar en el futuro y transformarse en polo de desarrollo. Se paga precio alto por vacuna cara. Sin embargo, algo está haciendo la local CFR Recalcine con su venture junto con el sector académico para el desarrollo de la primera vacuna terapéutica contra el alcoholismo.

Brasil en cambio, decidió otra cosa. Al tanto de su inmenso potencial como mercado (200 Millones de habitantes aprox) pero su escases de recursos, comparado con Chile,  desde hace algunos Brasil viene desarrollando una estrategia de partnership con las principales compañías farmacéuticas mundiales, como GSK en este caso. En que consisten estos partnerships? Ok, yo Brasil te compro la vacuna (Synflorix – la misma de Chile) a un precio más barato, por muchos años, y tu GSK te comprometes a traspasarme la tecnología de fabricación de la vacuna, en un plazo suficiente para que la deleznable farmacéutica obtenga beneficios aceptables por la operación. Resultado, en algunos años más, Brasil será capaz de producir por si mismo la vacuna satisfaciendo su necesidad local y además exportarla, y de paso fortaleciendo su industria local, generando conocimiento, desarrollando know-how para producir otras vacunas, etc etc. Para las compañías farmacéuticas esta estrategia es negocio bueno solo los primeros años , porque después deberán retirarse y se ganaran a otro competidor…..ero son las reglas del juego que Brasil impuesto.

No estoy diciendo que la estrategia de Brasil sea la adecuada para todas las realidades, menos la chilena. También esta decisión no pasa por las autoridades de salud solamente, sino que tiene que ver con un compromiso político y económico sobre como fortalecer y desarrollar la industria y los negocios en país. Lo importante es que hay oportunidades siempre y cuando se generen pensamientos o ideas que sean innovativas y estén dispuestas a considerar a los grandes conglomerados, en este caso las farmacéuticas, más que como aliados que como enemigos, ya que el punto final debiera ser para todos la salud de nuestra población.

Post originalmente publicado en Matasanos.org

Argentina announced inclusion of HPV vaccine in the national schedule: Really?

The Argentinean President, Cristina Fernandez, has announced yesterday that the government will incorporate the vaccine against human papilloma virus (HPV) in to the national immunization schedule established by the Ministry of Health, local press reported. The President announced the decision in the context of the launch of the National Institute of Tropical Medicine in Puerto Iguazu, pointing out that cervical cancer associated with HPV is the second leading cause of cancer deaths and kills about two thousand women per year. The vaccine will be indicated to girls of 11 years old  as part of the national schedule and it will be delivered free of charge.

That can be true? The announcement would represent a major breakthrough for the health of Argentinean woman in terms of cervical cancer prevention. However, there is a lack of information related to this announcement which might symbolize that its implementation is still  being worked out. At the moment,  the government has not been released information about which vaccine of the two available in the market (Gardasil/Merck – Cervarix/GSK) will be  included in the immunisation program and if there is a public tender ahead. In addition, even though the inclusion of the HPV was related to the national vaccination schedule, which means it is universal and will be provided free of charge, the President in the same speech has called  for the well off people to try to purchase th is  vaccine  from the private sector, in order to make sure enough coverage for the poorer sectors of the population. Further information will need to be disclosed  in order to assess this announcement  properly. Furthermore, it is interesting to note and understand why for Pneumococcal vaccine has not been included yet in the calendar, and HPV has been.

Chile: Collusion scandal in Drug Retailers – Lack of Regulation and Price Mechanisms

The Chilean public prosecution of the northern zone of Santiago (Fiscalia Centro Norte) has imposed legal charges on 18 executives from the three main drug stores (SalcoBrand, Cruz Verde and Farmacias Ahumada/FASA) and five Chilean pharmaceutical companies (Laboratorio Chile, Garden House, Medipharm, Recalcine y Grünental), as part of the long controversy that commenced in December 2008 about alleged price fixing in the Chilean retailer drug sector. The decision means that, according to the legal investigation carried out by the public prosecution, there is enough evidence to impose charges to the alleged perpetrators and carry out a trial. The possible consequences that the executives involved might face are custody sentences from 61 days to 3 years, coupled with fines in money.

The decision of the public prosecution came across a long process that started with the allegation made by the Chilean economic authorities and the subsequent legal investigation, followed by the guilty plea made by one of the main drug retailer involved (Farmacias Ahumada/FASA), which is thought to be a strategic manoeuvre in order to bring down possible sanctions. However, this statement was rejected by the other two companies involved in the allegation (SalcoBrand and Cruz Verde). Despite of this confession, the public prosecution maintained opened the investigation and during 2009 it seized laptops and files belonging to several executives from the pharmacies and pharmaceutical companies, discovering key e-mails and files that it would confirm the suspicions regarding a likely agreement amongst these companies, in order to deliberated raise and fix prices of over the counter drugs and chronic treatments.

The alleged executives and employees are:

Sergio Purcell Robinson, CEO de Fasa

Roberto Leopoldo Belloni Pechini, CEO de Salcobrand

Ramón del Rosario Ávila Silva, Commerce-Manager de Salcobrand.

Ricardo Germán Ewertz Münchmeyer, Commerce-Managerde Fasa.

Mario León Zemelman Riveros, CEO de Medipharm.

Marcelo Alejandro Flores Clavijo, fomer  Sales Manager de Laboratorios Recalcine.

Ricardo Iván Valdivia Kloques, Manager de la División Farma de Cruz Verde.

Alejandra Valeria Araya Donoso, category manager de Fasa.

Mehilin Velásquez Chau, category manager de Salcobrand.

Judith Margarita Carreño Oteiza, category manager de Fasa.

Paulina Inés Arriagada Luco, ejecutiva del laboratorio Garden House.

Lissette Judith Carrasco López, category manager Fasa.

Paula Alejandra Mazzachiodi Armijo, ejecutiva de Fasa.

Cecilia Alicia Rojas Mazuelos, ejecutiva de Laboratorio Chile.

Cristián Marcelo Catalán López, category manager de Cruz Verde.

Claudia Fanny Carmona Zúñiga, category manager de Salcobrand.

Gonzalo Izquierdo Rivera, ex jefe de ventas del Laboratorio Grünental.

Fernando Solovera Galdames, empleado del Laboratorio Chile

Price Fixing in 2008

The controversy started in December 2008, when the Chile’s competition watchdog, the National Economic Prosecutor (Fiscalia Nacional Economica), presented a lawsuit before the Free Competition Defence Court (FCDC), alleging that, between December 2007 and April 2008, three pharmacy chains (SalcoBrand, Cruz Verde and Farmacias Ahumada/FASA) had collaborated in raising the prices of more than 222 medicines, including contraceptives and drugs for treating diabetes and epilepsy. At that time, the FNE’s petition claimed that the three companies “have been guilty of the most serious crime that it is possible to conceive within the Free Competition Law: namely anti-competitive collusion. Together [the companies] fixed retail prices that they could not have fixed without collusion, thereby cheating the competition, defrauding consumers and acting against the public interest.”

Implications and the future….

The scandal of price collusion in the Chilean drug retailer sector has sparked concerns in terms of lack of regulation and the capacity of Chilean customer and patients in this case to face fair prices in a context of free market economy.  Specifically in the pharmacy sector, there has been a high risk of monopolistic behaviour  observed for a significant period of time given the fact  that these three pharmacy retailer concentrate 80% of the market share in terms of drug distribution in Santiago, the capital of Chile. Furthermore, the same companies had been involved in a  drug price war during 2006-2007, which almost destroyed the sector and their revenues. After this confrontation, companies decided to change their fierce competitive strategy to another more “friendly”  one in order to rescue the utilities of the business. This was supposed to be the origin of   a drug price fixing strategy. But what has been relatively surprising from the decision taken by the prosecutor is the confirmation, according to the judicial authorities, of the involvement of executives and managers from some Chilean pharmaceutical companies, who have joined pharmacies in this vertical strategy of price modification. Previously it was thought that the scandal would be limited to the retail sector only  but it doesn’t appear to be so now .  The controversy is expected to trigger improvements in the  drug regulation and a revision  in the way prices of drugs are established  as part of the  government’s short term agenda . With the scandal shaking patient confidence in the drug sector, the beginning of the formal trial combined with government’s regulatory efforts would represent chances for Chilean patients to recover their  trust on the system and especially, about prices of drugs.

Brazil: Limitation of ANVISA’s Power over IP triggers lawsuit in the UN

Representatives from more than 15 non-governmental organisations (NGOs) have presented legal action against the Brazilian government in the United Nations (UN) special arbitrator. The initiative is a reaction to the final opinion of the Attorney-General of the Union (AGU) that limited the powers of the National Agency of Drugs and Medical Products (ANVISA) in assessing applications for patents for pharmaceutical products, returning the entire responsibility to the National Institute of Intellectual Property. The legal action was presented to the special rapporteur on health rights of the UN, Anand Grover, and according to the text, change is a retrograde step that violates the country’s international obligations regarding the human right to health.

Before the decision made by the AGU, Louis Adams, ANVISA participated in the process of examining applications of intellectual property rights, using technical criteria such as novelty, inventiveness and industrial application influencing the decision making in parallel with INPI. The decision came after a long dispute between ANVISA and INPI that started 10 years ago, when the law determined that ANVISA should provide feedback on processes for granting drug licences. The dispute centres on ANVISA’s jurisdiction on the issue of patent approval wherein its interventions were not welcomed by INPI. The agency has released figures to support this contention, noting that throughout these seven years, out of 1,596 applications approved, 145 were disapproved by ANVISA afterwards. After the new legislation, ANVISA will confine its analysis only within the scope of health risks on the product to be patented, without the capability to reject drugs or supervise the patent process.

Concerns in Generic Industry

From the point of view of the generic manufacturers, the decision is threatening the whole generic industry, because it might result in extension of patents that otherwise would become public domain and therefore delaying the entry of new generics into the Brazilian market. Indeed, in parallel with the legal action presented by NGOs, the president of the Brazilian Association of Manufacturers of Generic Drugs (PróGenéricos), Odnir Finotti, called the resolution a setback in the Brazilian generic development. He stated that the participation of ANVISA has given transparency to the patent-grant process and on the other hand prevented pharmaceutical companies adopting strategies in order to try to extend their patents and prevent drugs becoming public domain, allowing the production of generics. In addition, he pointed out that his Association is preparing legal action attempting to stop the process, as well as the NGOs and other groups. However, according to several experts on intellectual property issues in Brazil, the rationale in the decision made by the Attorney-General is based on the facts that the only role of ANVISA is to support the patent process from a health risk point of view rather than to be involved in industrial settings. Moreover, they believe that the generic industry will not be affected given the fact that the process is not easy to manipulate and it has a normal rate of rejection in the context of international benchmarking.

Outlook and Implications

The decision taken by AGU about restricting the powers of ANVISA confirms a decision that had already been adopted in November 2009, but was questioned by the agency. The new regulation is sparking concerns amongst the generic drugs industry and NGOs, because it might impede or delay the entry of generic versions of drugs into the Brazilian market, due to the hypothetical pro-branded drugs industry role of the INPI, instead of ANVISA, which is supposed to defend the interests of citizens and the government in terms of its pro-generics strategy. The Health Minister, Alexander Padilla, has said that the decision will not change the Brazilian performance in relation to drug policy or the process of granting patents and described the necessary synergy that must exist “between Anvisa and INPI and among all government ministries”. In the meantime, NGOs such as Doctors Without Borders (MSF) announced that they will carry on with the legal action present to the UN, using the argument that the WHO itself supports the involvement of health entities such as ANVISA in the analysis of cases involving patented drugs. Legal actions, from either NGOs or the Association of Generic Manufacturers in Brazil will determine the future course of action. However, it is highly likely that the jurisdiction of ANVISA over the patent grant process has definitely been reduced to just a minor role, which is assessing potential risk.