Due to the Health Care Reform initiated in Chile in the late 80s, it is possible nowadays to talk about a national drug policy and seeking to complement the AUGE- GES plan the government has been developing new health care strategies and actively taking part in international forums.
One of the Chilean Health Care Reform goals was to bring universal access to health care for its citizens. The health care objectives for 2010 were given in a report by the Ministry of Health where the need to reduce out of-pocket expenditure on medicines and health care in general was stated. Thereafter, financial protection is provided with the intention to limit this kind of expenditure, making health affordable instead of a luxury. The same report highlighted that the access to health care is deterred in many cases due to a lack of financial sources when seeking health care attention, meaning that in many poor countries with a weak public health care system its citizens are deemed to pay out of their own pockets for health care expenses, which may be very costly in many cases.551 This situation may be one of the reasons for why restraining access
to medicines and not only to pharmaceutical patents is highly contended.
A National Drug Policy has been carefully implemented in Chile, since public health and access to proper health care is a matter of the State. During the Lagos government(2000 -2004) a national drug reform was necessary since the one dating from 1996 was not fair enough;; inequalities within the health care system did not grant access to health care or medicines for the whole Chilean population. On 4 April 2004 the Resolution Nº 515 abrogated the 1996 National Drug Policy.
549 See further, commercial processes <www.cenabast.cl/ingles/proveedores/chilecompra.html> accessed 14 September 2013
550 Meriches R, J., ‘AUGE el Nuevo Botín de las Farmaceuticas’ El Mercurio (Julio de 2005) <diario.elmercurio.cl/detalle/index.asp?id={2506c1e6-69b2-4c21-85e0-faa8c79372b3}> accessed 14 September 2013
551 Ministerio de Salud de Chile, División de Rectoria y Regulación Sanitaria, Departamento de Epidemiología Los Objetivos Sanitarios para la Década 2000 – 2010, Primera Edición, Octubre 2002, at 257<www.redsalud.gov.cl/portal/url/item/6bdb73323d19be93e04001011f013325.pdf> accessed 14 September 2013
This reform includes a 31 page document that is an explanatory tool that analyses the situation in Chile during that time and gives suggestions on areas that needed special attention. In that same year, the Chilean Senate was working to comply with the minimum intellectual property standards settled by the TRIPS Agreement. Furthermore, the tool highlights the importance in having generic pharmaceutical versions that will ensure access to medicines available and it also points out the need to include free medication within those clinical guides and protocols designed to provide attention in the AUGE-GES guaranties. The Doha declaration on the TRIPS and Public Health were also taken into consideration by this Resolution, especially when the data concerning the price difference between a generic product and a brand name drug is assessed. Among the recommendations made, the National Chart of Essential Drugs should be updated on average every two years, and mechanisms to ensure access to affordable medicines should be reinforced or redesigned together with the role of CENABAST.552
The report highlighted certain concerns regarding the use and prescription of generics, which basically is the fear by users of using a less effective and poor quality product due to cheap prices. Therefore, the National Drug Policy emphasises developing mechanisms destined to ensure quality, efficiency and good manufacturing processes. Brand loyalty and misinformation on the use of generics could be another reason restraining access to affordable medicines and a barrier for the entry onto the market of those products. Therefore, the government must provide enough information about the substitutability and security of the suggested generics through its national bodies. The issue on a lack of information on behalf of the responsible governmental bodies was raised at the Chilean Senate in its 10° Special Session on the 15 April 2009 by Senator Evelyn Matthei, who assured that due studies on bioequivalence that should have been provided by the National Health Institute – ISP were not available for the public or practitioners.553 This issue will be tackled later on in the study.
The Office of Procurement- CENABAST - adopted a different business model during 2004, as mentioned above. The new model consisted of scale purchase programmes or bulk procurement, enabling it to provide the public health care sector with affordable medicines. This is also a strategy recommended by the World Health Organization (WHO) in its guide on “How to Develop and Implement a NDP-National Drug Policy,” and therefore when reading the Chilean National Drug Policy it is very easy to come across the terminology, concepts, definitions and guidelines provided by this Organization in its attempt to harmonise health care policies.
This WHO guide suggests the use of price control policy, reduction of import duties on essential drugs, generating competition on basis of generic policies prompting generic substitution and good procurement practices among many
552 Politica Nacional de Medicamentos en la Reforma de Salud, aprobada por Resolución Exenta Nº 515 de 2 de Abril de 2004, Ministerio de Salud, at 1 – 31
553 Sesión 10, Especial del Senado de Chile, Análisis de la Situación Farmacéutica en Chile, from the 15April, 2009.Audiovisual Senate session
<www.senado.cl/prontus_audiovisual/site/artic/20090415/pags/20090415090512.html>accessed 14 September 2013. The ISP shall require bioequivalence studies of those generic products applying for a marketing approval.
other strategies to increase the affordability of medicines.554 Moreover, bulk
procurement seems to be one of the most efficient methods, or at least seems to be, working for Chile, since on average this country has the lowest medicine prices Latin America. In 2008, the average was $4, 73 in Chile, whereas the average in Latin America was $8, 50 according to the Cámara de la Industria Farmacéutica de Chile – The Chilean Pharmaceutical Chamber (hereinafter CIF Chile) and FIFARMA.555 In the same press article, CIF-Chile highlights that the
low prices are due to the free market policies being followed in the country and that there is practically no intermediary between the producers and the pharmacy.
One could think that a price control policy is used in Chile to regulate the pharmaceutical market, but it was not until 2009 that the Chilean Senate started suggesting that there should be some kind of price control policy for certain medicines.556 A project was submitted to the Senate to consider further
regulation for the pharmaceutical industry, but at the 14° Ordinary Session from the 5 May 2009, the Senate rejected the agreement project. Hence, no price control policy was or is enforced so far in Chile.
Following the recommendation made by WHO, the Chilean National Chart of Medicines contains a wide variety of essential medicines that must be available within the Chilean territory, but all of these are listed under their active component or generic name and not under any brand name product or patented drug. The Supreme Decree N° 466 in its Article 92 used to establish that those medicines included within the National Chart were to be available in their generic version or its brand name version; and the Supreme Decree N° 264/2003 Article 4, establishes the duties of the Health care authorities’ in enforcing every legal mechanism available to ensure the availability of those essential medicines in Chile.557 By interpreting those articles, and in connection with the Doha
Declaration on Public Health, that allows countries to make use of those flexibilities available in the TRIPS Agreement to deal with national emergencies, it could be assumed that if an innovative medicine is needed to provide treatment for any of the GES diseases that become a national emergency, then a compulsory
554 World Health Organization, How to Develop and Implement a national drug policy (Second Edition, 2001) 1-83
555 El Mercurio, ‘Carta: Precios de Medicamentos’ (27 July 2008) <www.cifchile.cl/detalle_not.php?id=37>
556 Press release, Colusión de Farmacias: Comisión de Salud le propondrá al Senado trabajar en conjunto con el Ministerio sobre la material, in Senado de Chile, Departamento de Prensa, Valparaíso, 14th April, 2009
557 Decreto Supremo N° 466 de 31 de Diciembre de 1984, Articulo 92: “… Drug stores shall keep in stock at list those pharmaceutical products listed within the National Chart of Medicines … those pharmaceuticals might be generics or its similar in the brand name version…” This article was eliminated in 2010 by Decreto 22 de 19 de Febrero de 2010, the new Decree in its Article 93 highlights that drug stores shall have in stock those pharmaceutical products within the National Chart and the same article provides a list of the active components/generic medicines
<www.leychile.cl/Navegar?idNorma=1011155&idParte=8885599&idVersion=2010-02-19> accessed 14 September 2013
licence could be sought by the Chilean Government if the medicine were to be patented within the country.558
On the one hand, nothing specific is highlighted within the Chilean legislation regarding the patentability or non-patentability of those medicines included in the National Chart, but on the other hand there seems to be various ways to reach the exception to avoid the patentability of a needed pharmaceutical; either by making use of the TRIPS flexibilities or by enforcing the national legislation or public health care policy. According to the articles quoted above and Article 51 part 2, from the Ley N° 19.996, national emergencies, public health crises and public non-commercial use among other situations are ground enough to pursue a compulsory license in Chile.559 WHO in its attempt to harmonise health care
policies and to help improve health care –access to medicines for all has developed guidelines regarding the implementation and use of traditional medicines within the national drug policies in many countries.
The Chilean Ministry of Health published a book containing 103 herbal medicines or plants used for biopharmaceuticals in its attempt to provide access to alternative ways for health care. Nowadays homeopathy is recognised in Chile as a form of alternative or complementary therapeutic treatment. According to the WHO, in its Publication on the Legal Status of Herbal Medicines, in 1992 Chile provided protection or regulation for traditional medicines within Law N° 19.253, but when searching for that legislation at the Library of Congress database the only legislative piece that pops up is the one creating the commission for the protection of indigenous communities. Furthermore, the WHO Medicine Strategy 2004-2007 proposes the use of traditional medicines (TM) and complementary and alternative medicines (CAM) as an integral part of the health care system. Therefore, it is suggested to create and implement a legislation regulating the use and protection for traditional plants.560 Chile became a signatory of the UPOV
convention in 1995; therefore, new plant varieties have been protected in Chile since that time.