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Compulsory Licenses of pharmaceutical products in South America
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2018-06-12 | 조회수 | 2,384 |
| 원문 | 한국보건산업진흥원 | ||
| 출처 | |||
Compulsory Licenses of pharmaceutical products in South America
- 글 Esteban Ortiz-Prado
- GPKOL위원
|
세부 전문분야 및 컨설팅 내용
◆ One Research Group, Faculty of Medicine, Universidad de las Americas, Quito, Ecuador; Department of Medicine and Center for Global Health and Translational Science, State University of New York Upstate Medical University, Syracuse, NY, USA, Global Pharma Key Opinion Leader) position at the KHIDI (Korea Health Industry Development Institute). |
Faculty of Medicine, Universidad de las Americas, Quito, Ecuador; Department of Medicine and Center for Global Health and Translational Science, State University of New York Upstate Medical University, Syracuse, NY, USA, Global Pharma Key Opinion Leader position at the KHIDI (Korea Health Industry Development Institute).
Objectives:
There is a lack of information about the compulsory licences in Ecuador. This paper aims to share the Ecuadorian experience regarding the experience within the compulsory licences in some pharmaceutical products
Methods:
This is a descriptive explorative analysis based on secondary source data retrieval from the international journals and books databases. A complete literature review was made and data was display using descriptive statistics.
This document tries to summarize the Ecuadorian experience regarding the obtaining of Compulsory Licenses of patented drugs, analyzing in a general the regulation around this process. We expose the main results in the process of requesting Compulsory Licenses in Ecuador without delving into legal technicalities that revolve around the procedure.
Results:
Demonstrate the role that the government of Ecuador had in terms of the regulation behind compulsory lincences and the process of obtaining licences with no positive results in the public health system.
Conclusions:
The lessons learned in this process of granting Compulsory Licenses leave important lessons for the Ecuadorian State. The process by which the analysis of more than 20 pharmaceutical products was carried out never responded to a technical logic but rather to political pressures within the government itself, leaving in the background the logic and the object for which this figure was created.
Keywords: Compulsory licences, Ecuador, DOHA declaration, TRIPS agreement, Sunitinib, Certolizumab.
INTRODUCTION
The analysis of public policies that revolve around guaranteeing access to medicines and public health has included the possibility of making the production and “branded” medicines more flexible by obtaining Compulsory Licenses (LO)(1,2). According to the "Agreement on trade-related aspects of intellectual property rights (TRIPs) developing countries are allowed to use of this mechanism in order to obtain one specific and unique license to the applicant country in order to produce (or request production by a third party) of one patented pharmaceutical drug(2,3).
The licenses and patents of the drugs in South America are very important in order to be able to use drugs that due to high cost can be produced or imported in each country(4). In South America like in other countries, drugs or pharmaceutical products have two components regarding the name, the Active Principal Ingredient (API) and the Brand Name. The active principle that it is used in the field of the chemistry to appoint to the component that carries the present pharmacological qualities in a substance(5) while the brand name or the commercial name refers to the protection of any pharmaceutical patent that is exclusive for 20 years(6). This is a right for companies who has invested several million dollars to discover a new drug, allowing protection for third party uses. This is a powerful commercial instrument so companies can obtain exclusivity on a new product or procedure gaining a solid position within the international market.
In the globe, there are two ways to recognize and commercialize medicines: the first is by its scientific denomination and the second by his commercial denomination or the brand name. Generics on the other way, are drugs with the same API that can be produced publicly. Its patent already expired or by have not been patented in the country of production(7,8).
In general, generic medicines are equivalent to the medicine of reference also known as the innovator, containing the same active principle in the same quantity but with lower prices and better patient’s adherence to treatment(9). The only differences that could find between a medicine of mark and the generic is the appearance (color, size, flavor, form, etc.) to the excipients, that uses them to him like substances employed to achieve the pharmaceutical form wished and that facilitate the preparation, conservation and administration of the medicines(10).
In some countries, is possible to obtain a period of protection wider for the pharmaceutical products like compensation by the loss of the real period of protection because of the delays in the obtaining of the approval for the commercialization awarded by the corresponding normative organ in matter of public health(11).
According to World Trade Organization (WTO) / World Trade Organization (WTO), Compulsory Licenses are instruments that allow the production of a patent medicine without necessarily receiving authorization from the owner of the same(1,12). The global process of requesting licenses to produce a patented medicine is a legal procedure protected and regulated in several international instruments and regulations that allow, especially in developing countries, access to expensive, necessary and difficult to access medicines.
When a new molecule is patented and its spread it to the world this invention can sometimes be reproduced by using regulations that allows third world countries to obtain a compulsory licence. It is very important to indicate that the patent does not concede when titling the “freedom to use” the medicines protected by the patent, but the right to exclude to others of the use of this medicine. Although this distinction can seem subtle, is fundamental to comprise the system of patents, his relation with the normative systems and the way in that the patents relate mutually(3,8,13).
In fact, it is
possible that exist patents that base in previous patents or for whose
commercialization demand statutory permissions or the use of other inventions
patented. In some cases, is possible that a company have to obtain a license on
the patents of other people to end to commercialize his own invention patented.
In the pharmaceutical industry, the right to exclude to others of the use of
the invention does not award the right to commercialize a new medicine by what
this last still will have to subject to determinate proofs (for example, the
clinical essays) and obtain the permission for the commercialization, independently
that it has been patented(14,15). The rights
awarded by the patent can be yielded in license, by means of an agreement in
which the headline of the patent agrees to authorize determinate specific uses
of the invention patented, generally in return of an only payment or of
royalties Table 1 (11,12).
Table 1 Some examples of the compulsory licenses awarded by several countries
|
Country |
Pharmaceutical product |
year |
Innovator Laboratory |
|
Israel |
Hepatitis B Vaccine |
1995 |
Biogen |
|
Canada |
Ciprofloxacin |
2001 |
Bayer |
|
Malaysia |
Didanosine |
2003 |
Bristol-MS |
|
Malaysia |
Zidovudine |
2003 |
Glaxo SK |
|
Brazil |
Efavirenz |
2003 |
Merck |
|
Indonesia |
Efavirenz |
2004 |
Merck |
|
Mozambique |
Lamivudine+nevirapine+stavudine |
2004 |
Boehringuer |
|
Zambia |
Lamivudine+nevirapine+stavudine |
2004 |
Boehringuer |
|
Brazil |
Kaletra |
2005 |
Abbott |
|
Brazil |
Imatinib |
2005 |
Novartis |
|
Thailand |
clopidogrel |
2006 |
Sanofi |
|
Italy |
Sumatripan |
2006 |
Sandoz |
|
Canada |
Ostelnavir |
2006 |
Roche |
|
Indonesia |
Lamivudina |
2007 |
Glaxo Smith Kline |
|
Thailand |
Efavirenz |
2007 |
Merck |
|
Thailand |
lopinavir/ritonavir |
2007 |
Abbott |
|
USA |
Ciprofloxacin |
2011 |
Bayer |
|
Indonesia |
Nepivarina |
2012 |
Boehringuer |
|
Indonesia |
abacavir |
2012 |
Glaxo SK |
|
India |
sorafenib |
2012 |
Bayer |
The purpose of this document is to provide an overview of what has been the process of Obtaining Compulsory Licenses for medicines in Ecuador. All the legal framework that precedes this interesting and often complicated process is available in several publications for its due deepening if required(16).
World Trade Organization 1994
The Agreement on Aspects of Intellectual Property Rights Related to Trade (TRIPS) establishes in its Article 31 that the use without authorization of the owner of the patent can occur "When the legislation of a Member allows other uses of the matter of a patent without the authorization of the owner of the rights, including use by the government or by third parties authorized by the government ... ".
Declaration of DOHA 2001
The Declaration issued during the IV Ministerial Conference held in Doha, Qatar in 2001 establishes the guidelines for the negotiations that revolve around the application of TRIPS and Public Health. Within this process, the unanimous adoption of the section that provides that "Each Member has the right to grant compulsory licenses and the freedom to determine the basis on which such licenses are granted" stands out, in a clear attempt to guarantee the right universal access to medicines in those countries where this prerogative was limited by economic factors.
Andean community
This regional body and its four member countries have a common objective that is summarized in achieving an integral regional development for which they have issued some instruments that validate and regulate the obtaining of Compulsory Licenses, among which is the so-called Decision 486 (Decision of the Agreement of Cartagena) that establishes the Common Regime of Industrial Property for the member countries. In chapter 7 of this instrument, specifically in articles 61-69, the compulsory licensing system is regulated, establishing the legal framework on the allocation of licenses to private applicants with the aim of guaranteeing access to quality medicines and combating behaviors and practices. of unfair competition with regard to the pharmaceutical industry.
On the other hand, there is a consensus that everything related to agreements "can and should be interpreted and applied in a way that supports the right of WTO Members to protect public health and, in particular, to promote the access to medicines for everyone. "
COMPULSORY LICENCES USE AND APPLICATION
The use of compulsory licences (CL) is intended to reduce the cost of expensive medicines that are protected by a patent. In some cases, CL are expedited in order to negotiate with pharmaceutical companies as a pressure mechanism that is not always well handed.
Pharmaceutical companies can also concede licenses with other pharmaceuticals in order to mutually allow them to use the respective technologies and take advantage of them. Likewise, in some cases several companies can create a “joint patent” (or a center of management of the rights of patent), to end to facilitate the granting of big number of licenses on several relative patents to a determinate technological field(3).
The majority of the CP licenses are negotiated between the institution requiring the license and the owner of the other. Ideally, governments would be the most appropriate institution asking for a CL, allowing the population in general get the benefits. In most of the cases this is not possible since the governments have no infrastructure to produce the drugs, letting the owner of the patent sue the solicitor and affecting the patent requirement.
In Spain for example, the current legislation allows the exploitation of a patent by a solicitor and when the licence is conceded the owner of the patent obtains the 50% of reduction in those annual income taxes(17,18).
it is Ecuador, the CL market just exploded in the last 10 years. The government of Ecuador ask the Ecuadorian Institute of the Copyright (IEPI) to extend them 9 compulsory licenses for 9 pharmaceutical products that are expensive. These medicines are used for the treatment of the HIV (Ritonavir, Lamivudine and Abacavir), the arthritis (Etoricoxib, Certolizumab), the cancer (Sunitinib), illnesses of the immune system and immunosuppressant’s (Mycophenolate sodium) and their cost are high in relationship to the minimal wage in Ecuador. In the Ecuadorian case, three of them were finally given to the government, however, the State did not managed them well and 3 year later the process is still open and no medications are being produced(19).
LIMITATIONS AND EXCEPTIONS OF THE RIGHTS OF PATENT
When a government need to ask for a CL, there are many limitations, including all the paperwork behind the requirement of a patent.
Considering the main restrictions, territorial limitation (as it has described previously, a patent is a territorial right that only has effect in the jurisdiction for which has been conceded). In this sense, temporary limitation (until 20 years from the date of presentation of the application, length that can expand in some countries in the case of products that are subjected to the approval of the corresponding normative organs, for example, determinate types of pharmaceutical products).
Limitation in the scope of the patent since these can only award exclusive rights on the invention claimed in the way described(13).
In other cases, the use of preliminary data is forbidden, increasing the difficulties specially for those developing countries affected by the diseases. However, in some countries, exist exceptions to the rights of patent that allow to third use the invention without the permission of the title of the patent, for example, to make investigations with ends no commercial using the invention patented (exception that designates often as “experimental ” are allowed) or to prepare and request the statutory permission of a pharmaceutical product before the date of caducity of the patent or pertinent patents.
These type of measures accelerate the commercialization of generic products after this date. Given the wide existent differences between the countries in these questions, generally suits that the companies are very informed of the concrete practice of each country before initiating this type of activities so that there is not any type of delay or lost the moment to commercialize a new drug. (OMPI, 2014)
In the Ecuador lace compulsory licenses constitute a legal resource that, inside the flexibilities of the planned copyright by the World-wide Organization of the Copyright (OMPI), allow a government to assign a third party permission to make a patented product or use a patented procedure, without the consent of the title of the patent, with the objective of addressing a priority situation for the country.
ECUADORIAN EXPERIENCE
The three first licenses issued in Ecuador were intended to promote better access to antiretroviral drugs (Ritonavir and Lamivudine + Abacavir). These licenses were issued after the fact that “IEPI” in Ecuador responded to the Minister of Public health and the public demand for medication intended to treat those thousands of patients infected with HIV in order to reduce those 700 annual average deaths due to this illness(20).
On the other hand, not all the licenses issued for medicines were antiretroviral drugs. In Ecuador, later on, the IEPI issued licenses for Etoricoxib (Arcoxia), medicine of checked effectiveness for the treatment of illnesses with acute pains and for Mycophenolate Sodic (MYFORTIC), drug used in the treatment of reception of renal transplantations.
In the year 2009, the compulsory licenses of national production with the aim of developer scientific investigation and increase of the active principles for the creation of generic medicines to lower cost, created the public pharmaceutical company ENFARMA, same that has by mission cooperates so that a greater percentage of the population can have access to medicines that serve in the treatment and healing of his illnesses.
Enfarma applied for more than 9 compulsory licences, however, just two were issued for the only pubic government funded pharmaceutical company. The two drugs were : Sunitinib and the most recent, Certolizumab. The problem with these two licenses was that in Ecuador the capabilities were not enough to produce medications in Ecuador, thus, all the international fighting was useless Table 2.
Table 2 Compulsory Licenses awarded in Ecuador since 2010
|
Active principle |
No. Patent |
Applicant |
Origin |
Therapeutic group |
Innovator Lab. |
|
Ritonavir |
pi-97-1142 |
Eskegroup s.a. |
USA. |
Antiretroviral |
Abbott |
|
Lamivudine + ritonavir Abacavir |
sp-98-2505 |
Acromax |
UK |
antiretroviral |
Glaxo |
|
Etoricoxib |
|
Acromax |
USA. |
anti-inflammatories |
Merck SD |
|
Lamivudina + abacavir |
pi-08-1913 |
Ginsberg |
UK |
antiretroviral |
Glaxo |
|
Micofenolato |
sp-97-1383 |
Ginsberg Ecuador s.a. |
USA. |
antineoplastic y/o immunosuppresses |
Syntex |
|
Sunitinib |
pi-07-1872 |
Enfarma ep |
USA. |
anticancer drug |
Sugen |
|
Certolizumab |
pi-2010-2027 |
Enfarma ep |
Belgium |
rheumatoid arthritis |
UCB Pharma |
|
Lamivudina + abacavir |
sp-98-2505 |
Oxialfarm |
UK |
antiretroviral |
Glaxo |
CONCLUSIONS
The related interaction between industry and governments it’s a very interesting topic. Understanding compulsory licenses is fundamental
since this will allow us to better apply legal tools in order to increase health access, less expensive medicines and auto-regulated prices
imposed by the offer and demand of massive international and multinational companies decreasing and controlling the price regulated by
international pharmaceutical companies.
The ability that countries have to request compulsory licenses is a great tool when overcoming lack of drugs, high prices and well known
abuses from big pharma companies.
The use of this tool varies from country to country, with better examples than others. Within the region, examples such as the Brazilian one
have served to help people with catastrophic illnesses such as HIV or cancer get more benefits likes cheaper drugs and better health care
access.
Other countries, such as Ecuador, have had less satisfactory experiences. For example, in Ecuador the drugs that were intended to treat cancer
were never produced. The prices were not diminished and the medicines continue to be sold at the same value, therefore, learn from our
mistakes and differentiate the needs versus the capabilities of each country is fundamental in order to reduce international legislation related
costs.
In Ecuador, the presence of legislation never contributed to the problem itself, actually, offering more than 10 CL have not be that effective in
reducing cost or increasing access.
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