The following is an English translation resolution 896, that was adopted by the Chile Chamber of Deputies on March 17, 2020, by a vote of 127 to 0. The original resolution, in Spanish, is available here. KEI has a blog about the resolution, with commentary Deputy Giorgio Jackson and Luis Villarroel of Corporación Innovarte, here.
RESOLUTION FOR THE GRANTING OF NON-VOLUNTARY LICENSES REFERRED TO IN ARTICLE 51º Nº 2 OF INDUSTRIAL PROPERTY LAW Nº 19.030 TO FACILITATE ACCESS AND AVAILABILITY OF MEDICINES AND TECHNOLOGIES FOR THE PREVENTION, TREATMENT AND CURE OF CORONAVIRUS COVID-19
Valparaíso,
To the Honorable Chamber of Deputies of the Republic.
I. CONSIDERING:
1. That the World Health Organization (WHO) declared COVID-19 a global pandemic on March 11, 2020 due to the alarming levels of expansion and severity of the outbreak after a 13-fold increase in the number of cases outside of China and tripling the number of people affected.
2. That, as the WHO informs, the coronavirus are an extensive family of viruses that can cause disease in animals as well as in humans. In humans, several coronaviruses are known to cause respiratory infections that can range from the common cold to more serious illnesses such as Middle East Respiratory Syndrome (MERS) and severe acute respiratory syndrome (SARS). The coronavirus recently discovered, called SARS-CoV-2, causes the coronavirus disease COVID-19, an infectious disease that to date is present in at least 130 countries, with more than 165,000 confirmed cases reported, and over 6500 deaths globally.
3. That, on March 7, 2020, a decree was published in the Official Gazette by which the Ministry of Health declared a sanitary emergency due to a public health emergency of international importance (ESPII) due to the outbreak of the new coronavirus (SARS-CoV-2).
That, in addition, Chile has already entered the phase 4 of this pandemic, as informed on March 16, 2020 by the President of the Republic on national television. The above unequivocally results not only in a Public Health problem, but in an emergency that threatens us with devastating consequences.
4. That, although to date we do not know what are the vaccines, medications, diagnosis, equipments, and other technologies that are useful for the surveillance, prevention, detection, diagnosis, and treatment of people infected with COVID-19, as a country we must be prepared so that, within our regulatory framework, the necessary measures and resolutions are taken expeditiously so that both the public and private sectors can generate the responses that this health emergency demands.
5. That it is possible to project, taking into account the international experience, that Chile’s current capacity in relation to beds as well as general infrastructure and the normal health supply system will be far exceeded, considering the seriousness of the problem. Considering this, and as a result of the international demand and the existing stocks in the internal and external market in terms of medicines, equipment and supplies, the health crisis will only deepen.
6. That the availability of novel medicines, supplies and equipment may also be restricted by legal monopolies resulting from patent rights and other forms of industrial property, which limit both the importation or manufacture, which is a risk for access that must be anticipated and corrected with urgency and due anticipation.
7. That, in this sense, it is necessary to take into account the Resolution 67.6 of the World Health Assembly, which asked Member States “12) to consider, when appropriate, the use of mechanisms to make use of the flexibilities provided in the Agreement on Aspects of Intellectual Property Rights related to Commerce in order to promote access to specific pharmaceutical products”.
Likewise, Resolution WHA 66.22 (2013) of the World Health Assembly that asked the Director General of the World Health Organization “to establish a global health research and development observatory within WHO’s Secretariat in order to monitor and analyse relevant information on health research and development . . . with a view to contributing to the identification of gaps and opportunities for health research and development and defining priorities in consultation with Member States . . .”;
Resolution 69.23 (2016) of the World Health Assembly, which requested the Director-General to “expedite the further development of a fully functional Global Observatory on Health Research and Development”;
And, finally, Resolución 72.8 (2019), adopted by the World Health Assembly, which urged Member States to adopt measures to improve the transparency of the markets for medicines, vaccines and other health products.
8. Taking into account articles 1, 19, No. 1 and 9, 52, No. 1, literal a), of our Political Constitution of the Republic and articles 1, No. 13, 311, and 114 of the Regulations of the Corporation Chamber of Deputies.
9. That, in addition, what has been previously stated by this Honorable Chamber should be considered: “the right to health is a constitutional right that can be demanded to the State of Chile, by direct mandate of our Constitution, in its art. 19 No. 9, it is not a mere programmatic provision, but comprises a series of positive and negative obligations for the State and whose beneficiaries are the persons, holders of the right. The Constitution develops some of these obligations, but the right to health protection itself is not exhausted in that list. There is already sufficient doctrine in this regard, following a harmonious interpretation of art. 19 and the idea of the minimum content of the law, as has been pointed out by international doctrine.”
That in the same sense this Honorable Chamber has indicated that “the constitutional mandate in its art. 5th inc. 2nd for the full application of the international treaties ratified by Chile and in force, including the International Covenant on Economic, Social and Cultural Rights, provides the right to health in its art. 12, together with the general observations that the ESCR Committee of the ICESCR has prepared in relation to the right to health. This treaty, in its paragraph 43, establishes a series of non-derogable obligations that, in no case can the signatory state fail to fulfill, which are non-derogable. These basic obligations are: a) Guarantee the right of access to health centers, goods and services; d) Provide essential medicines, according to the periodic definitions of the WHO; e) Ensure an equitable distribution of all health facilities, goods and services; f) Adopt and apply, on the basis of epidemiological evidence, a national public health strategy and action plan.”
10. That, in less critical circumstances on January 17, 2017, the Chilean Chamber of Deputies resolved to require the Ministry of Health to integrate into its policies, the obtaining of compulsory licenses when necessary, particularly with respect to Hepatitis C disease and medications for your treatment.
11. Finally, what is prescribed in the arts. 51º Nº 2, 51º bis C and 30º all of the Law Nº 19.030 of Industrial Property, norms that expressly establish the possibility of establishing compulsory licenses to patent rights for reasons of public health declared by the competent authority. In particular, that this situation fully meets the ground provided under art. 51º No. 2 of said law relating to the existence of reasons of public health or non-commercial public use and which must be declared by the competent authority (Ministry of Health) justifying the compulsory licensing.
III. THAT, THEREFORE, THE H. CHAMBER OF DEPUTIES, AGREES THE FOLLOWING DRAFT RESOLUTION:
1.- DECLARE: That pursuant to this background, the coronavirus epidemic worldwide and in our country, and its risks to the health of the Chilean population, in accordance with the aforementioned, constitute sufficient justification for the granting of the non-voluntary licenses contemplated in article 51º No. 2 of Industrial Property Law No. 19.039 to facilitate access to vaccines, drugs, diagnostics, devices, supplies, and other technologies useful for the surveillance, prevention, detection, diagnosis and treatment of people infected by the coronavirus virus in Chile, for public health reasons and/or national emergency, as provided in international laws, particularly the Doha Declaration on the TRIPS Agreement and Public Health.
2.- REQUIRE: The Minister of Health, Mr. Jaime Mañalich Muxi, to declare the existence of Public Health reasons for the granting of non-voluntary licenses provided in Article 51º No. 2 of Industrial Property Law No. 19.039, regarding all patent applications and issued patents related to vaccines, drugs, diagnostics, devices, supplies, and other technologies useful for the surveillance, prevention, detection, diagnosis and treatment of persons infected with the coronavirus SARS-CoV-2, por public health grounds.
3.- TO REQUIRE: The Minister of Health, Mr. Jaime Mañalich Muxi, to instruct the corresponding ministerial departments, as well as the health services and the Supply Center, to report the vaccines, drugs, diagnostic tests, supplies, equipment and others technologies that are projected will be required as an essential, for the purposes of the determination by the National Institute of Industrial Property of the the existence of patents or other industrial rights that restrict their importation or national production.
4. TO REQUIRE the Minister of Health to request the World Health Organization (WHO) Global Observatory on Health R&D to collect information on the research and development costs directly associated with vaccines, drugs, diagnostics, devices, supplies, and other technologies useful for the surveillance, prevention, detection, diagnosis and treatment of COVID-19, including the investments made by public sector institutions, private sector institutions, and charities.