Global health. The current scenario and future perspectives
274 groups, requested that the Ministry of Health issue a Declaration of Public Health Need for certain medications, including the Sofosbuvir mentioned earlier. This declaration would establish the required conditions for issuing a compulsory license or patent break in case of a health emergency to access treatments for Hepatitis C, which was being discussed in many countries. The Ministry of Health, together with other ministries, had to address this request not only from a health perspective but also from legal and political standpoints. There were strong health arguments. However, authorities were indecisive due to the pressure exerted against them by private sector areas as well as some public sector areas. The process was long and complex and lasted almost a year. It involved the formation of an interministerial working team, international coordination and a request that needed resolution before the new administration took office in the government change in March 2018. Thus, on March 9 th , 2018, Resolution No. 399 of the Ministry of Health was enacted, declaring reasons related to public health to justify the pronouncement on granting non-voluntary licenses related to patent rights affecting Sofosbuvir and any associations it has with other Direct-Acting Antivirals (Gobierno de Chile, 2018). This process is still ongoing. There is a declaration of public health need but no progress has been made towards nullification of the said patents at the INAPI (National Institute Of Industrial Property). Nevertheless, a proposal has been generated amending Industrial Property Law on compulsory licenses under Drug Law 2. The process of the Declaration of Public Health Need was a significant health milestone that was welcomed by countries in the region, and its media impact was crucial for initiating the update of the GES Decree incorporating DAAs for Hepatitis C treatment. Surprisingly, reactions came from the international pharmaceutical industry and several embassies where headquarters of these companies are located, as detailed in an investigation conducted by CIPER, a Chilean press outlet, in an article titled “Aggressive lobbying by laboratories against the resolution that lowers drug’s million-dollar price” (Sepúlveda, 2018). This is how the GES decree was updated by incorporating Sofosbuvir as a base medication along with other DAAs for the treatment of Hepatitis C. Several alternatives depended on the different genotypes of patients, with some of the included medications with extremely high prices because companies withdrew from negotiations. Once the GES Decree (Gobierno de Chile, 2017) was issued in February 2018, the company with which Sofosbuvir was negotiated registered a pharmaceutical product in Chile consisting of a pan-genotypic association. This means that it could treat all types of patients with Hepatitis C without distinction. Considering that the Decree included alternatives ranging from USD
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