This judgment\u00a0rules on the criminal complaint filed by patients and relatives of persons who were affected by the hepatitis C virus on account of the obstacles they found to access new treatments against this pathology. Given that among\u00a0the defendants there was a person with privileged jurisdiction, the initial assessment of the complaint in relation to this person was made by the Supreme Court.<\/p>\n
Background of the case<\/strong><\/p>\n As is generally known, when a new medicine obtains its marketing authorization the Ministry of Health must decide whether or not the product will be financed with public funds, and under what conditions. In the case of a product approved to treat HVC,\u00a0the decision process lasted\u00a0up to 10 months and, moreover, limitations to access to such medicinal product were approved.<\/p>\n The frustration in view of this situation,\u00a0together with the high initial expectations, explain why a group of persons decided to bring criminal proceedings against certain authorities and public employees of the Ministry of Health, as well as against the pharmaceutical company which had obtained the marketing authorization. The plaintiffs accused them of several crimes including homicide, injuries and offences against moral integrity, omission of the duty to provide assistance, administrative malfeasance, and prices\u00a0alteration.<\/p>\n The plaintiffs\u00a0based these\u00a0very serious accusations on the fact that the\u00a0persons responsible within the Ministry refused\u00a0to\u00a0challenge, expropriate or impose a compulsory licence\u00a0on the patent of the active ingredient. They also\u00a0argued that, in their opinion, there was an infringement of the legal duty\u00a0to set a price\u00a0for such medicinal product\u00a0which\u00a0would make it available for patients.<\/p>\n Criminal proceedings\u00a0must be the exception\u00a0and the last resort<\/strong><\/p>\n The Supreme Court\u00a0rejected the complaint\u00a0and considered that no prima facie evidence\u00a0of a criminal offence had been submitted. The court claims that\u00a0the possibility to take actions against a patent for reasons of public interest\u00a0falls within the authority\u00a0of\u00a0the administration, but there is no\u00a0legal obligation\u00a0requiring it to act in this way.<\/p>\n On the other hand, regardless of its level of diligence, the court\u00a0highlights\u00a0that the Ministry\u00a0provided early access\u00a0to the medicinal product\u00a0through\u00a0various programs, and\u00a0that\u00a0there was no evidence that\u00a0any regulation\u00a0had been violated during the decision-making\u00a0process regarding its financing.<\/p>\n The court concludes\u00a0warning against\u00a0the temptation\u00a0to pursue\u00a0these matters criminally, which, without\u00a0underestimating the difficult situation of the affected parties, should be the last resort, and not the first response to delays\u00a0in administrative procedures.<\/p>\n <\/p>\n