Juan Luis Beltr\u00e1n (Pamplona, 1946), BSc and Doctor of Law, has been the president of the Navarra Transparency Council since 2018. In addition to his work as a university professor and jurist, he has been advisor to the Navarra Ombudsman, president of the Jurists of Health Association and the Spanish Association of Public Health and Healthcare (SESPAS).<\/p>\n\n\n\n
The council that he leads is an independent body of the administration that is responsible for overseeing compliance with the obligations of the Navarra Public Administrations and public sector organisations for publishing their activities, as well as citizens\u2019 right to access the public information they have. An \u2018essential duty for any advanced democratic system,\u2019 as he states, and which is particularly relevant in the field of health, as transparency in medicine management largely depends on fair access to it and, consequently, the health of thousands of people.<\/p>\n\n\n\n
There is the impression in recent years \u2013 both in Spain and the world \u2013 that there is progressively more talk of transparency and that it is acquiring increasingly greater relevance.<\/strong><\/p>\n\n\n\n Definitely. In Europe, especially in Nordic countries and in North America, transparency is more of a tradition and laws have been enacted decades ago that obligate the administration\u2019s transparency. However, in Spain the issue has been delayed. The stimulus that has caused transparency to take on the importance it now has are the episodes of corruption in the last two decades.<\/p>\n\n\n\n So, is transparency a tool to fight corruption?<\/strong><\/p>\n\n\n\n The fact\nthat the administration and governors make public their decisions and the\nreasons for them is essential for good governance and good administration, to\nprevent decisions partially influenced by financial or personal interests. Transparency\nis also fundamental for accountability. Citizens have the right for the\nadministration \u2013 who we should never forget works at\nthe service of citizens \u2013 to account for its actions. And, of\ncourse, transparency is also essential for citizen participation, which is now\nmore present than ever in public policies. However, in order for citizens to be\nable to participate, they must be informed, as there is no information without\ntransparency.<\/p>\n\n\n\n In summary:\ntransparency is not an end in and of itself, but it is an essential\ncross-cutting mechanism to prevent corruption, for good administration, for\ncitizen participation, for accountability and for public integrity.<\/p>\n\n\n\n Is transparency in health particularly\nrelevant? Could the lack of transparency have direct consequences on people\u2019s\nhealth?<\/strong><\/p>\n\n\n\n Of course. Greater\nor lesser transparency has a direct impact on the population having better or\nworse overall health. This has been empirically proven. According to a health\nscale published by the Spanish Ministry of Health in 2018, there are two\nmillion people in Spain who do not buy the drugs that public health prescribes\nthem because the part they would have to pay (copayment) is too expensive for\nthem and they do not earn enough to assume this expense.<\/p>\n\n\n\n Why are\nthere two million people not buying the drugs they need? Because at present\nthere is a large number of medicines whose prices have doubled, tripled or quadrupled,\nwhich is also reflected in the copayment. And why are the prices so high? Well,\none of the reasons is the lack of transparency in price setting by the\nHealthcare Administration.<\/p>\n\n\n\n For example?<\/strong><\/p>\n\n\n\n There is\njust an enormous inequality in the negotiations between pharmaceutical\nlaboratories and the administration. The companies have information on how much\nit has cost them to develop a drug, information which is unknown by the\nadministration. Thus, the administration has fewer weapons to negotiate fairly\nwith the companies and to obtain more reasonable and balanced prices that\ncompensate the companies\u2019 costs, but also let it acquire them at a fair price,\nnot like now, with prices that keep going up. A recent book on this topic is\ncalled: Medicamentos:<\/em> \u00bfderecho humano o negocio?<\/em> (Drugs: Human Right or Business?<\/em>)<\/p>\n\n\n\n So there has been progress. Transparency law,\nlaws on drugs, jurisprudence\u2026<\/strong><\/p>\n\n\n\n Yes, of\ncourse. In recent years, we have seen how the state Transparency Council, an\nindependent body, has enacted several resolutions, based on claims for access\nto information. It also supported organisations such as No es Sano and the\nCivio Foundation, declaring their right to access the data they requested,\nwhich in this case were on the criteria used by the administration to approve\nthe use and buying of a drug. Things\nwere going quite well.<\/p>\n\n\n\n But\u2026<\/strong><\/p>\n\n\n\n Surprisingly,\nin the latest resolution in September of last year on another request for\ninformation, the Transparency Council did a complete turnabout and prioritised\nthe principle of confidentiality alleged by the pharmaceutical companies. Honestly\nit surprised all of us.<\/p>\n\n\n\n Principle of confidentiality?<\/strong><\/p>\n\n\n\n Yes. In\ngeneral, transparency legislation demands utmost transparency in all the\nadministration\u2019s actions and proceedings. The Spanish Drug Law, specifically\nits article 7, also establishes the general principle of maximum transparency\nin decisions made by the healthcare authorities related to medicines. However,\nsome groups of laws also establish limits. One of these limits involves not\nproviding information that could entail damages to companies\u2019 economic and\ncommercial interests. And article 97 of the Drug Law establishes the rule of\nconfidentiality for the technical and financial data submitted to the Healthcare\nAdministration by laboratories for the approval of a drug and setting its\nprice.<\/p>\n\n\n\n The\npharmaceutical companies are using this confidentiality rule to grasp at straws\nand deny this information when third parties require them to be provided by the\nHealthcare Administration that has them. <\/p>\n\n\n\n And are there more recent cases in this regard?<\/strong><\/p>\n\n\n\n Yes. Along\nthis same line, we have the resolution by the Basque Country Transparency\nCommittee from January 2020 that \u2013 like what the Ministry of Health\ndid \u2013 rejected the claim of the CIVIO Foundation, which wanted to know how\nmuch the Basque Health Service was paying for a specific cancer treatment. This\ndecision was based on two criteria: that disclosing economic data would affect\nthe laboratory\u2019s commercial interests and that knowing what the Basque Health\nService was paying could have a negative impact on the laboratory for\ndetermining the price in other autonomous communities, because it would have\nless negotiating capacity.<\/p>\n\n\n\n Naturally,\nthe pharmaceutical company \u2013 Novartis in this case \u2013 would rather keep the agreements reached secret, to then negotiate for\nthe prices it considers suitable in other autonomous communities, without\nreferences that, like a cap, could limit its negotiating capacity. However, and\nlogically, the autonomous communities do want to know how much other\ncommunities are paying in order to have the information that would give them\nmore negotiating power.<\/p>\n\n\n\n Did the government also deny access to this\ninformation?<\/strong><\/p>\n\n\n\n The\nargument of confidentiality and economic damages was used by the Basque\nCountry\u2019s Ministry of Health and it is the same argument that Farmaindustria\nhas been using, in representation of the pharmaceutical laboratories in Spain.<\/p>\n\n\n\n So has the administration accepted the\nindustry\u2019s argument?<\/strong><\/p>\n\n\n\n Based on\nthe first and successive decisions of the state Transparency Council granting\naccess to data on medicines, Farmaindustria became quite alarmed and started \u2013 for the first time \u2013 an important campaign with\nstatements in the press and articles in scientific journals calling for the\nnecessary confidentiality of the data provided for drug authorisations. This\ncampaign was so widespread and strong that it seems to have been taken on in\nsome way by the healthcare administrations, the Transparency Council and the\nBasque Transparency Committee.<\/p>\n\n\n\n And are they valid arguments?<\/strong><\/p>\n\n\n\n The alleged\ndamage to commercial and economic interests is largely a fallacy. In several litigation\nproceedings, laboratories have said \u2018look, they cannot make these data public\nbecause then the pharmaceutical laboratories will use them, which would damage\nour business\u2019. But that is a fallacy \u2013 I repeat \u2013 because these\nmedicines are protected by a patent, which gives them total exclusivity for\nmarketing and sale. It is simply an invalid argument.<\/p>\n\n\n\n Another\nargument the industry uses, for example, is that if there wasn\u2019t\nconfidentiality, prices would move towards evening out at a single price, which\nwould be relatively low for rich countries, but too high for the poorest\ncountries, making access complicated. Farmaindustria used this argument, as if\nthe pharmaceutical companies were NGOs that, instead of pursuing maximum\nbusiness profits, want to guarantee access to drugs by citizens of poor\ncountries. And, to achieve this laudable objective, they require\nconfidentiality. But I insist, this is false. Not long ago, the CIVIO\nFoundation conducted a study on drug prices in several European Union countries.\nAnd \u2013 to give one example \u2013 it discovered that for Sovaldi, the\nfamous drug for Hepatitis C, a more expensive price was agreed on for the\ncountries with lowest revenues like Portugal and Poland, than in countries with\nhigher earnings like ours.<\/p>\n\n\n\n In any case, recent laws in Spain, the WHO\u2019s\nhistoric transparency resolution and other countries\u2019 rulings do let us see a\nsignificant change in favour of transparency\u2026 Can we be optimistic? <\/strong><\/p>\n\n\n\n The lack of\ntransparency about medicine prices is a worldwide problem. Laboratories do not\nwant their technical and economic data to be publicised in any country, so that\nthey can have more negotiating freedom with each country\u2019s healthcare systems. However,\nthere are many civil societies and scientists interested in knowing these\nnumbers to be able to improve access to and management of medicines. There have\nbeen claims similar to those in Spain that have ended up in European courts of\njustice.<\/p>\n\n\n\n In fact,\nonly a few weeks ago, several rulings were published in which the European\nCourt of Justice took an absolutely clear position in favour of the right to\naccess this information. It gave precedence to higher public interests for its\ndissemination, an interest consisting of the need to have controls over the\nactivities of the European Medicines Agency. The latter also expressed its\nagreement with the sentence, in which healthcare and research professionals\ncontrol the granting of drug commercialisation authorisations.<\/p>\n\n\n\n I suppose\nthat these decisions will influence assurances of transparency and in courts\namong our bodies, which I hope will be more liable to grant the right to access\ninformation from now on.<\/p>\n\n\n\n And what is missing to advance more quickly\ntowards an R&D model for health that is more transparent and fairer?<\/strong><\/p>\n\n\n\n Two things\nare lacking to obtain more transparency in the system and everything\nspecifically related to health. One the one hand, modify the Spanish Medicine\nLaw, establishing clearer criteria, as they are not clear now. And, on the other,\nfor public organisations and senior executives to generate a culture on the\nvalue of transparency.<\/p>\n\n\n\n In Spain\nright now, a citizens\u2019 legislative initiative has been admitted for processing\nin the Congress of Deputies to modify the Medicine Law and to add a series of\nnew articles. They include, for example, introducing transparency in setting\nmedicine and medical device prices, as well as accountability in the healthcare\nadministrations\u2019 adoption of decisions. If\n500,000 signatures are obtained between now and June, they will start to enact\nthe law. And it would be very important.<\/p>\n\n\n\n A closing statement\u2026 <\/strong><\/p>\n\n\n\n The\npharmaceutical industry\u2019s reprehensible secrecy practices are making an\ninformed and solvent public debate impossible on the costs of producing, prices,\ntherapeutic value, accessibility and so forth of medicines. There are two interests at play here: the\npharmaceutical laboratories\u2019 economic interest and the public interest of\nassuring the fairest prices possible for medicines so that all citizens have\naccess to them. Of these two values\u2026 which one should prevail? The public\ninterest naturally, although right now it seems like the first is prevailing.<\/p>\n","protected":false},"excerpt":{"rendered":" Juan Luis Beltr\u00e1n (Pamplona, 1946), BSc and Doctor of Law, has been the president of the Navarra Transparency Council since 2018. In addition to his work as a university professor<\/p>\n","protected":false},"author":2,"featured_media":11315,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[309],"tags":[96,114],"class_list":["post-11313","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-slider-en","tag-espana","tag-precio-medicamentos"],"yoast_head":"\n