{"id":6849,"date":"2015-07-29T18:25:46","date_gmt":"2015-07-29T16:25:46","guid":{"rendered":"https:\/\/faus-moliner.com\/?p=6849"},"modified":"2016-02-18T12:39:02","modified_gmt":"2016-02-18T10:39:02","slug":"the-new-law-on-guarantees-and-rational-use-of-medicinal-products-and-medical-devices","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/the-new-law-on-guarantees-and-rational-use-of-medicinal-products-and-medical-devices\/","title":{"rendered":"The \u201cnew\u201d law on guarantees and rational use of medicinal products and medical devices"},"content":{"rendered":"

Background<\/strong><\/p>\n

In accordance with article 82 of the Spanish\u00a0Constitution and by virtue of the delegation that\u00a0was granted under Law 10\/2013, the Government\u00a0has approved the consolidated text of\u00a0Law 29\/2006 on Guarantees and Rational Use\u00a0of Medicinal Products and Medical Devices.<\/p>\n

This \u201cnew\u201d law aims to consolidate in one text\u00a0the various provisions of Law 29\/2006, which\u00a0have been subject to various amendments; and\u00a0at the same time, it clarifies and harmonizes\u00a0some of the provisions in the Law.<\/p>\n

In our CAPSULAS No. 159 of March 2015, we\u00a0provided some ideas on the draft consolidated\u00a0text that the Ministry of Health was discussing at\u00a0the time. In this newsletter, we shall discuss the\u00a0most relevant aspects of the text that has finally\u00a0been approved.<\/p>\n

Definition of active substance and reference\u00a0price system<\/strong><\/p>\n

In the project that the Government presented\u00a0in March, it was suggested that for the purposes\u00a0of the Law, in particular in relation with the reference\u00a0price system, the definition of active\u00a0principle would be linked to the level 5 ATC of\u00a0the anatomical-therapeutical-chemical classification.\u00a0This proposal, that we criticized at that\u00a0time, has not been finally included in the text.<\/p>\n

We cannot exclude that this idea comes up\u00a0again in the new Royal Decree on prices of\u00a0medicines, but this would be a mistake. In connection\u00a0with this matter, we think that it is important\u00a0to recall the view of the WHO, which states the following on its website: \u201cbasing detailed\u00a0reimbursement, therapeutic group reference\u00a0pricing and other specific pricing decisions\u00a0on the ATC and DDD assignments is a misuse\u00a0of the system\u201d.<\/p>\n

In the same way that the WHO strongly opposes\u00a0to the fact that companies use the ATC system\u00a0for promotional or commercial purposes, it\u00a0is also clearly against administrative decisions\u00a0regarding the reference price system being\u00a0based on the ATC system.<\/p>\n

Generic medicinal products (EFG) and non\u00a0-replaceable medicinal products<\/strong><\/p>\n

The draft from March contemplated adding, to\u00a0article 14 of the Law, that the identification of\u00a0certain medicinal products with the acronym\u00a0EFG would be without prejudice of the abilities\u00a0of the Ministry to exclude them as replaceable\u00a0products. It is fortunate that this wording was\u00a0not included in the final text. The law continues\u00a0stating that medicinal products can be identified\u00a0as EFG (i. e. as generics) on the basis of the determination\u00a0made by the Spanish Medicines\u00a0Agency regarding its interchangeability.<\/p>\n

Free prices<\/strong><\/p>\n

The draft presented in March contemplated adding to the Law that, for the purposes provid- ed in \u00a0the Law, medicinal products that are not publicly funded would be covered by the free prices
\nregime. At the time, we criticized this because in our legislation a \u201cregime of free prices\u201d\u00a0does not really exist. Free prices are the general\u00a0rule and this may only be restricted through a\u00a0law. This is clearly indicated in Law 7\/1996.\u00a0Therefore, we think that it makes sense to state\u00a0that the prices of the products reimbursed are\u00a0subject to a special price regime rather than\u00a0saying that products which are not reimbursed\u00a0are subject to a free price regime.<\/p>\n

Price modifications<\/strong><\/p>\n

In our last CAPSULAS we mentioned it would\u00a0be good to clarify in article 97 that the\u00a0modification of prices of medicinal products\u00a0must be made in a reasoned way and according\u00a0to objective criteria. The reference to\u00a0motivation and transparency, as required by\u00a0Directive 89\/101, is already included in section 5\u00a0of article 94 on the initial price fixing, and we\u00a0thought this was a good time to clarify that this\u00a0also applies to the modification of prices.\u00a0Although this has not been included in the Law,\u00a0Directive 89\/101 still obliges Member States to\u00a0use objective criteria in all price review\u00a0processes.<\/p>\n

Substitution of medicinal products<\/strong><\/p>\n

Once again, a good occasion has been lost to\u00a0clarify that the prohibition of substitution of\u00a0medicines which are classified as nonreplaceable,\u00a0without having the prior approval\u00a0of the prescribing doctor, applies to both\u00a0pharmacy offices and hospital pharmacies.<\/p>\n

In our opinion, guaranteeing that substitution\u00a0shall not take place in these cases, both in\u00a0pharmacy offices and in hospitals, is an issue\u00a0related to the protection of the public health,\u00a0and it should be carefully considered.<\/p>\n

Homogenous groups and biosimilars<\/strong><\/p>\n

The opportunity has also been lost to correct\u00a0the provision that says that when prescription is\u00a0written using the name of active ingredient the\u00a0pharmacist must dispense the product with the\u00a0lowest price within its homogenous group and if\u00a0all prices are equal, the generic or biosimilar\u00a0product. Biosimilar drugs cannot be substituted\u00a0when dispensed and therefore they should not\u00a0be included in any homogenous group. A recent\u00a0Judgment of the Supreme Court of 19 June\u00a02015 ratifies this idea.<\/p>\n

Which discounts are forbidden?<\/strong><\/p>\n

The Law continues to classify as a very serious\u00a0infringement to offer bonuses, gifts, awards,\u00a0contests, discounts or similar initiatives as ways\u00a0to promote or sell to the public the products\u00a0regulated in the Law. The consolidated text has\u00a0not clarified that this should only apply in\u00a0respect of discounts or other commercial\u00a0practices that are prohibited by the Law itself.<\/p>\n

This clarification would be convenient because\u00a0the scope of application of the Law is very wide\u00a0and includes cosmetic products and also nonreimbursed\u00a0products. Given that all of these\u00a0products are covered by the Law, it would\u00a0make sense to clarify that the infringements will\u00a0apply only to situations where the Law prohibits\u00a0any such practices.<\/p>\n","protected":false},"excerpt":{"rendered":"

Background In accordance with article 82 of the Spanish\u00a0Constitution and by virtue of the delegation that\u00a0was granted under Law 10\/2013, the Government\u00a0has approved the consolidated text of\u00a0Law 29\/2006 on Guarantees and Rational Use\u00a0of Medicinal Products and Medical Devices. This \u201cnew\u201d law aims to consolidate in one text\u00a0the various provisions of Law 29\/2006, which\u00a0have been subject… <\/p>\n

<\/div>\n

Read More<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[72,387,388,86,217],"tags":[],"coauthors":[105],"class_list":["post-6849","post","type-post","status-publish","format-standard","hentry","category-capsulas-en","category-medical-devices","category-medical-devices-2","category-pharmaceutical-and-life-sciences-law","category-pharmaceutical-and-life-sciences-law-2"],"acf":[],"yoast_head":"\nThe \u201cnew\u201d law on guarantees and rational use of medicinal products and medical devices - Faus Moliner<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/faus-moliner.com\/en\/the-new-law-on-guarantees-and-rational-use-of-medicinal-products-and-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The \u201cnew\u201d law on guarantees and rational use of medicinal products and medical devices - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Background In accordance with article 82 of the Spanish\u00a0Constitution and by virtue of the delegation that\u00a0was granted under Law 10\/2013, the Government\u00a0has approved the consolidated text of\u00a0Law 29\/2006 on Guarantees and Rational Use\u00a0of Medicinal Products and Medical Devices. 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