La entrada Más sobre intercambiabilidad y sustitución de medicamentos biológicos aparece primero en Faus Moliner.

The case in hand was initiated following a call for tenders as part of a Framework Agreement (FA) to supply epoetin alfa. Hospira appealed claiming that the definition of the subject of the agreement, which required that in the data sheet epoetin alfa featured as one of the ingredients of the medicinal product offered, represented a barrier to participating in the call for tenders, as it prevented holders of a biosimilar medicinal product (epoetin zeta) from being able to offer their products.

The Administrative Body of Contractual Appeals (OARC) of the Basque Country allowed the appeal as it believed the specifications limited the purpose of the agreement to a product with a specific active ingredient (epoetin alfa) and prevented equivalent products from being submitted, which represented a barrier to participating in the call for tenders. The OARC ordered the production of new specifications that had to included the term “or equivalent” in the definition of the subject of the agreement.

Biosimilars are not equivalents

Osakidetza appealed before the High Court of Justice, claiming that:

i) it is impossible to deduce that two medicinal products are bioequivalent based on the fact that they are biosimilar, they are in the same therapeutic group and they have the same ATC code;

ii) the judgment of the OARC confuses the concepts “bioequivalent medicinal products” and “biosimilar medicinal products”, when they are different figures, classifying epoetin alfa and epoetin zeta as equivalent medicinal products, despite this not being the case.

The judgment of the High Court of Justice upheld the appeal of Osakidetza. The judgment is based on the idea that the contracting body is responsible for drafting and approving the specifications and that in doing so they cannot ever breach the principles of free competition and equality required by European Community law. Based on the foregoing, unless the purpose of the call for tender so requires, the technical specifications cannot mention products linked to a specific source or production or specific procedures that favour or rule out competitors.

However, the Court adds that in this case, the purpose of the procedure was to continue with the supply of epoetin alfa for ongoing treatments; therefore, it was justified that the FA was called with reference to the active ingredient and not the therapeutic indication.

The High Court of Justice adds that the use of the active ingredient’s DOE (Spanish Official Name) in the specifications ensures the correct identification of the medicinal product sent out to tender, improving the accomplishment of the subject of the agreement without undermining the principles of free competition and equality and non-discrimination; and it concludes that the different epoetins are biosimilar medicinal products, but not equivalent medicinal products.

La entrada Purchase of biological medicinal products: reference to the active ingredient is valid for defining batches aparece primero en Faus Moliner.

In order to do this, we have grouped the decisions of the courts according to their topic, starting our tour through the regulation of pharmaceutical warehouses, and continuing to the important decisions on the contributions related to sales by the pharmaceutical companies, the regulation of the so-called “sunset clause”, data exclusivity, the definition of medicinal products or its assessment. We continue our journey analyzing the constant changes in public financing, the prescribing and dispensing medicinal products, the pharmaceutical provision, reference prices and homogeneous groupings. Finally, we end our publication with a comment on two important decisions regarding public procurement and a European reference to the regulation of orphan medicinal products.

La entrada The medicinal product in Courts in the year 2015 aparece primero en Faus Moliner.

This case begun when a doctor treating a patient with Parkinson came to the conclusion that, in this specific case, the generic medicinal product which the patient was getting from the pharmacy did not have the same effect as the branded product which the doctor had prescribed. The substitution had been carried out by the pharmacist in a correct legal manner, because the branded product had a price higher than the generic. However, given the circumstances, the doctor encouraged the patient to buy the branded product, which would not be reimbursed, and to file a claim for reimbursement later on.

The Law and individual rights

The Court that analysed this case ruled in favour of the patient, basing the decision on the need to protect his individual rights. According to the Court, what is crucial to resolve this case is not that the pharmacy was obliged to dispatch the generic product due to its lower price; but the fact that the patient had the right to protect his health and to obtain the branded product prescribed by the Neurology Service that was treating him if, in his case, the result obtained with the branded product were better than those obtained with the generic.

According to the Court the protection of the individual right of the patient is contemplated by Article 85 of Law 29/2006 on prescription, dispensation and substitution; because according to this article the principle that must prevail is that the prescription must be made in the most appropriate manner for the benefit of patients.

The Court also recalls that the same law provides that the sustainability of the system must be protected and it envisages that, because of this, the prescription and dispensation of the branded product is possible only if its price is not higher than the one of the generic one. However, according to the judgement, this rule has to be disregarded in the case of non substitutable products, and in order to determine whether a medicinal product is substitutable or not, it is possible and even necessary to take into account the individual situation of each patient. If the condition of a patient treated with a branded product aggravates when he starts being treated with the generic version, the Court says, these products must be considered as non-substitutable at least in the case of the specific patient.

Selection and Substitution of biological products

The ideas expressed in this judgment contribute to the debate on the situation of patients treated with biological medicinal products. For these products, where prescribing by brand name is compulsory, and where identification of the brand and of the batch of the product administered to the patient is required for pharmacovigilance purposes, substitution without the consent of the patient and the prescribing doctor is not only illegal but it also infringes the individual rights of patients recognized in the Constitution. This applies to any type of selecting measure that implies generalizing substitution or that makes the prescribers treat the new patients with a biologic medicinal product to the detriment of another. The doctor’s criterion, and the patient’s right to be informed and to be able to choose from the available alternatives must prevail in all cases, and especially in this one.

La entrada Substitution of medicinal products and individual rights of patients aparece primero en Faus Moliner.

CEFI, Centro de Estudios para el Fomento de la Investigación, has organized this Seminar with the aim of dealing with various matters in connection with the legal regime applicable to biologics in Spain.

The event has been opened by Maria Alonso Burgaz, President of CEFI; and by Regina Revilla Pedreira, President of Asebio.

In his speech, Jordi Faus has expressed his sympathy for the preparation of a new Royal Decree which could deal, specifically, with various aspects related to biological products. He has recalled that Article 45 of Law 29/2006 already contemplates this possibility in view of the special characteristics of these medicines.

This new regulation, in the opinion of Jordi Faus, should rely on a rigorous analysis of scientific and medical aspects; and take into account the position of the patients, of healthcare professionals, of those in charge of managing the healthcare system in general, and also of suppliers of these products. The new regulation should also address issues which are currently dispersed in various texts that have been adopted over time, and it should do so rigorously and with finesse, without forgetting that the issues at stake are rather complex and that legal certainty benefits all those whose position has to be taken into account.

La entrada Medicamentos biosimilares – Aspectos a considerar en una regulación específica aparece primero en Faus Moliner.

In this event, the Spanish Rheumatology Society has asked Faus & Moliner to speak about how Spanish law may impact on these issues.

Our partners Juan Suarez and Jordi Faus have worked extensively on this matter and have represented many companies in various procedures. At the course, Juan Suarez focuses on the new rules approved in July 2013, when Law 29/2006 was amended, and which foresee that only the Spanish Medicines Agency is competent to issue reports implying a comparison exercise between two medicines.

In some other European countries such as Italy, some Courts have already ruled that regional authorities should not carry out this selection of medicines unless the regulatory authorities have previously ruled that two products are therapeutically equivalent. The judgement of the Umbria Regional Court of 16 April 2013 is one of these cases.

In Spain, the Central Court for Administrative Contractual Appeals ruled, on 27 March 2013 that when approving an invitation to tender dividing the object of the contract in various lots, different active ingredients should not be included in the same group because therapeutic equivalence should not be taken for granted.

La entrada Equivalencia terapéutica – Marco legal aparece primero en Faus Moliner.