The editorial published in the issue of the Information Bulletin on drugs now in distribution marks an important change in communication on the generic. Or more precisely in the communication of its role in national pharmaceutical policy, which up to now has been played only on the price aspect. A logical approach but which, due to the way it was implemented, has obscured the other aspects, also causing a counterproductive effect. It is no secret that a higher cost is often associated with a higher value: if it costs more, there will be a reason. And so the editorial of the BIF goes on the attack, pointing out that the producers of specialty medicines spend on marketing, on average, twice as much as they devote to research, and in some cases promotional expenses absorb up to 46% of the entire company budget (estimates provided by the Study Center of the Italian Medicines Agency).
Therefore, this is the new message from AIFA, to a large extent it is here that "the savings given by the medicine with an expired patent must be sought and not on its quality". And AIFA also concedes that "equivalent medicines have probably been talked about too often starting from this point: savings. This has created a lot of distrust, even among healthcare professionals. From the requests for information we receive, it is clear that the prescriber or pharmacist has been led to think that the choice of the Healthcare Service to rely on the equivalent medicine is based above all on cash reasons, perhaps neglecting the quality element". Although it is understandable to register distrust and skepticism, not always disinterested, this economy not only produces savings - AIFA reiterates - but also the possibility of buying innovative medicines without giving up effective and safe therapies by now consolidated. It is not the only aspect mentioned and, in fact, other considerations are also reported which the sector operators often had, so to speak, on the tip of their tongue but which rarely entered into "serious" discussions. For example, generic and brand companies often have the same suppliers for raw materials which, in any case, "are certified with identical procedures for both equivalent medicines and those covered by patents" and the same is true for production processes. In short, "it is important to understand that no medicine is exactly identical to the other, therefore it is necessary to refer to rigorous standards that guarantee that any variability remains within the different individual response to the medicine. This is a problem that those who produce medicines face regardless of the patent coverage of the molecule".
All of this, of course, leads to the main issue, which is substitutability. AIFA agrees that "without prejudice to the bioequivalence of patent medicines with those that have lost their exclusivity, there may be medical reasons why the prescriber prefers to continue the treatment with a particular specialty: the inability to manage different packaging, the individual patient's response, and other considerations, may count as an exception to the general rule. This of course can happen both with equivalent medicines and with the originators and cannot call into question the procedures for verifying the quality of the medicine which are, in fact, the same". In short, it is admitted that all the discussions made so far on the role of excipients, to name one, have a foundation. So, the whole generic issue has its rational framework, but yes
