NewsEditorial notes

Häusermann (Assogenerici): “Grateful to the pharmacists for spreading the culture of generics”. Ed

The generic drug industry recognizes a great deal of merit to pharmacies, namely that of having 'educated' citizens in recent years to make informed purchases. This is an example of a real service pharmacy. “As manufacturers of equivalents – he explained Enrique Häusermann, President of Assogenerici, in column 'Federfarma's coffee' – we have never hidden the relationship of trust that binds us to pharmacies, because thanks to them generic medicines have had the opportunity to make themselves known and appreciated by patients.

We believe that by now trust in the role of the pharmacist can only be confirmed and increased, not only on our part but on the whole of the National Health Service. The evolution of the therapeutic offer, the wide availability of drugs, the growing attention to the therapy of chronicity - adds Häusermann - place the figure of the pharmacist at the center of Clinical Governance.

For example, the pharmacist has a fundamental role in terms of therapeutic adherence, not only because the pharmacy is present throughout the country but also, and above all, due to the particular relationship of trust that the professional establishes day after day with the patients" . Hand in hand with the discussion on generics, goes that of biosimilar drugs and their possible sale in pharmacies.

"I don't see why it should a priori prohibit certain categories of drugs from also being distributed in pharmacies - the President of Assogenerici points out - It is difficult to predict whether in the future there will be a larger number of biosimilar drugs in pharmacies, it will certainly depend a lot on the type of environment of prescription and administration”.

But it is on the recent pre-agreement for autonomy signed by the Gentiloni government with Veneto, Emilia Romagna and Lombardy, and which will be completed in the next legislature, that Häusermann makes further clarifications. Specifically, with regard to the chapter which refers to the Regions, subject to the consent of Aifa, the right to adopt decisions based on the therapeutic equivalence between medicines with different active ingredients.

“The therapeutic equivalence between active ingredients – he explains – is an extremely delicate matter, since it remains essential, in our opinion, that scientific criteria guide choices in this field and not economic ones. There are therapeutic areas where simplifications in matters of therapeutic equivalence risk taking care tools away from healthcare professionals and therefore from patients. We believe that the centrality of the Medicines Agency in this field must be safeguarded in every way. We cannot imagine that these assessments are left to the individual regions ”.

Federfarma – 03/14/2018

Related news: Assogenerics. "Pure" generics absorb 21.5% in units and 12.4% in pharmacy channel values


NotePharmacy margins, on medicines that can be paid for by the NHS, are fixed (law n. 662/96, amended by law n. 122/2010) in the gross amount of 30.35% (the theoretical amount due is reduced by the discount divided by price ranges that the pharmacies themselves are required to compulsorily grant to the NHS, the margin of pharmacies is regressive, i.e. it decreases in percentage as the price of the drug increases).

On generic drugs, a share equal to 8% of the industry margin is redistributed between wholesalers and pharmacies according to market rules.

With effect from 1 January 2005, the discount due by pharmacies to the NHS no longer applies to "specialties or generics that have a price corresponding to the reimbursement price" or reference price (Law No. 326 of 24 November 2003). The change aspired to create greater incentives for the marketing of cheaper equivalent products among off-patents.

However, it happened that the higher revenues obtainable from the pharmacy thanks to the removal of the obligatory discount due to the NHS proved to be lower than the higher revenues obtainable through the extra discounts granted by the manufacturer, and in some cases also by the wholesaler, to the pharmacy on equivalent products and more expensive

In the price range in which the sales of level "A" products are concentrated, there remained the convenience of marketing the most expensive off-patent product (presumably an off-patent originator or one of its old licensees), due to the fact that in this case more total resources are available for their division between the manufacturer, the wholesaler and the pharmacy.

However, the practice of some manufacturers of negotiating the recognition from pharmacies of wider revenue margins (extra discounts) than those established by law, as an incentive tool for the marketing of their "A" range products, has been prohibited by law.
A negotiation therefore in fact contrary to the law and through which the producer, for the same consumer price, renounces shares of his own revenue margin in favor of the retail distributor. A similar practice is also established in the relationship between the wholesaler and the pharmacy.

In addition to taking the form of a contra legem, the practice of extra discounts lends itself to amplifying the well-known distorting effect that revenue margins as a percentage of the price generate on the incentives of distribution (especially pharmacies) to channel the more expensive products to consumption, both terms of price per unit of product and in terms of packaging.

The margin provision does not affect i class C medicinespaid for entirely by the citizen. The only regulatory provision applicable to these medicinal products must be found in article 13 of the Royal Decree of 3.3.1927. which provided for the pharmacist's right to a margin of no less than 25% of the retail price.

Basically, the higher revenue margin of the generic is an incentive to sell it.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco