Amendment to Italian Liberalisation Law Restores "Equality" to Branded Drugs and Generics

Amendment on Liberalisation Close to Final Approval

An agreement has been reached by the Italian Chamber of Deputies on the measures in the wider liberalisation law relating to pharmacies and pharmaceutical care, which is set to bring in changes to the proposals announced previously. The amendment is due to come before the Senate, with a vote to be held on 2 March.

Innovative Pharma Content with Changes

Massimo Scaccabarozzi, the president of Farmindustria (the association of innovative pharmaceutical producers in Italy), is reported by Italian news agency AGI as saying that the new version of the amendment is an improvement on the previous one, as it does not discriminate against branded products. As the source reports, this is in line with the views of Minister of Health Renato Balduzzi. Scaccabarozzi is reported as saying that that the new amendment "restores dignity" to branded medicines, and preserves the prescribing freedom of doctors.

Under the amendment, in point 12 of article 11 (the article of the liberalisation law relating to pharmacies and pharmaceutical policy), it is stated that a doctor prescribing a medicine is obliged to inform patients of the presence on the market of medicines with the same active ingredient, form and route of administration, mode of action, and dosage unit. The pharmacist must substitute the proprietary medicine prescribed with the lowest priced equivalent (generic or originator), unless the doctor has expressly indicated that the drug prescribed is non-substitutable, or unless otherwise requested by the patient. The dispensing of medicines more expensive than the reimbursement price of those prescribed can only happen at the request of the patient.

Changes to Packaging Regulations Envisaged

Additionally, the amendment foresees that the Italian Medicines Agency (AIFA) will formulate a resolution by 31 December that will overhaul the present regulations on packaging, with the aim of rationalising the distribution system of pharmaceuticals and boosting the efficiency of public pharmaceutical spending. This will include even the possibility of single-drug packages. Doctors will be required to consider different types of packages as part of the changes.

Better for Parapharmacies

Italian news provider Oggi reports that parapharmacies participating in competitions for the opening of new pharmacies, which are due to be held within a year, will have additional points in the final ranking. The same source also reports that parapharmacies will be able to sell medicines classified under category "C" (non-reimbursed prescription medicines) that are chosen by AIFA as eligible for sale by parapharmacies in all locations, and not only in towns with less than 12,500 inhabitants as previously intended. Parapharmacies will also be able to sell veterinary products—including those on prescription—and galenical products.

The following are among the most important changes introduced in the amendment that also relate to pharmacies and parapharmacies:

• It is envisaged that instead of one pharmacy per 3,000 inhabitants, the maximum will be one pharmacy per 3,300 inhabitants, compared with the present level of one pharmacy for every 5,000.
• Pharmacies may remain open at times other than those mandated.
• Pharmacies may offer discounts on all products sold directly to customers, as long as they are provided with adequate information.
• Rules on the "extraordinary" competitions for the opening of new pharmacies are given, with non-pharmacists able to compete with qualified pharmacists.

Contrasting Responses

In response, head of Federfarma (the Italian association of independent pharmacists) Annarosa Racca is reported by Italian healthcare news provider Quotidiano Sanita as saying that the amendment is "short-sighted" and that qualified pharmacists will have little chance of winning the competitions. Racca is reported as saying that the amendment views pharmacies as "purely commercial operations", rather than essential elements of the public healthcare system.

In contrast, representatives of the Italian parapharmacy industry are understandably pleased with the amendments, which give them a substantially stronger position than under the previous draft.

Outlook and Implications

It appears Italian lawmakers are swinging from favouring one interest group to favouring the other; the previous draft was strongly opposed by owners of parapharmacies, while pharmacists were broadly supportive, but this has now been reversed. Although the amendment is likely to be approved and implemented, there is unlikely to be a pause in the vocal opposition from the various pharmacy associations in the country.

AIFA is due to compile a list of class C medicines that it will be possible for parapharmacies to sell; the authorities hope that allowing parapharmacies to sell these products will bring their prices down, thereby benefiting the economy, as Italians will be able to spend more elsewhere, while also boosting this sector of the economy. The opposition from pharmacies is understandable, as this will mean that their exclusive ability to dispense a certain range of products—likely to include drugs such as blockbuster erectile dysfunction drug Viagra (sildenafil; Pfizer, US)—will be lost, and they will have to compete with parapharmacies in the sale of these drugs. When the sale of over-the-counter medicines was liberalised several years ago, the consequence was a dramatic reduction in price; it is hoped that the same will occur this time.

As far as the regulations on pharmacy substitution are concerned, the fact that the head of Farmindustria is pleased with the changes indicates that they are less directly favourable to generics producers. Even in the previous version, however, the word "generics" had not been expressly used, rather the word "equivalents" was used, which applies to both originators and generics; the text of the amendment is more conciliatory towards the innovative industry though. The big test of these regulations will be in their enforcement, and the systems that are put into place to ensure this. Although electronic prescription is being introduced in Italy, it is still some way off a national rollout, and it is not clear how doctors/pharmacists will be incentivised to prescribe and dispense lower priced products.