The introduction of prescription by international non-proprietary name is the most important of a number of changes to the pharmaceutical-related provisions in the final spending review passed by the Italian parliament.
IHS Global Insight Perspective | |
Significance | The Italian parliament recently passed the final version of the spending review, within which the most important change to the pharmaceutical-related measures was the introduction of prescription by international non-proprietary name (INN). |
Implications | The government had already attempted to strengthen regulations on generic substitution earlier in the year, but many doctors have opted not to comply with the spirit of these regulations; the introduction of INN prescription is, in some sense, a response to this non-compliance. |
Outlook | This is nothing short of a revolution in the Italian pharmaceutical sector, in which generics continue to be marginal; there are bound to be protests and disputes, although the tough economic situation of the country and wider context of the need to bring down the public-sector deficit is likely to prove decisive. |
INN Prescription Comes Into Law
Prescription by international non-proprietary name (INN) has become law in Italy following the Italian Chamber of Deputies' passing of the final version of the so-called "spending review" on 7 August, including modifications put forward by the Senate. This is the most important change to the healthcare-related amendments to the spending review in its final form, from the point of view of the pharmaceutical industry. The introduction of INN prescription has been met with consternation by the innovative pharmaceutical sector and associations representing Italian doctors, with protests and ongoing disputes a likely prospect.
Patients Already Receiving Treatment Not Affected
Under the new regulations, prescription by INN is introduced for patients treated for the first time for a chronic disease, or being treated for a new episode of a chronic pathology, as explained by the Italian Ministry of Health (MoH) in a press release published on 3 August in response to requests for a clarification of the text of the amendment. The full press release can be accessed, in Italian, here. Thus, for patients with chronic diseases who are already being treated with branded/innovative medicines for which there are generic equivalents, INN prescription does not apply.
Some Leeway Left Open
Doctors retain the possibility prescribing brand-name products, stating on the prescription that it is non-substitutable, although they are required to write a short explanation of why they have decided to do this. Additionally, patients are also at liberty to request that they receive a product with a higher price than the reference price—whether it be a branded originator, branded generic, or other generic—but the patient is then required to pay the difference between the reference price and the higher-priced drug they have opted to buy.
The MoH also states that doctors are at liberty to write the name of a brand-name drug or a generic with a company name on a prescription, as well as the INN, although the pharmacist must, according to the law, dispense the lowest priced drug with this INN, irrespective of the name the doctor may indicate on the prescription.
Industry and Doctors Condemn Introduction of INN Prescription
Massimo Scaccabarozzi, the president of Farmindustria, the association of innovative pharmaceutical companies in Italy, has reacted to the introduction of INN strongly, stating, as reported by Italian newspaper Il Sole 24 Ore, that the spending review already contains significant cuts for the pharmaceutical industry, and that together with the addition of INN, these will be "unsustainable". Italian healthcare news provider Quotidiano Sanita reports the statement of Scaccabarozzi that the prices of medicines in Italy are already "the lowest in Europe", a contention he states is recognised by the European Parliament.
Additionally, the head of the Italian Federation of General Practitioners (FIMMG), Giacomo Milillo, has condemned the move, pointing to the confusion he believes it will cause patients and doctors, while also questioning the efficacy of INN prescribing in ensuring savings to the Italian National Health Service, as reported by Quotidiano Sanita. The source reports that Milillo has called for Health Minister Renato Balduzzi to initiate a roundtable discussion on the subject, while warning of protests following the passing of the spending review.
Introduction of INN Prescription Not Aligned with Electronic Prescription Systems
Quotidiano Sanita reports on the fact that the software systems for electronic prescribing are not yet adapted to the new rules on INN prescribing, but that despite calls for the introduction of INN prescribing to be delayed, there will be no delay, and doctors will be required to fill out prescriptions by hand in the mean time, either partially or fully, depending on what software they have at their disposal. The electronic prescription systems are to be adapted to INN prescribing within the next two months, the source reports, with the MoH, the Italian Medicines Agency, and the ministries of economy and finance involved.
Outlook and Implications
INN prescription is the most significant of the changes introduced by the Senate to the pharmaceutical-related provisions of the original spending review; other aspects of the Senate's amendments were more favourable to the pharmaceutical industry, particularly the lowering of the discount on reimbursed drugs required to be offered by pharmaceutical companies (see Italy: 27 July 2012: Italian Senators Tone Down Pharma Cuts in Spending Review; Final Vote Today).
The introduction of INN prescription—albeit a somewhat restricted version of it—is nothing less than a revolution in public pharmaceutical provision in Italy. Recent months have witnessed an ongoing dispute between the Italian generics sector and the country's doctors, particularly those represented by the FIMMG, with many doctors not complying with the new strengthened regulations on generic substitution that were introduced in the liberalisation law earlier in 2012 (see Italy: 30 May 2012: Attitudes of Doctors Continue to Hamper Development of Generics in Italy As Health Minister Issues Warning). The introduction of INN prescription into law represents a significant ratcheting up of pressure on doctors to adhere to generic prescribing, and shows that this Italian government, in line with its wider goals of reducing Italy's public-sector deficit, is serious about expanding the use of generics in the country.
Generics' use in Italy is very low in comparison with other major EU countries, and the still low proportion of the off-patent market accounted for by generics shows the very real room for increased generics use in the country. Although this is depicted as a negative development for the innovative pharmaceutical industry, in a wider sense, the possibility remains—as has been specified by the Italian MoH—that savings made on the use of generics will help to increase access to innovative medicines, which has also recently been set as a policy goal.
Considering the strong pro-branded culture in Italy and ingrained attitudes of doctors (and, as a consequence, of patients) against generics, however, it can be expected that there will be disputes and protests resulting from the introduction of INN prescription in the coming weeks and months.