The backlash against the implementation of a limited form of International Non-proprietary Name prescription in Italy has intensified, with the innovative pharmaceutical sector and doctors making strong statements against its implementation.
IHS Global Insight Perspective | |
Significance | The association of innovative pharmaceutical companies in Italy, Farmindustria, and groups representing general practitioners, have released strongly-worded statements against the recently implemented, limited version of prescription by International Non-proprietary Name (INN) in Italy, intensifying the dispute around this new regulation. |
Implications | The fact that INN prescription has been introduced, together with a wave of other restrictive regulations for the innovative pharmaceutical industry, seems to be exacerbating the negative response to it. |
Outlook | This is likely to only be the beginning of the dispute; in a country such as Italy, where generics are viewed with suspicion and have never really established themselves on the market, it is likely that branded manufacturers will continue to muster all their efforts behind preventing generics gaining a greater market share, even though greater use of generics could ultimately benefit them, through savings being used to pay for higher quantities of innovative medicines. |
INN Backlash Heats Up
The backlash against the introduction of a limited form of prescription by International Non-proprietary Name (INN) in August, as part of the Italian government's so-called "spending review", has intensified (see Italy: 20 August 2012: INN Prescription War Begins in Earnest in Italy Following Introduction Into Law). INN prescription has resulted in a reduction of the sales of branded medicines of 15% year-on-year (y/y) according to Massimo Scaccabarozzi, the president of the association of innovative pharmaceutical companies in Italy, Farmindustria, quoting figures from IMS Health, as reported by Italian news agency ANSA. Scaccabarozzi added that in the case of some companies, sales have fallen by 30%, and even 50%, in the first couple of weeks of September. Also, Scaccabarozzi is reported as saying that there will be a social cost of the continuation of the policy, referring to its impact on the domestic pharmaceutical industry and stating that the law does not allow innovative producers to compete.
Scaccabarozzi is reported by Italian newspaper Il Sole 24 Ore as having sent a letter to the Italian prime minister, Mario Monti, which has been signed by the trade unions representing workers employed in the pharmaceutical sector in Italy, to express their concern over the consequences of the implementation of INN prescription. He is reported as saying that, on the basis of initial estimates, as many as 10,000 workers in an industry that employs 65,000 may be threatened with redundancy, with factories closing and investment moving out of Italy. Il Sole 24 Ore reported Scaccabarozzi as saying that the regulations would cause all these problems, while not delivering any savings to the Italian National Health Service (SSN).
Generics Association Questions Figures
In response to Scaccabarozzi's statements, Giorgio Foresti, the head of the Italian association of generics producers, Assogenerici, stated that the figures quoted by the head of Farmindustria were a product of his imagination, ANSA reported. Foresti is quoted as saying that rather than the sales of branded medicines falling 15% y/y, in August 2012 their sales fell by 5.8% y/y, although this was merely in line with the normal competitive forces. He is also reported as saying that he believed that the concerns expressed by Scaccabarozzi, concerning the loss of jobs and closure of factories, were also unfounded, while he also contested the argument that INN prescription would not result in any savings for the SSN.
Doctors Continue Strong Opposition to INN Prescription
Doctors are also making their contribution to the debate. The regional branch of the Italian Federation of General Practitioners (FIMMG) in Lazio has called for "urgent measures" to protect doctors and patients in connection with the introduction of INN prescription, reported news agency ADN Kronos. Lazio's FIMMG has pointed to the recent decision by the Italian Medicines Agency (AIFA) to limit the substitutability of two epilepsy drugs—the UCB Pharma (Belgium) drug Keppra (levetiracetam) and Johnson & Johnson (J&J; United States) drug Topamax (topiramate)—calling for doctors to write on prescriptions for these drugs "do not substitute", due to concerns about efficacy. FIMMG Lazio goes on to question the entire basis of the INN prescription regulation, and questions the veracity of the media campaign that preceded it, which argued that generics were as effective as originators.
The Italian Society of GPs (SIMG) is quoted by Italian healthcare news provider Quotidiano Sanita as saying—in its own recent statement on INN prescribing—that every prescription needed to be weighted individually and that there needed to be clearer rules. The SIMG's president Claudio Cricelli is reported as saying that for the tens of millions of Italians with chronic diseases, the prescriptions are unchanged since the introduction of INN prescribing, as the regulations state that INN prescribing only applies to newly diagnosed chronic diseases. The SIMG also recommend that doctors do not substitute in the case of medicines with a narrow therapeutic index, such as in the case of immunosuppressants and anti-epileptics, antiarrythmics, and tricyclic antidepressants, among others. It added that it would be publishing a dossier clarifying which medicines fell into the category of narrow therapeutic index.
In this context, the Italian Ministry of Health has recently published detailed guidelines on how doctors and pharmacists should implement the INN prescription regulations, leaving no room for confusion as to what is expected of them.
Outlook and Implications
The reaction of Farmindustria is in line with its reactions to other restrictive policies and regulations imposed by the Italian authorities; although considering the sheer number of new regulations and cuts that have been imposed on the pharmaceutical industry this year, and particularly with the implementation so soon after the spending review of the "mini reform" of the public health sector (including new restrictive regulations for the pharmaceutical industry), it is understandable (see Italy: 13 September 2012: Final Version of Italian Healthcare Reform Revealed; Talks on INN Prescription Begin As Branded Drug Sales Drop 10%). However, the decision by the Italian authorities to make INN prescription apply only to patients who are newly diagnosed with chronic diseases—as well as new episodes of non-chronic diseases—means that its financial impact is unlikely to be as great as estimated by Scaccabarozzi.
While there are undoubtedly examples of generics not showing the same efficacy as originators, these are the exceptions, and the level of opposition to the limited form of INN prescription that has been introduced in Italy is disproportionate. The Italian authorities had tried to strengthen the regulations on generic substitution in pharmacies in its so-called "liberalisation law" (also known as the "Save Italy" law) in March, but doctors did not accede to their wishes, and the use of generics actually declined after this law was introduced. Thus, the government's response was that in the economic circumstances in which Italy found itself, and INN prescription, even in a limited form, something radical had to be done. Considering the fact that even the main European organisation representing innovative pharmaceutical companies, the European Federation of Pharmaceutical Associations and Industries (EFPIA), is in favour of wider use of generics in those markets—such as Italy, where generics use is so much less widespread than in, for example, the United Kingdom and Germany—because of the savings that it can generate for healthcare systems in these countries, it is difficult to understand the intensity of Farmindustria's opposition—indeed, Farmindustria is an associate member of the EFPIA.