The November 4 2002 Decree on the Drug Handbook’s updating process has enforced the new provisions that revolutionize the NHS’ refund criteria of drugs. In fact, after twenty-five years, group B and all its drugs have completely disappeared.
These drugs, which for years had known a series of changes in trend concerning refund terms, have been divided between Groups ‘A’ (completely refunded by the NHS) and ‘C’ (entirely charged to the patient). Group B comprised a series of drugs, which were not considered essential and had been subject to various forms of prescription charges - first 50% of the drug’s price was charged unconditionally to the patient, then a maximum limit was set and recently the prescription charge was removed. This was decided towards the end of the former legislature. At this stage drugs were entirely charged to the NHS, except at a regional level and only in certain Regions, which presented a marked disproportion in conditions, where the prescription charge was re-established. In practice, with the current system we should not speak of drug groups anymore, but only of refundable or non-refundable drugs - group ‘A’ is totally charged to the NHS and group ‘C’ is totally charged to patients. But the Central Commission of Medicine’s intervention does not limit itself to re-assessing these drug groups, since the new Drug Handbook introduces a structural change in the drug classification and refunding process. This change has been proudly opposed by the Pharmaceutical Industry. The general logic the CCM and the Ministry of Health have followed consists in: 1. ensuring the widest possible coverage of all clinically and epidemiologically relevant pathologies; 2. guaranteeing doctors a possible choice among the various active principles; and, 3. defining a refund value that can help economize by exploiting the considerable variability of price between drugs of comparable effectiveness and tolerability. The first objective undoubtedly achieved by the new Drug Handbook could be the removal, together with group ‘B’ drugs, of the disproportion that had risen in certain Regions. The latter, not knowing how to reconcile the NHS’ budget, had reintroduced a prescription charge limited only to this drug group. It is obvious that as this re-assessment has not solved their problem, having instead worsened it, the very Regions could extend the prescription charge also to the entire group ‘A’ drugs, further increasing the disproportion. Another objective the CCM means to achieve by reviewing the costs is to free the refund price of Italian drugs from having to adjust to the Average European Price (AEP). Unfortunately the European Community has only its name in common, as every state has its laws and, despite the common currency, prices differ and comply with the many different legislative decisions concerning drugs and all other consumer goods. Suffice to think that Fiat Uno, paid always in Euros, has prices that range from 9% more to 20% less, depending on the country of purchase. But the former Drug Handbook comprised more or less identical drugs, even though the cost of one could clearly exceed the other, as long as their cost was adjusted to the Average European Price. Naturally there are European states, such as England, where prices are free and even bound to the sterling and the Government negotiates and establishes company profits through a control mechanism that precedes the entire refund system. There are also states like Germany where prices are free but refund prices are established for the various Länder’s KrankenKassen. Hence the distortion in the average price, which the very Italian system also contributed to inflate. Naturally, the Drug Handbook’s new classification, with the cost-effective criterion, has caused havoc in Pharmaceutical Firms that, through the Pharmaceutical Industry, try to express their worry for the future of the very Italian Pharmaceutical Industry. The latter is already greatly penalized by the legislation that authorizes the marketing of the so-called general drugs, products with an expired patent. The Pharmaceutical Industry especially complains that, in the sphere of the NHS’ expenditure, which we wish to contain, no other sector has felt the impact of such drastic restraining measures in the past year. On the other hand, the Pharmaceutical Industry also complains about the questionable comparisons between the cost-effectiveness of active principles belonging to the same therapeutic category. These comparisons have been made “presuming” equality and considering average daily dosages etc., notwithstanding the fact that, globally, the prices the NHS can refund are 9.76% below the European average (4.55 if we consider only the prices of drugs that are still under patent rights), though, rightly, the price reduction was targeted at individual drugs that exceeded all limits and not on the entire sector. The pharmaceutical sector’s cut in profits could thus have repercussions on investments in productive and research areas, and even on the survival of certain firms operating in this field. Hence the Pharmaceutical Industry hopes for a new atmosphere in relations between public institutions and companies, to draw a reference picture that can lead to productive development in the pharmaceutical industry.