By Ministerial Circular of 23 March 2017, the Ministry of Health clarified the conditions under which unauthorised medicinal products may be purchased abroad within the procedure laid down by the Ministerial Decree of 11 February 1997.
1. Importation of medicinal products under exceptional circumstances and at patients’ expense
The Ministerial Decree of 11 February 1997 (“Decree”) provides for the procedure that must be followed for the importation of medicinal products that are properly authorised abroad, but not in Italy, shipped into Italy upon the request of the treating physician. The medicinal product, although requested by the physician, must be paid for by the patient. The Decree does not constitute an exception to the general rule that medicinal products may be placed on the Italian market only once they are authorized. Indeed, according to Article 2 (1-bis) of the Decree, the importation must be “justified on objective and exceptional grounds”. The procedure is intended to monitor the importation, which is subject to clearance from the competent health unit of Italian customs (USMAF). If the importation of a medicinal product appears to be “excessive” compared with the trend observed in the past, the USMAF must request additional clarifications as to the “medical and epidemiological rationale” that justifies the importation. Such regulation has been confirmed by Article 158 (6) of the Legislative Decree No 219 of 24 April 2006 (Italian Pharma Code) and may be regarded as Italian law. The objective and exceptional grounds boil down to the lack of a valid and approved therapeutic alternative in Italy and the certified indispensability of the medicinal product, authorised abroad, to treat a named patient.
2. The lack of therapeutic alternatives
While the Ministerial Circular of 23 March 2017 is intended to provide an interpretation of the existing law, it may, in fact, bring about a material change.
According to the Ministry of Health the lack of a valid therapeutic alternative “may be acknowledged also when:
a) regardless of whether a similar regularly approved medicinal product is available on the market, the medicinal product to be imported presents a different dosage, route of administration, excipients or formulation of active ingredients;
b) the patient does not have access to the medicinal product available in Italy, as he/she does not meet the eligibility criteria for the supply of the medicinal product at the expense of the National Health System, or because it is overly expensive”.
The first exception relies on the assumption that any difference in the dosage, route of administration, excipients or active compounds always amounts to a distinct clinical benefit, whilst this may be not always the case. Hence, whether an unmet clinical need may justify the importation, should be evaluated on a case by case basis.
The second exception may be actually of concern since it appears to be based exclusively on economic grounds. It may be worth noting that the National Health Service was established in 1978 for the purpose of providing the general public with full healthcare coverage, which is usually free of charge in case of serious and life threatening diseases. The lack of eligibility for the supply, free of charge, of a medicinal product should therefore be decided on exclusively clinical grounds (i.e. the medicinal product is not indispensable). To be sure, budgetary limits must be taken into account. However, allowing the patients to buy at their own expense in low cost jurisdictions generic copies of innovative medicinal products does not appear to be an answer.
While the exception should apply on a named-patient basis, there is a risk that expensive medicinal products may not be approved in Italy, prices undergo further deflationary pressure that approval is delayed, or that products may not be purchased by hospitals operating under budgetary constraints, relying on the assumption that patients may eventually buy them in low cost jurisdictions. Rumour has it that the provision has been introduced for the benefit of patients, who are not eligible for the treatment with the new (and expensive) anti-HCV medicinal products and would thus be allowed to purchase such products in low cost jurisdictions. Of course, this pattern may apply to several expensive medicinal products. While the move may superficially appear to benefit patients, it may actually open the door to large scale distribution of non-approved and low cost medicinal products in Italy. As we learned from our experience with counterfeited goods, single purchases may snowball even and eventually lead to a parallel commercialisation of unauthorised medicinal products. In addition, when it comes to rare or relatively rare diseases, single purchases matter.
A similar regulation was introduced by amending Law No 648 of 23 December 1998, providing for early access. In that case, early access was extended to the supply of unauthorised medicinal products (or their off-label use) also where there is an approved therapeutic alternative but the off-label use is justified on economic grounds. The Italian Supreme Administrative Court has submitted a request for preliminary ruling by the European Court of Justice, on the ground that such provision may be inconsistent with EU law.