March 29, Italian Health Minister officially approves personal importation (by individuals for their own use) of generic drugs when the version licensed in Italy is inaccessible to that individual due to price. Italian health service insurance covers hepatitis C medications for many; this directive affects those who either do not meet current treatment criteria, or who are experiencing delays due to lack of clinical treatment capacity, and do not want to wait for treatment – but cannot afford the patent version available in Italy.
Note: It does not offer to reimburse these individuals, just officially permits importation. English (unofficial) translation follows.
Hepatitis C, green light to the purchase of generic drugs abroad
A circular from the Minister Lorenzin allows those that do not correspond to the criteria for obtaining the drug from the Italian health service, or those who do not want to wait to get their treatment, to go and buy the drugs abroad or to order it to be shipped.
Patients who do not meet the criteria set by AIFA to get the hepatitis C drugs, can purchase the generic medicine abroad, provided it is for personal use. This is the decision set in a circular issued by the Minister of Health Beatrice Lorenzin, which has revolutionized the care system for tens of thousands of people and, above all, marks a new direction in the field of care for this infectious disease.
It should be noted that the circular does not specifically talk about hepatitis C and this makes the decision applicable to other medicines if people experience similar situations. The story now is known: to get free medication patients must fit into certain clinical categories. Until now access to care was guaranteed only to the sickest patients, even though recently AIFA has expanded greatly the scope of the criteria up to cover almost all patients. The problem is that in Italy the HCV epidemic is too widespread (some even say between half a million and one million people) for every patient to receive treatment quickly. As a consequence in many might like to receive treatment earlier than the moment they will receive the call of their center of hepatology. They can do this by using the rules of the circular. Moreover, for some time now, many patients have been purchasing the drug abroad, going to buy it in India or, experiencing more difficulties especially from a legal point of view, ordering it via the internet. The circular of the MoH is addressed to these people.
“As it is well known – it is written in the act – no medicinal product may be marketed in Italy without obtaining a license from AIFA or from the EU.” The Ministry introduces two exceptions to the principle: “Medicines placed regularly for sale in foreign countries but not allowed on the market in Italy, shipped from abroad at the request of the doctor,” or “medicines regularly registered in foreign countries, which are taken personally by the traveler at the time of ‘entry into the national territory, provided that they are intended for personal use for a therapeutic treatment not exceeding 30 days. ” The two cases are the ones that are taking place in this period. But if the latter has never been questioned in the sense that the law allows to return from other countries with medicines if there is a prescription in the suitcase, the former is disruptive, because it recognizes the opportunity to buy on the internet, drugs of certified origin. Even in this case a prescription is required and patients have to send a form filled by their doctor to the Ministry.
All this can be done, as explained later in this decision, when there is no a viable therapeutic alternative that is to say when in fact there is an authorized treatment in Italy based on the same active ingredient than what you buy abroad but this one is different in several respects (dosage, packaging, etc.). This expedient can be used especially “when access to drugs available in Italy is not possible for the patient, as s/he does not fit in the criteria set for the treatment by the NHS or because of its cost”. It seems that the circular was written thinking of Sovaldi, the first drug marketed by Gilead and purchased by the Italian State only for certain categories of HCV patients. This is why so many patients have tried to be treated abroad and some have also seen a court upholding their right to have the drug shipped. Now that the access criteria have been expanded, thanks to the use of other similar drugs, and thanks to the deal that AIFA is negotiating, fewer people will be excluded by the government HCV program. But still there will be tens of thousands of patients that will not have immediate access. They can buy the drug in India or Egypt and maybe even ask the Italian local health authorities to obtain a reimbursement for the medicine.
The Minister of Health, Beatrice Lorenzin, said: “In recent weeks we have had many reports concerning drugs, regularly imported by Italian patients for personal use, that were stuck in customs, because, even though they were legally allowed in a foreign country, they were not authorized in Italy. The Dogana blocked these drugs on the basis of a restrictive interpretation of the regulations in force, believing, against the scientific evidence, that the two drugs were identical even if there were differences concerning dosage, excipients, and mode of administration. With my circular this was clarified. But above all it is clear that there cannot be a viable therapeutic alternative for the Italian patient when the drug licensed in Italy is not actually accessible to all, as too expensive, as is the case with drugs against hepatitis C and other innovative medicines. Therefore, we removed a hateful bureaucratic obstacle in the way towards freedom and effectiveness of care. “