Decree Law n. 23, 17 February 1998 “on urgent provisions as for clinical trials in the oncological field and other regulations pertaining health care”  

THE PRESIDENT OF THE REPUBLIC  
In accordance with articles 77 and 87 of the Constitution;  
In accordance with the extraordinary need and urgency to issue provisions to exceptionally regulate the clinical trial of the Method of Professor Di Bella and the use of drugs for unauthorised therapeutic indications, to cope with an extraordinary  situation currently taking place in Italy following physicians' frequent resorting to drugs authorised with different therapeutic indications to treat oncological pathologies and the consequent claim of the involved people to obtain the free distribution of the prescribed drugs through jurisdictional means;  
In accordance with the deliberation of the Council of Ministers and of the Ministry of Health, along with the Ministry of the Treasury, of the Budget and Economic Planning;  

ISSUES  
the following decree law: 

Article 1.  
(Special discipline of the MDB's clinical trial)  

 1.The Minister of Health develops a coordinated programme of clinical trials, also notwithstanding the provisions in force, with the regions and the autonomous provinces in order to examine the oncological activity of the drugs used according to the Di Bella method (MDB) as defined in documents undersigned and filed at the Ministry of Health. 
 2.The trials mentioned in section 1 are carried out on patients who gave their written and informed approval according to protocols approved by the National Oncological Commission, after consulting the Drugs Single Commission, in scientific and oncological institutes, hospitals and university institutes chosen by the regions and the autonomous provinces upon the Ministry of Health's request and considered suitable for such trials by the National Oncological Commission. A national ethical committee established ad hoc with a Minister of Health's decree is to give its opinion on the protocols.  
 3.The Health Institute's task is to co-ordinate the centres carrying out the trials, the supplying, the control and the distribution of the drugs as well as the establishment of a public information centre. Florence's Military Pharmaceutical and Chemical Institute prepares the drugs of the MDB whose formulation is different from that included in drugs regularly to be found on the market.  
 4.The Minister of Health examines the drug-producing companies' free supplying of the drugs to be used in the trials as laid down in section 1 and nevertheless takes measures to limit the costs for the drugs' supplying and distribution to the centres carrying out the trial.  
 5.The drugs to be used for the clinical trials as laid down in this article both considered individually and as a whole are not submitted to the controls as laid down in article 1, section 1, letter c) of the Presidential Decree dated 21 September 1994, n. 754.  
 6.The charges of the supply, the distribution of the drugs and of the activities carried out by the Central Health Administration, including those to be carried out by the Health Institute, are paid by the Ministry of Health and the overall amount must not exceed 10 billion lira for the year 1998. Further charges necessary for the trials, including those for the insurance coverage of the patients undergoing the experimental treatment, are paid by scientific institutes and other facilities in which the trials are carried out respectively affecting the financing set aside by the Ministry of Health in accordance with article 12, section 12, letter a), n. 3), of the law decree dated 30 December 1992, n. 502 and following changes, and the ordinary allocations of the National Health Fund.  
 7.The charges as reported in the first sentence of section 6, equal to 10 billion lira for the year 1998, are covered by reducing the appropriation set by the reserve unit of the Ministry of the Treasury, of the Budget and Economic Planning for the same year.  
 8.The measures and the documents to be used for the MDB's clinical trial, before the date of the present decree's enforcement, are valid and operative provided they comply with the discipline of the present article.  
 9.The results obtained by the trials carried out in compliance with what the present article lays down are submitted to the Drugs Single Commission to determine competence in accordance with article 1, section 4 of the decree law dated 21 October 1996, n. 536, turned by the 1996 law n. 648.  

 Article 2  
(Confirmation of competence of the Drugs Single Commission as laid down by article 1, section 4, of the decree law of 21 October 1996, n. 536, turned by the law of 23 December 1996, n. 648)  

 1.The carrying out of the trials as laid down in article 1 does not account for the acknowledgement of the use of the drugs due to what is stated in article 1, section 4, of the decree law of 21 October 1996, n. 536, turned by the law of 23 December 1996, n. 648. Thus, the Drugs Single Commission continues to be responsible for determining, according to the technical criteria adopted by the same, whether the requirements to enforce the discipline laid down by the above-mentioned provision of the law exist. However, the drugs still lacking the results of the second phase of the clinical analyses must not, for any reason, be included in the list laid down by article 1, section 4, of the above-mentioned 1996 decree law n. 536.  

 Article 3  
(Observance of authorised therapeutic indications)  

 1.With the exception of the provisions of sections 2 and 3, when prescribing a medical preparation or other industrially-produced drugs, physicians must follow the therapeutic instructions, the ways and methods of administration laid down by the authorisation for market introduction issued by the Ministry of Health.  
 2.Physicians can, in some specific cases, on their own responsibility and provided that the patient was informed and gave his approval, use a drug which was produced industrially for an indication or an administration way or method or use different from the authorised one and recognised by the enforcement of article 1, section 4, of the decree law of 21 October 1996, n. 536, turned by the law of 23 December 1996, n. 648. They can do so if they have the objective elements to prove that the patient cannot be treated with drugs whose therapeutic indication or administration way or method have already been approved. Such use, furthermore, must comply with guidelines or studies published in scientific magazines having international credit.  
 3.The exception consists in the case in which physicians, on their direct responsibility and only in the oncological field, used or uses, until the end of the trial as laid down in article 1, octreotide and somatostatin-based drugs beyond the approved therapeutic indications, if objective elements induce or induced physicians to believe that the patient cannot be positively treated with drugs already been authorised for a specific pathology, provided that the patients give their written approval stating that no scientific results proving the drugs' effectiveness exist yet.  
 4.If physicians resort to the options laid down in sections 2 and 3, the right of the patient to receive the drugs by the National Health Care System apart from the hypothesis laid down in article 1, section 4, of the decree law of 21 October 1996, n. 536, turned by the law of 23 December 1996, n. 648 will not for any reasons be acknowledged.  
 5.The physicians' infringement of the present article's provisions is an offence of regulations and will be prosecuted according to the legislative decree of the provisional head of state dated 13 September 1946, n. 233. In case of infringement of the section 3 provisions, the minimal sanction is the suspension of the professional activity practice.  

 Article 4  
(Supplying of drugs belonging to the MDB to people)  

 1.To ease the treatment of the patients in the exceptional hypothesis laid down in section 3 of article 3, the Minister of Health fixes the selling price of the drugs, or without prejudice to the patent protection, of generic drugs containing somatostatin or octreotide, to the national health care system. The selling price will be agreed with pharmaceutical companies authorised to put the drugs on the market or with other associations belonging to them.  
 2.The agreed price, notwithstanding the current provisions, is also the public selling price of the drugs containing somatostatin and octreotide prescribed by physicians in accordance with article 3, section 3.  
 3.According to the agreements between the Minister of Health and the associations of the public and private pharmacies, pharmacies give the drugs included in section 2 to the clients on behalf of the Local Health Care Units, and receive no remuneration or reimbursement for their professional activity.  
The medical prescription to be kept by the pharmacist is required and must report the following note: “Prescription made in accordance with article 3, section 3, of the decree law of 17 February 1998, n 23” written by the physician. The clients' cost for these prices is laid down in section 2 and the money is collected by the pharmacies on behalf of the Local Health Care Units.  
 4.Pharmacists must send the Ministry of Health a copy of the prescription of the drugs containing somatostatin or octreotide every fifteen days in accordance with section 3.  
 5.The infringement of this article's provisions on the part of pharmacists is offence of the regulations to be prosecuted according to the legislative decree of the provisional head of state dated 13 September 1946, n. 233.  

 Article 5  
(Prescription of magistral preparations)  

 1.In accordance with the provisions of section 2, physicians can prescribe magistral preparations containing only active principles included in the pharmacopoeias of the European Union countries or that are part of industrially-produced drugs authorised to be sold in Italy or in another countries of the European Union.  
 2.Physicians are allowed to prescribe magistral preparations containing active principles already included in drugs whose authorisation to be marketed was revoked or not confirmed for reasons not concerning the risks to use the active principle.  
 3.The physicians' prescriptions must report the exceptional needs that justify the extemporaneous prescription as well as  the patient's approval.  
 4.The pharmacist must send every month the prescription as in section 3, both the original and the copy, to the local health care unit or hospital that, in turn, send them to the Ministry of Health to be controlled also in case article 25, section 8, of the legislative decree of 29 May 1991, n. 178, is enforced.  
 5.The provisions in sections 3 or 4 are not to be considered when the drug is prescribed for therapeutic indications corresponding to those of the industrial drugs authorised having the same active principle.  
 6.The infringement of the present article's provisions on the part of physicians and pharmacists is offence of regulations to be prosecuted according to the legislative decree of the provisional head of state dated 13 September 1946, n. 233.  

Article 6  
 (Enforcement)  
1.The present decree comes into force.