Monthly Archives: June 2015

On-line Sale of OTC Medicinal Products

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Effective as of tomorrow (July 1, 2015), Italian consumers will be able to purchase over-the-counter (“OTC”) drugs on-line.

Legislative decree nr. 17 of 2014 (“Decree”), enacting EU Directive 2011/62, introduced an innovative way of marketing medicinal products for pharmacies and authorized retailers. In order to do so, pharmacies and retailers must meet several conditions, aimed at preventing marketing of counterfeit products.

  1. First of all, pharmacies and retailers must be authorized by either regional entities, provinces or other competent authorities, upon providing the following information:
  • name, VAT and full address of the logistic site;
  • starting date of on-line sale;
  • website address and any other information that may be necessary to identify the seller’s website.

Any change must be communicated within 30 days, subject to forfeiture of the authorization.

  1. Secondly, the seller’s website must contain at least:
  • information relating to the authorizing authority;
  • a link to the Ministry of Health’s website;
  • a specific logo, including a link to the list of the authorized pharmacies and retailers, maintained by the Ministry of Health.

Additionally, the Ministry of Health’s website shall contain a link to a website created by the European Medicines Agency, which will include information on the purpose of the specific logo, as well as on the risks relating to medicinal products that are unlawfully supplied to the public. The Ministry of Health’s website will also contain information relating to the applicable laws and regulations, including any information on differences vis-à-vis other countries as to conditions regulating the supply of medicinal products.

  1. Lastly, distribution shall be carried out in compliance with good distribution practices.

The Italian Agency for Pharmaceutical Products (Agenzia Italiana del Farmaco, “AIFA”) will be in charge of enforcing the new set of rules. AIFA will direct an anti-counterfeiting system in cooperation with the Ministry of Health, the High Institute for Health (Istituto Superiore di Sanità, “ISS”), the Anti-counterfeiting and Health Department of the Police (Nuclei Antisofisticazione e Sanità, “NAS”), and the Customs Authorities. The system will receive reports concerning allegedly counterfeit medicinal products, and AIFA will coordinate seizure of actually counterfeit medicinal products.

Furthermore, the Ministry of Health, upon AIFA’s proposal, will have the power to issue cease and desist orders directed at on-line sellers, as well as orders aiming at blocking the access to websites selling counterfeit medicinal products.

Lastly, on-line sale of prescription drugs will be punished with imprisonment up to one year and a fine between Euro 2,000.00 and Euro 10,000.00, whereas on-line sale of medicinal products by unauthorized individuals or entities will be punished with imprisonment from 6 months to 2 years and a fine between Euro 3,000 and Euro 18,000. On-line sale of counterfeit medicinal products will be instead punished with imprisonment up to 3 years and with a fine between Euro 2,600.00 to Euro 15,600.00.

The measures introduced by the Decree appear balanced. On the one hand they grant an overall wider access to OTC medicinal products along with a presumable price reduction; on the other hand they set forth a solid enforcement system preventing and punishing marketing of counterfeit drugs. As with every innovation in the field of health, only time will tell if benefits and risks are actually balanced.

3D Printing In Healthcare: Regulatory Issues To Consider

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The Democratization of 3d Printing: Joys and Sorrows

A fascinating technology is becoming more and more widespread and may completely change the world of manufacturing as we know it: 3D printing. An object passed through a 3D scanner or a file downloaded through the internet may enable almost anybody to produce an unlimited number of 3D copies.

This is a classic example of an innovative technology that is going through the process of “democratization”: with the price of 3D printers now in the range of tens of thousands of Euros, a manufacturing method, which was once available only to a few, may now be found in every architecture firm, in your garage and… in your hospital.

A beautiful National Geographic title points to the revolutionary aspects of 3D printing: “As epoch-making as Gutenberg’s printing press, 3-D printing is changing the shape of the future.” As in many other “revolutions”, it is difficult to imagine its full potential at its onset. Therefore, 3D printing sparks both enthusiasm and anxiety. Many intellectual property owners have much to fear from the possibility of producing countless unauthorized copies of products looking exactly like theirs. While the music and movie industries already suffered when home taping or file sharing became commonplace, 3D printing may impact nearly all industries. Others point to the risks connected with the complete lack of control over the production of guns or other dangerous objects (with others questioning how serious of a threat this might be).

3D printing is already vastly used in the field of medical practice, and many more uses can be imagined in the future (printing organs for transplants is no longer an entirely futuristic scenario). Recent research on 3D programs deployed in Italian hospitals point to the advantages related to 3D models of patients for pre-surgery planning, for training, as well as for obtaining the patient’s informed consent. None of such uses are likely to trigger legal or regulatory issues, if data protection aspects are correctly handled.

Is 3d Printing a Regulated Activity? Is a 3d Printed Item a Regulated Object?

If, instead, a 3D object is created and used closer to patients, it is possible that a regulated item is obtained (most likely a medical device or an advance therapy medicinal product), or that a regulated activity is carried out, with a host of regulatory consequences. In fact:

3d Printing and Liabilities

Who is responsible if a 3D printed medical object is defective? The process of 3D printing involves a number of potentially responsible individuals, who may be liable, in full or in part. A Court would have to determine what went wrong. Depending on the circumstances, the doctor prescribing the 3D object, the surgeon implanting it, the radiologist choosing the images on which the 3D printing process is based, the manufacturers of the 3D printer or of the materials used, the user of a 3D printer… each of them may be responsible for the defect.

However, this is not a new scenario in medical technology, where product liability is always potentially connected with medical malpractice and where finding out the exact responsibility of each subject can be challenging. Italian law sets forth joint liability of all responsible persons and indicates that the person who paid damages has recourse against the other liable persons on the basis of risks, faults and consequences. If such allocation of liability is not possible, then each person is liable in equal parts.

Conclusions

There is often a general sense that an innovative technology is so new that it happens in a legislative vacuum, because how could the legislator have already foreseen rules specific to 3D printing? We have written about a similar approach in the field of medical apps. Instead, new technologies typically land on a pre-existing landscape of applicable regulations, which should be taken into account by innovators and users of innovation. Regulatory authorities may not be ready to start enforcement actions against 3D printing, but may decide to do so in the future.

 

TO REIMBURSE OR NOT TO REIMBURSE? A recent judgement on scientific evidence and appropriateness of care.

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A judgment by the Italian Supreme Court published on April 10, 2015, determined that an alternative cure must be covered by the Italian National Health Service even in the absence of compelling scientific evidence as to its efficacy.

Health is protected by Italian law as a fundamental right of the individual, as well as a collective interest of the community, and dignity and freedom of the human being must always be respected. These general principles are enshrined in the Italian Constitution (section 32) and in section 1 of Legislative Decree no. 502/1992. Therefore, the right to health is framed as an absolute and fundamental right, a theoretical approach that – given the many restraints affecting patients’ access to care – may appear almost fictional.

Further, Italian legislation sets forth that the National Health Service must offer uniform essential levels of care and assistance, taking into account human dignity, equal access to care, quality and appropriateness of therapy, as well as economic factors. (These latter economic factors often appear most pressing, as patients affected by hepatitis C are currently learning!).

With regard to reimbursement, the Italian National Health Service must cover assistance services which show, for specific clinical or risk conditions, scientific evidence of a significant health benefit, from an individual and collective standpoint, compared to the resources employed. Such concept is often called “appropriateness” and is something with which doctors, hospitals, patients and authorities struggle daily. Nobody will deny that all the above mentioned factors are of primary importance, but balancing them can be difficult in practice.

The recent decision by the Italian Supreme Court (Corte di Cassazione, judgement no. 7279 of 2015) determined that a quadriplegic patient was entitled to free access to a non conventional therapy (so called “DIKUL” therapy), even in the absence of compelling scientific evidence as to its efficacy, when it was proven that the patient benefited from it through a sworn appraisal of a Court appointed expert. The Court pointed out that, while no compelling scientific evidence was offered, the efficacy of the therapy was in doubt, but not openly proven as not efficacious.

In its reasoning, the Court reiterated the higher hierarchy of the constitutional right to health over the discretional administrative decision of the hospital to administer a certain therapy. Further, the Court emphasized that the efficacy principle set forth in Italian law may be based on actual benefits to the patient brought by the DIKUL therapy: the mere absence of available scientific evidence in favor of the DIKUL therapy was not sufficient to deny its access to the patient. Only if there had been scientific evidence proving that the DIKUL therapy was inefficacious, then its reimbursement could have been denied.

We have already commented on the infamous Stamina case in this blog, a case where the well intentioned desire of Courts and Parliament to help otherwise helpless patients prompted the recourse to a therapy which completely lacked any scientific basis and breached many legal provisions actually aimed at protecting patients (e.g., GMP manufacturing requirements, informed consent of patients).

The recent Supreme Court decision confirms the sometimes difficult relationship between scientific evidence and access to a certain therapy, particularly in cases of patients affected by diseases for which there are limited therapy options.