All posts by Alessandro Di Carlo

Electronic medical records and patients: a love and hate relationship.

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What’s the status of e-health in Italy?

A fairly reliable benchmark may be represented by the implementation of the Electronic Medical File (Fascicolo Sanitario Elettronico) (“EMF”). The EMF was first introduced by Law Decree nr. 179 of 2012, as converted into law no. 221 of 2012; it was then implemented by way of Ministerial Decree dated September 3, 2015. The purpose of the EMF is to provide a tool to patients and healthcare professionals by collecting and providing web access to health-related data like hospitalizations, medical checks, drug administration, home assistance, and access to emergency rooms. In other words, the EMF promises to make all data relating to patients’ health readily available and accessible from any place in the world at an unparalleled speed.

Despite the intents, the new comprehensive tool is far from reaching the expected success.

Why that?

A legal-related reason may lie in the privacy concerns that the creation, population and maintenance of EMFs bring about. EMFs are in fact populated with data collected by healthcare professionals in the course of patients’ lives. The fear that data may be inadequately protected on the internet, and thus inappropriately divulged, may in fact push patients to deny their consent to the creation and population of EMFs. After all, although data are supposed to be processed in accordance with the provisions of the Code for the Digital Administration, and appropriate measures must be taken in order to ensure access authentication and authorization, suspicion may still populate patients’ mind as to the safety of the data processing.

Quite interestingly, a more common reason seems however to prevail. Italians just do not know about the EMF! According to a survey carried out by the Observatory for Digital Innovation in Health on a sample of 1,000 citizens, 83% of them has never heard about the EMF before, 88% ignores if such service is currently active in their Region, and 95% has never sought information about it[1]. Also, EMF seems not to be the most appealing item in blog discussions: out of 400,000 comments on e-health on the web, only 11% relates to the EMF[2]. Such a low impact seems to go hand in hand with quite a low use of other e-health services provided by hospitals and other health-care centers. Only a few patients seem in fact to have taken advantages of services like on-line booking of medical checks, testing records, and payments[3].

If, as mentioned, psychology plays a major role in the implementation of the EMF, so do the efforts thus far made by Regions and healthcare professionals. An inquiry into the implementation of the EMF in the Emilia Romagna Region reveals that not all services set forth in the law are currently included in the available EMF, and the availability of the services may depend on where the interested patient resides[4]. Also, hospitals and healthcare professionals seem to be responsible for having passively accepted the EMF, without truly understanding its potential[5]. Health-care professionals are reported to oftentimes look at the EMF as a burden rather than a revolutionary tool[6]. Lastly, many hospitals and healthcare centers keep on maintaining their independent presence on the web in parallel; as a consequence, patients rely on their website to use services that would be available on the EMF[7].

What can be done?

Perhaps the EMF would be more popular if patients were able to enjoy it through a mobile app, provided that security concerns are adequately addressed. Patients may thus access the EMF more easily, monitor the processing of the collected data and promptly report any inaccuracy or errors. However, if this suggestion may represent an improvement, it would in any case require further education and promotion through healthcare professionals and healthcare centers.

[1] Il Sole 24 Ore Sanità, September 29 – October 5, 2015, page 10.

[2] Ibidem.

[3] Ibidem.

[4] Il Sole 24 Ore Sanità, October 20 – October 26, 2015, page 8.

 

[5] Il Sole 24 Ore Sanità, October 20 – October 26, 2015, page 8.

[6] Ibidem.

[7] Ibidem.

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.

New Environmental Crimes Introduced: Time to Update Your Corporate Compliance Program!

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On May 19, 2015 the Italian Senate passed bill no. 1345-B, introducing new environmental crimes. The law will become effective the day after its publication on the Official Gazette, following promulgation by the President of the Republic. The law introduces the following environmental crimes in the form of delitti (i.e. the most serious form of crimes), punishable with imprisonment and fines. It is important to note that such crimes are included among the crimes that give rise to criminal corporate liability pursuant to Legislative Decree 231/2001 (“Decree”).  As a result, companies who have already set up an organizational and control model aimed at exempting it from criminal corporate liability must update it in order to take into account prevention of the newly introduced criminal conducts. The new crimes can be described as follows:

  • Polluting.    Anyone who unlawfully damages or jeopardizes in a significant and measurable way waters, air, the surface or the underground, as well as ecosystems, plants or animals, is punishable with imprisonment between 2 and 6 years plus a fine between Euro 10,000.00 and 100,000.00. Sanctions may be higher in case of pollution of protected areas (such as historical sites) or protected plants or animal species. Also, imprisonment can reach as far as 20 years in case of death or injury as a consequence of pollution. As far as companies are concerned, commission of such crime leads to the imposition of monetary sanction between 250 and 600 quotas as per the Decree. Blacklisting sanctions set forth in the Decree may also apply.
  • Environmental disaster. This crime punishes, alternatively, the irreversible alteration of an ecosystem’s equilibrium, the alteration of an ecosystem’s equilibrium the restoring of which is particularly burdensome or can be achieved only by extraordinary measures, or the offense to public safety in light of its effects or the number of people affected. The mentioned conducts are punishable with imprisonment between 5 and 15 years. Also in this case, if protected areas or species are damaged, imprisonment can be increased by one third. The commission of such crime by a company leads to the imposition of monetary sanctions between 400 and 800 quotas, as per the Decree. Also in this case, blacklisting sanctions may apply.
  • Trafficking and disposal of highly radioactive materials.                       Unlawful sale, purchase, receipt, transportation, importation, exportation, supply, detention, transfer and disposal of highly radioactive materials are punished with imprisonment between 2 and 6 years, plus a fine between Euro 10,000.00 and 50,000.00. Sanctions may be increased in case of danger of damage or deterioration of waters, air, the surface or the underground, as well as ecosystems, plants or animals. Also, if any of the conducts jeopardizes the life or safety of individuals, sanctions may be increased by one half. Companies may be punished with monetary sanctions between 250 and 600 quotas in accordance with the Decree.
  • Hindered control. Hindrance of vigilance and control activities on environment, hygiene and safety on the workplace is punished with imprisonment between 6 months and 3 years.

If the above crimes are committed in the form of organized crime, sanctions already set forth against organized crime are increased by one third, and, if companies are involved, they may face sanctions between 300 and 1000 quotas as per the Decree. Sanctions are increased by one third to one half in case any public official or person in charge of a public service carrying out environmental-related offices partakes in the criminal organization. Not only the law provides for new crimes, but it also incentivizes remedial actions. Sanctions are in fact diminished by one half to two thirds in case remedial actions are taken to prevent occurrence of further consequences or to restore the status quo ante. Also, whistle-blowing is incentivized by reducing sanctions by one third to one half. Quite interestingly, the law prevents the statute of limitations from running in case of stay of proceedings ordered to allow remedial actions to be taken. Lastly, failure to take remedial actions, if ordered by a judge or by the law, is punished with imprisonment between one and four years plus a fine between Euro 20,000.00 to 80,000.00.

Defective Medical Devices: an Interesting Decision by the ECJ

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On March 5, 2015 the European Court of Justice (“ECJ”) delivered a ruling on product liability that could have consequences for manufacturers of medical devices.

FACTS OF THE CASE. The quality control system of a company selling pacemakers and implantable defibrillators in Germany found that a component utilized to hermetically seal pacemakers may experience a gradual degradation. That defect could lead to premature battery depletion, resulting in loss of telemetry and/or loss of pacing output without warning. In light of such circumstances, the manufacturer issued a warning recommending physicians to replace the implanted pacemakers with others provided free of charge. At the same time, the manufacturer also recommended physicians to turn off a switch in the defibrillators.

PROCEEDINGS. The insurance companies, covering patients whose pacemakers or defibrillators had been replaced, instituted legal proceedings to obtain reimbursement of costs relating to such replacements. The German High Court raised a preliminary question before the ECJ asking whether the devices that had been replaced may be classified as defective, despite lack of evidence that the actual product implanted was defective, on the basis of the corrective measures recommended by the manufacturer. Moreover, the German Court asked whether costs of replacing those pacemakers and defibrillators could be classified as damages, for which the manufacturer may be liable pursuant to the Product Liability Directive[1].

ECJ RULING. In its ruling, the ECJ stated that, in order to determine whether or not the manufacturer was liable, (i) the function of such products, (ii) the vulnerability of patients utilizing them, (iii) the costs borne to replace them, and (iv) the costs relating to turning off the switch of defibrillators had to be taken into account and balanced. In this respect, the ECJ observed that even the potential lack of safety of those products gave rise to the manufacturer’s liability, in light of safety standards that patients could expect from that kind of products and the abnormal possibility of damages to patients, who would be at risk of death. In addition, and in more general terms, the ECJ affirmed that costs borne to replace potential defective devices may constitute damages inasmuch as the expenses incurred are necessary to remedy the defect. However, such a judgment, as pointed out by the ECJ, pertained to the merits of the claim, and must therefore be ascertained by a national Court.

CONSEQUENCES OF THE RULING. Under the Product Liability Directive claimants must produce evidence of the defect, damages arising therefrom and a causation link between the two. By contrast, the ECJ’s decision establishes that even potential defects may be considered as defects. As a consequence, consumers appear to be relieved from the burden of proof that products are actually defective. By the same token, manufacturers’ right of defense seems to be compressed, as – when there are corrective measures recommended by them – the ruling does not leave any room for proof of lack of liability.

WHAT WILL BE THE IMPACT OF THE RULING.  The ECJ’s approach to product liability adopted in the ruling at hand appears to be skewed towards consumers’ protection. A cynical reading of the ECJ’s judgment may even prompt manufacturers to be reluctant to “admit their own mistakes” and issue safety warnings regarding their products! As often happens with legal issues affecting innovation and health policies, balancing of interests is key.

[1] Council Directive 85/374/EEC of July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products. According to the Directive, the producer is liable for damages caused by a defect in his product.

Hospital Use Of ATMPs: Toward A Stronger Protection Of Patients Resorting To Compassionate Use

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The Italian Ministry of Health has recently strengthened the requirements to obtain the authorization to manufacture and use advanced therapy medicinal products (“ATMPs” [1]) which are non-routinely produced. In fact, following the enactment of the Decree of the Ministry of Health of January 16th, 2015, published only last week (the “ATMP Decree”)[2], more control on such drugs’ hospital use is expected. The ATMP Decree does not apply to ATMPs under clinical trial and solely focus on compassionate use of non-routine ATMPs.

THE PREVIOUS REGULATORY SCENARIO. Prior to 2006, the use of gene therapy and cell therapy medicinal products, for which a marketing authorization had not been obtained, was authorized only within clinical trials[3]. In 2006[4] non-profit manufacturing and compassionate use[5] of gene therapy and somatic cell therapy medicinal products was first allowed.

The 2006 Decree allowed the use of such products on the basis of certain requirements, checked by the Agenzia Italiana del Farmaco, the governmental agency in charge of pharmaceuticals (“AIFA”). Given the lack of therapeutic alternatives in a life threatening condition, the requirements for production and use of gene therapy and cell therapy medicinal products were not especially strict and heavily relied on the patient’s consent and positive feedback by the Ethics Committee, as well as on the self-certification on the existence of the requirements by the doctor responsible for the drugs administering.

THE NEW RULES INTRODUCED. The ATMP Decree was introduced to protect consumers from fraudulent conducts. Even though the Decree does not make specific reference to it, it is widely accepted that the ATMP Decree aims at limiting the proliferation of cases like the famous “Stamina case”, where therapies for treatment of life-threatening diseases have been provided to patients in sheer lack of scientific grounds[6]. AIFA will enforce the new rules by way of on-site inspections that may lead to suspension or revocation of a previously granted authorization to manufacture, as well as to the prohibition to administer the drug. The ATMP Decree can be summarized as follows:

  • AUTHORIZATION TO MANUFACTURE. Manufacturing of ATMPs for non-routine hospital use now requires a prior authorization by AIFA, which is only issued to GMP (Good Manufacturing Practices) certified manufacturers[7]. Prior to issuing its authorization, AIFA checks compliance of the manufacturing site. The process may altogether take up to 120 days, save for further inquiries by AIFA[8].
  • AUTHORIZATION TO USE. Use of ATMPs is limited to “compassionate use”. Only certain public research hospitals will be suitable candidates to obtain AIFA’s authorization[9]. Moreover, the authorization will be released only upon approval by (i) a Committee for the Assessment of Admissibility to Phase I of Clinical Trials, composed of expert biologists and clinicians, and (ii) by the concerned hospital’s Ethical Committee. The authorization is issued after an analysis of all documents necessary to assess risks and benefits of the proposed treatment, as well as data concerning safety and efficacy available from previous clinical trials.
  • COOPERATION BY MANUFACTURERS AND PHYSICIANS.
    • Manufacturers of ATMPs must ensure traceability of medicinal products as well as of patients for thirty years, and must report to AIFA any adverse events. Also, manufacturers can deliver ATMPs only after authorization to use has been issued and in compliance with a physicians’ prescriptions.
    • Physicians, on the other hand, must ensure that the patient’s informed consent is obtained, and must comply with Good Clinical Practice principles in administering ATMPs in accordance with the protocol approved by the Ethics Committee. Finally, traceability of the drug and patient must be ensured and adverse events must be communicated promptly.

CONCLUSIONS. Manufacturing and use of ATMPs on non-routine basis shall follow objective requirements, to be assessed by governmental entities who are able to appreciate their scientific basis, rather than – as in the past – used under the mere responsibility of physicians and on the basis of self-certified manufacturing facilities. If, on the one hand, it would be advisable that all who need to resort to compassionate use of medicinal products can access medicinal products as quickly as possible, on the other hand it must be ensured that the same people receive adequate protection from deceitful conducts. The Stamina case showed how vulnerable to deception patients who are in a life threatening condition without any available cure can be to false hopes spread by therapies without scientific basis: the recent ATMP Decree attempts to protect them.

 

[1] According to Section 2 of Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004 ATMPs include gene therapy products, somatic cell therapy products and tissue engineered products.

[2] The ATMP Decree has been published on the Official Gazette no. 56 of March 9th, 2015 and will become effective fifteen days after publication.

[3] See Section 1 of Ministerial Decree of March 2, 2004. Such non-routinely manufactured drugs were also excluded by the scope of the Pharma Code (Legislative Decree no. 219 of 2006) which focused on the industrial manufacturing of medicinal products and excluded non-routine drugs from its scope.

[4] Ministerial Decree n. 25520 of December 5th, 2006.

[5] According to Ministerial Decree n. 11521 of May 8th, 2013 “compassionate use” or “expanded access” of medicinal products may occur when no suitable alternative is available, in case of life-threatening situations, when serious harm to a patient’s health is potential, or in case of serious diseases with fast progression.

[6] The “Stamina Method”, created by Prof. Vannoni for the treatment of neurodegenerative diseases, is based on the conversion of mesenchymal stem cells into neurons and apparently lacks any scientific foundation. The method itself was also harshly criticized by Nature, one of the most prestigious scientific journals (http://www.nature.com/news/italian-stem-cell-trial-based-on-flawed-data-1.13329). Prof. Vannoni manufactured ATMPs while completely disregarding GMPs. Prof. Vannoni was criminally charged and prosecuted for organized crime with the purpose of fraud and recently plea bargained.

[7] Principles and guidelines of GMPs are contained in Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

[8] The process also includes submittal of request for authorization, along with a report on the ATMP.