A Serious Flaw in the Slovenian Health Care System
Anuška Delić, Maja Čakarić, Oštro editorial board, ICIJ
Medical devices concern everyone, yet no one really cares about them. Certainly not as much as about medicines. In the framework of a global investigation project by the International Consortium of Journalists and its media partners, the Implant Files, we found that the regulation of medical devices in Europe – and in Slovenia – is largely inadequate and full of loopholes. And the patients are completely at the mercy of this system. A system that is ruled by manufacturers and their business secrets, one that treats the public merely as a fly in the ointment of development.
»For any official explanation of the adverse event and further information you can contact the manufacturer or their authorised representative within the EU.« This is how the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) dismissed the father of a young patient whose life depends of his medical device.
His medical device stopped working twice in five years and seriously threatened the young man’s life. But he was lucky – the hospital where they provide care for him has a 24/7 emergency service and, in the case of both adverse events, a team was gathered within an hour and saved his life.
The boy, let’s call him Blaž, has cerebral palsy. His father, let’s call him Igor, wishes to acquire a report from JAZMP regarding the investigation into the last adverse event because the cause of Blaž’s device malfunctioning was the same twice in five years. Oštro’s editorial board knows the identities of the father and his child but will not disclose them due to their right to privacy.
Igor has nothing bad to say about the hospital or Blaž’s doctor. But thinks otherwise about the manufacturer of the medical device – he is considering a lawsuit. If he would file a lawsuit, he would be one of thousands of people around the world who seek justice in court with regard to medical devices.
He found out from Oštro journalists who participate in the Implant Files about serious adverse events and recalls regarding his son’s same device in other countries.
With the project carried out in cooperation with more than 250 journalists from 36 countries and the International Consortium of Investigative Journalists (ICIJ) we tried to get to the bottom of what is happening in the medical devices industry. Implant Files show that medical technology made great leaps forward, while the safety requirements lag far behind.
During the investigation we gathered more than eight million documents concerning medical devices. The data about this project is now available to everyone in the International Medical Devices Database (IMDD).
The findings of this global investigation are a cause for concern and are further reinforced by the fact that apparently almost no one in Slovenia, except few people at JAZMP, is aware of serious deficiencies in the current system and the system that will come into force in 2020 with the new EU Regulation. No one, including the Minister of Health, Samo Fakin, and the National Institute of Public Health, has anything to say about this.
They are not aware that the Slovenian patients are prescribed high-risk medical devices, the majority of which – as much as 90% according to some sources – entered the European market without being clinically tested on people.
Europeans treated as guinea pigs
In Europe, extensive clinical research must be carried out for all new medicines before they come on the market, in order to ensure a satisfactory ratio between their safety and effectiveness.
This does not apply to all medical devices, however. Manufacturers present most of their new products as a newer or a more advanced version of an existing medical device. In such a fast-track process only their technical compliance is examined.
»Tests« are carried out later. During actual use. On patients. As it is, the existing system treats European – and, of course, Slovenian – patients as guinea pigs. This opinion was expressed by experts on both sides of the Atlantic who spoke with journalists of the Implant Files project.
Numerous American devices acquire the European certificate of conformity (CE) – various products, from toys to coffee machines, in the European market are labelled with it – before the American certificate which is conferred by the US Food and Drug Administration (FDA). The medical device industry itself calculated that it can acquire the certification for their device as much as three years faster than in the US.
And for this reason, large manufacturers of medical devices, even though they are predominantly American, like to »hop« over the Atlantic to get their CE mark in Europe. When their products obtain a CE mark in the European Union, they can start selling the devices, either straight away or with some technical examinations, in countries such as India, the Philippines, Singapore, Saudi Arabia and most of the South American countries.
The so-called notified bodies in EU member states are entrusted with the task of examining medical and other devices before they are allowed to be put on market and play a crucial role in manufacturers’ products being successfully certified. In Slovenia, this body is the Slovenian Institute of Quality and Metrology (SIQ), owned principally by the state.
But more than a few of these notified bodies are entirely private companies – and they consider business secrets sacred and public interest a fly in the ointment of development.
And as it looks, the CE mark can nowadays be acquired by going »shopping«. If the first notified body will not grant you a certificate, the second or the third will, won’t they?
In 2016, the British Medical Journal (BMJ) published results of a study in which they examined the characteristics of 206 new medical devices that came on the EU and US markets in the last six years. The devices which were first certified in Europe were three times more often a subject of safety measures and recalls in comparison with the devices certified in America. Let’s repeat this: three times more often.
All the medical devices that were investigated by the Implant Files journalists and that were first granted a certificate in Europe rather than in the US were later recalled and their manufacture was put on hold or discontinued.
Regulation tailored to the industry‘s whims
Medical devices are extremely varied and include everything from contact lenses, adult diapers and artificial ankles to crutches, dentures, cardiac pacemakers and insulin pumps. No one in the European Union knows how many certified medical devices, which are safe for use, are on the market.
Rough estimates for the EU are from 500,000 to 750,000. We have no estimate for Slovenia. JAZMP does not have this data because the applicable legislation »does not grant it the power to maintain the register of all medical devices available on the market in the Republic of Slovenia«. It only maintains the register of devices by manufacturers established in Slovenia. It currently contains a little less than 5,700 products.
In 2020, however, everything is supposed to change for the better, claim representatives of competent authorities, manufacturers, suppliers and also the Minister of Health. This is when the new EU Regulation on medical devices will come into force.
It has been in the making since 2008, when, following a public discussion of the European Commission proposal about recasting the field, awareness arose that the regulation of medical devices market in Europe is utterly deficient and that their safety requirements are not adequate.
When ten years later the Regulation was adopted, this awareness melted into thin air.
As revealed by the investigation behind the Implant Files, the main culprits were the medical devices industry and notified bodies which, with their uncompromising lobbying, crippled crucial changes that the new provisions were supposed to bring to this field.
Ten years ago, at the very start, these interest groups undermined the efforts to establish a new department for medical devices within the European Medicines Agency (EMA) that would be on an equal footing with the one regulating the medicines market.
According to the European Commission’s proposal, the competence for examining and certifying high-risk medical devices would be transferred to this department. The medical devices would also have to undergo clinical research under the watchful eye of this department.
The resistance was fierce. When the European Commission published the proposal for restructuring the Regulation on medical devices, it received as much as 200 comments during a public discussion – most of them were submitted by the industry, whereas only a quarter of them were submitted by national regulators and health care professionals.
The notion of an authority that would destroy the symbiotic relationship between the medical device industry and the notified bodies and in this manner become a bastion of public health was infamously squashed.
In 2012, when the draft of the new Regulation was published, it no longer contained any traces of the need to break up the symbiosis between manufacturers and the alleged guardians of the public interest. This idea was cast aside as »inadequate« because it would supposedly have a negative effect on the EU’s budget, manufacturers and innovation opportunities without significantly improving the safety of medical devices.
Journalists found this information in an »impact assessment« study on the effect of the proposed legislative amendments published by the European Commission in 2012.
Footnotes in the documents reveal that one of the studies on which the European Commission relied when it changed its heart about introducing stricter safety measures, was authored by an American lobbying company Boston Consulting Group that pursued the interests of the medical device industry in the US. Company representatives did not reply to questions of Implant Files journalists.
The new Regulation was finally adopted in 2017. The process spanned the tenure of two Commission presidents, three parliaments and 11 leaderships of the EU Council, the body which together with the parliament passes laws.
Many industry representatives hailed the new Regulation as victory.
Perhaps this is also how the Minister of Health Samo Fakin sees it. We addressed more than ten questions to him through the Public Relations office, like, for example, if he believes that medical devices in Slovenia are adequately regulated. He did not provide any real answers to specific questions, while his replies revealed a lack of knowledge of the topic and represented the new EU Regulation as some sort of deus ex machina.
He detected one issue: »Public awareness could indeed be greater and vigilance events should be reported on (health care personnel – doctors, nurses).«
Slovenia: Poor adverse events’ reporting
JAZMP has received only 258 reports on adverse events in the last three and a half years, out of which only a meagre 10% was submitted by medical institutions.
Vigilance is an official term for »establishing, collecting and evaluating complications involving medical devices and other findings about their safety, as well as measures for reducing the related risk «. But the system of vigilance is not fully operational in Slovenia.
According to our source close to JAZMP, the agency finds out about many adverse events from the media, while doctors often only report them to the manufacturers and not to JAZMP.
These practices are not in line with the law which says that doctors, pharmacists and other health care workers must report to the JAZMP within 24 hours following an adverse event, or after they find out about it. Reporting by health care workers to manufacturers is, on the other hand, optional because the law stipulates that they merely »can« report on adverse events.
The rules for manufacturers or their authorised representatives and suppliers are much stricter. Among other things, they must manage their own system of monitoring, collecting and submitting data about adverse events. They must also employ a person who is trained in this field and responsible for vigilance. They are obliged to report any adverse events to JAZMP within 24 hours.
Our investigation shows that in Slovenia, as well as in all other European countries, the journalists of which participated in the Implant Files, adverse events are underreported. In the course of a year-long investigation, Oštro’s journalists also found examples of good practice as regards keeping adverse events and medical devices in check in some of the health care institutions and at one of the distributors.
JAZMP did not comment on the level of underreporting on adverse events by manufacturers, adding that they do not receive many reports from health care workers and users. »Experience shows that JAZMP is not informed of all adverse events.«
This is in contradiction with the main principle of the system for reporting on adverse events: the traceability of medical devices.
Each medical device must be traced from the factory and certification authority to hospitals, doctors and, of course, the patient and the same applies in reverse. Reporting on adverse events which are suspected to have caused or could have caused »death of patient, user or other person or a serious deterioration in the health of the subject« is of vital importance in the chain of actors involved in the vigilance of medical devices.
Supporters of the new EU Regulation expect an improved vigilance in the EU on the basis of introducing the Eudamed database which is supposed to become operable in 2020.
With regard to public access to the Eudamed database, however, the European Commission stopped short of making it publicly accessible. At the moment it merely guarantees that, besides basic information regarding devices, only manufacturers’ safety notices notifying users of corrective measures will be accessible to the public.
They are still thinking if and what kind information on adverse events should be publicly available to European citizens, professionals, researchers and students. »The decision regarding this has not been made yet,« was the reply one of the journalists received.
Currently, vigilance data is not being collected yet. By none of the 28 bodies.
Closed to the public
Medical devices make life of many patients and their loved ones easier and better, as well as prolong it. However, there are also many people that, due to complications with them, experienced serious deterioration of health, had their lives turn for the worse or even suffered death.
According to data that journalists gathered in a year, medical devices that broke, burst, bent or broke down in some other manner are linked to 1.7 million injuries and almost 83,000 deaths in the last ten years. A little shy of half a million reports on complications refer to surgical procedures related to the removal of a medical device due to complications.
We have no such statistical data for Slovenia because we are still fighting a Freedom of Information battle with JAZMP hoping to achieve disclosure of information regarding injuries and deaths of patients. JAZMP made this data confidential because it falls under the protection of personal data, according to the agency.
Data on adverse events in Slovenia that JAZMP finally sent us is therefore incomplete and offers only a glimpse into the number of devices which were a subject of an adverse event. Because JAZMP also refused to reveal information on events where the root cause has not been established yet, we had few records left to examine.
We only gained access to 29 among 258 rows of information that provide very limited data on adverse events in Slovenia in the last three and a half years.
The root cause is established during an investigation following a serious adverse event. It must be carried out by the manufacturer who must report its findings and adopted measures to JAZMP. These measures may involve an elimination of deficiencies or »reducing the risk of death or serious deterioration of health associated with the use of medical device that is already placed on the market.«
The system is based on manufacturers’ demands, only occasionally applied vigilance and the principle of being closed to the public – the patients and their relatives. JAZMP informs the patients of the reason for an adverse event, but it does not provide them with a report of an investigation.
Agency and the Seven Employees
Why is there no transparent system of reporting on adverse events in Slovenia? If you ask Samo Fakin, the Minister of Health, this is JAZMP’s jurisdiction.
He also explained that the agency publishes »important notices regarding adverse events on its website. The Inspectorate also performs its duties by publishing notices and carrying out controls. The promotion of medical devices reporting is also a part of the obligations under both new Regulations.«
At the time of publication, there was not even a single safety notice or adverse event report published on the JAZMP website. It is not known what the Minister had in mind.
In the spring of 2018, medical devices segment in Slovenia was overseen by only one inspector; data from September show an increase – to three inspectors.
The lonesome inspector, as can be concluded from JAZMP’s last annual report, carried out only six out of 16 planned inspections – a modest goal to start with – of the medical devices market. Inspectors in the field of medicines, on the other hand, have surpassed the number of planned inspections by as much as 30%: they carried out 97 of them.
One inspection of medical devices for every 16 inspections of medicines.
Similarly, the structure of personnel in the two fields is very different. Last year only 5.3% of people employed at JAZMP were involved with the medical devices sector (7 employees), whereas the medicines sector employed as much as 61.7% of personnel (82 employees).
We asked Samo Fakin, Minister of Health: How can an agency – severely understaffed in the field of medical devices – implement all the provisions required by the new regulations as well as ensure the traceability and control of medical devices in the Slovenian health care system?
Minister Fakin had nothing to say.