The ‘Implant Files’ is the new investigation led by more than 250 journalists and 59 medias around the globe – among them Le Desk in Morocco – all members of the International Consortium of Investigative journalists (ICIJ). This new investigation reveals the dramatic lack of regulations and controls surrounding medical devices in almost all the countries ICIJ looked at. This represents an unprecedented effort in trying to make sense of this incredibly complex and flourishing industry, by analysing more than 8 million documents that ICIJ was able to collect and helping create a database of adverse events resulting from faulty devices.
The implant files are the result of a year of investigative work, conducted by over 250 journalists in 36 countries, under the umbrella of the ICIJ. It looks at the opaque world of implantable medical devices and the potential dangers they pose to patients’ health, due to the lack of proper testing, control and regulation across the world.
The Implant Files differs from previous investigative reporting led by the ICIJ in two important ways. First it does not proceed from a leak and secondly, it does not deal with the financial meanderings of the wealthy and their chosen tax havens.
This year-long investigative work has culminated in the creation of the International Medical Devices Database (IMDD), offering unprecedented insight into opaque and malfunctioning regulatory and traceability systems. This database allows users to explore more than 70,000 recall events, safety alerts and field safety notices executed in 11 countries. Users can also search by device name, by manufacturer, or by country. If most of the information available on the IMDD was already part of the public domain, or obtainable through Freedom of Information requests, it is however for the first time compiled in such an easy and accessible way, filling a critical information void for patients, medical professionals and health authorities.
The IMDD presents the groundbreaking potential to explore medical device failures and recalls from across the world. In many instances, it includes the level of risk associated with the use of the recalled device, the causes for a given recall and details of the corrective actions taken. Device design (22.7 percent), was the most common cause for recalls of implantable devices as reported to the U.S. Food and Drug Administration (FDA) over the last decade.
Manufacturers, their lobbying power and lack of scrupules are at the heart of this investigation. In an industry estimated at 400 billion dollars, the race to ever greater profit and market shares – thus the constant push for innovation – are the core strategies of manufacturers’s R&D and marketing plans, at the expense of device security and patients’ interests.
Using the FDA’s recall and data, ICIJ and its partners have revealed that during the past decade, over 5 million faulty devices have been reported around the globe, of which 82,742 have resulted in the patients’ death.
In the this first part of our investigation into the Moroccan side of the Implant Files, we look back at the country’s history of weak regulatory practices in this domain. Le Desk, in this investigation, reveals new information about the past and present that will help build a picture of the current state of affairs, including how both public and private institutions have failed to secure the industry and prioritise patients’ health.
Starting off on the wrong premise
Morocco. January 1996. The country is in the midst of a witch hunt targeting the business community. Led by Driss Basri, at the time Minister of Interior and right-hand man of defunct king Hassan II, its aim is to get rid from all sorts of corruption-related ills. In the inventory of cases built in this government-led effort to clean up shop and rein in “Casablanca’s capitalists”, one particular case stands out, the one referred to as the “contaminated blood” case – one that the government blows out of proportion and does not shy away from “holding up as an example”.
The Ministry of Health announces the following by way of a press release, in order to explain the contaminated blood fiasco : “ within the context of our fight against the illicit entry of goods and in light of the recent seizure of pharmaceutical products, the Casablanca-Anfa prosecutor has ordered the Pasteur Institute of Morocco to conduct [a series of] quality controls. Their results confirm the presence of hepatitis C virus antibodies as well as HIV antibodies [in the tested blood samples]”.
In an attempt to look in control of the situation, the state scrambles to find the ideal scapegoat. One single person ends up being accused for the “contaminated blood” fiasco : a Casablanca-based pharmacist, Moncef Benabderrazik. A section of the press, loyal to Basri, shows no mercy on him and holds him responsible for a situation with potential catastrophic implications prior to the courts judging him and sentencing him. He is found guilty and sentenced to 6 years of jail time for importing dangerous and contaminated products (blood) that could potentially transmit AIDS to patients. Despite a formidable counter-investigation by Moroccan newspaper La Vie Economique and expert testimony in defence of Mr. Benabderrazik, the jail sentence held.
This debacle, the gamma-globulin case, allowed for incredible abuse of power and yet had one beneficial effect according to a source working at the Ministry of Health, who asked for anonymity, explaining it as follows : “ [The contaminated blood case] brought to the forefront the challenges and potential dangers posed posed by the wide array of products being imported into the country without undergoing any kind of control or being regulated in any way”.
In fact the control process for imported goods has been thought out by the government and health authorities over twenty years ago and yet was never implemented. “A ministerial circular dating back to 1997, that has no legal force and is thus not legally binding” was the only legislation in place up to 2013, says our source, allowing for substantial chaos to reign in this domain. “As for the provisions of the 2013 law [meant to regulate the import and marketing of medical devices], they are not strictly complied with”, maintains our source.
It should however be noted that the regulatory framework of the medical device sector “has clearly evolved” over the last few years, says Abdel Majid Bellaiche, expert and consultant in the health sector. As such, the legal provisions have been improved upon over the last six years, by a series of Dahirs, decrees, Orders and bulletins, aiming to reign in the anarchy in terms of regulations. However, Bellaiche adds, importers enjoy the same ease of procedure when looking to launch a new medical device. “The only requirement being to obtain a registration certificate, to allow for the import and commercialisation of any medical device”, he explain.
Le Desk paid a visit to the registration services of medical devices in Rabat. Their offices, situated next door to the anti-poison center, are located in the teaching hospitals neighbourhood of the capital. There, we were able to find out just how basic and accessible to all the technical file needed in order to apply for a registration certificate is. In the midst of an indescriptible chaos, the crowd of applicants fight their way to try and obtain the much sought after document that will allow for the marketing of their medical devices, imported from Europe, the United States, the United Arab Emirates or even China. In this mayhem, the rule of law seems very far away, almost nonexistent. Rather, preferential treatments and cosy arrangements between applicants and officers of the health authority have taken precedence, and all parties seen keen to keep this lucrative market organised as such.
Throughout this investigation, a recurring explanation to the absence of a comprehensive and rigorous system of oversight and control was the excessive number of products considered to be medical devices. By the current definition, these go from gauze and bandaids to the most sophisticated scanners and implantable devices. No particular attention is given nor added precautions taken when it comes to implantable devices. “There exists 6,000 to 7,000 references of registered medical devices in the country, however the reality is a number closer to 40,000 types of medical devices currently in circulation”, states a health department civil servant, acknowledging that his own department, being the only place with the authority to receive registration requests, is “under the water and unable to distinguish the high-quality medical devices from those of poorer quality”.
In fact, there simply is no appropriate structure in Morocco for the control of medical devices. In theory, the responsibility of the control rests entirely on the National Laboratory of Medical Controls [NLMC], whose “personnel went from 13 to 3 individuals”, acknowledges an official of the Ministry of Health, requesting anonymity, as most our sources have in this investigation, fearing retribution for their testimony.
“In order to be able to control all the imported medical devices, we would have to implement costly test benches, and invest heavily in specialised human ressources and train them and pay them accordingly. This is currently not the case in Morocco” explains our source, despite the [financial] support Morocco receives from the World Health Organisation (WHO) and the many training programs Moroccan teams are part of in Japan (paid for by the Japanese cooperation organism), the United States or France.
At one point in time, thanks to the Global Fund to Fight AIDS, a lab was created within the NLMC to test the safety of condoms. “This lab turned out to be one of the best in the world and was sought after by several African and European countries”, tells a former executive at the NLMC, who gave up on his public servant job and moved on to the private sector, in order “to avoid being trapped someday in a counterfeit, corruption or accidental death scandal”.
No traceability and no controls
The medical device market is structured around three or four key players specialised in a number of medical products and a myriad of small medical supplies and equipment shops, that respond to the Ministry of Health’s many calls for tenders, whose contract prices have been on a declining trend for the past few years.
One of the provisions in the Ministerial Circular mentioned earlier, meant to protect Moroccan patients, is that all controls on medical devices should occur prior to the deliverance of an authorisation to market. A provision that was not retained and made into law due to the insistance of Dr. Omar Bouazza, former chief at the Pharmacy and Medicine Directorate, of whom Le Desk had exposed his failures and deceits that ultimately led to his removal from office, to see it scrapped. In fact, Bouazza had urged then Minister of Health Lahoussine Louardi that the Law 84-12, at the time in the making, should require solely post-marketing control, in an effort to “facilitate market access and obtain lower prices for public hospitals”. A key argument to push for this approach was to allow “the government to not have to shoulder any responsibility in the occurrence of an adverse event”, says Bellaiche, who deems the current state of affairs to be “grave” and hopes that the newly minted Pharmacy and Medicine Directorate chief will “find a way to bring more order into this chaos”.
The difficulty of pre-marketing control is one faced by many countries around the globe, even those with higher budgets and qualified staffs. In 2012, the European Commission gave up on the idea it was discussing at the time of a pre-marketing authorisation system for medical devices. The commission claimed that such an endeavour would require the creation of a new European body of control, meaning new expenses for the EU. According to its report on this matter, the Commission argues that such an addition to the control process would not only be a burden to the budget but would also hamper the competitiveness of “Made in EU” devices by lengthening the waiting period before they can be placed on the market (“Impact Assessment 2012.09.26”).
The EU relies thus solely on post-marketing control. This is not to say that a posteriori control cannot be a safe way to monitor and vet medical devices. However, its efficiency relies heavily on the clear condition and understanding that product traceability is guaranteed through an iron-clad system so that recalls may be carried out.
Nonetheless, there remain flaws in the oversight and control mechanisms, that often have catastrophic consequences. Each scandal surrounding a given medical device sheds a light on these caveats as was the case with the infamous and often cited PIP breast implants.
The investigation led by ICIJ and its media partners has shown that the lack of regulations is an issue faced by an incredibly large number of countries, even those with the most advanced mechanisms in place. In some countries, as is the case in Morocco, health monitoring authorities are in over their heads having failed to institute a viable and streamlined system of controls equipped to deal with the complexity of the medical device world.
With regards to countries with stronger public institutions, the ICIJ investigation has brought to the public’s attention that these nations have an additional fight to take on : that against armies of lobbyists paid to impede ambitious regulatory overhauls of the medical device industry from ever going through. The European Union seems to be particularly concerned by this, which is particularly worrisome and poses a serious health problem around the globe, given the trust that is put in their CE mark.
The Implant Files investigation reveals that a number of European politicians have been misled on numerous occasions by these same lobbyists, leading them to be misinformed supporters of certain medical devices on the basis of forged studies. Knowingly or not, many European regulators have played into the hands of the medical device manufacturers and their lobbyists whose interest is in ever faster timeframes for their medical devices to be placed on the market. Regulators have failed to put a limit to this continuous quest for profits and to place future patients’ health at the heart of their concerns.
Scandals in the world, not in Morocco
The global investigation sheds a light on several manufacturers whose products have been recalled and some discontinued. Amongst those leading in the medtech field, Medtronic has imposed its mark as a giant in the field, with profits of over $30 billion. The meteoric rise of this company over the last decade has not gone unnoticed. In fact, in 2008 its struggles started with a probe led by U.S. authorities, investigating bribery allegations against doctors and an intent on the part of the company to defraud an American health care program. However, Medtronic managed to rise to the top by doubling its profits in the last decade – launching hundreds of new medical devices and opening offices in over 160 countries (including one in Casablanca, Morocco in 2016).
Medtronic’s new strategy is to introduce countless new implantable products into the market, as quickly as possible, thus without ensuring their safety. This led the company to be accused in a number of countries of promoting unauthorised devices, of scamming their government, of price fixing, of paying off doctors to conduct scientific studies favourable to their devices and of anti-competitive practices. Medtronic’s rapid success has come at a great cost to patients’ health. Worse still, the Implant Files reveal that over the 2008-2017 period, 292,000 adverse events have been tied to the use of a Medtronic device, as well as 9,300 deaths.
Amongst Medtronic’s bestsellers, insulin pumps take a leading place in worldwide sales as well as most problematic devices. They were however introduced in 2017 by a Moroccan, family-owned business Africa Diabetes, with press releases in several outlets announcing the newly launched MiniMed insulin pumps. However, these same pumps were linked to 75,000 declared adverse events, of which 300 led to the patients’ death, in 2014 and 2015. These numbers did not seem to discourage Africa Diabetes to present this pump as a revolutionary device, and failing to mention any of the known and recorded adverse events. Given the impossibility to trace medical devices back to patients – due to the inexistence of a national database – we are unable to say if any adverse events were caused by these pumps.
A similar situation occurred with the now infamous and withdrawn from the worldwide market ASR hip implants, from manufacturer DePuy Orthopaedics, a subsidiary of American giant Johnson & Johnson. These implants turned out to be faulty and gravely dangerous to patients’ health. In the wake of the global scandal caused by these DePuy devices, scarcely written about in the Moroccan press, most recipients of these devices in countries from around the globe were able to call in patients in order to have their hip devices surgically removed and replaced. “In Morocco, given the lack of product traceability, these devices were not a cause for worry nor extended conversation given that the health authorities could not know if they were implanted on any patients in the country”, a source close to the matter explains. The president of the Moroccan Society of Orthopaedic and Trauma Surgeons implied that these implants could not have been used by his colleagues “since they are to costly”. Mere speculations, sit is actually impossible to know if these DePuy implants were actually marketed on Moroccan territory.
These examples show that even when it comes to scandals that have shaken the world, Morocco has remained immune to them, not because its health authorities knew its patients to be safe from any potential harm caused by these faulty devices, but rather because they are powerless in the face of such events.
In addition to issues of easy access to market, uncontrolled imports, inexistence of a database and lack of traceability, Morocco, as several other countries, faces a serious threat from illicit trade of medical devices, says a regional representative of Johnson & Johnson. He goes on to say that “the threat stems more from parallel market trade than from counterfeits”, presenting however just as much of a danger to the patients’ health, given the non-conformity of the black market with proper transportation, handling and stocking standards.
Worse yet, a member of the National Laboratory of Medical Controls [NLMC] we spoke with, informed us that certain importing companies get through the minimal customs controls in place with their cargo stamped with the CE mark, when in reality they are fraudulent goods, of unknown origin and quality. “In some cases the CE is actually referring to ‘Chinese Export’ !” he adds.
Opacity and useless regulations
There exists, in Morocco, a national adverse event and recall database according to one source who works at the Ministry of Health. However, “there is no system implemented to update this database, making it not reliable. That is the reason why it has not been made public”. He goes on to say that the “very rare are the surgeons who report any adverse events or defective devices, since there is so much collusion between practicians and manufacturers […] The medical device safety monitoring department is more of an empty vessel. By and large, the lab is not notified by doctors”.
As for customs classification (chapter 28 and 30), they do not act as a strong safety net to curb reckless imports of medical devices, the main reason being that custom duty applies solely on the basis of the product’s material rather than its specific nature or usage.
The system around medical devices, while unregulated, is being described by sources who are at the heart of the public health administration, as excessively controlled by the state, allowing a handful of big players to be advantaged and have the upper hand on the marketplace. “One supplier holds sway and is given priority at the Sheikh Zayed (public) hospital in the capital : Promamec. However, back when it was known as Comamec, the company faced a backlash over a case of false manifesto”, reveals our source in the hospital’s administration. As for the capital’s other major public teaching hospital, Avicenne, the supplier of choice is Techos. In a similar fashion, a few other names of suppliers are mentioned to describe how the market of public call for tender is divided amongst a lucky few : Steripharma, Sterifil, Cyclopharma, IM Santé… It should be noted that the private sector is no stranger to facing similar plays made by a cartel of suppliers. The director of a private hospital in Casablanca explains that private doctors tend to sign countless declarations of non-conformity of certain medical devices in order to exclude certain manufacturers and brands from the market – and therefore favour others.
Besides the national adverse event and recall database, another provision in the 2015 law regulating the medical device industry, is the National Advisory Committee for Medical Devices. Created in order to review and authorise all medical devices that come into the Moroccan market, “it has so far failed to fulfil dits mandate and does not convene to evaluate every medical device file as it is meant to do”, says our source at the Ministry of Health. “During a meeting, 600 to 800 medical device files may be hastily reviewed. This committee also faces a serious competency shortage”, sys the same source – referring to an internal warning issued in November 2017 by Faouzi Rabii, a pharmacy inspector at the Hospital and Ambulatory Care – of which Le Desk obtained a copy. This report points out the grave mix-up made between a product’s type and manufacturer by those meant to control them.
“Medical devices should have a clear identification, just as any medicine put on the market does. Their files should unambiguously state their manufacturer, traceable references, data on the composition, verifiable technical elements. This task – of creating such a complete and accessible files – lies with the Pharmacy and Medicine Directorate”, concludes Bellaiche. Given the way things currently stand, in a market defined by chaos and unenforced laws, this objective seems currently out of reach.
This article was first published in French