Previously, we wrote a blog post or two (fine, three) criticizing EMA for the slow and clunky transition from the Internet Explorer reliant XEVMPD to a more modern system (IDMP). As this blog post is being written, the transition to IDMP is still very much ongoing and probably will be for another couple of years, at least. It’s also worth noting that the system selected for holding medicinal product information is hardly a new technology, but we can hope it will be a step forward from the XEVMPD’s ancient system.

Sometimes, we stop and wonder. We live at a time when people working in Pharma can spend 8 hours at work using decades-old technology to manage information about medicinal products and then go home to ask DALL-E to paint them a new picture or ChatGPT to write an essay on what’s wrong with XEVMPD in about 2 minutes.

And no, this blog wasn’t written by ChatGPT or any other AI tool.

Meanwhile, in Japan

For those of us who struggle to emulate Internet Explorer in order to follow the legal requirements and submit information to the authorities, the Japanese digital minister gave a nice reminder that things could be even worse. The digital minister of Japan, Taro Kono, made headlines last year because he has a goal to upgrade the business administration of the country to the current millennium.

“I’m looking to get rid of the fax machine, and I still plan to do that,” he said.

In Japan, there are about 1,900 government procedures that require the business community to use discs, i.e., floppy disc, CD, MD, etc., to submit applications and other forms. While the 40-year-old floppy disk technology mainly reminds people of installing Doom II on their PC or of their first visits to the computer class in the 1990s, in Japan they are still part of the everyday bureaucracy. Floppy disks continue to be used in Japan due to the country’s strict regulations around how data can be transferred within the government bureaucracy. 

Japan is also quickly pushing towards establishing a digital national ID system. This does not come as a surprise because OECD study from 2017 shows that Japan is at the bottom of the bracket when it comes to preparedness of utilization of electronic health records (EHR). While in the EU, only some of the slower agencies such as EMA were still using Internet Explorer in March 2022, in Japan 49% of businesses were using the now forcibly removed browser.

Facsimile and other ancient methods

If floppy disks and internet explorer make you feel depressed about the state of technology in life sciences, let this one sink in: fax machines are still commonly used in healthcare, and not just in Japan.

Hospitals and healthcare centers fax documents because of lack of technical skills of the staff to use computers and the electronic health record systems that are now being implemented and improved everywhere. 

Use of fax is still part of the pharmaceutical industry, as well. Fax number is still almost always asked about in due diligence processes, audit questionnaires, RfPs or other documentation, and is covered by effective guidelines and legislation.

Fax machines as we know them were developed in the 1960s and commonly used in the 80s and early 90s. During the past 30 years they became largely obsolete when the internet and email became the standard way of communication.

It’s good to point out that “newer” information storage and transfer technologies, that some of us might consider more modern, are also past their expiration date and becoming obsolete. Email (1960s) is actually about the same age as fax machines and older than floppy disks, and for example DVD technology is soon turning 30 years old and will face the same fate as floppy disks, at least in a working environment. That being said, we have to point out that you can still find mentions of DVD in effective legislation and guidelines around the world and email is so ubiquitous that it’s probably not going anywhere any time soon.

Cloud transformation

We want to emphasize that the regulators and government agencies consist of smart people too, and these smart people do not live in bubbles. They know they are using aging technology and many of them are pushing things forward. Let’s take EMA’s cloud transformation initiative as an example. (Not because EMA would be any worse than other regulatory authorities, this just happens to be a topic we know well.)

EMA adopted a cloud transition strategy in 2017. The goal is obvious – modernization of the computer systems and bringing their processes to current day. But as with most public projects, it takes time. The strategy has a timeline until 2025 and as we’ve pointed out in several of our blog posts related to EMA’s system updates, the system development and technology adoption projects usually take a lot longer than planned. EMA has described in its joint 2025 strategy with HMA that building the capabilities in the organization is one of the key aspects. What if they fail bringing in the talent and updating the skills of the existing employees?

Also, we want to highlight in the historical context of this post that the first commercial cloud storage was launched in 1983 and that even Amazon S3, which runs half the internet, is already at driving age (at least in some states). That is to say that cloud has been around for a long time and while it has not been the most suitable solution in the pharmaceutical regulatory setting for several reasons (security, price, connectivity etc.) we should also look into our own society: if the pinnacle of multi-year transformation strategy of our central medicines agency is to acquire required technical knowhow to adapt a 40-year-old technology, isn’t there an issue somewhere? To simplify the matter quite heavily: cloud services are older than the people who are now trying to wrap their heads around this “new” technology.

It would be a low-blow to go and blame the educational system, but it does seem that something needs to change in the way we learn and embrace the changing environment. At least in Finland, the jump from “pen and paper” system to using computers, tablets and phones daily in early education has happened only in the past decade. If this is the speed that we can implement new technologies to basic education, what will happen now that any 7-year-old can use ChatGPT or Bing to do all their school work? (And the 7-year-olds of today will know how to do it, even if their teachers wouldn’t.) This should resonate with almost anyone who has been watching the morning news discussions about the weekly AI breakthroughs that seem to disrupt whole industries.

Rat poison is good for you

Slow implementation of new technologies and sticking with legacy systems are issues that almost all healthcare professionals run into almost daily when working with patients and the administration related to hospitals and care homes. As hinted at in the beginning of this blog post, today it is easy to get swept up by the possibilities of BioGPT for literature review, blockchain in healthcare, VR in remote surgical operations, metaverse for relieving the hospital queues and ideas such as singularity giving us hope of living forever if we just make it to the 2030s. 

To bring you down to earth, just think of a nurse in the US faxing a COVID-19 adverse event form or a clerk in Japan sending important business data on a floppy disk (that must have been manufactured at least 12 years ago, probably much more, because nobody makes them anymore.)

In the pharmaceutical industry we live by the “old is gold” standard. The most used active pharmaceutical ingredients for headache, pain relief and to bring down fever, paracetamol (1852), acetylsalicylic acid (Aspirin, 1899) and ibuprofen (1961), are all dangerous substances if used incorrectly but nobody has managed to develop better, affordable and easy-to-use options. 

Speaking of pain relief, while the probably most effective cough medicine, Heroin (1898), is no longer used for its original purpose nor its secondary use in pain treatment, other products from the same opiate family are still commonly used for pain management. Opium poppy has been cultivated for thousands of years and different forms of its extract have been used for pain relief for hundreds if not thousands of years. While opioids are great for cough suppression and taking the pain away, they also have a seriously negative side effect profile. 

And it is not just pain relief that seems to be stuck in the past. Methotrexate (1947) is still one of the most commonly used drugs in cancer treatments. Medical cannabis products have been approved relatively recently to certain markets around the world but cannabis has been cultivated and burned for thousands of years. Other previously banned or controlled substances that are now the object of cutting edge research, are for example LSD (1938) and Ketamine (1962). LSD and other psychedelics are also just a laboratory version of the millenia-old tradition of consuming certain mushrooms for their side-effects.

To wrap up this pharmaceutical history lesson and to finally circle to the second part of the blog post’s title, let’s mention that Warfarin (1954) is still one of the go-to treatments for blood thinning and rodent control (killing rats).

Things will change

Pharmaceutical industry is innovating, but maybe in the wrong areas. Concentration seems to be in the most profitable areas such as oncology, Alzheimer’s, Parkinson’s, MS etc. While these are areas that need effective treatments, what we all (everyone) really could use is some new antibiotics, effective but non-addictive pain medication, vaccines and preventative treatments (monitoring and alerting systems).

It might seem weird to put two quite different areas side to side: computers and medicine. The history of computers starts in the mid 20th century while medicine has been part of human history since the beginning. However, the point that we are trying to make is that development of medicine and healthcare in general has been stagnant for literally thousands of years: we get sick, we seek help, doctor or shaman has a treatment which is either consumed orally, by inhaling, by rubbing ointment or we get treated by the healthcare professional in a hospital or sacred ritual site, and finally there is an end result to the treatment.

Of course there has been development in some treatment areas (such as those listed above) and sometimes the medicinal products are less dangerous and even more effective than the placebo. Nowadays patients have better survival rate in the hospital than outside, which wasn’t always the case. While the pharmaceutical industry is a relatively new addition (a couple hundred years or so) to the healthcare ecosystem, in essence the companies are producing industrialized versions of the tribe healer’s potions. So, despite all the improvements, the basic steps of the treatment process have remained the same since the beginning of written history. 

Meanwhile, the history of computers has developed in 70 years from a warehouse full of machinery being able to do “simple” calculations to watch-size devices that are able to produce complex models that are able to access “all” the knowledge in the world. Now computers have become part of all areas of life, including healthcare and medicine. And it seems that because there is an inherited resistance to change in the healthcare system, the change may happen from the outside. 

This means that the future of medicine will look different. Instead of the traditional healthcare professional patient relationship, the patient will be responsible for their own health and treatment. The main decision maker will be you, with the help of the computer. Google has been the most trusted doctor in the world for years and now that the machines are able to answer our questions with the same style and confidence as any trained physician, why would anyone go to the hospital and queue to get answers that they can get in seconds anywhere? Don’t forget that the machine has access to “all” the information while the doctor only has access to what they have learned..

With smart devices such as phones, watches and smart glasses combined with AI, the treatment of illness will give way to prevention of illness. The most common illnesses could be avoided without the weak link of the equation – humans. And when implants seem to be a very likely piece of our future, that weak link will also become at least a bit stronger.

And still, our prediction is that when all of us live in this future with cyborgs and flying cars, the Japanese bureaucrats will still be requesting their floppy disks, French tax administrations will be stamping their paper forms, and the American nurses will be sending medical records with their fax machines.