***I will now be sharing the English version of the Turkish article I have written before (04.10.2021).
It has been quite a while since I wanted to share my thoughts with you about replicas that have been on our agenda in the healthcare industry in recent years. While sharing my thoughts on this subject in this article, I will also try to bring to your attention possible risks of replicas.
Before going into details, I strongly stress that my thoughts and evaluations have nothing to do with a particular institution or brand and solely aim at providing information and raising awareness.
Substitutes & Replicas
A substitute is a product that can be used in place of another product that is used for a certain treatment but is not available. We physicians often use the term “equivalent” for a product that can be used in place of the original product. An equivalent drug is well acknowledged not only by healthcare professionals but also by patients in general who use the drug. They are usually said to have the same content as the original drug, but these drugs are made available incurring lower costs during both the manufacturing and marketing phases. This is why they are sold cheaper than original drugs and they create a new market segment for themselves. Each of these substitutes has a different packaging design and is never sold in exactly the same packaging as the original product.
A replica, on the other hand, is a product released for sale using a marketing tactic implying that it is a similar product to, or a copy of, the original product as we see them often in recent years. Looking from outside, replicas cannot be easily distinguished from the original products. Similarity in appearance with the original product, not quality is the priority in the sales targets of such products. For this reason, they have lower prices.
Replicas are also found in many other industries such as technology and clothing; as cheap as they may be, the uncertainty involved in the materials used in their make-up may have a negative impact on product quality and human health.
Health is certainly a very special, ethical matter we cannot compromise for ourselves and our loved-ones. Neither patients nor physicians would want to use or have their affiliates use a product which is not original or equivalent, not backed by scientific trials and evidences, and not approved by official bodies. Despite this, we see lately that replicas are replacing substitutes, equivalent products, also in the healthcare industry in Turkey. The meanings of a substitute and a replica have almost intermingled and replicas began to be marketed as if they were substitutes.
Medical Devices Industry and Replicas
I want to regretfully say that replicas started to be used recently at considerable rates also in the medical devices industry, in which I am personally involved as a surgeon.
The main reason for this is, of course, economic concerns. Harsh reflections of economic problems in global markets on our country and excessive rises in foreign exchange rates have led to incredible increases in the costs of medical devices. Dropping general profitability in the healthcare industry has induced institutions to use equivalent and replicated products instead of original ones under a cheaper price policy. Since local manufacturing of original products is very rare, we can obtain such products only through importation.
Another problem at this point is that physicians working at institutional hospitals are no longer being asked for their opinion and approval in selection of medical material as it used to be. In this state of affairs, many medical firms selling replicas entered the Turkish market and such entries are still going on.
Replicas & Possible Risks
Replicas are coming mostly from the People’s Republic of China. We know that China is the world leader in the production of replicas in almost all industries. I do not see any harm in their presence in world markets of various industries with their own brands making use of learned technologies. The main problem here is that the standard quality processes that a replicated medical device goes through before appearing on the market is not the same as that of the original product, cheap raw materials are used in their production, and the approval processes are carried out in a very speedy manner. And maybe the most important of all is that a replicated device has exactly the same appearance as that of the original product in its design and technology.
We should bear in mind that we are now facing a completely different situation as opposed to the contract manufacturing China was providing to companies producing original products and we should be careful.
What are the characteristics of original medical devices? Let’s talk about this a little if you wish.
Common Characteristics of Original Medical Devices
- Original medical devices go through serious scientific R&D processes before they are made available for use.
- All such devices are original, they are not copied products.
- Since safety is a priority and very important in the use of original medical devices, they are made subject to many safety tests before they are released for use.
- Before being introduced to the market, these devices will have received approval certifications from globally recognised institutions (FDA for America, UKCA for Great Britain, BfArM for Germany, etc.).
- To improve human health, there are medical support and education programs for the users of original devices.
Now, let’s move to the characteristics of replicated devices.
Common Characteristics of Replicated Medical Devices
- No research and development (R&D) works are carried out for replicated devices, they are produced making use of previous contract manufacturing experience.
- Such devices are not original; their designs are made to resemble their originals.
- Whether they go through satisfactory safety procedures is unknown.
- Use of cheaper raw materials is preferred to lower the price of the product.
- Institution approvals for the device are usually obtained from China (SFDA, CFDA) and the local authorities of the country in which they will be used. Almost none of them have any approvals from the FDA (American Food and Drug Administration) or any other developed country.
- Again, almost none of them have any sales/marketing activities in developed countries (USA, Canada, UK, Germany, etc.).
Please do not draw the meaning “Chinese products are bad, never use them” from what I have been telling above. Of course, that is not the case! What I want to say here is this: Health is a very sensitive subject. Use of replicated products or devices in the healthcare industry is not the same as using them in other industries.Some problems that may arise from use of replicas in healthcare can threaten the health of many people in an exponential way. We, physicians would not want imperfections associated with medical devices to harm our patients and affiliates.
So, what should persons and institutions using or intending to use replicated devices be careful about?
Cautions about Use of Replicas
- An official commission should be established to investigate in detail the products introduced by replicated product companies in the medical device market.
- Besides the approvals given to replicas by production centres, their international validation approvals should also be obtained (FDA for America, UKCA for Great Britain, BfArM for Germany, etc.).
- The Turkish ISO (Turkish Standards Institute) should exhibit a much more meticulous approach in this respect, exercising due diligence in the investigation and authorization stages.
- Many replicated products show their CE (Certificate Europe) approval as reference, but the CE approval has become a very easily obtained certification, unfortunately. The ISO criteria should supersede the CE criteria.
- A group of concerned physicians should participate in replicated product procurement commissions at all healthcare institutions.
- Hospitals and institutions using replicas should be kept under strict surveillance; any problems there should be investigated in detail and reported.
We, as physicians, should always keep this in mind; if we are choosing to use a particular medical product for ourselves and our affiliates, we should be conscientious to use the same product for our patients. Opting for substandard cheap products to lower costs will result in higher middle and long term costs in healthcare.
Finally, I would like to share a saying that is used in digital marketing, which I like.
“If you are not willing to pay the price of a product, you are the product”.
Once you choose to use a product cheaper than its original in the healthcare industry, you will inevitably be facing some kind of a complication.
Prof. Halil COSKUN M.D.