A drug solution in a modern syringe like novel food – regulatory issues of a drug, medical device and novel food (a borderline product)
Publication date: April 11, 2023
A drug in a disposable dispenser as a slimming agent – is it legal?
Press controversies related to the use of modern drugs created for the treatment of chronic diseases for procedures with the use of their side effects raise a number of legal problems related to the legality of using such medicinal products for non-dedicated procedures with the use of side effects of the medicinal substance.
Legal assessment on the example of press releases about the use of diabetes drugs, such Ozempic for slimming. Regulatory issues between the drug law and the law of medical devices.
Particular attention in the public space has recently been drawn by the popular among celebrities phenomenon of using a drug for diabetes by healthy people as a preparation for drastic slimming. This is a very interesting practice from the perspective of regulatory issues. It is important to use a serious drug in a medical device like novel food, which raises the question of regulatory issues. It is also important that this preparation is sold in a modern disposable syringe, in which the pre-filled solution has a specially dedicated dispenser in the form of a modern syringe.
Using a drug solution in a factory medical device like novel food – identifying drugs with unexpected off-target effects.
Ozempic has accidentaly become a multi-targeted drug. It is the trade name for an injectable solution containing the drug semaglutide, which is used to treat type 2 diabetes. This drug works by increasing the release of insulin and lowering blood sugar levels. It is sold in pre-filled pens that allow you to administer your dose easily and safely. Recently, Ozempic has also gained popularity as a way to lose weight. Some people use this drug off-prescription in the hope of helping them lose weight. There are studies suggesting that semaglutide can lead to weight loss in some patients, but using it for weight loss without medical supervision can be not only dangerous but also ineffective. The drug suppresses appetite by affecting the central nervous system, making patients less likely to eat high-fat foods, and as a result, quite significant weight loss has been observed.
It is worth noting that medicine such as Ozempic is a prescription drug and its use should always be consulted with a doctor. Pre-filled pens with medicines such as Ozempic are regulated by drug safety authorities and their regulatory status depends on the laws of each country. In most cases, you need a prescription from a doctor to buy and use this medicine. On the official website of the manufacturer of the drug, we can read that producer is experiencing higher than expected demand for Ozempic, which results in its limited availability in pharmacies around the world.
What should be drawn attention to in this respect is also the activity of regulatory authorities that regulate the sale and trade of Ozempic. Polish Ministry of Health has published a new notice on medicinal products, foodstuffs for particular nutritional uses and medical devices at risk of unavailability. The list included 256 items. So-called anti-export list includes medicines, certain food products and medical devices that may become a scarce product, therefore special regulations are needed. This new list of medicinal products, foodstuffs for particular nutritional uses and medical devices at risk of shortage include: painkillers, insulin or formula milk. It also includes Ozempic.
Legal aspects of using diabetes drugs such as Ozempic as a disposable pen in Poland and the European Union
From a regulatory perspective, an interesting issue is whether in Poland and the European Union (EU) a pre-filled pen, i.e. a drug that is filled once in a dispenser, can be considered a medical device. In this case, in addition to the restrictive provisions of the pharmaceutical law, it should also be assessed from the perspective of the requirements of medical devices.
In the European Union, there is Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, which entered into force in May 2020 and replaced the Medical Devices Directive. This Regulation defines the requirements for the safety and effectiveness of medical devices, and the application of these rules is also important from the perspective of pre-filled pens. In the case of medicines that are also associated with medical devices, additional requirements for their registration and marketing authorization should apply. Drugs on the border between a drug and a medical device are drugs that have both medicinal properties and mechanical, physical or chemical effects, and their purpose is to prevent, diagnose, treat or alleviate a disease or injury. Such medicines are subject to specific regulatory requirements and must be assessed by regulatory authorities, such as the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) in Poland or the European Medicines Agency (EMA) in the EU, before being approved for marketing.
The conclusion is that the pre-filled pen, which is filled once in the dispenser, should also be analyzed from the perspective of the legislation on medical devices both in Poland and in the European Union. If it is also a drug on the borderline between a drug and a medical device, it must be assessed by the appropriate regulatory authorities before being allowed on the market.
Placing a medical device on the market
Placing a drug or medical device on the Polish or European market requires meeting certain regulatory requirements. Although there are similar procedures in both cases, there are some important differences between them. In Poland, placing a drug on the market is regulated by national law, including in particular the Pharmaceutical Law and the Regulation of the Minister of Health on procedures related to the marketing of medicinal products. In turn, in the European Union, the marketing of medicines is regulated by legal provisions unified under the European Medicines Agency (EMA) and the European Commission. Similarly, placing a medical device on the market in Poland is regulated by national law, such as the Medical Law Act, the Medical Devices Act, and regulations of the Minister of Health.
In the European Union, placing a medical device on the market is regulated by EU law, in particular by the Directive on Medical Devices and the Regulation on Medical Devices. An important difference between placing a medicine on the market and a medical device is also the time required to obtain an authorisation. In Poland, procedures related to placing a drug or medical device on the market are longer than in the European Union. In Poland, it usually takes about 210 days, while in the EU it is about 120 days.
Another difference is also the requirement of CE certification, which is required for most medical devices placed on the EU market. This certificate confirms that medical devices meet the safety and health requirements required by EU law. In Poland, such a certificate is not required, although manufacturers of medical devices may decide to obtain it in order to improve their image and quality.
The difference between placing a legal drug on the market and a medical device is that the requirements for placing a drug on the market apply specifically to drugs, while the notification of the sale of a medical device applies to medical products that are not drugs. The requirements are similar in that they both require testing and proving the effectiveness and safety of the product, but are specific to the type of product that is being marketed. Whereas, the differences between the marketing of a medicine and a medical device are that the introduction of a medicine requires approval by a regulatory agency, and the introduction of a medical device requires compliance with certain requirements, but does not always require approval by a regulatory agency.
The above rules, of course, apply to the legal use of the drug and the use of a medical device for a dedicated medical procedure for which the drug or device was created. Such a regulatory problem, however, is compounded by the practice of prescribing such a borderline product for purposes other than intended for healthy people from the perspective of a dedicated disease.
The black market and the growing popularity of misuse of drugs with unexpected off-target effects on the internet
Nowadays, the problem of obesity has become one of the biggest health challenges. Therefore, many people are looking for effective ways to fight overweight and obesity. Unfortunately, some of them decide to look for slimming drugs on the black market, which can lead to serious health problems. Keep in mind that looking for weight loss drugs on the black market is illegal and carries serious health risks.
Drugs sold in this way (specifically, the way and purpose of selling such a preparation) are not approved by regulatory authorities and do not meet the standards of safety and effectiveness. They may contain unknown ingredients or toxic substances that can lead to unpredictable health effects. In addition, many weight loss drugs work by suppressing appetite or increasing metabolism, which can lead to serious metabolic and hormonal disorders. An example of such a phenomenon is the non-dedicated turnover of Ozempic. Meanwhile, Ozempic – like any drug – has a long list of side effects. As we read in the leaflet, the most common are nausea, vomiting, abdominal pain, diarrhoea, constipation, dizziness, but it also happens that acute pancreatitis, hypoglycaemia or diabetic retinopathy occur.
In most cases, people who express a positive opinion about a drug used to treat overweight or obesity (not related to type 2 diabetes, for which the drug is intended), take it for a short time, only a few weeks or months. Most of the reviews focus on the positive effects and concern questions about the availability and cost of the product, and information about side effects is rarely discussed. Uncontrolled use of medication can lead to excessive weight loss, dehydration, heart rhythm disturbances and other serious health problems. The problem of finding drugs for weight loss on the black market is particularly acute in countries with weak regulatory standards and in developing countries. According to press reports, the drugs with unexpected off-target effects such as Ozempic are gaining more and more popularity over time as a kind of dietary supplementation, which means that it is missing in pharmacies around the world for dedicated procedures, and Poles in search of this drug supposedly “fragment” prescriptions and specially go to Czech in search of a cure. On the Internet, you can also come across numerous sales offers with the content – “I have Ozempic 0.5 and 1 mg for sale, please leave an e-mail”.
The problem of the growing popularity of diabetes medications concerns, according to press reports, even the biggest celebrities, such as the founder of Tesla – Elon Musk recently lost almost 30 pounds (or about 13 kg), and when asked about his “secret formula”, he indicated, among others, just to use the medicine with semaglutide.
What are prescription pharmacies and the problem of online pharmacies in the United States
The problem of a prescription drug in Poland under the Pharmaceutical Law Act concerns the status of pharmacies that not only sell ready-made drugs, but also prepare prescriptions and mix active substances. According to the Polish Pharmaceutical Law, pharmacies are the only places where you can perform activities related to the sale of medicinal products. This means that pharmacies are the only places where you can dispense prescription drugs and carry out their prescription production. In Poland, prescription pharmacies are authorized to prepare prescription drugs, i.e. to mix active substances in specific doses and drug forms, based on an individual medical prescription. These pharmacies must meet certain technical requirements, including appropriate equipment and medical staff. Pursuant to the Act, a prescription pharmacy must meet specific requirements, such as having qualified staff and appropriate equipment and pharmaceutical tools. This pharmacy must also be registered as a specialist pharmacy.
Prescription pharmacies are required to follow strict procedures for the preparation of medicines, including grinding and mixing of active ingredients. All these activities must be performed in accordance with pharmaceutical requirements to guarantee the safety and effectiveness of the drugs. In Poland, prescription pharmacies play an important role in ensuring the availability of non-standard and personalized medicines that cannot be found in ready-made form on the market. However, due to the complicated drug production process, prescription pharmacies are subject to strict control and supervision by regulatory authorities, such as the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).
In the US, there are some online pharmacies that offer substances similar to semaglutide, but in stronger concentrations than Ozempic. Illegal online pharmacies may offer these substances without a prescription or proper medical evaluation, which poses a risk to patients’ health. Buying drugs from illegal sources can lead to serious health problems because the quality, composition and safety of these drugs are not controlled by any authorized bodies. In the United States, online drug sales are regulated by the Federal Food and Drug Administration (FDA) and state regulators. Still, there are other problems with online pharmacies that sell drugs in higher than normal concentrations, such as:
- Lack of regulation: Some online pharmacies operate without proper licenses or approvals from regulatory authorities, which can lead to the sale of drugs with incorrect concentrations or the wrong quality.
- Lack of prescription: Some online pharmacies allow customers to purchase medications without the required medical prescription.
- Mislabeling of products: Some online pharmacies may mislabel products, thus misleading the customer.
Another problem is the inability to obtain advice from a pharmacist, which can lead to errors in dosing or drug interactions. There is also a risk that illegal online pharmacies may sell drugs that do not comply with substance control laws, such as opioids.
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