Expired medicines - what is the practice in the EU

Expired medicines represent a specific waste stream that poses risks to the environment and human health. This fact causes EU countries to have a special approach and legislation indicating at the state and municipal level the methods for their collection, management and treatment. Member States follow regulations and directives established at the European Union level, adapting them to their national legislation. Countries such as Germany, France, the United Kingdom and Bulgaria have developed special regulatory frameworks for pharmaceutical waste management. In Bulgaria, this is REGULATION No. 4 OF 16 MAY 2018 ON THE CONDITIONS AND PROCEDURES FOR THE DESTRUCTION OF MEDICINAL PRODUCTS (TITLE AMENDED - SG, NO. 111 OF 2020), issued by the Minister of Health.
However, in order to successfully implement the legislation, Member States rely on several factors simultaneously, namely: awareness and engagement of the population, building an appropriate and easily accessible infrastructure, repeatability and regularity, and subsequent control. The common practice is to return old medicines to pharmacies and/or to special hazardous waste collection points, from where they are delivered to incinerators for incineration.

The organization of the old medicines collection system varies in different regions of Germany. The common practice is to return them to pharmacies or to specialized mobile collection points. The collected old medicines are incinerated. During incineration, the active ingredients of the pharmaceutical products are destroyed and do not pose a risk to the environment or human health.

32 years ago (1993) in France, the joint efforts of pharmaceutical manufacturers and wholesalers launched the Cyclamed program. Initially started as a voluntary organization, due to the concern of companies for the environment, the program has become a working system for the collection and destruction of old medicines. The medicines are returned to pharmacies. Every year, over 9,000 tons are burned in one of the 50 incinerators in the country. All you need to know about sorting and collecting expired medicines

In Lithuania, Greece and Austria, old medicines are returned to pharmacies, where they are collected and handed over for incineration.

In our country
A special regulation has been adopted in Bulgaria that regulates the collection and incineration of expired medicines, including those that do not meet quality and safety requirements, have a changed appearance, are counterfeit or of unknown origin, and have been confiscated for the benefit of the state. However, the organization of collection from households remains outside the scope of the regulation.

It is a commitment of the municipalities, which have a different approach.

The widespread practice is to hand them over to mobile points or specialized sites. Unlike other EU countries, pharmacies do not participate in this organization. This practice has been implemented in our country recently and due to the lack of information campaigns, repetition and lack of infrastructure for their collection, activity is still low.

What are the fines in the EU if you do not comply with the rules

The sanctions for non-compliance with the regulations vary in the different EU member states. Each country individually determines control mechanisms, which may include revocation of licenses, administrative sanctions and monetary fines. There is no publicly announced summary information by member state regarding the collected quantities of waste from expired medicines. The same applies to Bulgaria.

How dangerous are expired medicines?
There are many scientific publications on the subject supporting the claim that unsustainable management of pharmaceutical waste leads to the possibility of them ending up in the wrong places and causing a negative effect on the environment and human health. Once in the sewer system or in landfills, the active substances contained in medicines pose a threat to aquatic ecosystems. Hormones and antibiotics contained in certain medicines, once in the soil, can lead to changes in biodiversity. Recently, there has been increasing talk about the risk of developing antibiotic residency resulting from improper management of pharmaceutical waste. Antibiotic resistance is considered the next big medical problem. Antibiotics released into the environment can lead to the development of resistant bacteria, which can make treatment difficult in humans and animals.

According to data from the World Health Organization (WHO), antibiotic resistance is the new medical problem.

It is estimated that in 2019, 1.27 million people died globally from antibiotic resistance, and it indirectly contributed to the deaths of another 4.95 million. Antimicrobial resistance

How to dispose of drugs and the problem of dumping them in rivers

The correct and safe method of disposing of drugs is through thermal treatment (burning) in an incinerator. This is also the European practice. This type of facility also has the ability to use waste heat to produce electricity. This prevents them from ending up in landfills, water bodies, soil and other inappropriate places that pose risks, while at the same time using them as a raw material for energy production, which is entirely in the context of the circular economy. As is evident from media reports, not all medicines end up in the appropriate facility and are dumped in rivers, landfills, mines, and unregulated dumps. One of the reasons for this is that the generators, the owners of this type of waste, are unwilling to pay for the incineration service, which is why they conclude contracts with intermediary companies offering inexplicably low prices without caring about what happens next and what the path of the waste is. The mass perception of waste owners in Bulgaria is that once they hand it over to a licensed company, including one that only has a storage or transport permit, they are not responsible for its subsequent treatment. They look for companies that will offer them the most favorable conditions to get rid of it, and thus spread the problem further. And here we come to the control by the institutions. The regulation on the destruction of medicines is under the control of the Ministry of Health, while the control of waste management is under the control of the Ministry of Environment and Water. Practice shows that when control is in several departments, doors are opened for abuses.

As for citizens, they currently rely only on information and self-awareness. Other holders of old medicines, besides households and distributors, are hospitals and the Customs Agency, when it comes to counterfeit or confiscated medicines for the benefit of the state.

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