to the point: Healthcare & Life Sciences Q2/2025

Digital healthcare is on the rise – and increasingly crossing borders. But who can treat whom, where and under which law? These questions lie at the heart of Case C-115/24 (UJ v Österreichische Zahnärztekammer), in which Advocate General Athanasios Rantos delivered his Opinion on 8 May 2025.

The case concerns an Austrian dentist cooperating with two German companies via the "DrSmile" platform. Central to the proceedings is the question of whether Austrian dentists may participate in orthodontic treatments for Austrian patients, where the services are offered and managed by DZK, a German-licensed private clinic. The Austrian Dental Chamber contests this cooperation under national professional rules.

In his Opinion, Advocate General Rantos made several key points:

• Not all digital care is telemedicine: Only medical services delivered exclusively via ICT – without any physical contact – qualify as telemedical services under EU law.
   
• Country-of-origin principle applies: The applicable rules for such services are primarily determined by the Member State where the provider is situated (in this case Germany).
   
• National rules must respect EU freedoms: Strict national requirements on practice structures (e.g. shareholder composition of dental clinics) or professional involvement may violate EU internal market rules unless clearly justified by overriding public interest.
   
• EU professional qualification rules do not apply to remote-only services: Recognition of professional qualifications under Directive 2005/36/EC does not apply in the absence of physical cross-border activity. Austria therefore cannot require compliance with its domestic professional rules in such cases.

This Opinion highlights the growing legal complexity surrounding cross-border digital healthcare. It underscores the need for legal clarity and proportionality in Member State interventions, especially where innovation in healthcare delivery challenges traditional regulatory categories. The CJEU's upcoming ruling will provide an important precedent for the future governance of cross-border digital health services within the EU internal market.

At the end of last year, the European Union adopted its most significant packaging legislation in decades: Regulation (EU) 2025/40 on Packaging and Packaging Waste (commonly referred to as the PPWR). This sweeping legal act, spanning over 100 pages, entered into force on 11 February 2025 and will become applicable on 12 August 2026.

Key highlights of the PPWR

• Extended Producer Responsibility
  
  A central pillar of the PPWR is Extended Producer Responsibility (EPR), which holds producers accountable not only for the manufacture and distribution of their products but also for the management of their packaging waste. While current EPR rules differ across EU Member States, the PPWR introduces a unified framework. The regulation also introduces eco-modulated EPR systems, which incentivise sustainable packaging design by adjusting fees based on environmental impact – lower fees for environmentally friendly packaging, encouraging the development of sustainable alternatives.
   
• Ban on certain single-use packaging
  
  The regulation prohibits specific types of single-use packaging, such as plastic packaging for fresh fruit and vegetables under 1.5 kg, small plastic sachets for condiments, sauces, jam, instant creamers, sugar and spices used in catering facilities, miniature bottles of cosmetics and toiletries in hotels, and lightweight plastic shopping bags.
• Mandatory packaging labels
  
  Packaging must now bear harmonised labels indicating material composition, helping consumers sort waste correctly.
   
• Mandatory recyclability and packaging design requirements
  
  All packaging must be designed for recyclability, with efficient recycling in mind. Packaging must also be minimised in volume and weight. The regulation bans features such as double walls, false bottoms or unnecessary layers that create the illusion of larger product volume.
   
• Mandatory recycled content in plastic packaging
  
  The PPWR sets minimum targets for recycled content in plastic packaging made from post-consumer waste.
   
• Support for deposit-return systems
  
  The regulation sets ambitious collection targets for plastic bottles and metal cans. If Member States cannot meet these targets through other means, they will be required to introduce deposit-return systems.

The PPWR marks a significant shift in how the EU approaches packaging and waste. While packaging plays a vital role in product protection and distribution, it also represents a major source of environmental waste. The regulation responds to the urgent need to reduce packaging waste, increase recycling rates and accelerate the transition to a circular economy. The ultimate goal is to keep packaging out of landfills and in the production cycle as a reusable resource.

Clinical trials

The Clinical Trials Regulation is fully operational as of 31 January 2025, marking the official launch of the EU Portal CTIS, which now serves as the central platform for managing all active and ongoing clinical trials within the European Union. Therefore, starting 31 January 2025, all EU/EEA clinical trials must be conducted in accordance with the CTR and be processed via CTIS.

The European Medicines Agency ("EMA"), responsible for overseeing the implementation of the Clinical Trials Regulation, released a new clinical trial map in March 2025. The introduction of CTIS marks a significant advancement in the efficiency of rare disease treatments and the adoption of innovative technologies. The system features a publicly accessible, searchable database designed for healthcare professionals, patients and the public. The clinical trial map, developed using data from CTIS, enables users to locate ongoing trials by geographic region and medical condition. This initiative is expected to enhance access to clinical research and emerging technologies for patients and consumers throughout the EU.

European Health Data Space

Regulation (EU) 2025/327 on the European Health Data Space (the "EHDS Regulation") came into force on 26 March 2025. Its primary objective is to facilitate improved access to and sharing of patients' and citizens' health records, e-prescriptions, medical images and test results across EU Member States, guaranteeing informed treatment decisions and ongoing patient care.

Implementation of the EHDS Regulation will occur in stages over the next years. The process will involve the development and adoption of over 20 Implementing Acts and the establishment of relevant governance structures in the next four years. The EHDS Regulation will become applicable from 26 March 2027, but the first set of priority data categories – such as patient summaries and e-Prescriptions or e-Dispensations – is expected to become operational by 26 March 2029. The rules on secondary use will also begin to apply from that date. By 26 March 2031, the EHDS Regulation will extend to include additional data categories.

Health data cybersecurity

In January 2025, the European Commission introduced an EU Action Plan on the Protection of the Health Sector from Cyberattacks. This plan addresses the increasing risk of cyberthreats targeting hospitals and healthcare providers. Its aim is to strengthen the sector's capacity to prevent, detect, respond to and recover from cyber incidents. The plan builds on existing EU cybersecurity frameworks, including the NIS2 Directive and the Cyber Resilience Act. The EU's cybersecurity agency will set up a pan-European Cybersecurity Support Centre, offering tailored guidance, tools, services and training to hospitals and healthcare providers. Ensuring cybersecurity is critical for the successful implementation of the European Health Data Space.

European Shortages Monitoring Platform (ESMP)

On 2 February 2025, the European Shortages Monitoring Platform (ESMP) became mandatory for marketing authorisation holders to report shortages of centrally authorised medicines. Reporting can be carried out using templates via the ESMP user interface or through automated machine-to-machine communication. The ESMP plays a vital role in managing and preventing medicine shortages across the EU and EEA by streamlining and automating data collection, thus providing regulatory authorities with real-time information on the availability and demand for medicinal products.

Critical medicines

In March 2025, the European Commission also put forward a proposal for a Critical Medicines Act. This proposed legislation is intended to strengthen the  security of the EU's critical medicine supply by addressing shortages, reducing dependence on single suppliers and supporting increased pharmaceutical manufacturing within the EU.

Austria is preparing for a major update to its tobacco legislation. A draft law from January 2025, initiated under the former Minister of Health, proposes a new Tobacco and Nicotine Protection Act. The reform aims to modernise the legal framework by clarifying and simplifying existing rules, better reflecting new product categories, improving enforceability, and strengthening consumer and youth protection.

The proposal introduces a new product category called "Other Products", covering nicotine-containing products without tobacco (e.g. pouches or sprays). For these products, key elements include a nicotine content limit, registration and labelling requirements, a nationwide sales ban for under-18s, strict advertising and sponsorship restrictions, and limited distribution channels.

Another central aspect is the gradual implementation of several EU directives. In compliance with Directive (EU) 2022/2100, heated tobacco products – particularly tobacco sticks used in heating devices – will no longer be exempt from EU rules on combined health warnings and information messages, and flavoured variants will be banned entirely. This aligns the regulation of heated tobacco with the strict standards already applied to cigarettes and roll-your-own tobacco.

The changes regarding heated tobacco products were addressed by the current government in mid-June 2025, with a parliamentary vote expected in the coming weeks. However, the broader draft law – and especially the proposed regulations on nicotine pouches – has not yet been formally taken up. It remains unclear when and how Parliament will address the full proposal, and whether it will be adopted as is, amended or delayed.

Nevertheless, given the focus on public health and the potential for increased tax revenue, both the changes to heated tobacco products and the regulation of nicotine pouches, which have so far been freely marketed, appear likely. Businesses in this sector should prepare for stricter national rules, particularly concerning product labelling, distribution and marketing.

In its decision of 25 March 2025, the Supreme Court confirmed its earlier decision in the interim proceedings (4 Ob 80/22a) that pharmaceutical law does not prohibit the advertising of active ingredients to healthcare professionals and pharmaceutical companies (i.e. doctors, pharmacists, pharmaceutical manufacturers), even if they are advertised as suitable for use in magistral formulas prepared in pharmacies. The plaintiff based its action for injunctive relief against the corresponding advertising of active ingredients on the prohibition of advertising for unauthorised medicinal products. The Supreme Court clarified that active ingredients have been excluded from the definition of medicinal products and defined separately, in line with EU law, since 2013 following the implementation of Directive 2011/62/EU. As the advertising ban only covers medicinal products but not active ingredients, advertising for active ingredients is not inadmissible (4 Ob 178/24s).

Schoenherr represented the defendant in these proceedings.

The Bulgarian Commission for Protection of Competition (CPC) has launched a comprehensive sectoral analysis of Bulgaria's wholesale and retail pharmaceutical markets. The aim is to examine the structure and functioning of the medicines supply chain, the behaviour of market participants and the causes behind the recent shortages of medicines in the country. The investigation will consider factors such as production delays, raw material shortages, increased demand, distribution issues, parallel exports and price regulation, all of which may contribute to the problem.

With direct patient payments for healthcare in Bulgaria reaching 34 % of household income – significantly higher than the EU average of 14.5 % – the affordability and pricing of medicines have become matters of heightened public concern. The analysis will also address suspected issues like unequal treatment of pharmacies by wholesalers and parallel trade in banned medicines. The CPC will assess whether these challenges stem from objective circumstances or from anti-competitive practices that distort the market and harm consumer rights. If evidence of unfair commercial practices, abuse of dominant position or prohibited agreements is found, the CPC will initiate further proceedings. In collaboration with the National Revenue Agency and the Commission for Consumer Protection, the CPC will also monitor for unjustified price increases, especially in light of the upcoming adoption of the euro, to ensure that any such increases are not the result of anti-competitive behaviour.

Selling over-the-counter (OTC) medicines online in Bulgaria is possible, but pharmacies must follow strict rules to ensure safety, transparency and compliance with the law. Only authorised pharmacies can sell OTC medicines online, and there are clear requirements for registration, website information, delivery and advertising. Here's a straightforward guide to the essentials.

Getting authorised and setting up online sales

To sell OTC medicines online, a pharmacy must first have a valid retail permit. Before starting online sales, the pharmacy must provide the Bulgarian Drugs Agency (BDA) with details about the business, the website address and the developer or the person maintaining the website. The BDA will check the website for all required information, such as the pharmacy's name, address, licence details and a list of medicines offered. Online sales can begin only after the BDA approves the application and lists the pharmacy in its public register of online retailers. Each pharmacy's online shop must display the EU logo for online sale of medicines. The pharmacy is also required to provide links to the websites of the BD, the Bulgarian Pharmaceutical Union and the Bulgarian Association of Assistant Pharmacists', and to provide information on the authorities supervising their activity.

Customer data and delivery

Pharmacies do not need to collect special health information from customers for OTC sales but must comply with general data protection rules (GDPR). Customers should be informed about how their data is used, and consent must be collected in Bulgarian. Medicines must be delivered safely and within 24 hours, with proper packaging to maintain quality – especially for products requiring temperature control. Pharmacies can use third-party couriers for delivery but remain responsible for safe transport.

Advertising and other key rules

Advertising OTC medicines is allowed under strict guidelines. Advertising campaigns and materials are subject to authorisation by the BDA. Ads must clearly state that the product is a medicine, include necessary usage information and avoid misleading claims. Pharmacies must also provide clear information about consumer rights, delivery costs and payment methods on their websites. Compliance with good distribution practices is essential, and all information must be presented to customers in a form that is easy to find and understand.

By following all the necessary steps, pharmacies in Bulgaria can compliantly sell OTC medicines online, providing convenience to customers while meeting all regulatory requirements.

The Medical Devices Regulation (MDR) definition of a medical device includes standalone software and mobile applications with a medical purpose, including AI-based "transcription" tools and software designed to analyse and draw conclusions from a patient's clinical data. The pre-investment assessment requires a multidisciplinary approach to identify regulatory risks, verify compliance and protect the investment value. Non-compliance with the regulatory requirements can expose investors to significant legal, financial and reputational risks.

The definition scope

Under the MDR, any software or app intended to diagnose, prevent, monitor, predict, provide a prognosis, treat or alleviate a disease is classified as a "medical device". As a result, the due diligence process must now cover a much wider range of products, including those that may not have been initially developed or regulated by the MDR. This is often the case with AI-based transcription and diagnostic software or so-called "accessories for a medical device".

Checking the box

Investors must now carefully determine whether each product in the target's portfolio falls within the MDR's scope. This usually requires a detailed review of the product's intended use, marketing claims and actual functionalities. Legal and technical expertise are essential to avoid misclassification that may entail negative regulatory and financial exposure.

Due diligence of the target's compliance must include:

• assessment of the product classification;
   
• risk assessment and management processes for products and services;
   
• review of technical documentation for conformity with safety and performance requirements;
   
• analyses of records of conformity assessment procedures; and
   
• cross-check of evidence of (authentic) CE marking and registration with the competent authorities.

The due diligence should also identify any past or ongoing regulatory investigations, non-conformities or adverse events that could affect the investment's value or viability. The risk of non-compliance may result in product recalls, fines or even market bans.

Since the MDR also imposes obligations for post-market surveillance, incident reporting and continuous risk management, investors must ensure that targets have dedicated regulatory personnel and access to MDR expertise to maintain compliance until the exit.

The Bulgarian Parliament has passed significant amendments the Tobacco Products and Related Products Act (the "Act"), with a particular focus on regulating e-cigarettes and products (food and beverages) containing high levels of caffeine. These amendments were approved at the second reading on 19 June 2025.

The changes in the Act intend to completely ban the offering and sale of of nicotine-containing products with a nicotine concentration exceeding 20 mg/unit. The prohibition on the placing on the market of tobacco for oral use is extended to include disposable electronic cigarettes, regardless of whether they contain nicotine (i.e. to all types of vapes).

Among the tobacco industry related bans, the Act also introduces changes to the Child Protection Act, by adding (i) a vague legal definition of "products with high caffeine content" and (ii) an age-related ban for purchasing and consuming such products. Products with high caffeine content are defined as: i) those with caffeine levels higher than 150 mg/L; ii) those representing an original combination of caffein (no specific amount is mentioned here), taurine, vitamins and other substances with nutritional and physiological effect, including glucuronolactone, inositol, carnitine, creatine and plant extracts (guarana, mate, ginseng etc.).

The legislative process for these amendments has raised concerns regarding transparency and compliance with European Union procedures. The main issue is that the Act introduces technical barriers to trade. Further, the Bulgarian Parliament proceeded with the second reading of the bill before notifying the European Commission under the TRIS procedure, which has yet to be completed – an action that could potentially breach EU procedural requirements.

While influencer marketing is a popular and powerful tool in many industries, the Czech Republic draws a clear line when it comes to medicinal products and medical devices.

Under the Czech Act on the Regulation of Advertising, it is prohibited to recommend medicinal products or medical devices through recommendations by individuals who, due to their actual or perceived social status, could encourage their use. This includes not only influencers, but also celebrities, athletes and politicians – in short, anyone with public reach.

Even though social media campaigns may seem attractive – for example, for products related to aesthetic medicine – the ban applies without exception to all medicinal products and medical devices, including over-the-counter (OTC) products and medical devices of all classes.

Moreover, the ban extends beyond regulated products. It also applies to the advertising of so-called "products targeting human health" – items that are not officially classified as medicinal products, medical devices or food for special medical purposes, but which are marketed in a way that suggests they are. Think "healing" stones, wellness candles and similar products with implied health benefits.

Breaking the rules comes at a price

Violating this prohibition can lead to significant financial penalties – up to CZK 2m (approx. EUR 80,000).

If you are active in the health or wellness sector in the Czech Republic, it is essential to stay on the right side of the law – no matter how tempting influencer campaigns may seem

Following a concerning increase in overdose cases – including some involving children – the Czech Republic has decided to regulate new psychoactive substances appearing on the market. Many of these substances occupied a regulatory grey zone, often marketed as souvenirs or collectible items, making it difficult to control them under existing laws.

Starting 1 January 2025, two new categories of substances were created:

1. Psychomodulating substances: These are psychoactive substances that, according to current scientific knowledge, do not pose a serious risk to public health or do not have a significant social impact on individuals or society.
    
2. Listed psychoactive substances: These are psychoactive substances for which serious health and social risks cannot be ruled out.

To fall into either category, a substance must be included on an official government list.

The list of listed psychoactive substances acts as a kind of quarantine for newly emerging substances. Once listed, these substances undergo further scientific review to assess their risks. This review can result in reclassifying substances as psychomodulating or addictive. While a substance remains on this list, it cannot be legally marketed or produced. The currently effective list is already quite extensive and includes substances like HHC, HHCP and HHCH.

Psychomodulating substances, on the other hand, are allowed on the market but under stricter regulation than alcohol or tobacco. Key restrictions include:

• ban on sales to minors;
   
• sales only in specialised shops;
   
• ban on sales via vending machines;
   
• online sales restricted to specialised shops with mandatory age verification; cross-border online sales are prohibited;
   
• requirement to obtain a special licence for handling (including selling) psychomodulating substances;
   
• rules on labelling, packaging, composition, appearance, quality and characteristics;
   
• ban on foods containing psychomodulating substances; and
   
• blanket ban on all forms of advertising and sponsorship that promote these substances

The draft list of psychomodulating substances includes kratom, kratom extract, cannabis with up to 1 % THC, and cannabis extract and tincture with up to 1 % THC. However, this list is not yet in effect, as the notification period to the European Commission is still ongoing. According to our sources, the Commission has raised an objection regarding the classification of one substance. More clarity is expected by the end of the summer, particularly on whether the list will be approved as-is or require amendments.

Unlike tobacco products and electronic cigarettes, nicotine pouches are not yet regulated at the EU level. Stepping into this legislative vacuum, the Czech Republic has become the first EU Member State to introduce specific national rules for these products. Until recently, nicotine pouches were governed only by general product safety and chemical regulations.

The new framework closely mirrors existing rules for tobacco and e-cigarette products, setting clear standards for the composition, appearance, quality and characteristics of nicotine pouches. It also introduces sales restrictions, allowing nicotine pouches to be sold only in specialist tobacco shops, grocery stores and daily or periodical newspaper outlets, and strictly prohibiting sales to individuals under 18 years of age.

Additionally, manufacturers and importers must comply with a notification obligation to the Ministry of Health, submitting detailed information both about the products themselves and their market presence.

Unlike tobacco and electronic cigarettes, the advertising of nicotine pouches remains unrestricted for the time being. However, this issue is under discussion, and regulatory developments in this area are expected.

On 1 January 2025, in response to the rapid changes in the professional medical environment and the broader reality, the new Polish Code of Medical Ethics (KEL) came into force. Although some observers consider the changes to be evolutionary rather than revolutionary, the amendment undoubtedly introduces significant reforms that adapt the rules of professional practice to the modern challenges of the medical field.

The most groundbreaking issue concerns the use of artificial intelligence (AI) in diagnosis and therapy. One of the provisions of the new KEL allows doctors to use certified AI algorithms, on condition that patients are notified and give their conscious consent whenever AI plays a key role in the diagnostic or therapeutic process. The doctor retains full responsibility for medical decisions. In contrast, in cases where AI merely supports the doctor's activities (e.g. improving the quality of the diagnostic image), the patient's consent is not mandatory, although transparency about the technologies used is recommended.

The new code also promotes modern forms of contact with the patient. A doctor can use remote consultations if the doctor knows the patient (i.e. it is a follow-up consultation on the same case) and the relevant standard of care is maintained. At the same time, treatment based solely on online forms, without the doctor's actual participation, has been banned – a clear attempt to combat the phenomenon of so-called prescribers.

These changes highlight the increasing role of technology in the medical field, while emphasising the responsibility of the doctor and the need to maintain high ethical and professional standards.

The Polish government is introducing regulatory changes aimed at reducing bureaucracy and helping pharmaceutical companies operate more efficiently. These reforms focus on two main areas: simplifying the process for requesting medicine samples and eliminating unnecessary reporting obligations related to planned delivery locations of medicines.

Easier process for requesting free medicine samples

Currently, to request free samples of medicines, doctors and authorised healthcare professionals must complete a written form, signed either by hand or with a qualified electronic signature. This procedure often causes unnecessary delays and paperwork. The planned change will allow such requests to be submitted by e-mail, text message or other forms of electronic communication, enabling faster processing while still ensuring that only authorised individuals can request and receive samples. The rules on the samples themselves remain unchanged: each sample must be labelled "free sample – not for sale" and accompanied by the official product information. No more than five samples of the same medicine may be provided to the same person per year.

No need to report planned delivery destinations

Currently, pharmaceutical companies must inform the national monitoring system (ZSMOPL) where they intend to deliver medicines before the delivery occurs. This is impractical, because companies often do not know in advance which one of 400 wholesalers based in Poland will receive the products (the decision depends on various operational factors and is often made ad hoc). The reform will eliminate this requirement, reducing unnecessary duplication of data. Importantly, wholesalers will continue to provide daily reports on actual deliveries, so the government will still have full insight into the market and the availability of medicine.

Summary

These planned changes will reduce formalities, save time and make it easier for companies to focus on their core activities. The reforms strike a balance between easing the burden on businesses and ensuring that the authorities still have the information they need to safeguard public health.

In recent months, we have observed that the authorities have increasingly focused on verifying whether products bearing nutrition and health claims are registered in the national register of nutrition and health claims for food products.

In this context, it is important to note that Romania imposes distinct notification requirements for fortified foods and for foods making nutrition and health claims.

Fortified food are products to which vitamins, minerals or other substances have been added. They require prior approval before being marketed in Romania. The notification procedure is governed by Order of the Ministry of Health No. 369/2010.

Separately, according to Government Decision No. 723/2011, establishing the legal framework for the application of Regulation (EC) No 1.924/2006 on nutrition and health claims made on foods, foods bearing nutrition and health claims as provided for in Regulation 1924/2006 must be notified to the competent authority.

Both procedures are relatively straightforward, requiring submission of the signed Romanian product label, together with additional information to the competent authority. The registers of fortified food and of nutrition and health claims are available on the website of the Ministry of Health.

In conclusion, if a fortified food also bears nutrition and health claims as defined by Regulation 1924/2006, it must be registered in both registers.

Retailers selling tobacco or nicotine-based products in Romania should be aware of new legal obligations introduced by Order No. 331/2025, issued by the National Authority for Consumer Protection (ANPC). This Order, which came into effect on 11 May 2025, imposes new requirements to improve consumer information and protect minors.

According to the legislation, any economic operator directly selling tobacco products, electronic cigarettes, refill containers, heated tobacco devices, nicotine pouches or non-combustible inhalation products in shops must display signage at the point of sale that explicitly prohibits sales to individuals under 18 years of age.

The law requires the use of an official information notice, which can be downloaded free of charge from the ANPC's website. This notice must be posted in a visible area within the customer's line of sight.

Additionally, the Order introduces accessibility requirements for the benefit of visually impaired customers. Retailers must ensure that the mandatory information is also available in formats accessible to people with visual impairments, either audio recordings or other physical or digital aids.

The Order does not introduce the prohibition itself but regulates how consumers are informed of the existing prohibition, requiring retailers to display a visible and accessible notice, including for individuals with visual impairments.

Romania has prepared important amendments to its national honey legislation through Joint Order No. 144/1597/480/2025, aligning domestic rules with the EU's Directive 1438/2024. These updates will come into force on 14 June 2026 and apply to all producers, importers, distributors and retailers of honey in Romania.

The new regulation updates the provisions of Order 522/798/317/2003 and focuses on improving consumer information, traceability and product authenticity, particularly for blended and industrial-use honeys.

The most significant amendment concerns country-of-origin labelling, which becomes mandatory and detailed. All honey products must list the country or countries of origin for the honey used. For blended honeys, the countries must be shown in descending order by weight, along with the percentage share of each country. If a honey blend contains more than four countries of origin, and the top four account for over 50 % of the blend, only those four need to have their percentages listed. The remaining countries can be named in order of quantity, without showing percentages. Small packages (under 30 g) may use two-letter ISO country codes instead of full names.

A transitional period is provided, allowing business operators to sell the products labelled under the old rules until the exhaustion of stocks, but no later than 14 December 2026. After that date, only products conforming to the new standards may be placed on the market.