The Life Sciences Law Review: Denmark
The Danish life sciences industry contributes considerably to both R&D, economic progress and employment in Denmark. An analysis from the Danish Ministry of Industry, Business and Financial Affairs published in February 2019 shows that the value increment in the life sciences industry has increased by 88 per cent in eight years. By comparison, the value increment in the industry in Denmark as such has increased by 17 per cent during the same period. Furthermore, the productivity level is twice as high in the life sciences industry compared to the overall economy.
The regulatory framework for medicines for human use in Denmark is based on EU Regulation (EC) No. 726/20042 and Directive 2001/83/EC,3 which are implemented in national Danish law primarily in the Health Act,4 the Medicines Act,5 the Pharmacy Act6 and the Ethics Committee Act.7 The regulatory framework for medical devices is based on EU Regulation 2017/1745,8 which is implemented in the Medical Devices Act.9
The requirements and procedures for marketing authorisation of medicines are partly covered by European Union (EU) law, whereas national law regulates pricing and reimbursement. The competent authorities are the Danish Medicines Agency (DMA), the Danish Ministry of Health, the Danish Health Authority and the Danish Patient Safety Authority. In the decision-making with respect to regulation of medicines, a number of advisory bodies advise the DMA, such as the Medical Products Committee, the Pharmacovigilance Council and the Reimbursement Committee.
The regulatory regime
Medicines are defined as any product that (1) is presented as a suitable product for the treatment or prevention of diseases in human beings or animals, or (2) may be used in or administered to human beings or animals to restore, change or modify physiological functions by a pharmacological, immunological or metabolic effect or to make a medical diagnosis.10
Medical devices are defined as devices intended for diagnosis, prevention, monitoring, treatment or palliation of diseases, compensation for injuries or handicaps, examination, replacement or change of the anatomy or a physiological process or contraception, provided that the expected principal effect in or on the human body is not elicited through pharmacological, immunological or metabolic means, but which effect can be supported through these means.11
In borderline cases, the DMA may decide that the product or group of products shall exclusively be regulated by the Medicines Act. Classification as a medicine is normally given priority over classification as foods, cosmetics etc. Medicines approved by the European Medicines Agency (EMA) will maintain their classification status in Denmark.
ii Non-clinical studies
Conducting non-clinical studies of compounds must be made in compliance with the principles of good laboratory practice (GLP) defining the standards for planning, conduction, monitoring, recording and reporting of in vitro and in vivo studies.12 The Animal Experiments Inspectorate (AEI) grants permission to conduct animal studies on vertebrate animals and foetuses of mammals in accordance with the Animal Experiments Act.13 The Act implements parts of Directive 2010/63/EU regarding conduction of animal studies.14 The AEI approves all animal experiments in Denmark and undertakes inspections of facilities where animal experiments are carried out.
iii Clinical trials
Conducting clinical trials of medicines in humans is regulated by the Medicines Act15 implementing Directive 2001/20/EC16 as amended by Regulation (EU) No. 536/2014.17 The Regulation lays down the basis for the development of the Clinical Trials Information System (CTIS). CTIS will be the single-entry point for submitting, assessing, authorisation, supervising and reporting a clinical trial in all member states in the European Union. Under the present rules, application for authorisation of clinical trials of medicinal products in humans must be filed to the DMA or EudraCT18 by the sponsor. The sponsor or its representative must be domiciled in the EU or European Economic Area (EEA). Application for authorisation can take place through DKMAnet. Guidelines can be found on the DMA's website. Clinical trials of medicines in humans must be conducted in accordance with the principles of good clinical practice (GCP).19,20 Before consenting to participate, trial subjects must receive adequate written and oral information about the clinical trial. Informed consent forms must be signed by the trial subjects and stored by the primary investigator.21 The informed consent must also contain information about inspections performed by the DMA and a description of the DMA's unconditional access to all trial and patient data. A publicly funded compensation scheme covers injuries to human subjects occurring in clinical trials (see Section VI).
The definition of the term 'sponsor' in Danish law is not the same as in Directive 2001/20/EC, defining a sponsor as an individual, company, institution or organisation that takes responsibility for the initiation, management or financing of a clinical trial.22 Danish law defines the clinical trial sponsor as the individual, company, institution or organisation that takes the overall responsibility for the initiation, management and, in some cases, financing of the clinical trial.23 The clinical trial sponsor must comply with obligations regarding registration of the trial in EudraCT, reporting of trial results to EudraCT and reporting of suspected unexpected serious adverse reactions24 that arise during the trial to the DMA.
iv Named-patient and compassionate use procedures
The DMA may in special circumstances and to a limited degree authorise the sale or dispensing of approved medicines or pharmacy compounds that are not licensed for marketing in Denmark.25 Such compassionate use permits are only issued for medicines manufactured by pharmaceutical companies and in situations where the unlicensed medicine cannot be substituted by a medicine already marketed in Denmark and provided that there are therapeutic reasons to choose a medicine not marketed in Denmark. Doctors, veterinaries and dentists may apply for a single permission for use of unlicensed medicine in specific patients or apply for a general permission to hospital departments. The application for compassionate use permits must be filed to the DMA containing information about the indication for use, name of the medicine, active ingredients, medical form, strength, producer, distributor and medical justifications for the application. Medicines prescribed for compassionate use are also subject to the rules for reporting adverse events to the DMA.26
v Pre-market clearance
Medicines can only be marketed and sold in Denmark upon approval by the EMA or the DMA.27 The same applies for natural medicine products and strong vitamins and minerals. Approved medicines must be included in the medical register.28 The applicant for and holder of a Danish marketing authorisation must be established in the EU or EEA or represented in Denmark by a company established in the EU or EEA.29 The abridged application procedure may be applied for authorisation of generic medicines. In such a case, the applicants may omit some or all of the preclinical and clinical trial data if bioequivalents can be documented with a reference product and regulatory data exclusivity for the reference product has expired.30,31
To ensure that medical devices meet all requirements for quality, safety and efficiency, manufacturers must follow a number of procedures including conformity assessments before marketing the devices.32
vi Regulatory incentives
For medicines, patents may be granted for 20 years from the date of filing in accordance with the Danish Patent Act.33 The holder of a marketing authorisation for a medicine may benefit from a data protection period of 10 years from the first marketing in the EU or EEA. The data protection period may be extended to 11 years if new indications are approved later.34,35 EU regulations concerning supplementary protection certificates (SPCs) for medicinal products allow for a supplementary protection of a maximum of five years without the possibility of extension.36 However, if the patentee has tested the suitability of the medicines for children, the supplementary protection for medicines may be extended by an additional six months.37 If the regulatory authority approves a paediatric indication, a further six months' extension of the SPC can be allowed.38 An application for a paediatric extension should also be filed with the Danish Patent and Trademark Office (DKPTO).39
vii Post-approval controls
Holders of marketing authorisation for medicines must (1) establish and maintain a pharmacovigilance system; (2) comply with national rules on reporting of suspected adverse reactions; (3) have access to a person qualified within pharmacovigilance domiciled in the EU;40 and (4) report periodic safety updating to the DMA or the EMA.41 Side effects must be reported to the DMA or the EMA. Doctors, dentists, midwives, veterinaries and pharmaceutical companies must report all suspected adverse events and exposure reactions in patients or animals they are treating no later than 15 days after the said persons have become aware of the event.42 It is not mandatory to report adverse events caused by medication errors to the DMA. Apart from generic medicines, during the first two years of marketing, all adverse events must be reported. Thereafter, reporting only covers serious or unexpected adverse events and exposing reactions. The reporting requirements apply from the time when marketing of the medicine has begun.43 Pharmacists, consumers, patients, relatives and lawyers may all report adverse events directly to the DMA. The DMA has introduced strict reporting of all adverse events occurring for medicines under special surveillance. A list of these medicines can be found on the DMA website.44 The DMA may amend, suspend or revoke a marketing authorisation for a medicine.45 The same applies to medical devices involving a health or safety risk.46
viii Manufacturing controls
Manufacturing of medicines and intermediates requires an authorisation from the DMA.47 Manufacturing of medicines must be made in accordance with good manufacturing practice (GMP) guidelines and European Commission guidelines listed in Volume 4 of the Rules governing medicinal products in the European Union.48,49 Manufacturers must have at least one qualified GMP person permanently and continuously at their disposal. The DMA may amend, suspend or revoke a permission, if the conditions for the permission or the terms set out the by DMA are not met.
ix Advertising and promotion
Advertising of medicines must be adequate and objective and must not mislead or exaggerate the characteristics of the medicinal product.50,51 In addition, advertising of medical devices must not be suitable to endanger the safety or health of the patient, the user or any third party.52 The advertising information must be in accordance with the authorised summary of product characteristics. Advertising for prescription medicine to the general public is not allowed. Direct advertising to healthcare professionals (HCPs) is, however, permitted.53,54
x Distributors and wholesalers
The DMA issues authorisations to distributors and wholesalers of medicines.55 Such authorisation requires a separate regulation for the specific type of permission (e.g., transport and import of medicines and intermediates, wholesale of medicines or retail sale of non-pharmacy prescription medicines).56 Information about authorised distributors and wholesalers can be found on the DMA website. Transport companies that only provide transportation of medicines do not need an authorisation. However, pharmaceutical companies must ensure that medicines are transported in compliance with the good distribution practice (GDP) rules.57 Distributors and wholesalers must approve and review their suppliers regularly to monitor the suppliers' compliance with the GDP rules.
xi Classification of products
The DMA determines whether medicines are classified as prescription medicines or as over-the-counter medicines (OTC) and divides the prescription-only medicines into groups.58 Some OTCs are placed freely in pharmacies, shops and retail stores and are no longer to be placed behind a counter or locked in a cabinet. A list of these OTCs can be found on the DMA website.59 Natural medicines, traditional herbal medicines and homeopathic products are also regulated by the DMA, whereas complimentary medicines and vitamins are regulated by the Danish Veterinary and Food Administration.60
Pharmacies are legally obliged to substitute the cheapest medicine within the relevant substitution group when dispensing medicine. If a medicine has a patented indication, it may have an effect on how the DMA establishes the substitution group to which the medicine belongs. The marketing authorisation holder of a medicine with a patented indication must therefore inform the DMA about the patent or SPC and its expiry date. The DMA will then verify the patent or SPC in collaboration with the DKPTO. If the patent or SPC affects the substitution rules and groups, these will be changed accordingly. In practice, this means that the pharmacy should dispense the medicine with the patent-protected indication.61
xii Imports and exports
Import of medicines and intermediates requires an authorisation from the DMA.62 Guidelines and application forms for authorisation can be found on the DMA website.63 Companies authorised by the DMA to import medicines are supervised regularly by the DMA. Inspections are performed in accordance with the GMP or GDP rules. A list of companies authorised to import medicines and intermediates in Denmark (in Danish) can be found on the DMA website.64 The DMA regularly submits import authorisations to EMA's EudraGMDP database as they are issued.65
xiii Controlled substances
Manufacturers, wholesalers and others who handle medicines classified as narcotics or psychotropic substances (euphoriants) must apply to the DMA for an authorisation. Such authorisation may be granted if the substances are prescribed to drug addicts for medical purposes. Dispensing of the medicines may be made for doctors, pharmacists and institutions involved in treatment of drug addicts.66 A list of euphoriants subject to control by the Danish authorities is available on the DMA website.67
On 1 January 2018, a four-year medicinal cannabis pilot programme was introduced68 whereby the DMA may grant authorisation to produce cannabis intermediate products and to cultivate cannabis for medicinal use and produce cannabis bulk and cannabis primary products from Danish-grown cannabis.69
The DMA inspects the development, manufacturing, distribution, dispensing and monitoring of medicines and medical devices to ensure that obligations and requirements set by legislation are complied with.70 The representatives of the DMA have access to holders of authorisations and companies registered with the DMA without a court order to comply with their inspection tasks and to comply with a request from another EU or EEA country, the European Commission or the EMA. The DMA normally gives a notice of 14 days or more prior to an inspection visit. An inspection can last a few hours or several days depending on the area of complexity and risk.
Violation of the regulatory requirements in the Medicines Act, Sections 7, 39 and 64 regarding marketing, advertising, sale, import and distribution of medicines is sanctioned by fines or prison from four months and up to 18 months. Legal entities are subject to criminal liability.71 The DMA may also amend, suspend or revoke an authorisation.72
Pricing and reimbursement
There is free price formation on medicines in Denmark.73 When bringing a pharmacy-only medicine to the market in Denmark, the pharmaceutical company must register the pharmacy cost price and any changes thereof no later than 14 days before the price comes into force.74,75 Prices are fixed for 14-day periods. The pharmaceutical companies must provide to the DMA the price list with information about prices for medicines for sale during the subsequent 14-day period. According to the national substitution rules, when dispensing prescribed medicine, pharmacies are obliged to substitute the prescribed medicine to the cheapest generic or parallel-imported medicine.76 The rules on rebates are very strict. A distributor can only give rebates to private pharmacies that are strictly related to cost-saving activities.77,78 In the secondary healthcare sectors, Amgros,79 the joint procurement service of the Danish Regions,80 conducts tendering procedures for purchase and supply of medicines and medical devices.
The DMA determines which medicines are eligible for reimbursement based on advice from the Medicines Reimbursement Committee.81 Reimbursement is provided from the Danish Regions82 and can be granted as general reimbursement or as conditional reimbursement for prescription-only medicines. General reimbursement is determined by the DMA upon application from the pharmaceutical company bringing the medicine to the market. In a trial period from 1 January 2019 to 31 December 2021, the DMA may upon application determine to grant general reimbursement for a prescription-only medicine on terms of risk sharing.83 In special cases, the DMA may determine to grant individual reimbursement, which is granted upon application from the doctor or dentist and is given to prescription-only medicines for individual patients. The doctor must document in the application why the patient concerned needs treatment with a particular medicine.84 For terminal patients the DMA can decide to grant 100 per cent reimbursement of the medicine ordered by the doctor, if the doctor has determined that the prognosis is a very short life expectancy (e.g., a few weeks or months) and that hospital treatment with a view to recovery must be regarded as futile.85 A doctor can also apply for an increased reimbursement if a patient needs a more expensive generic medicine, even if there are less expensive alternatives on the market, for example if the patient is allergic to additives contained in the less expensive medicine. Increased reimbursement means that the grant is based on the actual price of the medicine instead of the reimbursement price.86
Administrative and judicial remedies
The DMA is the national administrative body under the Ministry of Health. The DMA administers the legislation on medicines, reimbursement, pharmacies, medical devices and euphoriants and is responsible for the monitoring, control and enforcement of medicines, clinical trials and pharmacy regulations. Decisions made by the DMA can in general be appealed to the Ministry of Health. A negative decision from the DMA or the Ministry of Health can be appealed to the courts if challenged by a party with a legal interest in the case.
Financial relationships with prescribers and payors
The Danish Health Act provides the legal framework for pharmaceutical companies' relationship with HCPs.87 The interaction between HCPs and the pharmaceutical industry is highly regulated to ensure that any cooperation takes place in an ethically responsible manner. Apart from the national rules in the Health Act, an ethical code issued by the Ethical Committee for the Pharmaceutical Industry (ENLI) applies. Only members of ENLI are covered by its special regulations and subject to its sanctions.88
i HCPs' affiliation with pharmaceutical companies and medical devices companies
Doctors, dentists undertaking clinical duties and proprietary pharmacists cannot operate or be affiliated to a pharmaceutical or medical company or a specialty store with medical devices unless the HCP has notified the DMA of such relationship or received permission from the DMA to such affiliation.89 Affiliation means ownership or co-ownership, whether personal or via another legal entity, or ownership of securities or other financial affiliation. The rules apply to pharmaceutical companies that have a marketing authorisation from the DMA in Denmark (Medicines Act, Section 7(1)), or a permission from the DMA to produce, import and distribute medicines in Denmark (Medicines Act, Section 39) and to medical companies established in Denmark manufacturing, importing or distributing medical devices in risk class IIa, IIb or III. The rules also apply to medical devices for in vitro diagnostics or active, implantable medical devices and representatives for such companies, apart from public hospitals and to specialty stores that are established in Denmark and where the distribution of medical devices consists of more than 50 per cent of the range of products or turnover. The obligations do not cover affiliations between public hospitals and HCPs.
ii Financial benefits for HCPs
As a main rule, pharmaceutical companies, etc. cannot, for advertising purposes or to otherwise promote the sale of medicines, give or offer financial support to HCPs. However, two exceptions apply. It is permitted to pay for services from an HCP or a pharmacy if such payment is proportionate to the service. Payment can only be made in the form of direct payment, not by set-off, payment in kind or other indirect manner. HCPs must apply for permission from or notify their affiliation to a pharmaceutical company, etc. to the DMA when receiving such payment.90 Moreover, HCPs attending educational and promotional activities with a scientific or professional purpose may receive financial support in the form of payment of the reasonable cost in relation to dining, travelling and accommodation.91 Pharmaceutical companies' financial support to HCPs' activities outside Denmark is subject to notification to the DMA. Information about financial support is published on the DMA's website for a period of two years. Such information includes unambiguous identification of the HCP (name and authorisation number, if any, profession, pharmaceutical company, information about activity and date of termination of the activity). Similar rules apply to financial support with respect to medical devices.92 The rules regarding financial support in respect of medical devices do not include discounts on medical devices.
Special liability or compensation systems
In Denmark, a publicly funded compensation scheme has been established to cover injuries occurring in connection with medical treatments in the public and private healthcare system and injuries that result from adverse events from medicine use or personal injuries occurring during clinical trials.93 The persons that are covered by the compensation schemes are patients, trial subjects and donors. To obtain compensation, the person must have been injured by a treatment made by a HCP or from the use of medicines. The time of injury and causal relationship must be documented. Compensation cannot be awarded to injuries that may be related to the basic condition of the patient. If the personal injury is covered by the compensation scheme, the patient or relatives cannot claim compensation directly from the courts or based on other applicable law.94 The Patient Compensation Association (PCA) is the competent body to perform assessment of the claim. Decisions by the PCA can be appealed to an independent board. If the independent board upholds the decision, a legal complaint may be filed to the ordinary courts. In cases where compensation has been awarded and patient injury was caused by a defect or flawed, dangerous characteristic of the medicine, the government can file a recourse claim against the producer.95 Filing for recourse is limited as producers are only legally responsible for injuries caused by a defective medicine, and not developmental injuries or already known adverse effects.96
Transactional and competition issues
i Competition law
The Danish Competition Act implements general European competition law principles and legislation97 and the life sciences sector is subject to merger control, prohibition against state aid, abuse of dominating position and anticompetitive agreements. The Act comprises block exemptions that are of importance to the sector. Of particular interest are sanctions for entering into cartel agreements, which may include imprisonment of up to 18 months if the infringement is intentional and of an aggravated nature. In 2018, the Danish Competition Council ruled that a pharmaceutical distributor had abused its dominant position by charging unfair prices (a 2,000 per cent price increase over a six-month period) for a particular medicinal product for which the distributor held an exclusive distribution contract. The Competition Appeals Tribunal (CAT) upheld the decision. The distributor appealed the CAT's decision to the Maritime and Commercial High Court who confirmed that it was illegal for the distributor to abuse its dominant position to increase the price by 2,000 per cent. The case has been submitted to the Danish State Prosecutor for Serious Economic and International Crime.
ii Transactional issues
Transactional issues of special relevance to medicines and medical devices in the Danish life sciences sector are not considerably different from those in other European jurisdictions. The issues of particular relevance relate to intellectual property rights and permits and licences and certificates required for operations to remain valid after a transaction. This may include manufacturing authorisations, licences for the wholesale of pharmaceuticals and licences for the handling, import or wholesale of substances such as narcotics and marketing authorisations.
On 19 March 2019, the Danish Regions and the Danish Association of the Pharmaceutical Industry (LIF),98 a trade association for the researching pharmaceutical industry, entered into a new agreement regarding prices on medicinal products sold to hospitals for the period from 1 April 2019 to 31 March 2023. The agreement reduces the list prices of hospital-only medicines with a total of 12.5 per cent over the four-year period. In addition, an agreement between the LIF, the Danish Regions and the Ministry of Health on a cap on the prices of prescription medicine was entered into for the period from 1 April 2019 to 31 March 2022. This agreement introduces a price ceiling on the prices of prescription medicine for the named period.
Medicine prices are unrestricted in Denmark with respect to the primary and secondary health sector. Since 2009, price cap agreements have been made between the Ministry of Health, the Danish Regions and the LIF regarding hospital-only medicines and since December 2006, regarding prescription medicine. The new agreements extend the original agreements with subsequent extension agreements. The agreements will apply to hospital-only medicine and prescription medicine marketed by the LIF's member companies. The members will, if permissible under competition rules comply with the terms of the price cap agreements.
In future, the Danish Medicines Council (DMC)99 will apply the quality-adjusted life-year (QALY) method when assessing whether new hospital medicines shall be recommended as standard treatment. The main purpose of the QALY method is to ensure better transparency in the decisions of the DMC. However, the QALY method will not stand alone as the DMC will continue to apply the seven principles for prioritising of hospital medicine as decided by the Danish Parliament. In addition, the severity of a disease can also be included as a parameter in its decision-making. With the introduction of the QALY method, the review time will increase to 16 weeks instead of 12 weeks.
The Danish Regions will introduce a new 'Treatment Council'. The purpose is to assess whether the price on different treatments and technologies measures up to the effect for the patients. The members of the Treatment Council will include patient representatives, health finance managers and representatives from the hospitals, the Danish Medical Society and the Danish Society of Nurses. The purpose is to identify new technological solutions from business and industry, which can be extended to the entire healthcare system. The intention is to conduct 15–25 evaluation annually. The Council may also conduct analysis of basic questions regarding treatment regimes and how to organise better treatments. The new Treatment Council will start up in the early part of 2021.
1 Karin Absalonsen is a partner at Nyborg & Rørdam Law Firm P/S.
2 Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004, laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.
3 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended.
4 Health Act. Consolidated Act No. 903 of 26 August 2019.
5 Medicines Act. Consolidated Act No. 99 of 16 January 2018.
6 Pharmacy Act. Consolidated Act No. 801 of 12 June 2018.
7 Ethics Committee Act. Consolidated Act No. 1388 of 1 September 2020.
8 EU Regulation No. 1745/2017 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
9 Medical Devices Act. Consolidated Act No. 139 of 15 February 2016.
10 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 2(1).
11 Consolidated Act No. 139 of 15 February 2016 on Medical Devices as amended by Act No. 1554 of 18 December 2018.
12 Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances.
13 Animal Experiments Act. Consolidated Act No. 474 of 15 May 2014.
14 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.
15 Medicines Act. Consolidated Act No. No. 99 of 16 January 2018, Section 88.
16 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
17 Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. The application of the Regulation is conditional on an independent audit of the new EU portal and EU database. The audit was completed on 8 December 2020 and Go-live is planned for December 2021, for more information see: www.ema.europa.eu/en/news-events/publications/newsletters#clinical-trials-information-system-(ctis)-highlights-section.
18 European Union Drug Regulating Authority Clinical Trial Base. EudraCT will be replaced by CTIS. The present rules will continue to be in force during a transition period of up to three years. The Commission has issued a guidance document on 20 November 2020, see https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/regulation5362014_qa_en.pdf.
19 Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
20 Executive Order No. 695 of 12 June 2013 on good clinical practice in clinical human trials.
21 Executive Order No. 498 of 13 May 2018, Sections 6, 7, 8 and 9 on informed consent of participating in clinical trials.
22 Directive 2001/20/EC, Article 2(e).
23 Executive Order No. 695 of 12 June 2013, Section 2(1), No. 6 on good clinical practice.
24 Executive Order No. 295 of 26 April 2004 on clinical test with medicines in humans.
25 Medicines Act. Consolidated Act No. No. 99 of 16 January 2018, Section 29.
26 Executive Order No. 1823 of 15 December 2015 on reporting of adverse events for medicinal products.
27 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 7.
29 European Commission. EudraLex – Volume 2. Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use.
30 Executive Order on Marketing Authorisation No. 1239 of 12 December 2005, Section 9.
31 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, Sections 10, 10a, 10b and 10c.
32 Executive Order No. 1263 of 15 December 2008 on medical devices, Executive Order No. 1269 of 12 December 2005 on medical devices for in vitro diagnostic, Executive Order No. 1264 of 15 December 2008 on active, implantable medical devices.
33 Patent Act. Consolidated Act No. 40 of 29 January 2019, Section 40.
34 Directive 2001/83/EC on the Community code relating to medicinal products for human use amended by Directive 2004/27/EC, Section 10.
35 Executive Order on Marketing Authorisation No. 1239 of 12 December 2005, Sections 9(2) and 12.
36 Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products.
37 Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No. 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No. 726/2004.
38 Regulation (EC) 1901/2006 on medicinal products for paediatric use, Section 36.
40 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 53.
41 Executive Order No. 1823 of 15 December 2015 on reporting of adverse events from medicine use.
42 id., Section 4.
43 id., Section 4.
45 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Sections 14–16.
46 Executive Order No. 2008/1263, Executive Order No. 2005/1269 and Executive Order No. 2008/1264, see note 31.
47 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 39.
48 Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
49 European Commission. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.
50 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Chapter 7.
51 Executive Order No. 1153 of 22 October 2014 on advertising rules for medicines.
52 Executive Order No. 1155 of 22 October 2014 on advertising rules for medical devices.
53 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 66.
54 Executive Order No. 1153 of 22 October 2014 on marketing of pharmaceuticals, Section 11.
55 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 39.
56 Executive Order No. 1358 of 18 December 2012, Executive Order No. 1541 of 18 December 2019 and Executive Order No. 1274 of 27 November 2017.
57 Executive Order No. 1358 of 18 December 2012 on good distribution practice of pharmaceuticals.
58 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 61(2), and Executive Order No. 857 of 12 June 2020 on prescription and dose dispensing of medicines.
60 Executive Order No. 1239 of 27 November 2017 on the regulation of complementary medicines.
61 Executive Order No. 857 of 12 June 2020 on the prescription and dose dispensing of medicines, Section 62(7-8).
62 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 39.
66 Executive Order No. 950 of 23 June 2020 on euphoriants.
69 Medicinal Cannabis Pilot Programme Act. Consolidated Act No. 1668 of 26 December 2017 as amended by Act No. 1519 of 18 December 2018.
70 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 44.
71 id., Section 104(1) and (2).
72 id., Sections 15, 16 and 40.
73 See also Section VIII.
74 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 77.
75 Executive Order No. 1399 of 2 December 2015 on prices and delivery of medicines.
76 Executive Order No. 857 of 12 June 2020 on prescriptions and dose dispensing of medicines, Section 62. See also Section II.ix.
77 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 71 b.
78 Executive Order No. 1153 of 22 October 2014 on advertising of pharmaceuticals, Part 9.
81 Executive Order No. 1781 of 18 December 2018 on the medicines compensation system.
82 Health Act. Consolidated Act No. 903 of 26 August 2019, Section 143.
83 id., Section 152(2).
84 Executive Order No. 1781 of 18 December 2018.
85 id., Section 10.
86 id., Section 12.
87 Health Act. Consolidated Act No. 903 of 26 August 2019, Chapter 61 a.
89 Executive Order No. 693 of 3 July 2019 on healthcare professionals' relationship with pharmaceutical companies and medical devices, Sections 8, 9, 10 and 12.
90 Executive Order No. 1153 of 22 October 2014 on advertising for medicines, Section 24.
91 id., Sections 26–28.
92 Executive Order No. 1155 of 22 October 2014 on advertising for medical devices.
93 Act on the Right to Complain and Receive Compensation. Consolidated Act No. 995 of 14 June 2018.
95 Product liability covers the EU rules in Directive 85/374/1985/EE, the Danish product liability rules based on case law and the rules in the Danish Product Liability Act. Consolidated Act No. 261 of 20 March 2007.
96 id., Section 5(1).
97 Competition Act. Consolidated Act No. 155 of 1 March 2018.