I INTRODUCTION

Medicines for human use are regulated in Denmark by EU Regulation (EC) No. 726/20042 and Directive 2001/83/EC,3 which have been implemented in national law primarily in the Health Act,4 the Medicines Act,5 the Pharmacy Act6 and the Committee Act.7 The legislation lays down the harmonised EU requirements for regulation of medicines in Denmark. Advertising and promotion of medicines are partly covered by EU law, whereas pricing and reimbursement are regulated by national law. The Danish Medicines Agency (DMA) is the competent authority. Other relevant competent authorities are primarily the Danish Ministry of Health, the Danish Health Authority and the Danish Patient Safety Authority. Several statutory advisory bodies have been established to advise the DMA in its decision-making with respect to regulation of medicines, namely the Medical Products Committee, the Pharmacovigilance Council and the Reimbursement Committee.

II THE REGULATORY REGIME

i Classification

Medicines for human use are defined as:

any product that (a) is presented as a suitable product for the treatment or prevention of diseases in human beings, or (b) may be used in or administered to human beings to restore, change or modify physiological functions by a pharmacological, immunological or metabolic effect or to make a medical diagnosis.8

The decision as to whether a product will be deemed a medicine, a medical device or another regulated product depends largely on the presentation and the product's demonstrated mode of action. The DMA determines whether medicines should be classified as over-the-counter medicines (OTCs) or prescription medicines.9 The decision as to whether approved medicines should be restricted for use in specific patient groups and prescribing status is also decided by the DMA. Medicines approved by the European Medicines Agency (EMA) will maintain their classification status in Denmark. Natural medicines, traditional herbal medicines and homeopathic products are also regulated by the DMA, whereas complementary medicines and vitamins are regulated by the Danish Veterinary and Food Administration.10 Prescription medicines may be dispensed only by pharmacies,11 but it is permitted for some OTCs to be sold elsewhere.12 As of 1 January 2018, some OTCs are placed freely in pharmacies, shops and retail stores, and are no longer be placed behind a counter or locked in a cabinet.13 A list of these OTCs can be found on the DMA website.14

ii Non-clinical studies

Non-clinical studies of compounds must be conducted in compliance with the principles of good laboratory practice (GLP).15 GLP defines the standards for the planning, conducting, monitoring, recording and reporting of in vitro and in vivo studies. All animal studies must be carried out in accordance with the principles of Directive 2010/63/EU.16 Permissions to conduct animal studies on vertebrate animals and foetuses of mammals must be granted by the Animal Experiments Inspectorate (AEI).17 The AEI approves all animal experiments in Denmark and undertakes inspections of all facilities where animal experiments are carried out.

iii Clinical trials

Clinical trials on human beings are regulated by Directive 2001/20/EC18 and Regulation (EU) No. 536/2014 as implemented into Danish law.19 All clinical trials must be conducted in accordance with the principles of good clinical practice (GCP).20, 21 Before initiation of the study, the protocol may be subject to approval by the DMA and an ethics committee.22 Trial subjects must receive proper written and oral information about the trial before consenting to participate. Informed consent forms must be signed by the trial subjects and stored by the primary investigator.23 As clinical trials may be subject to inspection by the DMA, participants must be informed about this before consenting to participate. The informed consent form must contain a section describing the DMA's unconditional access to all trial and patient data.24 Injuries occurring in clinical trial subjects are covered by a publicly funded compensation scheme (see Section VI).25

Sponsor

In Danish law, the clinical trial sponsor is defined as the individual, company, institution or company that takes the overall responsibility for the initiation, management and, in some cases, financing of the clinical trial.26 The trial sponsor has several legal obligations, such as registration of the trial in EudraCT, reporting of trial results to EudraCT and reporting of adverse events occurring during the trial to the DMA. The definition of the term 'sponsor' in Danish law (as stated above) is not the same as in Directive 2001/20/EC, which defines a sponsor as an individual, company, institution or organisation that takes responsibility for the initiation, management or financing of a clinical trial.27

iv Named-patient and compassionate use procedures

In special cases, the DMA may authorise the prescribing of unlicensed medicines, such as those approved but not marketed in Denmark or pharmacy compounds.28 Hence compassionate use permissions are only granted in situations where the unlicensed medicine cannot be substituted by a medicine already marketed in Denmark. Physicians, dentists and veterinary surgeons may apply for a single permission for use of unlicensed medicines in specific patients or apply for a general permission that allows use of an unlicensed product for all patients affiliated with a specific hospital department or general practice. When applying for compassionate use permissions, the DMA usually requires information about the name of the medicine, active ingredients, medical form, strength, producer, distributor, indication for use and medical justifications for the application. Medicines prescribed for compassionate use are also subject to the rules for reporting adverse events to the DMA.29

v Pre-market clearance

Medicines must be approved by the EMA or DMA and included on the medical register (www.medicinpriser.dk) before they can be marketed in Denmark.30 The applicant for and holder of a marketing authorisation must be established in an EEA country, or represented in Denmark by another EEA company.31 Generic medicines may be authorised according to the abridged application procedure, in which applicants may omit some or all of the preclinical and clinical trial data if bioequivalence can be documented with a reference product and regulatory data exclusivity for the reference product has expired.32

vi Regulatory incentives

Patents may be granted for medicines for 20 years from the date of filing as provided in the Patent Act, Section 40.33 When granted a marketing authorisation for a medicine, the marketing authorisation holder may benefit from a data protection period of eight years from the first marketing in the EEA.34, 35 If new indications are approved later, the data protection period may be extended to 11 years. Danish law concerning supplementary protection certificates (SPCs) is harmonised with EU Directives. The duration of an SPC is limited to a maximum of five years without the possibility of extension.36 Supplementary protection for medicines may in turn be extended by an additional six months if the patentee has tested the suitability of the medicines for children in accordance with Regulation (EC) No. 1901/2006 and Regulation (EC) No. 1 902/2006.37, 38 Article 36 of Regulation (EC) No. 1991/2006 allows for a further six-month extension of the SPC if a paediatric indication is approved by the regulatory authorities. An application for a paediatric extension should also be filed with the Danish Patent and Trademark Office (DKPTO).39

Patented indications

When dispensing medicines, pharmacies are legally obliged to substitute the cheapest medicine within the relevant substitution group.40 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. Consequently, the marketing authorisation holder of a medicine with a patented indication must inform the DMA about the patent or SPC and its expiry date, and the DMA will subsequently 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. This means in practice that the pharmacy should dispense the medicine with the patent protected indication.41

vii Post-approval controls

Marketing authorisation holders of medicines are legally obligated to establish and maintain a pharmacovigilance system, have access to a qualified person situated in the EEA and to comply with national rules on reporting suspected adverse reactions.42 The reporting requirements of adverse events from medicine use are described in Executive Order No. 1823 of 15 September 2015. According to Section 4(1) thereof, physicians, dentists, midwives, veterinary surgeons and pharmaceutical companies are legally obliged to report all suspected adverse events and exposure reactions in patients or animals they are treating.43 It is not mandatory to report adverse events caused by medication errors to the DMA.44 Pharmacists, consumers, patient relatives and lawyers may all report adverse events directly to the DMA. All serious adverse events must be reported to the DMA no later than 15 days after a physician, dentist, midwife or veterinary surgeon becomes aware of the event.45 During the first two years of marketing, all adverse events must be reported. After the two-year period, reporting obligations cover serious or unexpected adverse events only.46 For generic medicines, only serious or unexpected adverse events and exposing reactions must be reported; the reporting requirements apply from the time when marketing of the medicines has begun.47 Additionally, 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.48

viii Manufacturing controls

Manufacturers of medicines must have a manufacturing authorisation, under Section 39 of the Medicines Act. Medicines are to be manufactured in accordance with Good Manufacturing Practice (GMP)49 guidelines and the European Commission's guidelines listed in Volume 4 of the Rules governing medicinal products in the European Union.50 Manufacturers must have at least one qualified GMP person permanently and continuously at their disposal.51 Permissions will be granted by the DMA, and the DMA will regularly inspect the companies.

Distributors and wholesalers must also be authorised by the DMA, under Section 39 of the Medicines Act, and may also be inspected by the DMA. Information about authorised distributors and wholesalers may 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 GDP rules.52 Distributors and wholesalers must approve and review their suppliers regularly to monitor the suppliers' compliance with the GDP rules.

ix Advertising and promotion

Advertising of medicines is regulated in Part 7 of the Medicines Act and Executive Order No. 1153 of 22 October 2014 on advertising rules for medicines.53 The main purpose of the legislation is to protect the public against misleading and prohibited advertising of medicines and to ensure that the public have access to objective and adequate information about medicines. Advertising for prescription medicine to the general public is not allowed,54 but direct advertising to healthcare professionals (HCPs) is permitted.55

x Controlled substances

Manufacturers, wholesalers and others who handle medicines classified as euphoriants (e.g., narcotics or psychotropic substances) need a manufacturing, import or wholesale licence that specifically includes those substances.56 Authorisation of narcotics or psychotropic substances may be granted if the substances are prescribed to drug addicts for medical purposes. Dispensing of the medicines may be made by physicians, pharmacists and institutions involved in treatment of drug addicts.57 A list of euphoriants subject to control by the Danish authorities is available on the DMA website.58

III PRICING AND REIMBURSEMENT

i Pricing

The pricing of medicines is in general fixed and no approval by the authorities is required. Prices are fixed for 14-day periods, and therefore pharmaceutical companies must, every 14 days, provide to the DMA a price list with information about medicines for sale during the subsequent two-week period, under Section 77 of the Medicines Act. Price registration is mandatory if pharmaceutical companies intend to market medicines in Denmark.59 The national substitution rules determine that pharmacies are legally obliged to substitute a prescribed medicine to the cheapest generic or parallel-imported medicine when dispensing.60 Only rebates strictly related to cost-savings activities by the distributor can be given to private pharmacies.61 In the secondary healthcare sector, discounts in the form of reduced medicine prices are achieved through price tenders conducted by Amgros, the Danish regions' joint procurement service.62

ii Reimbursement

Reimbursement of medicines is determined by the DMA based on recommendations made by the Medicines Reimbursement Committee.63 Several types of reimbursement may be granted, under Section 152 of the Medicines Act. Pre-approved reimbursement means that the medicine has achieved general reimbursement at the time of marketing in Denmark and therefore the physician may prescribe medicines at reimbursed prices directly to the patient.64

For medicines not generally reimbursed, the physician may apply for individual reimbursement, of which there are three types: single, increased and reimbursement for the terminally ill. Single reimbursement is for special cases where the patient can obtain reimbursement for a medicine that does not have general reimbursement. To obtain single reimbursement, the physician must apply to the DMA and document why the patient concerned needs treatment with a particular medicine.65 The physician may apply for increased reimbursement if a patient needs a more expensive generic medicine, even if there is a less expensive alternative on the market; for example, if the patient is allergic to additives contained in the less expensive medicine.66 Increased reimbursement means that the grant is based on the actual price of the medicine instead of the reimbursement price. Terminally ill patients who choose to spend their last time in their own home or in a hospice can have their medicine expenses covered if prescribed by a physician. The physician or the hospital can apply for a licence for reimbursement of the terminally ill patient.67

IV ADMINISTRATIVE AND JUDICIAL REMEDIES

The DMA is the national administrative body 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 tried by the courts if challenged by a party with a legal interest in the case.

V FINANCIAL RELATIONSHIPS WITH PRESCRIBERS AND PAYERS

HCPs' professional interactions with the pharmaceutical industry are highly regulated to ensure that cooperation takes place in an ethically responsible manner. The interaction is primarily regulated by national rules and an ethical code issued by the Ethical Committee for the Pharmaceutical Industry (ENLI). Only members of ENLI are covered by its special regulations and subject to its sanctions.68 The Danish Health Act, Chapter 61a provides the legal framework for pharmaceutical companies' relationship with HCPs. The specific rules are set out in Danish Executive Order No. 1154 of 22 October 2014 on healthcare professionals' relationships with pharmaceutical companies as amended by Danish Executive Order No. 1685 of 16 December 2016. An overall description of the rules follows hereafter.

i Financial benefits for healthcare professionals

Pharmaceutical companies' financial support to HCPs is regulated in Sections 26 and 28 of the advertising rules for medicines.69 According to these rules, when attending educational and promotional activities with a scientific or professional purpose, HCPs may receive financial support in the form of payment of the reasonable costs in relation to dining, travelling and accommodation.70 Pharmaceutical companies' financial support to HCPs' activities outside Denmark is subject to notification by HCPs registered by the DMA. Information about financial support will be published on the Agency's website for a period of two years. The following information will appear on the website: unambiguous identification of the HCP (name and possibly an authorisation number), profession, pharmaceutical company, information about activity and date of termination of the activity.

ii Healthcare professionals' affiliation with pharmaceutical companies

Physicians and dentists undertaking clinical duties and proprietary pharmacists must notify the DMA of any relationship with pharmaceutical companies or apply for permission before they establish a relationship with a pharmaceutical company.71 The rules apply to pharmaceutical companies that have marketed medicines in Denmark (Section 7(1) of the Medicines Act) or companies with permission to produce, import and distribute medicines (Section 39 of the Medicines Act). Affiliations between HCPs and public hospitals do not need to be reported to the DMA.

A relationship includes any professional or financial relations with a pharmaceutical company. A professional relationship may cover individual tasks (e.g., research, teaching or the writing of articles), or full-time or part-time employment. Generally, all types of relationships are covered by the rules, as well as activities for which the HCP does not receive payment. Financial relations also cover HCPs who own or hold shares in a pharmaceutical company.72 Scientific advice, ownership, positions of trust and ownership of shares in the pharmaceutical company to a value of more than 200,000 Danish kroner require approval by the DMA. Information about teaching and research activities, as well as ownership of shares in pharmaceutical companies to a value up to 200,000 kroner are only to be notified to the DMA. When establishing a relationship with a physician, dentist or proprietary pharmacist, a pharmaceutical company must inform the person of his or her notification duty, as well as the company's reporting requirements, and publish the information on the DMA website.73 Pharmaceutical companies' notification to the DMA must be repeated once a year and no later than on 31 January each year by using a specific template on the DMA website.74 The information will be deleted from the DMA website after a two-year period.

VI SPECIAL LIABILITY OR COMPENSATION SYSTEMS

Patients, trial subject and donors are covered by a publicly funded compensation scheme, which covers injuries occurring in connection with medical treatments in the public and private healthcare system; injuries that result from adverse events from medicine use, and personal injuries occurring during clinical trials.75 The basic conditions for obtaining compensation are that the person must have been injured by a treatment made by an HCP or from the use of medicines. Time and causal relationship must be documented. Compensation can only be awarded for damage caused by the treatment or medicine and not injuries that may be related to the patient's basic condition. If the personal injury is covered by the compensation scheme, the patient or relatives are prevented from claiming compensation pursuant to other laws.76 Assessment of claims is made by the Patient Compensation Association and decisions may be appealed to an independent board. If the decision is upheld by the board, a legal complaint may be filed. In cases where compensation has been awarded and the patient injury was caused by a defect or flawed dangerous characteristic of the medicine, the government might file a recourse claim against the producer.77 The opportunities for filing for recourse are limited, as producers are only legally responsible for injuries caused by a defective medicine, and not developmental injuries or already-known adverse events.78

VII TRANSACTIONAL AND COMPETITION ISSUES

Transactions within the Danish life science sector are not considerably different from those in other European jurisdictions. General European competition law principles and legislation are applicable in Denmark.79 Sanctions for entering into cartel agreements under Danish competition law may include imprisonment for up to 18 months if the infringement is intentional and of a grave nature, whereas the sanctions under EU competition law are limited to fines.80 On 31 January 2018, the Danish Competition Council ruled that a pharmaceutical distributor had abused its dominant position by charging Amgros unfair prices (a 2,000 per cent price increase over a six-month period) for a certain medicinal product for which the distributor held an exclusive distribution contract. The decision was upheld by the Competition Appeals Tribunal on 29 November 2018. The case has been submitted to the Danish State Prosecutor for Serious Economic and International Crime.

VIII CURRENT DEVELOPMENTS

The second half of 2019 is expected to see the Danish government propose a bill for an external reference pricing (ERP) system. The ERP system will work as a price regulation measure to reduce list prices on medicinal products in Denmark. The ERP system will apply to both hospital medicines and medicines eligible for subsidy that are not covered by the voluntary price-cap agreement concluded between the Danish government and the Danish Association of the Pharmaceutical Industry (LIF). Pharmaceutical companies that have not joined the voluntary price-cap agreement must report their prices on medicinal products in nine selected 'comparable' countries, which are Finland, Sweden, Norway, the United Kingdom, Ireland, Austria, the Netherlands, Belgium and Germany. The Danish list price on the specific medicinal product will be calculated as an average based on the reported nine prices. The ERP system could enter into force as early as 2020; however, uncertainty exists because of the Danish parliamentary election that will take place in the first half of 2019.

In February 2018, the Danish regions adopted joint regional policies for continuity training and skills development in collaboration with the industry. By now, three out of the five regions have transposed the principles by entering separate agreements with LIF. The three regions are the Capital Region, the Region of Southern Denmark and the Region of Zealand. The agreements govern the sponsoring of healthcare professionals by pharmaceutical companies. The purpose of the principles is to facilitate a sound industry collaboration without risking the impartiality of the hospital staff. Though the agreements differ, they generally provide that invitations must be sent to the hospital management instead of the individual staff member. The companies may not, directly or indirectly, put names on the staff members they wish to attend training events. The hospital management decides at its discretion who shall be able to attend the events. The invitation cannot be subject to other obligations. Pharmaceutical companies organising or backing specific continuity training and skills development events targeted at the regions' hospitals must report such events to ENLI, which will verify that the rules are complied with. Consequently, pharmaceutical companies that have not joined ENLI will be unable to continue their training activities, since ENLI will not take and verify invitations received from companies that are not its members. Since the adoption of regional policies in the beginning of 2018, ENLI has more than doubled its number of member companies that are not part of either LIF, IGL (the Danish Generic and Biosimilars Medicines Industry Association) or FPM (the association for parallel imports of medicines).

Finally, there has been some deliberation with respect to the scope of tasks for the recently established Danish Medicines Council. The issue concerned the Council's possible recommendation for off-label use of medicinal products. Among its responsibilities, the Council must provide the five regions with recommendations to ensure fast and homogeneous use of new and existing medicines. To achieve this, the Council issues joint regional treatment guidelines. Expert committees assist in the medical assessment in relevant therapeutic areas and produce drafts for such guidelines. In early 2018, a protocol for such assessment revealed that the Council intended to include comparators that were not licensed for the therapeutic indications of the medicines that they were compared to (off-label). This prompted pharmaceutical companies and LIF to address the issue to the Council, arguing that such comparison could be perceived as an (indirect) recommendation for off-label use, ignoring the rationale for the marketing authorisation system and jeopardising patient safety by encouraging treatment with unlicensed medicines. It was argued that such comparison could consequently be considered illegal advertisement. Following some debate in the media, the Council informed that it had added to the protocol that the comparator in question will not be included in the recommendation.


Footnotes

1 Martin Dræbye Gantzhorn is a partner and Emil Bjerrum is a senior associate at Bech-Bruun 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.

4 Health Act. Consolidated Act No. 1286 of 2 November 2018.

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. 1083 of 15 September 2017.

8 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 2(1).

9 Executive Order No. 1654 of 18 December 2018 on the prescription and dose dispensing of medicines.

10 Executive Order No. 1239 of 27 November 2017 on the regulation of complementary medicine.

11 Medicines Act. Consolidated Act No. No. 99 of 16 January 2018, Section 60.

12 Executive Order No. 1274 of 27 November 2017 on the sale of over-the-counter medicine outside pharmacies.

13 Executive Order No. 1275 of 27 November 2017 on the sale of over-the-counter medicine in pharmacy outlets.

15 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.

16 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.

17 Animal Experiments Act. Executive Order No. 474 of 15 May 2014.

18 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.

19 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.

20 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.

21 Executive Order No. 695 of 12 June 2013 on good clinical practice in clinical human trials.

22 Medicines Act. Consolidated Act No. No. 99 of 16 January 2018, Section 88.

23 Executive Order No. 498 of 13 May 2018, Section 7 and 8 on informed consent of participating in clinical trials.

24 Executive Order No. 498 of 13 May 2018, Section 12(1).

25 Consolidated Act No. 995 of 14 June 2018, Section 19(3) on complaints and compensation.

26 Executive Order No. 695 of 6 December 2013, Section 2(1), no. 6 on good clinical practice.

27 Directive 2001/20/EC, Article 2(e).

28 Medicines Act. Consolidated Act No. No. 99 of 16 January 2018, Section 29.

29 Executive Order No. 1823 of 15 December 2015 on reporting of adverse events for medicinal products.

30 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 7.

31 European Commission. EudraLex – Volume 2. Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use.

32 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, Sections 10, 10a, 10b and 10c.

33 Patent Act. Executive Order No. 221 of 26 February 2017.

34 Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, Article 10.

35 Section 9 of the Executive Order on Marketing Authorisation No. 1239 of 12 December 2005.

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) No. 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use.

39 Danish Patent and Trademark Office: www.dkpto.org.

40 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 60(1) and Executive Order No. 1654 of 18 December 2018 on the prescription and dose dispensing of medicines, Section 62(1).

41 Executive Order No. 1654 of 18 December 2018 on the prescription and dose dispensing of medicines, Section 62(7-8).

42 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Sections 53 to 56(a).

43 Executive Order No. 1823 of 15 September 2015 on reporting of adverse events from medicine use.

44 id., Section 4(6).

45 id., Section 4(5).

46 id., Section 4(3).

47 id., Section 4(4).

49 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.

50 European Commission. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.

51 Executive Order No. 1358 of 18 December 2012 on the manufacturing and import of medicines and pharmaceutical intermediates.

52 Executive Order No. 1359 of 18 December 2012 on good distribution practice of pharmaceuticals.

53 Executive Order No. 1153 of 22 October 2014 on advertising rules for medicines.

54 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 66.

55 Executive Order No. 1153 of 22 October 2014 on marketing of pharmaceuticals, Section 11.

56 Executive Order No. 557 of 31 May 2011 on euphoriants.

57 id., Section 4(1)(4).

59 Medicines Act. Consolidated Act No. 99 of 16 January 2018, Section 75.

60 Executive Order No. 1654 of 18 December 2018on prescriptions and dose dispensing of medicines, Section 62.

61 Executive Order No. 1153 of 22 October 2014 on advertising of pharmaceuticals, Part 9.

63 Executive Order No. 671 of 3 June 2016 on the medicines compensation system.

64 Directive 2014/24/EC of the European Parliament and of the Council of 26 February 2014 on public procurement as implemented into Danish law by Executive Order No. 671 of 3 June 2016 on the medicines compensation system.

65 Executive Order No. 671 of 3 June 2016 on the medicines compensation system, Section 6.

66 id., Section 11.

67 id., Section 9.

68 Ethical Committee for the Pharmaceutical Industry. Available at: www.enli.dk.

69 Executive Order No. 1154 of 22 October 2014 on healthcare professionals' affiliation with pharmaceutical companies.

70 Danish Pharmaceutical Marketing Authorisation Act (Executive Order No. 1153 of 22 October 2014, Section 28.

71 The rules also apply to medical device companies established in Denmark. Further restrictions apply.

72 Executive Order No. 1154 of 22 October 2014 on advertising of pharmaceuticals.

73 id., Section 16(1-4).

74 id., Section 17.

75 Act on the Right to Complain and Receive Compensation. Act No. 995 of 14 June 2018.

76 Patient Compensation Association: http://pebl.dk/en.

77 Product liability covers the EU rules listed in Directive 85/374/1985/EE, the product liability rules based on case law. And the Danish Product Liability rules specified in the Consolidated Act No. 261 of 20 March 2007.

78 Product Liability Act. Consolidated Act No. 261 of 20 March 2007, Section 5(1).

79 Competition Act. Act No. 155 of 1 March 2018.

80 Commission Regulation (EU) No. 316/2014 of 21 March 2014 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of technology transfer agreements.