The right to life 

Article 2.1 ECHR: “1. Everyone’s right to life shall be protected by law. No one shall be deprived of his life intentionally save in the execution of a sentence of a court following his conviction of a crime for which this penalty is provided by law.” Article 6.1 ICCPR:  ‘Every human being has the inherent right to life. This right shall be protected by law. No one shall be arbitrarily deprived of his life.’

The right to the highest attainable standard of health

In Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), States Parties recognise ‘the right of everyone to the highest attainable standard of physical and mental health’.  The Committee on Economic, Social and Cultural Rights (CESCR), which supervises the implementation of the ICESCR, has published a comprehensive interpretation of the aspects necessary for the right to health’s realisation in its General Comment 14 (GC 14). Below is a summary of GC 14’s key elements:

(1) States have duties to respect, protect, and fulfil the right to health;

(2) It is recognised that the right to health is subject to resource constraints and progressive realisation; 

(3) Nonetheless, certain aspects of the right to health are of immediate effect;

(4) Access to healthcare goods, services and facilities should be available, accessible, acceptable and of good quality:

(5) The ‘accessibility’ qualifier includes the dimension of ‘affordability’;

The right to health imposes legal obligations on governments to realise this right to the greatest extent possible. Access to medicines is a fundamental element of this right. Governments therefore also have the duty to create laws and policies that promote and ensure citizens’ access to medicines. 

The Corporate Responsibility to Respect Human Rights

The United Nations Guiding Principles on Business and Human Rights hold that ‘the responsibility to respect human rights is a global standard of expected conduct for all business enterprises wherever they operate.’  This standard ‘exists independently of States’ abilities and/or willingness to fulfil their own human rights obligations’. Private companies therefore have stand-alone obligations to respect human rights.  Beyond the general standards outlined in the UN Guiding Principles, The Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines indicate that pharmaceutical companies have specific obligations in relation to access to medicines, and provide standards for determining if, and when, pharmaceutical companies may have violated human rights and should be held accountable.  Principle 33 reads as follows: ‘When formulating and implementing its access to medicines policy, the company should consider all the arrangements at its disposal with a view to ensuring that its medicines are affordable to as many people as possible.’ 

The unwritten duty of care  

According to section 162 of book 6 of the Dutch Civil Code (DCC), ‘a person who commits a tort towards another which can be imputed to him, must repair the damage which the other person suffers as a consequence thereof.’ The third category of torts relates to acts or omissions that violate ‘a rule of unwritten law pertaining to proper social conduct’. This last category constitutes an unwritten standard of due care, any breach of which will be considered a tort.  The Court determines this standard of care by considering ‘all relevant facts and circumstances of the case’. In the landmark judgement against Royal Dutch Shell, the Dutch Court paid significant attention to the UN Guiding Principles. This case sets an important precedent, with the Court ruling that private companies have individual obligations (in this case, to reduce CO2 emissions), independently of existing State obligations, and that this obligation is enshrined in Dutch tort law in article 6:162.  Accordingly, pharmaceutical companies also have a corresponding duty of care, which may be breached by, e.g., setting high prices that result in displacement of care and loss of life. 

The OECD Guidelines

The Organisation for Economic Cooperation and Development (OECD) is a forum composed of governments which promotes trade and free market policies. The OECD Guidelines for Multinational Enterprises (OECD Guidelines) are a set of recommendations aimed at encouraging responsible business conduct.  The Guidelines set international standards relating to many areas of business conduct, including human rights. They are not legally binding on the companies themselves, but on the signatory governments. Corporate misconduct can be resolved through a special grievance mechanism, implemented through a representative in the signatory State (known as a National Contact Point/NCP).   Most importantly, the OECD Guidelines establish that the responsibility to respect human rights applies to corporate entities, such as pharmaceutical companies. 

Abuse of a dominant market position 

Article 24.1 of the Dutch Competition Act (DCA) holds that ‘undertakings are prohibited from abusing a dominant position’. More specifically, Article 102 of the Treaty on the Functioning of the European Union (TFEU), states:  ‘Any abuse by one or more undertakings of a dominant position within the internal market or in a substantial part of it shall be prohibited as incompatible with the internal market in so far as it may affect trade between Member States. Such abuse may, in particular, consist in:

(a) directly or indirectly imposing unfair purchase or selling prices or other unfair trading conditions;

(b) limiting production, markets or technical development to the prejudice of consumers;

(c) applying dissimilar conditions to equivalent transactions with other trading parties, thereby placing them at a competitive disadvantage;

(d) making the conclusion of contracts subject to acceptance by the other parties of supplementary obligations which, by their nature or according to commercial usage, have no connection with the subject of such contracts.

Market dominance usually occurs when a private company enjoys a position allowing it to function independently from its competitors, and controls a majority share of the market. This is sometimes measured by market share – e.g., above 40% – but this is not a perfect measure of dominance. In United Brands v Commission, the Court of Justice of the European Union (CJEU) described the dominant position as one ‘of economic strength enjoyed by an undertaking which enables it to prevent effective competition being maintained on the relevant market by affording it the power to behave to an appreciable extent independently of its competitors, customers and ultimately of its consumers’. Misusing the regulatory framework by, for example, extending patent protection for drugs in order to delay the market entry of generic products, is considered to be an anti-competitive practice and an abuse of such a dominant market position. Charging excessive prices for a medicine during the patent protection period can also be considered an abuse of dominance.