A/HRC/23/42 65. Regulators in some of the developing countries surveyed by the Special Rapporteur reported the use of outdated methods and processes for enforcement, largely due to the lack of technical capacity, financial and human resources. For example, one such State regretted having sufficient inspectors to guard only 3 out of 41 ports of entry. Inspection of foreign production sites is an even greater challenge for resource-constrained importing countries. Regulatory bodies in many countries are generally funded by user fees, collected through licensing fees and inspection activities.96 However, these funds are insufficient to sustain effective regulation, given the scale and volume of production and import in most countries. States should therefore substantially increase budgetary support for their regulatory authorities to sustain the quality control activities and increase recruitment and training of staff. Regulatory bodies of importing developing countries could cooperate with their counterparts in the exporting countries to build regulatory capacities, share local inspection information of companies under their jurisdiction, and conduct joint inspections through cost-effective use of resources. 66. The Special Rapporteur also notes the ongoing global debate to deal with the growing challenge of counterfeit medicines. He points out that since the term “spurious/sub-standard/falsely-labelled/falsified and counterfeit” (SSFFC) medicines was coined, it has regrettably been used as a catch-all phrase to represent anything from poorquality to “counterfeit” medicines, which is specific to the domain of trademark violations.97 Such a linkage is counterproductive to access to medicines. This type of conflation was demonstrated by incidents in which unilateral action was taken by some countries against legitimate generic medicines as being counterfeit and even under the national laws in some countries which included generic medicines under the definition of counterfeit medicines, thereby threatening their import into that country. The Special Rapporteur expresses concern that an international legal remedy focusing on enforcement of trademark rights to counter the problem of counterfeit medicines takes away from the public health focus of strengthening of regulatory capacities in developing countries to deal with poor quality medicines and instead diverts limited State policing machinery to enforce private rights. IV. Recommendations 67. The Special Rapporteur calls upon the States to shift from the dominant market-oriented perspectives on access to medicines towards a right-to-health paradigm in promoting access to medicines. He emphasizes that access to affordable and quality medicines and medical care in the event of sickness, as well as the prevention, treatment and control of diseases, are central elements for the enjoyment of the right to health. 68. The Special Rapporteur urges States to adopt and implement a national plan of action on medicines and ensure that the right-to-health framework for access to medicines is fully integrated in the plan of action. 69. The Special Rapporteur encourages States to ensure that central principles of non-discrimination, transparency, accountability, and multi-stakeholder participation, particularly of affected communities and vulnerable groups, are 96 97 20 A. Breckenridge and K. Woods, Medicines regulation and the pharmaceutical industry, British Medical Journal, vol. 331 (2005), pp. 834-836. Gaurvika M. L. Nayyar et al, Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa, Lancet Infectious Diseases, vol. 12 (2012), pp. 48896, p. 488.