The pharmaceutical industry role in ensuring access to medicines in different countries

Abstract

Introduction: Different aspects of medicines pricing regulation often represent an obstacle of the patient access to medicines, especially in the developing countries. The main objective of medicines price regulation is to cope with rising health expenditures. Thereby, drug manufacturers, refusing to be present in these markets restraint and preventing access to vital medications and essential medicines. The purpose of the study is evaluation of international medicines pricing regulation carried out between health systems and the pharmaceutical industry.

Materials and methods: Has been carried out a descriptive analysis on medicines pricing regulation in different countries in order to determine potential methods of collaboration between pharmaceutical industries and local decision makers. Discussion results: Access to medicine depends on each country's unique capabilities, including the government policies and various factors: availability, affordability, accessibility and quality/acceptability. Most European countries employ a huge variety of regulation measures at the same time both on the demand and on the supply side: supply side regulation: in patent drugs - price controls: administrative or statutory pricing, external reference pricing, rate of return regulation, negotiations and price-volume agreements, direct expenditure controls: payback, direct expenditure controls: price volume agreements, cost-plus pricing; supply side regulation: off patent drugs - tendering for generics pharmaceuticals in primary care, price capping for generics and linking these to the originator price; supply side regulation: reimbursement methods - positive and negative formularies, internal reference pricing, HTA, innovative pricing and reimbursement schemes. Currently, the pharmaceutical R&D is oriented mainly to the treatment of non-communicable diseases like cancer, Hepatitis C, tuberculosis, rare disease, diabetes. In 2014 have been approved on the EU market 30 new active substance (NAS) – from which 13 NAS take an orphan status, 5 - alimentary tract and metabolism, 7 - anti-infective, 11 - anti-cancer and immunomodulatory, 1 – cardiovascular, 1 – nervous system, and 5 – other diseases; on US market 45 NAS, 21 with orphan status, 9 - alimentary tract and metabolism, 7 - anti-infective, 15 - anti-cancer and immunomodulatory, 3 – nervous system, and 11 – other diseases. The collective impact of the Trans Pacific Partnership (TPP) on the pharmaceutical industry will be to grant at least 10 years of additional monopoly to innovators in various ways. This may reduce pressure on innovators for researching new drugs and developing new remedies. Consequently, the society at large will suffer. This would also mean that patients in TPP countries would have to continue to pay higher prices for 10 more years. Those who can’t afford these will have to suffer without medicines that could have cured them.

Conclusion: The tension between managing cost and fostering innovation of medicines remain a big problem. There is need for greater cooperation between countries and stakeholders on what constitutes a fair reward for industry innovation while preserving access and sustainability. This should involve better balancing of the value of innovation with equitable, affordable patient access, collaboration among health systems might benefit from including a particular focus on chronic care, specialty medicines and rare diseases. Companies remain conservative in their approach to patents, and some of them have been the subject of settlements or decisions relating to ethical marketing, bribery or corruption standards or competition laws in the last two years.