Regulatory challenges in drug delivery: Pharmaceutical pricing

Anthia A Zammit

Regulatory challenges in drug delivery: Pharmaceutical pricing

Anthia A Zammit

Anthia Zammit Legal, USA

: J Pharm Drug Deliv

Abstract

We are unfortunately subject to an optimistic bias when we evaluate how, and to what extent, drugs and other medical therapies will be available, affordable, and accessible to patients. In developed countries, the pricing and affordability of medicines is a controversial issue that highlights health and economic inequalities, and great challenges for the future. The issue of unaffordable healthcare is rendered more challenging with technological advances and the demographic growth of the geriatric population. Legislation could be instrumental in the creation of equitable solutions. EU healthcare access and drug entry; the implementation of regulatory requirements aimed at ensuring quality, safety, and efficacy of medicines and vaccines for human use; and the European Transparency Directive (Council Directive 89/105) outlining procedural requirements for pricing and reimbursement of medicinal products will be discussed. These issues must be taken into account since few of the hundreds of drugs in clinical development ever reach the stage of final approval, having failed to produce the anticipated results expected by the investigators. These trials can take up to 20 years to complete, and several billion dollars to reach the stage of approval or denial by the regulatory agency involved. When failing to demonstrate viability, pre existing expenditures may be passed onto the price the pharmaceutical company charges patients. In the cancer industry for example, several new drugs cost up to $100,000 for a course of treatment. It is essential that the legislators in each of the countries where the medicinal product is to be introduced be able to negotiate a fee arrangement where the patient will not be denied treatment and the drug company be compensated reasonably for development costs.