Generics as a Vehicle to Improve Market Access

In low and middle-income countries, around 17.6 million people each year die of treatable infectious diseases, reproductive health issues, and childhood illnesses. Millions more experience poor quality of life from chronic diseases.

The high costs of developing innovator drugs means that those treatments are often out of reach for least developed and developing countries, and even in developed countries. Affordable generics offer one major solution to this monumental problem. As such, some governments have used compulsory licensing to secure generics, if a voluntary license is not forthcoming.

However, with more patent owners recognizing that market access has shareholder value as well as patient benefits, voluntary licenses are becoming increasingly desirable. Generics as a Vehicle to Improve Market Access summarises different approaches to providing generics as a route to improve market access and evaluates the impacts of these strategies.

This report features exclusive perspectives from key people in the field of market access, including representatives from the pharmaceutical and generics industries, consultants specialising in generics and market access, and individuals from independent market access organisations, such as a voluntary licensing model.

Key features of Generics as a Vehicle to Improve Market Access include:

• Views from branded and generic Pharma
• Latest definitions and data on the needs for expanded market access
• Up-to-date look at the impact of the TRIPS agreement
• Demonstrated results of generic competition
• Examples of compulsory and voluntary licensing agreements
• Voluntary licensing models - ViiV Healthcare and Medicines Patent Pool
• Impact of expanded access on revenues and R&D
• PR impact for branded and generic Pharma
• Role of government in securing market access
• Other mechanisms for improving market access

The comprehensive report summarises the key issues around this important subject, and provides a wealth of pertinent tables, charts, and data points from sources such as the Access to Medicine Index, as well as a robust set of references, all in one convenient document.

As well as a detailed exploration of ways in which generics can improve market access, the report offers insights into other mechanisms, such as differential pricing and price-cutting, branded generics, distribution and organisational changes, and even drug donations. This report will help you to:

• Receive clear definitions of the key issues (e.g., which countries are “least developed”?)
• Gain insights into the perspectives of generics companies and big pharma
• Learn about companies who support voluntary licensing agreements
• Find out which companies have compulsory and voluntary licensing agreements in place, and for which drugs
• Understand the PR value of voluntary licensing and other routes to expanded market access
• Review other mechanisms to improve access, such as differentiated pricing
• Hear what industry thought-leaders think are the answers to improving market access

Generics as a Vehicle to Improve Market Access answers key questions including:

• Is market access to low cost drugs just a developing world issue?
• Which therapeutic areas are most critical?
• How does intellectual property affect market access?
• Why do generics improve market access?
• Why is compulsory licensing needed?
• Does expanded access affect revenues and reinvestment into R&D?
• What is the PR impact of voluntary licensing?
• Which models for improving access will be the most effective?

”Market access is a major ethical dilemma,” Asa Cox, founder, Generic Pharma 2.0 & New Pharma Mag.

”According to UNAIDS, there are around 34 million people living with AIDS, and the vast majority of them don’t have access to medicines,” Kaitlin Mara, communications manager, Medicines Patent Pool.

”Virtually all countries have been affected by the economic crisis, and healthcare spend is under increased scrutiny … In this context, the attractiveness of generic pharmaceuticals is bound to increase,” Rachid Ezzikhe, deputy corporate marketing officer, Tabuk Pharmaceutical.

”We need to be thinking of ways to build on each other's inventions, using licensing, royalty payments and whatever other mechanisms are at our disposal.” Peter Maybarduk, program director - Access to Medicines, Public Citizen.