B7 - Breaking down barriers to patient access – How to bring stakeholders together


Organised by the FIP Industrial Pharmacy Section in collaboration with the FIP Social and Administrative Pharmacy Section


Gabrielle Wiederkehr (ACCESS Regulatory Consulting GmbH, Switzerland) and Katja Hakkarainen (StatFinn & EPID Research, Sweden)


There are several barriers to effective access to medicines across the pathway from drug development through regulatory approval to initial treatment and proper patient management. The nature of those barriers differs substantially in various parts of the world. In emerging markets, they include low awareness of patients and healthcare professionals of the right treatments or the benefits of new medicines, inadequate accessibility to care as often there are not enough hospitals, diagnostic equipment or trained medical staff, lack of availability of medicines in local pharmacies or hospitals and affordability.

In the industrialised world, market access used to be assured if a pharmaceutical product was safe, effective and of good quality. Today, as private and government payers grow more powerful, market access to innovative new drugs is far more challenging due to the need to contain rising costs, the proliferation of competing drugs in the same therapeutic area, reliance on evidence-based medicine and health technology assessment which drive payer decisions. In addition, growth of the generics segment and the emergence of biosimilar drugs have given payers additional choices when deciding which products they will cover.

Furthermore, an important step to market access remains the need to obtain regulatory approval. Even though technical requirements have been harmonised over the past few years to a large degree, there are still substantial differences in how regulators actually approach the reviews.


14:30 – 14:40 Introduction by the chairs

  1. 14:40 – 15:15 What is needed from stakeholders to remove barriers to market access in emerging markets?
    Sola Solarin (Savanté Consulting, Nigeria)
  2. 15:15 – 15:50 What obstacles stand in the way of faster development and launch of innovative new medicines and how can they be overcome?
    Hermann Schulze (Mallinckrodt Pharmaceuticals Ltd, Switzerland)
  3. 16:10 – 16:45  Benefits and risks of early market access
    Richard Huckle (Pope Woodhead & Associates Ltd, UK)
  4. 16:45 – 17:20 Can real-world evidence contribute to faster access of medicines to the patients?
    Katja Hakkarainen (StatFinn & EPID Research, Sweden)

17:20 – 17:40 Q & A

Learning Objectives

At the end of this session, participants will be able to:

  1. Identify the key barriers for patient access to medicines in different parts of the world;
  2. Identify potential ways to overcome those barriers;
  3. Describe how the different stakeholders could more effectively collaborate and contribute to faster and wider access of medicines to patients;
  4. Describe potential risks and risk management of early access to medicines.

Type of session: Knowledge-based