Articles

Report from FIP Congress, Seoul, 2017

Gaby Wiederkehr, November 20, 2017

First some background on “FIP”:  FIP, the International Pharmaceutical Federation, is the global body representing pharmacy and pharmaceutical sciences.  Through 140 national organizations, academic institutional members and individual members, FIP represents over three million pharmacist and pharmaceutical scientists around the world.

Gabrielle Wiederkehr, M.Sc., Report from FIP (cont.) …

FIP is subdivided in several Sections, such as Academic Pharmacy, Community Pharmacy, Hospital Pharmacy, Industrial Pharmacy, Military & Emergency Pharmacy, and Social & Administrative Pharmacy.

FIP’s ambitious mission is improving global health by advancing pharmacy practice and science to enable better discovery, development, access to and safe use of appropriate, cost-effective, quality medicines worldwide.

Among numerous approaches to accomplish this mission, FIP is sponsoring international symposia, conferences and training programs for pharmaceutical scientists and practitioners.

As an Executive Committee Member of the Industrial Pharmacy Section, I am involved in preparation of programs for the yearly World Congress of Pharmacy & Pharmaceutical Sciences.  At this year’s Congress in Seoul I was chairing a session on “Accelerating access of medicines to patients globally.”

The presentations and subsequent discussions were focusing on barriers to effective access to medicines worldwide and how to overcome them.  Hurdles across the pathway from drug development through regulatory approval to initial treatment and proper patient management were addressed.

The nature of barriers differs substantially in various parts of the world.  In emerging markets, they include low awareness among 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 or trained medical staff), lack of availability of medicines, and most importantly, affordability.

In the industrialized 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 for containing 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.

Obviously, an important step to market access remains regulatory approval. Even though technical requirements have been harmonized over the last years to a large degree, there are still substantial differences in how regulators actually approach the reviews, and particularly in emerging markets, questionable administrative hurdles are raised.

Regulatory agencies are increasingly offering expedited review and development programs, which is particularly relevant for treatments of serious conditions with an unmet medical need in the developed world.

A recurring topic was pricing and affordability, particularly in emerging markets, and the role Big Pharma is considered to play.

In this context reference was made to a program that Novartis introduced in late 2016 to help fight key chronic diseases in emerging markets. Fifteen off-patent medicines are offered to governments and public sector customers at a price of a symbolic USD 1 per treatment per month.

Most people felt this was a great initiative, except for a colleague from Nigeria. He explained that this initiative has destroyed a local Nigerian generics company.  This company was successfully manufacturing the said drugs and supplying the whole country with affordable, good quality medicines.  After the market was saturated by the Novartis drugs, nobody was buying the local drugs any longer, the company went bankrupt and several hundred employees lost their jobs.

This story left me somehow at a loss and showed that every coin has two sides and often we know just one.

 

Original:

*With this article I like to share a recent experience from the yearly FIP Congress in Seoul in September 2017.

First some background on “FIP”:  FIP, the International Pharmaceutical Federation is the global body representing pharmacy and pharmaceutical sciences.  Through 140 national organizations, academic institutional members and individual members, FIP represents over three million pharmacist and pharmaceutical scientists around the world.

FIP is subdivided in several Sections, such as Academic Pharmacy, Community Pharmacy, Hospital Pharmacy, Industrial Pharmacy, Military & Emergency Pharmacy, Social & Administrative Pharmacy.

FIP’s ambitious mission is improving global health by advancing pharmacy practice and science to enable better discovery, development, access to and safe use of appropriate, cost-effective, quality medicines worldwide.

Among numerous approaches to accomplish this mission FIP is sponsoring international symposia, conferences and training programs for pharmaceutical scientists and practitioners.

As an Executive Committee Member of the Industrial Pharmacy Section I am involved in preparation of programs for the yearly World Congress of Pharmacy & Pharmaceutical Sciences.  At this year’s Congress in Seoul I was chairing a session on “Accelerating access of medicines to patients globally”.

The presentations and subsequent discussions were focusing on barriers to effective access to medicines worldwide and how to overcome them.  Hurdles across the pathway from drug development through regulatory approval to initial treatment and proper patient management were addressed.

The nature of 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 or trained medical staff, lack of availability of medicines and most importantly affordability.

In the industrialized 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 for containing 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.

Obviously an important step to market access remains regulatory approval. Even though technical requirements have been harmonized over the last years to a large degree, there are still substantial differences in how regulators actually approach the reviews and particularly in emerging markets questionable administrative hurdles are raised.

Regulatory agencies are increasingly offering expedited review and development programs, which particularly is relevant for treatments of serious conditions with an unmet medical need in the developed world.

A recurring topic was pricing and affordability, particularly in emerging markets and the role Big Pharma is considered to play.

In this context reference was made to a program that Novartis introduced in late 2016 to help fight key chronic diseases in emerging markets. Fifteen off-patent medicines are offered to governments and public sector customers at a price of a symbolic USD 1 per treatment per month.

Most people felt this was a great initiative, except for a colleague from Nigeria. He explained that this initiative has destroyed a local Nigerian generics company.  This company was successfully manufacturing the said drugs and supplying the whole country with affordable, good quality medicines.  After the market was saturated by the Novartis drugs, nobody was buying the local drugs any longer, the company went bankrupt and several hundred employees lost their jobs.

 

This story left me somehow at a loss and showed that every coin has two sides and often we know just one.