Category — Pharmaceutical

New German Health Minister Takes Aim At Traditional Pharma Companies.

Newly appointed German Healthcare Minister Philipp Roesler – liberal – Free Democratic Party in likely move to break big pharma stronghold and submit new products to insurance pricing scrutiny and impose an “efficiency and clinical effectiveness /outcomes” pricing performance ratio.

Not totally dissimilar to the British NICE economic and clinical effectiveness system.

Sign of the times perhaps to introduce new effectiveness and economic liberalization in the DME (durable medical equipment) sector of the ever increasing homecare industry.

Maybe not – Roesler is clearly risking his parties popularity as a junior member in Chancellor Angela Merkel’s Christian Democrat Party.

Here is a thread from The BMJ where NHS physicians enter into the argument of the value (moral, ethical and commercial) of medical (pharmaceutical) sales reps.

The original letter from Dr Shane O’Hanlon starts like this:

It was switching to decaffeinated coffee that started it all. In a flash of lucidity I realised the dubious ethical basis for drug company representatives’ courtship of doctors.

Doctor – Sorry to say but so long as anybody works for money, including doctors, they could be asked the same thing. Doctors are very quick to court sales people when they “need” something. Medical Journals are quick to solicit and accept drug company advertising, and there is nothing wrong with that. It is also very ethical.

It becomes unethical when the conversation between a doctor and a sales rep concerning a product or service cannot be published in the local newspaper – that’s the acid test. In 99% of cases it can be.

The argument is the same one that has been made for years and usually ranges from “I don’t like them, they waste valuable time, they are (yes) commercial” etc.

The counter argument is that in fact the medical sales rep does provide a service – even if it is to only alert the doctor to a new product so that he or she can go and do their own research (which is what hopefully they do anyway).

Obviously there are good and bad sales people (and doctors) in every industry. I am making an assumption that most are good, so here goes.

Doctors, you get what you deserve – many of you treat appointments with sales reps with little respect for the content of their message (after having kept them waiting way past scheduled (and cancelled) appointment times). Even when the sales person is finally in front of many of you – you look at your watch and say “you have two minutes” as you continue to click on the keyboard.

If you have pre-determined that the sales rep will have nothing useful to say – then why agree to the appointment in the first place?

Without a doubt there are medical / surgical sales reps that are way better trained on a particular subject than the doctor is. This is of course the reason why so many sales people are invited into the OR (Operating Theatre) to explain the use of complex, and often life saving medical devices.

It is true that with modern media there are now improving ways of getting the message across to the doctor, which is good for all. In the mean time next time you the doctor complains or is rude to a sales rep – think first about the value of pharmaceutical and medical companies, especially when you demand samples of products, a demonstration, or support for an important clinical trial that you are going to publish.

Pharmaceutical companies – make sure you have the right message and you are sending it in the most effective way.

(To all the pharmaceutical representatives out there looking for a job – rest assured that you have great value. If you can succeed and survive selling into the hospital jungle – you can excel anywhere).

Press Release:

Biotech from Saxony-Anhalt in America

Halle (Saale) – 05.18.2009. The state of Saxony-Anhalt will participate in the world’s largest biotechnology fair, BIO International, in Atlanta, GA, USA this year.

From the 18th to the 21st of May, 2009 the state will promote new technologies from the medicinal and green biotechnology fields, with it’s own presentation within the common German booth. The trade-show appearance is a result of a collaborative effort with the Saxony-Anhalt investment and marketing corporation mbH (Investitions- und Marketinggesellschaft Sachsen-Anhalt mbH). “We are pleased that the fair’s organizers have again invited a company, namely the novosom corporation from Halle, to present and discuss its technology” commented Dr. Jens Katzek, Managing Director of BIO Middle Germany (BIO Mitteldeutschland), on the participation of the Halle-based Biotech Company novosom.
[Read more →]

ICH Q10: final guidance for implementing an effective quality management system for the pharmaceutical industry.

The FDA has just issued its final guidance on ICH Q10.

This internationally harmonized guidance is intended to assist all pharmaceutical manufacturers by describing a model for an effective quality management system called pharmaceutical quality system. Based on International Organization for Standardization (ISO) quality concepts, it includes applicable good manufacturing practice (GMP) regulations, and complements ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management.”

Interestingly, this model can be implemented throughout the different stages of a product lifecycle and strengthen the link between pharmaceutical development, manufacturing and commercial activities.

It reinforces the need for Leadership which is essential to establish and maintain a company-wide commitment to quality and for the performance of the pharmaceutical quality system to achieve product realization, to establish and maintain a state of control and to facilitate continual improvement.

FDA also insists that companies use knowledge and quality risk management and apply this guidance to their outsourced activities and the purchase of raw materials while conducting assessments of suppliers and service providers before entering into an agreement.

Market rumors abound that pharmaceutical sales reps at Pfizer may be the next to go. CNBC and Bloomberg are announcing the possibility that 2400 US domestic sales employees (about a third of the sales force) may be let go due to off patent drug expiry, and no doubt the current world financial crisis?

The irony is that we reported about a month ago that Pfizer was ranked number 1 in traditional detailing by physicians.

Pharmaceutical Sales Rep Calls And Sales Force Effectiveness – The Trend

It would not surprising of course to see sales rep layoffs coming in the medical device business as well – judging by the recent news at Cardinal.

Economic Downturn Hits Hospital Supply And Medical Device Business

Ahead of the next Pharmapack Conference, the European Commission has revised its guidance on the readability of consumer pharmaceutical labeling. This includes primary and outer packaging labels as well as leaflets / inserts.

The main purpose of this document is to provide guidance on how to ensure that the information on the package label and package leaflet / insert is accessible to and can be understood by those who receive it.

It includes information on how the requirements for Braille must be met with a suitable package leaflet format for the blind and partially-sighted consumer.

Interestingly, one of the conference topics on day 2 will address how Braille can be applied, verified and measured.

The guidance indicates that as a minimum the (invented) name of the drug followed by its strength should be available in Braille on the packaging of the product. Space being an issue for small volume products, recommendations such as contracted Braille or certain defined abbreviations are given.

The guideline also includes an example of methodology of validating the acceptability of the package insert.

This guidance has a fast approaching deadline – next June.

The EU document (PDF file) is available from the European Commission Website.

Bruno Cocheteux is a Managing Partner at Sibaya Lifescience!

This conference, supported by industry opinion leaders and exhibitors will take place in Paris January 21, 22, 2009.

The event provides a unique opportunity to not only update on state of the art scientific developments but also to do business with like minded people in the drug packaging and drug delivery business.

The location is LA GRANDE HALLE DE LA VILLETTE – HALL Charlie Parker.

View Larger Map

Bruno Cocheteux is a Managing Partner at Sibaya LifeScience!