Pharmaceutical News 2.0

Carl Weissman 5/29/09

Tell me if this makes sense to you:

—If I buy a diamond, I can own it for as long as I like;

—If I produce a brand name for a product, provided that I trademark it, I can own it for as long as I would like, until and unless it becomes “generic” (like the term “escalator”, which actually started as a brand name);

—If I write a novel, provided that I copyright protect it, I can own it until I die, and my heirs can maintain those rights for 70 years longer; but,

—If I invent a drug, even if I protect that intellectual property to the full extent of U.S. patent law, I can only own it for 20 years from the date I file for a patent on it.

I can own a tangible good forever, I can own a trademark virtually forever, I can own a copyright for my entire life plus 70 years. But property which is more intrinsically a part of me – my idea, my invention, the product of my intellect – I am only allowed to own that for 20 years after I reveal it to the patent office.

Rationally, it seems obvious that all property – whether tangible or intellectual – should be subject to the same rules and laws of ownership. If you can own a gemstone forever, you should be able to own an invention forever. In fact, if a society wishes to impose differential standards for ownership rights to different types of property, wouldn’t it make more sense that preferential treatment be given to those items which are the product of your talent, your creativity, your self, over those things which you earn or purchase based upon that product of your efforts? The logical extension of this argument, in any free society, is that you should be able to own all property, whether purchased or invented, physical or ethereal, for as long as you wish. Patents, trademarks, copyrights, title – all should be perpetual.

Read the rest of this article on drug patent laws here.

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Excerpt…

FREETOWN (AFP) — Sierra Leone has shut down a group of clinics run by Egyptian doctors for allegedly administering fake drugs as part of crackdown on illegal practices in the health sector, officials said Wednesday.

“We investigated after receiving a number of complaints from patients being given fake drugs and sub-standard injections for the treatment of typhoid in at least nine clinics run by the Egyptians,” said Alimamy Turay of the Sierra Leone Pharmacy Board.

At least four patients complained of feeling dizzy and had to seek medical relief elsewhere, he added.

On Tuesday, the health minister announced a crackdown on fake and unregistered foreign doctors operating in Sierra Leone, estimated to number around 200.

Sierra Leone is struggling to recover from a bloody, decade-long civil war which ended in 2001. An estimated 120,000 people were killed and thousands had their limbs hacked off by rebel fighters trying to overthrow the government.

The conflict left the health care system in tatters with less than one physician per 10,000 inhabitants, according to figures from the World Health Organisation.

Read the rest of this article here.

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EFPIA, the voice of the pharmaceutical industry in Europe, of which the Irish Pharmaceutical Healthcare Association (IPHA) is a member, has announced an important step in the industry’s efforts to protect Europe’s citizens against counterfeit medicines. EFPIA has agreed to run a pilot of its coding and identification solution (1) in Sweden later this year in partnership with Swedish retail pharmacy chain Apoteket AB and local wholesalers Tamro and KD.

Under the EFPIA solution, pharmacists will check a unique identification code on each individual pack when it is dispensed to the patient. These codes are generated and applied by manufacturers using a simple 2D data matrix barcode, which contains a unique serial number. The scan will reveal any duplication of data on packs and will trigger the system to immediately alert the pharmacist to the possibility of a counterfeit product, who can take the necessary steps.

“The threat posed by counterfeit medicines is real and growing,” said David Brennan, CEO of Astra Zeneca. “As an industry, we are focused on patient safety and ensuring the public can have confidence in their medicines. This coding system represents a major step forward towards that goal”.

“We are pleased to partner with EFPIA in this project” said Director General of Apoteket AB, Stefan Carlsson. “The 2D matrix coding solution contributes not only to the improvement of patient safety with regards to counterfeiting, but also to more effective ways of managing pharmaceutical products in pharmacies in the future.”

Director General of EFPIA, Brian Ager, added, “Obviously we share the European Commission’s concerns on counterfeit medicines. Therefore we are committed to making proactive contributions to reduce the risk; this initiative further underlines our commitment to patient safety.”

The coding solution is being developed in collaboration with GIRP (the European Federation of full line wholesalers). It has the potential to provide an efficient and cost-effective method to meet the new traceability requirements, being proposed by the European Commission, to combat the infiltration of counterfeit medicines into Europe.

The pilot is expected to last between three and four months and will be entirely financed by the pharmaceutical industry. It will be a scaled-down version of a full EFPIA solution: a key goal is to demonstrate that it is a practical and effective solution for manufacturers, pharmacists and patients alike, providing a standardised and interoperable system throughout Europe. The system is designed to ensure product identification from point of manufacture to point of dispensation, ensuring that the authenticity of each unit can be ascertained before it reaches the patient.

(1) For more information on the coding and identification solution visit here.

What are counterfeit medicines?

Counterfeit medicines are any brand (or generic) medicines and active pharmaceutical ingredients (APIs) that are deliberately and fraudulently mislabelled by unauthorised parties with respect to source, and / or composition and / or therapeutic quality. They include products without active ingredients, or with the wrong active ingredients, or with insufficient active ingredients, or with fake packaging. Sometimes they contain substitutes, or are diluted with foreign or toxic bodies, to increase the quantity of the original medicine.

Read the rest of this article here.

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