Pharmaceutical News 2.0

Excerpt:

MONDAY, OCTOBER 26, 2009
Filed from Portland, Oregon

PRESIDENT CORREA’S POLICY PRESCRIPTION

“I as President can order that we issue a compulsory license for Brand X, so they can copy this medicine and make generics, and the people have access to this medicine, to health, to a cure for their illness. [Applause.] And this is exactly what we are going to begin to do, with respect to medicines, with respect to agrochemicals, with respect to everything possible.”

Rafael CORREA Delgado
July 16, 2009

Context: Rafael Correa is the president of the Republic of Ecuador. First, elected in 2006, President Correa was re-elected as the leader of his country of 14.6 million people in April. The comment above is from a speech he gave this past summer on national television - and before a live audience. That was the speech. On Sunday, October 18, President Correa announced his intention to move forward with a policy of compulsory licensing for pharmaceuticals.

Comments, Part I. There are a number of strands to this story. One thread leads to the Ecuador’s economic policies, especially those involving Ecuador’s dealings with the rest of the world. From the repudiation of debt to the raising of numerous tariffs, these are policies that have gotten the world’s attention.

Another strand links to the WTO tortured discussions and current policies on “access to medicines.” WTO Director-General Pascal Lamy has described these policies as a balance between the long-term need to foster innovation and the short term necessity of ensuring that poor countries have access to the medicines they need at prices they can afford to pay.

A third strand, of course, relates to the global discussion of healthcare policy.

Read the rest of the thoughts on President Correa’s pharmaceutical patent policy.

Pharmaceutical Patents pharmaceutical patent

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.

The World Health Organisation (WHO) estimates that 8% to 10% of the medicines in the global medicine supply chain are counterfeit, reaching as high as 25% in some countries. The largest counterfeit market with close proximity to the EU is Russia, where it is estimated that 12% of medicines are counterfeit (1). Counterfeit medicines are entering Europe’s legitimate supply chain in increasing numbers. More than 4.081 million counterfeit medicines packs were seized at Europe’s borders in 2007, a 51% increase on the previous year (2). According to the World Health Organisation, around one percent of medicines in Europe are now counterfeit (3).

To date Ireland has had few incidences of counterfeits attempting to enter the legitimate supply chain however continued vigilance is required. The reality is that as long as repackaging and breaking of seals in the distribution chain is allowed, patient safety will be at risk and the potential for more incidences will only increase.

IPHA encourages patients to purchase prescription medicines through authorised distribution channels only and continues to raise awareness of the dangers of purchasing medicines online. A report published in 2008 revealed that a frightening 62% of medicines purchased on the internet were fake or substandard (4). The pharmaceutical industry spends billions in developing reliable, safe, life-saving and life-enhancing medicines. The system that enables such medicines to reach patients, through the collaboration of regulators, pharmacists, healthcare professionals and the manufacturers of medicines, has protected Irish consumers very successfully.

The European pharmaceutical industry recently proposed a European track and trace system to enhance product security. A pilot project which will see the mass serialisation of pharmaceutical products was launched in Sweden in 2009. Industry has also called for a ban on repackaging of pharmaceutical products; clearly defined liabilities for all involved in the distribution chain (including brokers, traders and agents); stricter auditing rules and controls of the supply chain; application of penalties for trafficking in counterfeits and for patients to be encouraged to purchase prescription medicines through authorised distribution channels only.

The EU Pharmaceutical Package which has begun the co-decision procedure in the European Parliament includes draft counterfeit medicines legislation which has taken note of industry’s calls and includes proposals for increased Good Manufacturing Practice inspections on a risk basis in non EU countries; the use of tamper evident packaging; strengthening of product identification at individual pack level; a ban on repackaging of medicines and auditing of the entire medicines supply chain.

Only when these are implemented will European patients be guaranteed a genuine pharmaceutical product.

1. Association of International Pharmaceutical Manufacturers (AIPM) and the Coalition for Intellectual Property Rights (CIPR) 2002
2. 2006 Customs Seizures of Counterfeit Goods. European Commission. 31 May 2007. http://ec.europa.eu/taxation_customs/customs/customs_controls
   /counterfeit_piracy/statistics/index_en.htm
3. Counterfeit Medicines – a New Update on Estimates. Position statement by the International Medical Products Anti-Counterfeiting Taskforce (WHO). November 2006.
4. Counterfeiting Superhighway (EAASM) 2007 http://www.eaasm.eu/Media_centre/News/
   The_Counterfeiting_Superhighway

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Dallas Police Department officials initially proclaimed 2001 a banner year for drug busts, reportedly seizing 1,440 pounds of cocaine and 238 pounds of methamphetamine with an estimated street value of $65 million.

An investigation by WFAA-TV (Channel 8), however, discovered that nearly half the cocaine and a quarter of the methamphetamine seizures contained little or no illegal drugs. Through extensive interviews while tracking lab results and court records, WFAA-TV found that a key ingredient in at least several seizures was gypsum, the main component of Sheetrock.

In a series of broadcasts beginning Dec. 31, WFAA-TV reporter Brett Shipp and producer Mark Smith questioned the legitimacy of dozens of drug cases made by a cadre of street-level DPD narcotics officers and their paid confidential informants.

The suspects in the “fake drug” cases often were curiously similar. Most were recent Mexican immigrants working as auto mechanics or day laborers; few spoke English or had prior criminal records. Often, the alleged drugs were found in duffel or trash bags inside vehicles parked at auto shops or loaned to the suspect.

Many suspects only learned that they faced drug charges days after their arrests. Most, if not all, claimed to have never seen the alleged drugs; several passed polygraphs when asked if they knew about the seized items.

Facing minimum 15-year-to-life prison sentences, many defendants languished in jail for three months or more before the seized substances were sent off for lab tests that later revealed little or no drugs. The findings contradicted the results of field tests police say they conducted during the arrests.

Cases often were based primarily on the word of informants. Police say one of the informants received more than $210,000 - about a third of all the money DPD paid its nearly 150 informants for 2001. Despite dozens of arrests, police produced only a single videotape to help corroborate the drug charges. Few of the seizures - several dubbed the largest in Dallas County history - led to the confiscation of money, weapons or other assets.

Because of the questions raised by several dozen fake-drug cases, prosecutors have dismissed more than 80 cases - including legitimate busts. Nearly all the cases involved two undercover officers and three informants. The FBI is investigating several officers and their payments to these informants.

The cases have also prompted Dallas police and prosecutors to enact a number of policy changes, including:

* all seized drugs are sent immediately for lab analysis

* prosecutors will not seek to indict a suspect until the lab results are completed

* the police chief will be notified of any payment to an informant greater than $1,000

* every three months, audits will be performed on funds used in DPD narcotics cases

* narcotics officers will receive additional training in conducting field tests on drugs

This timeline charts the major developments in the ongoing investigation.

Check out the rest of this time line on fake drugs and the Dallas Police investigation.

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