Pharma fraud is a term to describe several illegal activities involving the manufacturing, marketing, and distribution of pharmaceuticals.

Definition and examples

For example, Pharma fraud refers to:

• Trade involving counterfeit drugs: the practice of falsely claiming to be an authorized product of another firm, including but not limited to the use of another firm's mark to deceive the public.
• Deliberately manufacturing and marketing products that do not contain the required active ingredients or not contain the right amount of active ingredient.
• Packaging and labeling of drugs that make false claims regarding medical properties, including but not limited to the active medical ingredients, the date of expiration of products, or the methods of storage.
• Marketing of products using false claims regarding the efficacy of the product which will lead to the irrational use of medicines or deliberately failing to provide information about safety concerns of the product.
• Deliberate suppression of data, including evidence from clinical trials, that reveal adverse effects of the medicine.

Regulation

Because of a lack of regulation and enforcement, the quality, safety and efficacy of both imported and locally manufactured medicines in many developing countries cannot be guaranteed. Subsequently, smuggling and illegal importation of drugs are common. Substandard and counterfeit drugs are then not only sold in these countries but also exported or re-exported. According to the World Customs Organization, counterfeit drugs are a $200 billion a year industry.

Meningitis epidemic in Niger

In response to a meningitis

Meningitis

Meningitis is inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The inflammation may be caused by infection with viruses, bacteria, or other microorganisms, and less commonly by certain drugs...

 epidemic in Niger

Niger

Niger , officially named the Republic of Niger, is a landlocked country in Western Africa, named after the Niger River. It borders Nigeria and Benin to the south, Burkina Faso and Mali to the west, Algeria and Libya to the north and Chad to the east...

 from February to May 1995 (41, 000 cases reported), the Niger authorities organized an extensive vaccination

Vaccination

Vaccination is the administration of antigenic material to stimulate the immune system of an individual to develop adaptive immunity to a disease. Vaccines can prevent or ameliorate the effects of infection by many pathogens...

 campaign. In March 1995, Niger received a donation of 88,000 Pasteur Mérieux and SmithKline Beecham vaccines from neighboring Nigeria. A Médecins Sans Frontières

Médecins Sans Frontières

' , or Doctors Without Borders, is a secular humanitarian-aid non-governmental organization best known for its projects in war-torn regions and developing countries facing endemic diseases. Its headquarters are in Geneva, Switzerland...

 (MSF) team working with local health authorities noticed that the vaccines from Nigeria

Nigeria

Nigeria , officially the Federal Republic of Nigeria, is a federal constitutional republic comprising 36 states and its Federal Capital Territory, Abuja. The country is located in West Africa and shares land borders with the Republic of Benin in the west, Chad and Cameroon in the east, and Niger in...

 had an unusual appearance and inquiries were made. Pasteur Mérieux laboratories confirmed that the batch numbers and the expiration dates did not correspond to their manufacturing records. The drugs supplied by these companies had been substituted with counterfeit drugs. Tests carried out found no traces of active product, which confirmed that they were false. Bottles and labels were, however, copied to perfection. According to estimates, around 60,000 persons were inoculated with false vaccines out of a total 5 million vaccinated during the campaign.