Colombia President Juan Manuel Santos issued a decree that seeks to promote lower pharmaceutical drug prices in the country. Pharmaceutical companies criticize the move, claiming it will allow sub-standard drugs to enter the market.
The new legislation aims to reduce the price of biotechnological medicines by between 30 and 60%, the president said last week after signing the decree.
Under the new decree, bio-similar versions of biologic drugs, such as Trastuzumab (sold as Herceptin), an expensive drug for breast cancer, or Rituximab, an expensive drug used to treat both cancer and autoimmune diseases would be made available on the Colombian market.
Biotechnological medicines have contributed to major advances in the treatment of diseases such as diabetes, rheumatoid arthritis, some cancers and other diseases where traditional therapies cease to have an effect.
Last year, 35% of the total pharmaceutical market in Colombia was producing biotechnological medicines.
The legislation, which took three years to pass, has come under fire by Colombia pharmaceutical watchdog Afidro and the U.S government, who have pressured President Santos to ensure that the new legislation is made more restrictive to keep unsafe drugs out of the market.
Afidro, who is affiliated with well-known pharmaceutical companies Abbott, Sanofi, Novartis, Janssen, GlaxoSmithKline, Boehringer Ingelheim, Bayer, Sanofi and Pfizer, claims that the health of Colombian citizens is being put at risk by the new legislation.
In an open letter the Colombia government responded that the new decree required that any new drug must pass a series of nine tests to coincide with requirement of regulatory bodies Health Minister Alejandro Gaviria stated that “the most important thing is the safety and health of patients; therefore the only biotechnological drugs that will enter the market are those that rigorously meet the quality requirements that all applicants must submit.”
Need for change
The Health Action International Association released a study in 2009 which showed Colombians were paying the highest prices for medicines out of 93 countries worldwide.
The fact that the Colombian health system has been paying high amounts for medicines has made it possible for laboratories to take advantage of this situation and charge extortionate prices well above the global average.
Former Vice President Angelino Garzon said in 2011: “Colombia is the country in the region that has highest drug prices. What we want is that the pharmaceutical chemical industry understands that the prices of the drugs must be lowered, is not fair that in some neighbouring countries drugs are dramatically cheaper.”
For a box of Aprovel tablets which is used to treat patients with high blood pressure and produced by Sanofi an affiliate of Afidro, it was found that Colombian were paying $85,000 CP (42 USD) more than in Brasil. For this price they could buy another box of the medication.
Using the example of ciproflaxacin – a commonly used patented antibiotic- it was found that Colombians were paying 200 times the price at which the drug was sold legally in five Asian countries.
A more competitive drug market in which hospitals and patients could choose between a wider range of products, rather than being forced to buy expensive branded products by pharmaceutical giants would put pressure on laboratories and producers to lower prices in line with other countries.
Concerns raised by pharmaceutical watchdog with close ties to pharmaceutical giants
The letter from Afidro states that the current legislation is not in line with international legislation and will allow potentially dangerous medicines to enter the Colombian market.
Afidro are not alone in their concerns. On September 8, 2014, U.S Vice President Joe Biden wrote to President Santos and registered a complaint about the regulations in Colombia to register biosimilar drugs.
A 2014 U.S National trade report on national trade barriers stated:
“The proposed draft decree would establish three pathways for the approval of biological medicines. The first two pathways appear to be aligned with World Health Organization guidelines as well as U.S. Food and Drug Administration (FDA) approval processes… By contrast, the third pathway is an abbreviated pathway that does not appear to require the same detailed information and clinical evidence to prove the quality, safety, and efficacy of a product…”
It is claimed that the new legislation lowers the minimum health and safety requirements that any product must pass in order to be verified safe and used in Colombia.
The Colombia Ministry of Health responded that the new legislation ensured the safety of new drugs on the market, and that there was no need to make changes to the system in place.
- Carta abierta a President al presidente de Colombia. (AFIDRO)
- Enfrentamiento entre ministerio y farmaceuticas por ingreso de biotecnologicos al pais. (El Espectador)
- Decreto de biotecnologicos: acceso a medicamentos seguros… (Colombia ministry of health)
- 2014 National trade estimate report on foreign trade barriers (Office of US trade representative)
- Los precios de los medicamentos en Colombia por David Bardey (La Silla Vacia)
- Colombia es el país con los medicamentos más caros (Finanzas personales)