@MSF Video: Patents and the fight for #generics

Intellectual property protects those items that we can’t live without – think Netflix and the iPhone 7 – and those that we would surely die without, including life saving and extending medications.  Today’s video covers the latter and the barriers much of the developed world faces courtesy of patent laws that protect pharmaceutical companies.  This issue has come to recent attention as the UN’s Panel on Access to Medicines published its recommendations to Big Pharma’s chagrin.

At the crux of the UN Recommendations is a struggle that pits profits against people.  Enacted in 1995 by the World Trade Organization, the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced minimum standards for protecting intellectual property, including patents on medicine.  TRIPS proved a boon for international trade, but set a 20-year patent on novel medication.  Only after the patent lapses can generic alternatives hit the marketplace.  It is at this point when many lifesaving and extending drugs are first available to the developing world.  The price tag of a medication to treat HIV/AIDS can drop from $10,000 per year to $200 due to generics.

Under TRIPS, each country has the right to a grant compulsory license, as stated in this excerpt:

Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

(b)   such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;

In layman’s terms, if it is in the public’s best interest, generic drugs can be pursued without the patent holder’s consent.

A few years after TRIPS, South Africa attempted to pass an act that would grant a compulsory license for antiretroviral therapy in response to a staggering HIV/AIDS epidemic. The act was met with a lawsuit by 40 multinational companies and the United States, citing South Africa in violation of the TRIPS agreement, though executed in the midst a public health crisis.  Despite controversy, President Nelson Mandela signed the act into law and the lawsuit was eventually dropped.  In response, the World Trade Organization signed the Doha Declaration in 2001 to further clarify the right to grant compulsory licenses.

Nearly 20 years after TRIPS and Doha, the developing world continues to suffer from catastrophic levels of health inequality.  Africa, among the hardest hit, is home to nearly half of all tuberculosis cases and 91% of HIV-positive children. Countries that attempt to circumvent TRIPS, even in the direst of public health crises, are subject to retaliation by termination of trade agreements that help keep their economies afloat.

Earlier this year, Colombian Health Minister Alejandro Gaviria, warned a large pharmaceutical company, Novartis, that a compulsory license to pursue a generic form of a popular cancer drug was imminent if Novartis didn’t lower its prices.  In a letter from the Colombian Embassy in Washington, Colombia’s government was threatened by the United States with withdrawal of support to join the Trans-Pacific Partnership trade zone and funding to facilitate a peace deal with a longstanding rebel group.

The exorbitant cost of pharmaceuticals can also threaten consumers in developed countries.  Recent outcry over the soaring price of the anaphylaxis drug, EpiPen, has many in the United States worried. The price of EpiPen has gone from $60 to over $600 in recent years and are now exclusively sold in two-packs, further increasing the cost for consumers.  A similar product, Adrenaclick, is not considered equally therapeutic to EpiPen and pharmacies are unable to fill prescriptions.  Another pharmaceutical company applied to make a generic version, but the application was rejected by the FDA.

This has led to repercussions such as children carrying expired EpiPens and EMTs dispensing epinephrine by syringe, which makes it much harder to administer the correct dose.  A recent article in the American Journal of Medicine suggests that EpiPens be added to a list of preventive medicines, effectively lowering the copay without lowering the overall price of the drug by the pharmaceutical company, Mylan Specialty.  The cost would likely be shifted to consumers in higher deductibles.

In light of the UN recommendations, what is the next step to guarantee medications are available to those who need them?  Dr. Bernard Pecoul of Drugs for Neglected Diseases Initiative urges action, not apathy:

“Governments mustn’t allow the report to become yet another exercise that describes the current failures of the medical innovation system without contributing concrete steps to address those failures. Responsibility now clearly falls on them at the highest political levels to act by putting in place innovative and practical solutions.”


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s