Patent laws blamed for high medication prices

The call to fix the patent law by TAC and Doctors Without Borders was initiated by their realisation that companies keep prices artificially high in South Africa by filling multiple patents on the same medicine

The South African government, to a certain extent, provides free healthcare to poor people. But the link between trade and health has raised eyebrows at the affordability and effectiveness of medication influenced by patent laws in the country.

The word ‘patent’ is defined as the right granted to anyone who invents any new useful and non-obvious process or product. In the health sector, a patent can be provided to the company that claims the intellectual property rights to sell a new approved drug from countries outside of the one they operate from. This has an impact on the pricing of the product.

The country’s current patent laws can delay the introduction of generic medicines in South Africa, limiting patients’ access to more affordable treatment. Unless specific changes are incorporated into the draft intellectual property (IP) policy from the department of trade and industry, South Africans will continue to pay unbearably high prices for medicines, even when lower-cost generic alternatives are available elsewhere.

A Bloemfontein pharmacist, Palesa Santho, says generic medicine – a drug product that is comparable to the patent brand – is as good as the original drug. Santho explains the process of manufacturing a generic drug.

“The generics work just as good as the original drug but they can never be 100 percent the same. Like Pepsi and Coke, they taste the same but they are slightly different. How do generics come about? There is a drug that is introduced. This drug was manufactured by a certain company after extensive research of molecular properties and efficacy.

“After a few years, other companies are allowed to copy the recipe of this drug. But the company that introduced the drug is not obliged to give the recipe. The copier will have to figure it out (but ingredients of medications, not the recipe, are written on the pack),” Santho explained.

“However, even after the copier has managed to figure out the recipe and make the generic medicine, this copy has to be compared with the original drug,” said Santho. According to Santho, the generic drug must still pass stringent tests.

“If the copy works far better than the original drug then it is not accepted as the generic. The generic should never be superior to the original drug but come close. Once all the necessary tests are done and the generic has been tested on animals and on humans and is considered safe to use, it will be registered and made available.

Generics are good and we as a country depend a lot on them because they are usually more cost effective. But there are those generics that may give different or additional side effects as compared to the original drug,” said Santho.

Last week, The Weekly reported that the United States Food and Drug Administration (FDA) had approved Dolutegravir. The medication was made by ViiV, a joint venture between pharmaceutical company Pfizer and GlaxoSmithKlein and Japanese company Shionogi.

It will be sold under the brand name Tivicay and form part of a class of antiretroviral drugs (ARVs) called integrase inhibitors, which work by interfering with one of the enzymes the HIV needs to multiply.

The dolutegravir or Tivicay will not be easily available in poorer countries but voluntary licenses will be granted to some generic companies. This license will allow these companies to produce cheaper versions of their patented products. It will also give them permission to low income or least-developed countries to access cheaper drugs.

This drug may not be affordable in South Africa. It was also reported that this drug is without site effects, an aspect that could encourage adherence by the HIV patients. “There is no drug that has zero side effects; even the polluted air we breathe in has side effects,” emphasised Santho.

Considering patent laws impact and after consistent pressure from the Treatment Action Campaign (TAC) and other health sub-sector, the South African cabinet voted to release the Intellectual Property Policy (IPP) draft law that will soon be open for public comment for 30 days.

Health experts and activists in South Africa say a two-fold battle is raging, one to ratify and then use the limited litheness afforded under international law for accessing more affordable medicine. On the other side is the war against big pharmaceutical companies and big power interests that are trying to re-shackle Africa’s intellectual property constraints.

The draft law is supposed to amend the country’s patent law that is considered to be costing ill people dearly. This law in its current form denied access to affordable medication because drug companies are easily granted monopolies by extending patents.

As a result, health organisations and government are paying heavily to provide life-saving drugs to those who can’t afford it. The call to fix the patent law by TAC and Doctors Without Borders was initiated by their realisation that companies keep prices artificially high in South Africa by filling multiple patents on the same medicine.

TAC and MSF are asking for the IP policy to include the implementation of a substantive pre-grant patent examination system, as required by Section 34 of the existing Patents Act, as well as stricter patentability criteria. These changes, along with other patent law reforms, will promote generic competition and increase access to more affordable medicines.

“This practice, known as ‘evergreening’, extends patent monopolies and blocks generic competition. For example, in South Africa, to treat a patient with chronic myeloid leukaemia (CML) for one year with Novartis’ cancer drug imatinib, costs over R387 000, pricing it out of reach for most South Africans and medical aid schemes,” stated Fix Patent Laws website.

According to this website, even though Novartis’ 20-year patent on the imatinib compound expired in South Africa in April 2013, an additional patent for a ‘new use’ of imatinib does not expire until 2022.

The memorandum TAC and MSF delivered at the National Workshop on Intellectual Property and Public Health in Pretoria made the following demands on behalf of ordinary South Africans:

1) Implement a substantive patent examination system for pharmaceutical patents to limit the number of patents granted in South Africa.  Excessive patenting keeps prices artificially high and medicines unaffordable for patients.  Section 34 of the South African Patents Act requires that all patent applications are substantively examined, but to date, the dti has failed to take necessary steps to implement this provision.

2)  Curtail evergreening and abusive patenting through stricter patentability criteria. The Patents Act does not explicitly exclude patentability of new forms, new uses and new formulations of already-existing medicines.  South Africa should amend patentability criteria to interpret flexibilities available under international law in a pro-public health manner, and prevent the patenting of trivial changes to existing medicines.

3) Enhance public transparency of the Patents Office. In South Africa, patent applications are not available for public scrutiny, and the claims of granted patents are only accessible through time-consuming case-by-case requests to the Patents Office. The lack of information available online or through easily accessible publications makes it difficult to know when patents have been applied for, and to oppose abusive patents.

4)  Allow for pre-grant and post-grant patent opposition by a broad range of third parties. Greater transparency from the Patents Office should be accompanied by changes to the law that allow patent applications and granted patents to be opposed by a broad range of third parties, including generic manufacturers, researchers, civil society, and other interested persons.  Patent opposition provides patent offices with additional input from various stakeholders regarding the public health impact a patent may have, and helps curb abusive patenting of pharmaceuticals.

5) Broaden the grounds and facilitate procedures for issuing a compulsory license. South Africa can issue compulsory licenses for the production of generic versions of medicines that are rendered inaccessible due to high cost or limited supply—but South Africa has never issued a compulsory license for a pharmaceutical.  It would cost an estimated R1million in legal fees and takes up to three years of court proceedings to obtain a compulsory license at present—amended and easier procedures are needed.