ODARI DEAL COULD SOAR MEDICINE PRICES IN KENYA-uae GETGLOBAL صندBitFields

On January 14th of this year, President William Ruto and His Highness Sheikh Mohamed bin Zayed Al Nahyan, the President of the United Arab Emirates (UAE) entered into a Detailed Economic Partnership Accord (DEPA) between their respective countries.

The accord has been celebrated as This marks the initial such accord signed by the UAE with an African continental nation. The Ministry of Foreign Affairs states that this signifies a "transformational move towards boosting trade, investments, and economic collaboration."

Yet, when discussing trade agreements, experts often say that the critical elements are found in the specifics. While one could elaborate at length regarding the Kenya/UAE CEPA, initially, it should be recognized that this pact stands out as peculiar even within the realm of trade-related accords.

Typically, standard trade agreements include market access clauses that progressively decrease tariffs on products. However, this particular agreement does not incorporate such reductions. It prompts the question: What advantages will the nation gain from making significant concessions within the CEPAs? Since it maintains current tariff structures, Kenya could continue trading according to WTO regulations and still export to the UAE without needing to enter into less advantageous terms through the CEPA.

Setting aside all the consequences of the agreement, we should focus on how this trade deal could affect the healthcare industry. While it might not be feasible to analyze every aspect of the healthcare system, consider as an illustration the prevalence of diseases such as HIV/AIDS, tuberculosis, and cancer.

Kenya bears a substantial health-related financial burden due to this challenge. The National AIDS and STD Control Programme reports that more than 1.4 million individuals in Kenya are living with HIV/AIDS.

The nation experiences roughly 18,000 yearly fatalities linked to HIV/AIDS and currently provides antiretroviral treatment to approximately 1.2 million individuals, which represents around 86 percent of those infected with HIV. It’s important to note this statistic does not include potential disruptions caused by the cancellation of the United States President's Emergency Plan for AIDS Relief (PEPFAR), following the disbandment of the United States Agency for International Development.

Regarding tuberculosis (TB), approximately 133,000 new cases of all types of TB infection occur annually according to current estimations. In 2022, the nation documented 90,841 tuberculosis cases, representing approximately 68 percent of detected instances. Each year sees around 1,200 occurrences of drug-resistant TB. Additionally, the overlap between TB and HIV stood at 20 percent, indicating that one-fifth of those diagnosed with TB are also living with HIV. Regarding fatalities related to TB in 2022, there were roughly 12,000 deaths. In terms of cancer statistics, the situation is equally concerning. As recorded by the Kenya National Cancer Registry, the country encounters an approximate total of 42,000 newly registered cancer cases yearly. Annually, this leads to about 27,000 mortalities from cancer.

The cost of treating these conditions is high. For instance, with cancer, the price for common chemotherapy medications like Doxorubicin, Cyclophosphamide, or Paclitaxel ranges from Sh5,000 to 30,000 per dose, varying based on the specific drug and dosage. For branded or targeted treatment medications like Herceptin, Trastuzumab, Keytruda, or Pembrolizumab, the price ranges from approximately KES 100,000 to KES 500,000 per dosage, with some immunotherapy drugs potentially exceeding KES 1 million. In contrast, hormonal therapies such as Tamoxifen or Letrozole generally cost between KES 500 and KES 10,000 each month.

Patients with cancer require pain relief and supportive medicines like morphine and anti-nausea drugs, which can cost anywhere from KES 200 to 10,000 monthly based on the specific brand and dose. Such expenses pose significant financial strain on individuals, particularly during times of economic hardship.

The Kenyan government has been providing financial support to reduce the cost of certain medications for patients. However, when taking into account the extensive fiscal austerity measures being implemented as part of an agreement with the International Monetary Fund (IMF), these subsidies might not continue indefinitely.

If we add the potential cancellation of the PEPFAR program by the U.S. government to the equation, it creates a potent combination of challenges for the health sector concerning the management of healthcare expenses within the nation prior to implementing the Kenya/UAE CEPA, which will significantly affect healthcare costs. Imagine this scenario: the government has endorsed a trade deal that will drive up the prices of these medications even further!

I was surprised to discover that the Kenya-UE CETA includes provisions requiring market exclusivity and linkage. To put it simply, these requirements mandate exclusive access to the market for a specific medication for at least five years, starting from whichever occurs later: the submission deadline for the application materials or the granting of marketing authorization.

This means that even if there is no patent on a medicine, for example, because it is not a new invention like insulin, and therefore not eligible for patent protection, generic versions still cannot be approved by the Pharmacy and Poisons Board as safe and effective and so reach Kenyan patients for a period of five years. A hard linkage obligation on the other hand, prevents compulsory licences from being effective.

A compulsory license refers to a situation where a government permits another party to manufacture a patented item such as medication or utilize a specific process without obtaining permission from the patent holder. This action can also involve using the protected innovation directly. Such licenses represent one of several flexibilities within patent regulations outlined under the World Trade Organization’s TRIPS agreement concerning intellectual property rights. It is worth mentioning that the India-UAE Comprehensive Economic Partnership Agreement (CEP A), established in 2022, lacks clauses related to exclusivity and linkage due to India explicitly opposing these elements to safeguard public health interests.

Around the world, numerous instances illustrate how such provisions have driven up medication costs. Colombia became subject to data exclusivity legal obligations starting in 2002. According to a 2012 study, this requirement was projected to add $396 million in extra expenditures to Colombia’s public healthcare system between 2003 and 2022.

A further instance illustrating the effect of data or market exclusivity involves an older medication used for treating gout. Colchicine was granted three years of exclusive marketing rights in the U.S. for a new application of the drug. The company holding this right filed lawsuits aimed at removing older forms of colchicine from the market and subsequently increased the price over fiftyfold, resulting in an additional $50 million annual expense for supplying the medication in America. Additionally, the drug was awarded seven years of exclusive marketing status for treating a specific rare condition called familial Mediterranean fever, despite this being previously recognized usage. This scenario illustrates what Kenya might encounter should the Kenya/UAE CEPA be approved under its present terms.

Thankfully for Kenya, the 2010 Constitution includes robust safeguards to prevent such rulings. According to Article 21 of the Kenyan Constitution, both the state and its various bodies have a basic obligation to guarantee that the rights and fundamental freedoms outlined in the Bill of Rights are respected.

This responsibility involves monitoring, honoring, safeguarding, advocating for, and ensuring the rights and liberties. Particularly, Article 21 incorporates the right to health into the array of rights and freedoms that the state must support. As acknowledged in the Kenyan Constitution, the right to health entails having access to the best possible level of wellness, encompassing availability to medical services such as reproductive healthcare.

As all treaties must be approved by Parliament before taking effect in Kenya, the responsibility now lies with the legislative body to adhere to the Constitution and safeguard Kenyans from this exploitative pact. During such instances, the Parliamentary Caucus on Business and the Economy has played a positive role.

In light of the dispute surrounding the approval of the Kenya-UK Economic Partnership Agreement (EPA), the Caucus suggested changes to the Parliamentary Standing Orders concerning treaty ratifications, particularly due to the shortcomings in the Treaty-Making and Ratification Act regarding economic treaties. These revised rules will enable Parliament to either endorse the agreement’s ratification, approve it subject to conditions, or reject it outright. Consequently, I recommend that our legislative body suggests modifications to the Treaty, specifically requesting the elimination of provisions exceeding those stipulated under the TRIPS Agreement and advocating for the addition of a section dedicated to market access. The ball is now in Parliament’s court!