30 August 2000
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 Health Action International |
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30 August 2000
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Health Action International |
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The MSF Access Campaign team has
prepared a summary of the recent Nairobi conference on trade and access issues.
It highlights the presentations and discussions at the two-day meeting and gives
a good overview of the problems affecting access to essential medicines in Eastern
Africa. HAI Europe has the full proceedings
of the report if anyone wishes to order a copy.
"I am tired of not being able to treat patients because the medicines are too expensive. Africans should not be dying because of inability to pay when effective medicines can be available at affordable prices. These medicines are already available in countries such as Thailand, India, and Brazil."
Dr Christopher Ouma, AIDS project co-ordinator, Médecins Sans Frontières, Kenya
In an opening address Dr. Amukowa Anangwe, the Kenyan Minister for Medical Services, set the tone for the two-day East African "Improving Access" conference. His address carried the message of urgency and emphasised a strong political will to challenge a status quo which keeps life-saving medicines out-of-the-reach of many East Africans.
The Minister welcomed 180 delegates from Ethiopia, Kenya, Tanzania and Uganda, as well as 17 other countries, who met to strategise on improving access to essential medicines in East Africa. The meeting brought together people from ministries of health, national drug authorities, pharmaceutical companies, intellectual property officials and local and international NGOs. The high prices of critical essential medicines and the links between international trade agreements and local drug availability were a central focus of the conference.
Although many participants were already acutely aware of the high prices of life-saving medicines in East Africa, data presented by pharmacist Kirsten Myhr caused quite a stir. The presentation showed that East Africans sometimes pay more than twice what Europeans pay for many essential medicines. Myhr examined the retail prices of 15 medicines in Kenya, Tanzania and Uganda, then compared them with prices in Norway (about average within Europe). One example cited was the potent antibiotic ciprofloxacin, which was found to be twice as expensive in Uganda as in Norway. The malaria medicine mefloquine, for which there is a tiny market in Norway, was also twice as expensive in Tanzania where malaria is endemic. "The figures show that the entire region is suffering from reverse equity," said Myhr, "the poor are paying more than the rich".
Dr. Sam Muziki of the World Health Organization (WHO) put this pricing data in perspective when he explained that, in developing countries, 80% of drugs are paid for out of patients' pockets. According to data presented at the conference, the average Tanzanian would have to work 215 days to purchase a basket of 13 essential medicines, while a Canadian would only have to work 8.
In addition to this imbalance between wealthy and poorer countries, there is also a dramatic difference between prices in countries with and without patents on specific drugs. One example presented at the meeting was fluconazole, a treatment used for AIDS-related meningitis. In Thailand, where several generic versions of the product are readily available, competition has lowered the price to US $0.30 per 200 mg capsule. This same drug costs US $ 18.00 in Kenya, where it is patent protected.
In a panel discussion on the regional pharmaceutical market, there were various explanations for high East African drug prices: high producer or importer prices, strong patent protection in some countries, tariffs, taxes, and high wholesale and retail mark-ups. Liza Kimbo, who operated a chain of Kenyan pharmacies for many years, explained that the national practice of allowing pharmacists a 25% mark-up fee, rather than authorising a fixed dispensing fee provided an incentive for higher prices. However, Myhr said that "without taxes, tariffs, mark-ups and other fees, the price of a drug in Norway is about 54% of retail, and in Kenya, about 60%. This means that there is something else that is accounting for the fact that many drugs in Kenya are much more expensive than in Norway."
Parmindar Lotay, GlaxoWellcome's Regional Director of Sales and Marketing based in Nairobi agreed that there are national issues that need to be addressed but that Glaxo can also play an active role in improving access. He explained that for this reason the company is actively involved in the UNAIDS/five company project. He explained that it was premature to speak about how the program would be implemented in East Africa and the company was in contact with health ministries in the region.
Before turning to legal matters, the question of funding drug procurement and international pharmaceutical policies were outlined by the World Bank's Albertus Voetberg. He explained that the World Bank's involvement in pharmaceuticals is mostly restricted to procurement (Bank staff estimate that more than US$800 million is spent on buying drugs annually). According to Voetberg, in order to help countries efficiently use procurement funds, the Bank supports the use of generics and insists on procurement through competitive bidding. Voetberg also identified some other types of projects related to increased access to essential medicines for which the Bank could potentially provide loans such as, strengthening supply chains and improving regulatory capacity (including quality assessment/assurance). He explained that countries would need to initiate the Bank's activities in these areas by making loan requests.
This concept of balance between the rights of the patent holder (in this case multinational drug companies) and the rights of society or individuals is also reflected in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. This agreement, which establishes minimum standards in the field of intellectual property maintains that the protection and enforcement of intellectual property rights should be "to the mutual advantage of the producers and users, in a manner conducive to social and economic welfare". WTO member states have to comply with these standards by modifying, where necessary, their national regulations to comply with the rules of the agreement. The main change with respect to drugs is the obligation to grant patent protection for a minimum of 20 years. Correa noted that before TRIPS up to 50 countries did not grant patents for pharmaceuticals.
In contrast to Correa's message that patents are intrinsically linked to price, Mr. Mabroek of the African Regional Intellectual Property Organisation (ARIPO) argued that "patents are not inflating prices, since it only costs US $ 800 to apply for a patent", ARIPO, which is based in Zimbabwe, receives technical assistance from the World Intellectual Property Office (WIPO). WIPO is charged with assisting countries to rewrite their national laws in an effort to become TRIPS-compliant.
Problems of access are not always related to legal or patent issues. There is also the issue of preference for branded products when comprehensive national regulatory and quality systems are not in place.
Mr Mabroek from ARIPO said that "it is worth it to have medicine from a reputable company at a higher price". He went on to suggest that patented drugs are of better quality than generic drugs, because of the guarantee of the company's name and ARIPO's thorough examination of the claims. The drug regulatory experts in the conference appeared vexed at this analysis and Dr. Oteba, Uganda's chief pharmacist suggested that drug regulators and patent officials needed to more closely collaborate. He was referring to the fact that ARIPO has no jurisdiction or technical expertise in quality assessment, as this responsibility is held by the national regulatory authorities.
The potential of manufacturing and selling lower quality generic formulations was illustrated in a presentation by Hans Veeken of MSF who presented the case of SSG for the treatment of kala-azar. Pentostam®, Glaxo's brand version of the drug costs US$ 200 on average per patient, whereas the generic version of SSG costs 1/14 of the brand product price. However, some governments have been reluctant to register the generic. A case in point is the Sudanese government which was not convinced of the equivalency of the generic product. To overcome doubts, MSF conducted a trial to demonstrate the efficacy of the generic and is currently using the results of this study to advocate for generic registration. (note: a few weeks after the conference, after examining the available data, the Kenyan authorities agreed to provisional registration of generic SSG.)
The World Bank's Albertus Voetberg explained that their policy is to aggressively promote the use of generics, especially in the drug procurement programs that they fund. He cited the example of Zimbabwe, where consumer prices on medicines were reduced 20% as a result of competitive bidding among generic manufacturers.
In general there was a consensus on the strong relationship between prices and patents. For this reason, many presenters focused on offering strategies to limit exclusive marketing rights (patents) when this exclusivity results in prices that put life-saving medicines out of reach of people who need them.
Professor Correa advised countries to take advantage of three measures in the TRIPS agreement that could help safeguard health by improving access to medicines:
- Parallel imports : the right to import brand name products when they are
sold at lower prices in other countries.
- Compulsory licensing : the right to grant a license, without permission from
the license holder, on various grounds of general interest including public
health.
- 'Bolar Exception' (early working) : the right of a generic producer to conduct
tests and obtain approval from a health authority before the expiration of the
patent, so that cheaper generic drugs are available immediately upon patent
expiration.
Professor Correa explained that none of these safeguards are automatic and that *they must be written into national law*. He cited the text of the new Kenyan Industrial Property Bill, which will soon be considered by the Kenyan parliament, as an example of legislation that unnecessarily weakens a government's ability to curb monopoly abuse. This bill is designed to bring Kenya into compliance with WTO rules.
While many Kenyans have little or no access to life-saving medicines, neither the existing law nor the current text of the bill under consideration, allow parallel importing; the bill also limits the grounds on which a compulsory license can be issued. Ellen't Hoen, a drug policy expert with MSF, recommended that Kenya make full use of parallel importing and compulsory licensing to protect patients' access to medicines in Kenya. She also recommended that the Ministry of Health be consulted during the process of revising patent rules, and that the Kenyan government take advantage of support that is available from WHO, and health NGOs. Ms. 't Hoen pointed out that Kenya is only obligated to create laws that institute the minimum standards required by TRIPS and does not have to make more restrictive national rules.
Following an extensive discussion of parallel importation and concern about the impending Kenyan bill, Norah Olembo of the Kenyan Industrial Property Office, stated that, "there's no rush, there's time to look into it. We will examine the countries where it is allowed. We have to look at how it will affect our own nationals, and not just implement laws by copying what other countries have done. We must create laws that are good for our own people". Ms. Olembo advised health advocates not to demonstrate on the streets, but rather to knock on her door "as long as you recommend measures that are TRIPS compliant, they will be considered".
When a delegate asked why the proposed Kenyan rules are so restrictive, Carlos Correa responded that, "sometimes our countries are receiving advice that is not neutral, and doesn't support health-sensitive legislation". Professor Correa was referring to technical advice offered to developing countries by WIPO, the US and the European Union.
Dr. Amukowa Anangwe, Kenyan Minister for Medical Services, underlined the need to balance public health needs with private profit. He said that "it is essential to ensure that the right to issue compulsory licenses and to allow parallel importing are included in our national legislation".
Fred Kansiime (MoH Uganda) presented the case of the sleeping sickness treatment DFMO (eflornithine) as an example of pharmaceutical market failure. Despite the fact that the number of cases of sleeping sickness have skyrocketed, with a 1500% increase from 1976-1999, the only new promising treatment is out of production. The problem is that people who contract sleeping sickness tend to be poor, and do not represent a significant market for drug developers/producers. This presentation stressed the fact that without the involvement of the public sector and international organisations, there is no prospect of ensuring a steady production of existing treatments nor will there be new drug development programs.
There was a clear consensus among conference delegates that their national governments have the means to increase access to life-saving drugs. Compulsory licensing and parallel importing were identified as critical tools for developing countries to improve access to lower priced essential medicines. However, these safeguards must be adopted into national law before they can be utilised.
Promotion of generics was recommended by healthcare providers and pharmacists, possibly with legal mandates (such as mandatory generic prescribing rules that are applied in the US). Price controls, like those that are in place in most European countries, were also an avenue that delegates felt deserved study.
Participants also agreed that it is important to: reduce both excise and import taxes on essential medicines; increase competition among generic producers; improve distribution and quality control systems and standards; and address corruption and bureaucracy in the pharmaceutical sector.
Furthermore, delegates emphasised that there was a lack of information and awareness among national policy-makers, including ministries of health, on access issues. One critical role that was identified for ministries of health was oversight of revisions of patent law that is required as part of the process of becoming TRIPS-compliant. Finally, the delegates called on the WHO to be proactive in assisting countries with their legal needs on trade issues that impact public health.
East African participants expressed a need to build access coalitions and to mobilise networks of international organisations, religious institutions, medical practitioners, pharmacists, and NGOs. For many participants, the process of building these coalitions began at the conference.
Daniel Berman/Suerie Moon 28 July, 2000
For further information on this conference, please contact HAI or visit the MSF Access Campaign website.
