E-DRUG: Concerns about the Counterfeit Bill in Uganda
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[Although all E-druggers probably agree that counterfeits should be stopped, there seems to be an effort to make (potentially) patent infringing essential generic medicines look like counterfeits. Patent disputes need to be taken up by the patent holder, and not by drug regulators. Last year Kenya adopted a similar law; now it is the turn to Uganda. Sorry for the long message, but it is important to open the debate on this issue, as access to good quality generics might be at stake. WB]
Dear All,
Below find a copy of the petition expressing concerns over the Counterfeit Bill in Uganda to the Speaker of Parliament.
HON. SPEAKER OF PARLIAMENT
RE: THE COUNTERFEIT GOODS BILL THREATENS ACCESS TO MEDICINES FOR UGANDANS
As you may well be aware, government is in the process of enacting the Counterfeit Goods Bill, 2008, which is presently set for the second reading in Parliament. HEPS Uganda and its partners in the civil society support the government initiative to curb the proliferation of counterfeit goods.
However, our analysis of the Bill has found that it will hamper access to generic medicines, on which most Ugandans depend, if Parliament passes it in its present form.
We have five major concerns about the text and formulation process of the Bill:
a. The definition of counterfeiting is overly broad;
b. National Drug Authority (NDA) and Ministry of Health (MOH) have been left out in combating counterfeit medicines under the Bill;
c. There are no sufficient checks to the enormous powers the Bill gives the Commissioner of Customs;
d. The powers of inspectors to enter premises and make arrests without involving the NDA in case of medicines; and
e. Health stakeholders have not been adequately consulted.
1. The Bill's definition of counterfeiting is too broad
The definition of "counterfeiting" under the Bill is so broad that it includes generic medicines! The problem is that it covers all the three aspects of intellectual property rights (patents, trademarks and copyright), yet the official definitions by the World Health Organization and the World Trade Organization's agreement on intellectual property rights (TRIPS) only encompass trademarks. Indeed, by referring to the "authority of the owner of intellectual property rights", the definition confuses "counterfeiting" with patent infringement.
What makes a product counterfeit is its deliberate and fraudulent mislabeling, not its patent status as the Bill tries to imply. Mislabeling of a product is not a patent issue and for that reason issues of patent infringement should be left to the Industrial Property Bill, which is also in process, to avoid confusing the enforcement agencies.
Passing the Bill with this overly broad definition would have far-reaching consequences. It would in effect ban the local manufacture, exportation and importation of generic versions of medicines patented in Uganda. For example, such life-prolonging antiretroviral medicines (ARVs) as Abacavir and AZT-3TC, which are patented in Uganda until 2013 and 2017 respectively, would no longer be available to the 350,000 people living with HIV/AIDS (PHAs) who need them.
The World Health Organisation (WHO) advocates for, and promotes the production, availability and wide use of generic medicines because they are more affordable than branded medicines. But you will note, Hon. Speaker, that western pharmaceutical giants that own the patents have previously attempted to frustrate this effort by trying to enforce intellectual property rights on medicines that are badly needed in poor countries like Uganda, so as to keep prices high. What is important to note is that generic medicines are produced legally under flexibilities enshrined in the TRIPS Agreement and it would be catastrophic to ban them in Uganda, where they support almost all public health programmes.
The government of Uganda is obliged to fulfill the right of its citizens to the best attainable state of health by providing health care goods and services to those in need. This obligation requires government to avail essential medicines that are accessible and affordable to the ordinary person, and over the years, it has used generic medicines to make slow but steady progress in fulfilling this obligation. The most obvious benefit so far has been reduced HIV/AIDS-related deaths. Now the anti-counterfeiting legislation may reverse this progress and Ugandans who depend on generic medicines stand to pay with their lives.
If anything, there are adequate provisions in current laws to deal with counterfeit goods, including medicines; what is needed is to implement and enforce them effectively. These laws include the Trade Marks Act, the Copyright Act, the Penal Code, and the forthcoming Industrial Property Act.
Recommended definitions:
§ The definition of "Counterfeiting" in section 2 should be deleted completely from the Bill and the following inserted:
"Counterfeiting" means deliberately and fraudulently, with the intent to deceive, producing in any manner, counterfeit trademark goods and pirated copyright goods, including counterfeit medicines.
§ The definition of "Counterfeit goods" in section 2 and throughout the Bill be deleted and the following inserted:
"Counterfeit trademark goods" mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which
thereby infringes the rights of the owner of the trade mark in question in Uganda subject to any exceptions made to third parties under the Industrial Properties Bill.
"Pirated copyright goods" mean any goods which are copies made without the consent of the right holder or person duly authorized by the right holder in the country of production and which are made directly or indirectly from an article where the making of that copy would have constituted an infringement of a copyright or a related right in Uganda subject to any exceptions made under the Copyright Act.
"Counterfeit medicines" mean medicines which are deliberately and fraudulently mislabeled with respect to identity or source.
2. Omission of the Ministry of Health and National Drug Authority (NDA)
The Counterfeit Goods Bill, 2008 does not state whether it also targets substandard goods, but it seems to imply it by allocating the responsibility to administer the Act exclusively to the Uganda National Bureau of Standards (UNBS). As far as medicines are concerned, intellectual property rights are distinct from quality control issues because counterfeiting affects both branded and generic medicines. Where medicines are concerned, it is very possible for the administering agency without specialized expertise in medicines to confuse issues of violations or disputes with counterfeiting. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not counterfeits.
This is the reason we suggest that NDA should play the leading role in administering the provisions that relate to counterfeit medicines. NDA is the national regulatory agency for medicines, and as such has built specialized and unique expertise in the surveillance and quality control of medicines, including identifying and addressing counterfeits and medicines that do not comply with production and packaging regulations. Accordingly, NDA and its parent ministry (MOH) should be given roles in the fight against counterfeit medicines, to ensure that legitimate, quality generic medicines are distinguished from counterfeit medicines.
3. Powers of inspectors to arrest without warrants
The Counterfeit Goods Bill, 2008 gives powers to inspectors to enter premises and arrest people they suspect to be involved in counterfeiting without a warrant of arrest. Powers of such nature are always subject to abuse as they can be used to cover up incompetence, malice and blackmail, and as such are against the principles of law. Like the National Drug Policy and Authority Act 1993 (Ch 206) and the Uganda National Bureau of Standards Act, the anti-counterfeiting law must require inspectors to identify themselves and produce a warrant of arrest before effecting any arrests. Thus subsections 4, 5 and 6 of section 7 should be deleted from the Bill.
4. The unchecked powers and immunity from prosecution of the Commissioner of Customs
The Bill gives the Commissioner of Customs powers to seize at the point of entry goods that a patent owner suspects are being imported into Uganda - in doing so, whether rightly or wrongly, will be immune from prosecution. These powers, again are subject to abuse, and especially so in a situation where patent holders are taking advantage of every small opportunity to try to frustrate the international effort to provide affordable generic medicines to people in poor countries.
In effecting seizures, we suggest that the Commissioner of Customs should get guidance from a tribunal which the Bill/Act should establish to deal with legal issues arising out of enforcement of the Act. Such a Tribunal will expedite the resolution of cases relating to counterfeiting. We propose that another section, section 25, should be added to the Bill to establish the Tribunal (we propose the structure, powers and roles in an attachment to this petition). And, to avoid abuse of power, the Commissioner should be enjoined in all the cases filed to the courts of law relating to the seizure of goods (section 21).
5. Gaps in the process - Health Stakeholders not consulted
The process of formulating the anti-counterfeiting legislation needs to be inclusive because it has implications for not only the government and non-government sectors but for the general population as well. The importance of consulting widely to generate consensus cannot be over emphasized. Our findings indicate that consultations, particularly with the Ministry of Health, NDA, National Medical Stores (NMS), the Registrar General (patents office), health civil society, pharmaceutical manufacturers and other stakeholders have not been done. The dangers of not consulting are that counterfeiting has been interpreted from only a trade point of view, and there has not been input from the health perspective.
It appears the Bill is being rushed, given that we heard of it after it was published in October 2008, and in only five months, it has already been approved by cabinet and has passed the first reading in Parliament! In a country where draft laws ordinarily take years to reach Parliament, this apparent rush makes us suspect that western pharmaceutical interests may be behind its pace. To avoid such suspicion, Hon. Speaker, we request you and Parliament to give the parliamentary committee that will scrutinize the Bill sufficient time and resources to solicit views from all interested parties as the only way to have a final law that is relevant and acceptable by Ugandans.
Conclusion
We reiterate that the threat to public health that counterfeit products in general pose is real and we commend government for drafting the Counterfeits Goods Bill, 2008, to safeguard the lives of Ugandans. That threat is even higher if the counterfeit products are medicines.
However, the Counterfeit Goods Bill should deal with only counterfeiting and leave issues of intellectual property rights to the Industrial Property Bill.
Ensuring the availability of quality generic medicines at affordable prices can itself be an effective measure to discourage counterfeiting. And above all, combating counterfeit products must not be at the expense of the public health of Ugandans, that is why we call on members of parliament, through you, Hon. Speaker, to come up with a law that does not undermine access to generic medicines. We trust that you will consider the issues we have raised.
Yours truly,
HEPS-Uganda
cc the Prime Minister
cc the Minister for Trade
cc the Minister of Health
cc the Attorney General
cc the Clerk, Ugandan Parliament