TO: Major General Kahinda Otafiire
Minister of Justice & Constitutional Affairs
RE: Revision and re-introduction the Industrial Property Bill for consideration in Parliament ahead of 2013
We (the undersigned) are writing this Letter as Civil Society Organisations in Uganda working in areas of Intellectual Property and access to Medicines.
The purpose of this letter is to express our concerns about the delay to review and re-introduction of the Industrial Properties Bill to Parliament for debate. This Bill was read to the eighth Parliament as Bill no.5 of the year 2009. However, there were concerns that were raised on provisions of the Bill which threaten access to medicines and since then the Bill has been shelved and it lapsed with the eighth parliament.
We are aware that Uganda is party to the World Trade Organisation’s agreement on Trade Related Aspects of Intellectual Property (TRIPS). The TRIPs agreement seeks to bring strong enforcement of intellectual property even on essential goods such as medicines. It however, has flexibilities which apply to least Developed Countries like Uganda before the expirely of the transitional period in 2013 for general provisions and 2016 for pharmaceutical products’ patents.
Ten years ago on the 14th of November while at Doha, member states to the WTO agreed that the TRIPS Agreement does not and SHOULD NOT prevent Members from taking measures to protect public health. The Doha declaration is a reaffirmation of members’ rights to exploit the flexibilities as provided under the TRIPS agreement. Uganda is a least developed country with very limited technological capacity to support the pharmaceutical needs of its population. It should be noted that almost 90% of drugs in Uganda are imports of which most are generic versions which need protection from patent owners who may want to stop their sale in a bid to get market for their expensive brand name drugs; this would be a disadvantage to Ugandans as they will not be able to access cheap drugs.
It is for this reason that we seek your attention to ensure that the Industrial Properties Bill takes maximum advantage of the flexibilities detailed under the TRIPS Agreement and as provided by the Doha Declaration. We for these reasons call upon government under the leadership of your ministry to ensure that:
• The Bill should expressly provide under section 8 (3) that pharmaceutical products are excluded from patent protection until 1st January 2016 or such other date as may be extended in the future;
• The Bill should under section 28 (13) & (14) indicate that applications for pharmaceutical products should only be filed after 1st January 2016 or such other date as may be extended in the future;
• The government should enhance the effectiveness of third party patent oppositions under section 28 (7) through providing the necessary technical capacity to Registrar General’s office to enable them examine the substance of the opposition;
• The Bill should be amended under section 8 to exclude natural substances from patentability;
• The Bill should properly define the public emergency provision and indicate that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency;
• The bill (section 66(3)) should be brought in line with the minimum standards under article 31(h) of the TRIPS Agreement by 1 July 2013;
• Section 61(2)(e) of the Industrial Property Bill should be amended to provide that when using the draft article 31bis TRIPS system as an importing country, the patent holder in Uganda does not need to be remunerated, to the extent that adequate remuneration has already been paid to the patent holder in the exporting country;
• Section 61(1) of the Industrial Property Bill should be amended to include the possibility of administrative (as opposed to judicial) grants of compulsory licences for private third parties acting on their own behalf and account. The ministry of health should be authorized to issue the compulsory licence in the area of pharmaceuticals;
• On re-exportations of pharmaceuticals produced under compulsory licence under the WTO 30 August 2003 Waiver Decision, section 102(8) should not only refer to COMESA, but also to the partner States of the EAC;
• Section 60(1) (a) should be amended to include a reference to a maximum period of negotiations with the right holder before granting a compulsory licence;
• As regards parallel importations, the reference to “importation into Uganda” of patented products under section 43(2) should be deleted to provide for a rule of international patent exhaustion;
• The Bill should introduce a provision enabling Uganda to take advantage of August 30th Decision
As currently drafted, the Bill does not make full and maximum use of the TRIPS flexibilities and as such impedes access to medicines initiatives of Ugandans. It is important that the laws of our country aim at putting the citizenry’s priorities into perspective in order to promote public health for all. We therefore strongly urge you to consider review and subsequent tabling of this Bill soon, as in its proposed form; it would destroy the traditional balance between intellectual property protection and public access, a balance that is essential to our nation’s economic growth and competitiveness.
We are looking forward to working with you to address our Concerns in this Bill.
1. The center for Health Human rights and development (cehurd)
2. SEATINI Uganda
3. The International HIV/AIDS Alliance in Uganda
4. Open Society Innitiative for Eastern Africa (OSIEA)
CC: Mr. Frederic Ruhindi
State Minister for Justice & Constitutional Affairs
CC: Hon. Amelia Kyambadde
Minister of Trade, Industry and cooperatives
CC: Uganda Law Reform Commission