Due to a number of bottlenecks, the generic pharmaceutical manufacturers in the East African Community region produce at a cost disadvantage compared to their large-scale Asian counterparts. This article highlights some of the key areas where civil society has engaged and can still engage with local pharmaceutical industries to address these challenges
SYNERGIZING ROLES: EXPERIENCES OF CIVIL SOCIETY WORKING TOWARDS PROMOTING LOCAL GENERIC PHARMACEUTICAL MANUFACTURING IN THE EAC REGION
By Moses Mulumba
Executive Director, Center for Health, Human Rights and Development*(CEHURD), Kampala Uganda
Background & Introduction
Although civil society activists and local pharmaceutical manufacturers serve different objectives, the two groups have had to work together in the area of access to affordable quality medicines, which are much needed in the East African region. Indeed this is one of the unique working relationships where health-related civil society has had to move away from the traditional shelving away from private “profit oriented” pharmaceutical companies to combine efforts towards scaling up access to generic medicines in a region that is heavily burdened by diseases such as HIV, malaria tuberculosis and several other health challenges. I must quickly point out that the central reason that has led to this relationship is the realization that in order to deal with gaps of access to adequate basic medicines in the region, promoting local manufacturing is key. As UNAIDS, WHO and UNDP have advised, countries like those in the East African Community (EAC) need to invest in regional and national production capacities in the pharmaceutical sector and in the development of local expertise.
The pharmaceutical manufacturing sector in the EAC is largely dominated by generic manufacturing. In Uganda all existing local pharmaceutical companies are generic manufacturers. Generic medicines are pharmaceutical products usually intended to be interchangeable with an innovator product and manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights. It is significant to note that due to a number of issues including infrastructural challenges, tax policies, investment policies and others, the generic pharmaceutical producers in the EAC region produce at a cost disadvantage compared to their large-scale Asian counterparts. As such, even when local generic manufacturing offers such a huge opportunity for bridging the access to essential medicines gap, without addressing some of these tailbacks, the EAC region will be yet to realize the full benefits of local manufacturing.
As such, there are clear opportunities for health civil society to combine efforts with the local generic pharmaceutical manufacturers to address the bottlenecks to fully benefit from generic local manufacturing. The paragraphs below highlight some of the key areas where civil society has engaged and can still engage with local pharmaceutical industries to address these challenges.
Key Issues for Local Generic Manufacturers and Civil Society
Addressing the Legal and Policy Environment in the Region
The legal and policy environment for the production of local generic medicines still has a number of gaps that need to be addressed. There are a number of laws and policies that still need to be reviewed and others put in place both at the individual country level and at the EAC regional level. The legal environment touches a number of aspects including investment laws, tax laws and several commercial laws which cannot all be highlighted within the space for this paper. As an example, I will throw more light on the intellectual property regime, which is key for local generic pharmaceutical manufacturing. Except Kenya, all the other EAC countries are still listed as Least Development Countries and are therefore still exempted from Intellectual Property rights enforcement with respect to pharmaceuticals under the TRIPS agreement. This provides ample opportunities for these countries to maximize the benefits provided by the TRIPS flexibilities. The current legal reforms in the EAC countries indicate that countries are not fully utilizing these flexibilities. For instance, the TRIPS flexibilities have been only sparsely incorporated in Uganda’s process of enacting the Industrial Properties Bill. Similarly, Rwanda remains the only country in the region that has implemented the TRIPS Council’s August 30th decision which allows member states to grant compulsory licenses to import or manufacture urgently needed patented medicines.
Another disturbing development is the fact that countries in the EAC are at various stages of enacting laws to address counterfeiting and these laws have been defining counterfeiting so widely as to include generic medicines. This could hinder locally manufactured legitimate generic medicines from entering the channels of commerce, thereby undermining public health objectives in the region by obstructing access to essential generic medicines. These legal challenges exist regardless of continuous drug stock-outs occurring across the region. The current inability of governments in the region to wield the power conferred by the TRIPS flexibilities means that continuous health civil society engagement with the relevant stakeholders is required to protect the critical legal and policy space used by local generic pharmaceutical manufacturers.
Poor Infrastructure and Capacity Issues of Local Pharmaceutical Manufacturers
Another concern is that the technical and financial capacity of East African pharmaceutical manufacturers is compromised by a lacking technical labour force as well as low investment into the sector in the region. The private foreign investors who dominate the regional manufacturing sector inject limited financial resources into East Africa. Because of this, the regional governments still have a very vital role to play in facilitating the sustainability of pharmaceutical manufacturers. Quality Chemicals, which was initially a joint venture between the Government of Uganda and private actors, experienced a strong start following various forms of support provided by the Government of Uganda.
Low financial and technical capacity means that local manufacturers are unable to produce sufficient generic medicines to supply the high demand at affordable prices. This is further aggravated by challenges such as inadequate electricity supply and weak transport and communications infrastructures, increasing the cost of production of generics in the region. While regional governments should be commended for creating some tax incentives for investors and at times providing financial support, such support is usually not sufficient to enable companies to perform to capacity. This also affects other critical processes such as WHO prequalification, a prerequisite for successful local generic manufacturing.
Low Investments in R&D and Poor Signs of Technology Transfer
Directly related to the lack of capacity of local generic medicines manufacturers is the low level of technology transfer and investment in research and development. One of the cornerstones of the TRIPS Agreement as embodied in its principles and objectives is the adoption of measures (Article 7-9) that promote technological innovation, transfer and dissemination in the development of intellectual property laws. One way in which national technology innovation, transfer and dissemination can be achieved is by encouraging pharmaceutical companies, which are driven by foreign private investment, to train a local labour force and transfer advanced technology into the country. The continued importation of semi-processed raw materials made from raw materials already existent in the region and the perpetual importation of skilled labour creates a resource and labour dependence syndrome which significantly inhibits the development of the regional capacity to manufacture generic medicines. This is a critical area where civil society can engage with governments to promote local generic pharmaceutical manufacturing.
Civil Society Engagements In initiatives Promoting Local Generic Pharmaceutical Manufacturing
The EAC Partner State governments have relegated themselves to a mainly regulatory role in the pharmaceutical manufacturing sector. East African civil society organizations have often bridged the gap between governments and manufacturers, adding the voice of public interest into the sector. The following paragraphs highlight some of the instances in which civil society has engaged in initiatives that either directly or indirectly boost local pharmaceutical production in the EAC region.
– Intellectual Property Legal, Policy and Institutional Reforms: As the EAC Partner States worked on their legal reforms, health-related civil society has provided a critical eye to all the provisions suggested in the national legislation in the area of intellectual property to ensure that TRIPS flexibilities are fully utilized. Some of these flexibilities, such as compulsory licenses and the adoption of the August 30th Decision, are central to encouraging local generic pharmaceutical manufacturing. In addition to the legal reforms, health civil society organizations are undertaking a campaign to encourage national intellectual property offices to undertake the necessary reforms to do patent searches and registration at the country level as opposed to doing this at the regional level through ARIPO (African Regional Intellectual Property Organization), where patent pre- and post-grant opposition procedures are almost impossible. This will enable the opposition of possible patent grants for the benefit of local manufacturing of generic medicines.
– Influencing Policy Decisions: Health civil society organizations continue to play a critical role in defining the policy decisions both at the country and regional level. A clear example has been making a decision on the policy of legislating for the counterfeiting problem in the region. While the Government of Kenya had already embraced a law that broadly defines counterfeiting to include generic medicines, the civil society movement undertook several counteractive measures including a human rights court challenge on the possible implications of this approach on access to medicines in Kenya. With a successful court challenge, the law has been put on hold pending its revision to reflect the importance of access to generic medicines in Kenya.
– Promoting Public Trust in Locally Manufactured Medicines: There has been a lot of misconception about the quality of locally manufactured medicines within communities in the region. This has been partly due to current talk about counterfeits and substandard medicines. To clear this doubt in Uganda for instance, a group of civil society actors working towards access to medicines has fostered dialogues between the manufacturers and the public. Within these dialogues, the public has expressed some of the concerns and the manufacturers have addressed misconceptions. Civil society continues to play the role of bridging the gap between local pharmaceutical manufacturers and the public through sensitization and awareness campaigns to encourage the use of safe and efficacious generic medicines.
– Towards a Better Environment for Local Generic Pharmaceutical Manufacturers: Many of the challenges of pharmaceutical manufacturing in the region are related to the local infrastructural environment. For instance, commercial and taxing policies heavily affect the success of local generic pharmaceutical manufacturing. Health civil society organizations have engaged with the governments in the region to encourage them to address many of these challenges. For instance, Ugandan civil society organizations have campaigned for governments to waive taxes on health commodities including raw materials for local pharmaceutical manufacture.
– Delinking the Medicines Patent Status for Drug Registration: A further major challenge for locally manufactured medicines is registration with the national regulatory authorities to enable the medicines to enter the market. In the past there have been requirements by some EAC national regulatory authorities that in order for drugs to be registered they should not be on patents in other regions. This clearly bars the approval for marketing any locally manufactured generic medicines that may be on patent elsewhere even when the East African countries in question have no obligation to protect such patents. Health civil society has encouraged these governments through the drug regulatory agencies to delink drug registration from patent status in order to protect local generic pharmaceutical production.
– Regional and International Initiatives: Civil society organizations are currently involved in campaigns to mitigate possible consequences of regional and international trade negotiations that could affect local manufacturing of generic medicines. A key example is the Economic Partnership Agreement between the European Union and the EAC which introduced several provisions including intellectual property provisions that could deter local manufacturing of legitimate generic medicines. Health and trade civil society organizations in the region are working hard to get such provisions expunged from these initiatives.
Conclusions and Moving Forward
There is no doubt that successful local pharmaceutical manufacturing of generic medicines calls for some joint collaboration between local pharmaceutical manufactures and civil society organizations. While their general objectives seem different, the interests of the two sectors converge when it comes to bridging the gap in access to medicines in the region. The paragraphs above have indicated some challenges of local generic pharmaceutical production and how civil society efforts have tried to address some of these. The key message from this is the fact that while the local manufacturing sector can play an important role in increasing access to and promoting the affordability of medicines in the region, a lot of support is needed for them to not only increase their production capacity but also to make a greater contribution to healthcare in the EAC region. Health civil society now needs to get into wider campaigns for the development of regulatory guidelines stating requirements for manufacturers of generic medicines to develop local capacity and undertake increased technology transfer into the region while at the same time lobbying EAC partner states to create subsidies and concessions which can boost the local pharmaceutical manufacturers’ capacity to adequately provide the much needed legitimate, affordable and quality medicines. This should be in addition to scaling up wider campaigns necessary to sensitize the public on the safety of generic medicines and combat the current assumption that generic medicines are counterfeits.
*The Center for Health, Human Rights and Development (CEHURD) is an indigenous, non-profit, research and advocacy organization which is pioneering the enforcement of human rights and the justiciability of the right to health in Eastern Africa. CEHURD was founded in 2007 and was registered under the laws of Uganda as a company limited by guarantee Certificate No. 114712. It was formed to contribute towards ensuring that laws and policies are used as principal tools for the promotion and protection of health and human rights of populations in Uganda and in the East African region. CEHURD realizes this through a set of programs: (1) Human Rights Advocacy; (2) Community Empowerment; and (3) Research and Documentation. CEHURD focuses its efforts on critical issues of human rights and health systems in East Africa such as sexual and reproductive health rights, trade and health, and medical ethics which affect the vulnerable and less-advantaged populations such as women, children, orphans, sexual minorities, people living with HIV/AIDS, persons with disabilities, internally-displaced persons, refugee populations and victims of violence, torture, disasters and conflict.