中国企业需增进对非洲的了解

《中国投资》：非洲医药制品的短缺情况如何？本地化生产现状怎样？

桑爱玲:药物可及性是实现全民健康保障的重要一环。如果能获得必要的药品，就能及时治愈疾病，避免许多不必要的死亡。根据世界卫生组织的资料，全球目前有近20亿人口不能获得足够的药品，这些人口无法享受到医学科技发展的成果，甚至死于本可治愈的疾病。

特别是在非洲，药品可及性水平特别令人担忧。数据显示，47%的非洲居民无法获得基本的药品保障，而且这个数字仍然在随着人口增长而增加。现在非洲70%以上的药物都需要进口，仅有34个国家有一定程度的药品生产能力。这种过度依赖进口药物的现状是不可持续的，许多非洲居民也无法负担昂贵的进口药物。

鉴于这种情况，越来越多的非洲国家开始致力于创造和培育本国的制药行业，并为不断增长的人口提供基本药物供应。这个策略也已经得到了非洲各个国家的承认。 2007年，应非洲联盟大会的要求，各国卫生部长制定并通过了《非洲制药计划》（PMPA），并于2012年通过了相应的商务计划，以加快该计划的实施。这项横跨大陆的指导还得到了区域倡议的补充：2019年2月，非洲联盟通过了一项设立“非洲药品管理局”（AMA）的提案。非洲药品管理局的设立旨在促进非洲大陆的药品生产、提高医疗产品和技术的普及率、确保在非洲大陆上人们能获得快捷可负担的药品服务。

然而，撒哈拉以南非洲的药品生产落后于非洲其他地区。根据麦肯锡2019年报告的数据，非洲大陆总共有大约375家制药商，其中大部分位于北非，为13亿人口提供药品服务。相比之下，中国有超过5000家制药商服务于同等数量的人口。撒哈拉以南非洲的制药商主要集中在9个国家，包括肯尼亚，尼日利亚和南非。这些国家的产业规模相对较大，有数十家公司为当地市场生产药品，有些产品还出口到邻国。同时，非洲当地制造活性药物成分（API）的能力也非常薄弱，仅有南非的2家企业和加纳的1个企业在生产活性药物成分，这使得非洲的主要药企无法进行配方生产。

为响应非盟的号召，许多国家政府都承诺支援非洲的药品本地化生产，比如在坦桑尼亚。在联合国艾滋病规划署于2018年进行的市场分析中，21个受调查的非洲国家中，大部分都提供了药品本地化生产的激励政策。例如，60％的受调查国家将为企业提供免费的土地和/或计划设立企业园区；超过80％的国家为企业提供税收优惠，例如乌干达为相关机械进口提供关税豁免政策，赞比亚则为达到投资门槛的企业提供长达10年的免税期，阿尔及利亚则会停止可本地化生产药品的进口。

在2019年5月世界卫生大会期间，联合国艾滋病规划署与其他5个国际组织发表了联合声明，支持促进低收入和中等收入国家本地化生产有质量保证的药品和其他医疗卫生用品。这一倡议有助于实现全民健康覆盖和终结艾滋病流行的可持续发展目标。

《中国投资》：贸易能解决哪些问题、不能解决哪些问题？为什么需要本地化生产？

桑爱玲:国际贸易是确保药品和卫生用品可及的手段之一。通过进口，一个国家可以在医疗卫生用品极为短缺的时候填补本国的需求，但是这仅能作为短期的方案。想要寻求长期的、可持续的方法来解决医药和卫生用品不足的问题，本地生产才能做到自给自足。这亦可以促进卫生部门的综合发展，包括企业间的协同合作、促进国家经济发展。本地生产还能帮助人才培养、促进就业，尽管这需要相当长的时间和较多的精力及资源。

《中国投资》：中国在非洲医药制品市场所面临的机会和挑战是什么？

周凯：非洲的医药制品市场在不断扩大，以满足不断增长的需求。这也给了中国企业很多机会，中国对非的贸易和投资也不断增加。中国的产品性价比较高，受到普遍欢迎。比如说，《21国医药市场概况》中涉及到的国家全部都有从中国进口药品和医疗卫生用品，其中南非、埃及和及日利亚是进口总额最多的国家。单2017年一年，每个国家的总进口额都超过3亿美元。2017年，中非医药和卫生用品的总交易额增长至24.3亿美元，相较于2012年的20.9亿有了大幅的提升。基于此大背景，中国企业具有参与更多国际采购和供应的潜力，可以与非洲开展深度合作。

但是中国也面临着诸多挑战，其中最大的挑战就是对非洲缺乏了解。首先，非洲大陆有50多个国家，其医药市场仍处于发展阶段，市场化和信息化程度低。其次，各个国家之间的法律法规差异大，区域内不能做到协调一致。因此，中国企业要全面了解，有较大的困难，也需要更长时间。第三，非洲的政局不稳定，一些国家还会有传染病的流行。这些因素会影响中国企业做出是否登陆非洲的判断。

《中国投资》：联合国艾滋病规划署对中国企业的建议是什么？

周凯：中国所面临的挑战，一方面，企业要利用各种机会，加强对非洲的了解。这包括了当地的政策法规、当地市场的发展情况、现有的主要企业以及当地的市场规则等。现在，联合国艾滋病规划署与中国医疗保健品进出口商会（CCCMPHIE）保持着密切的合作，鼓励中国企业加入非洲市场，增强国际合作的管道。2018年8月，联合国艾滋病规划署促成了多个相关单位参与了非洲药物可及性及本地生产的会议，分享了政策和技术层面的信息。此次会议极大地帮助了各方达成共识、分享信息，是一个更深层次了解非洲这个不断增长时长的实用机会。

从中国的角度出发，中国企业要注重提高产品质量。无论是在国内还是海外，质量都是一个医药企业生存和发展的基础。中国的企业也应该考虑人才培养，以拥有能处理国际贸易和国际合作的人才。最后，企业还可以和已经在非洲和当地建立合作伙伴关系的企业取经，在出海的过程中借鉴它们的经验，为自身所用。

英文版

Chinese companies need to increase understanding of Africa

——Interview with Amakobe Sande, Country Director, UNAIDS China Office、 Zhou Kai, Policy and Strategy Adviser, UNAIDS China Office

By Yang Haixia  China Investment

China Investment: What is the present situation in terms of access to medicines and local production in Africa?

Amakobe Sande: Access to medicine is an important aspect of universal health coverage. Without access to essential medicines, the number of preventable deaths will continue to remain high as children and adults inevitably suffer and sometimes die from diseases or complications that might otherwise be prevented or cured. According to statistics published by the WHO, nearly 2 billion people around the world lack access to essential medicines, preventing them from benefiting from technological advances in the field of medicine and contributing to high rates of preventable deaths.

In particular, African countries are disproportionately burdened by limited access to medicines. Figures suggest that 47% of people in African countries still do not have access to essential medicines, with populations in many of these countries meanwhile set to continue expanding into the future. Currently, Africa imports over 70% of its pharmaceutical products, with only 34 countries in Africa possessing some level of pharmaceutical production capabilities. At any rate, this current state of overreliance on imported pharmaceutical products remains unsustainable, with many patients in Africa unable to afford the exorbitant costs of imported drugs.

Given these concerns, many African countries are increasingly committed to creating and nurturing well-functioning pharmaceutical industries and providing essential medicines to their own growing populations as part of those plans. These demands have been recognized and vocalized at both continental- and country-levels. In 2007, at the request of the Assembly of the African Union, the Ministers of Health developed and adopted the Pharmaceutical Manufacturing Plan for Africa (PMPA), and in 2012, a Business Plan for the PMPA was adopted to accelerate implementation. This continental guidance is complemented by regional initiatives, and just recently in February  2019, a Treaty for the establishment of the African Medicine Agency (AMA) adopted by AU, to promote the local production of pharmaceuticals on the continent; serves to roll back the prevalence of medical products and technologies but also ensure easy and affordable access to essential medicines on the continent.

However, pharmaceutical production in sub-Saharan Africa still lags behind other regions on the continent. According to data from a McKinsey report published in 2019, the continent has roughly 375 drug manufacturers in total, with most being situated in North Africa. This small group of manufacturers serves a population of roughly 1.3 billion people compared with over 5,000 companies serving a more or less equal number of people in China. Those companies operating in sub-Saharan Africa are largely clustered around 9 countries, including Kenya, Nigeria, and South Africa. The industry clusters located in these countries possess relatively high economies of scale, with dozens of companies producing for local markets and, in some cases, for export to neighbouring countries as well. Meanwhile, capacities for the local production of Active Pharmaceutical Ingredients (APIs) also remain quite weak, with only two companies in South Africa and one in Ghana able to produce APIs, meaning that the main companies operating in Africa are at present unable to fully engage in the production of pharmaceutical formulations.

To echo the present call from the AU, many national governments have already expressed their strong commitment to support the development of local production in their countries, including Tanzania for instance. In a market analysis conducted by UNAIDS in 2018, many of the 21 African countries surveyed reported having incentives and supportive policies in place to encourage the local production of pharmaceuticals. For instance, 60% of the surveyed countries are willing or able to provide freely allocated land and/or an industrial plan for developing a pharmaceutical park, while over 80% of countries provide tax incentives for local producers. To take but a few examples, Uganda provides import duty exemptions for machinery used in local production, Zambia provides a tax holiday for up to 10 years if investment thresholds are met, and Algeria prohibits imports of any drug that can be manufactured locally.

UNAIDS, together with five other UN and international organizations, released a joint statement during the World Health Assembly in May 2019, indicating their support for the promotion of locally produced pharmaceuticals subjected to quality assurance controls, along with support for other medical products and technologies produced in low- and middle-income countries. Promoting localized production in these countries will help ensure a path to achieving universal health coverage and ending the AIDS epidemic over the next decade, both of which dovetail with the objectives of the UN’s Sustainable Development Goals.

China Investment: What kinds of issues can and cannot be resolved through increased international trade? Why is localized production a necessity?

Amakobe Sande: The international trade is one of the modes of securing access to medicines and health commodities. By importing, a country could potentially fill supply gaps when shortages of these commodities are particularly acute, but this can only provide a short-term fix. In looking to long-term solutions and sustainable pathways to address ongoing shortages in pharmaceuticals and health products, local production can provide a self-sufficient means to secure local supplies, all while driving the comprehensive development of the health sector, including increased synergies across the industry and promote economic development of the country. It can also contribute to generating talents and expertise and boosting local employment, although it takes a great deal of time, efforts and resources.

China Investment: What opportunities and challenges do Chinese companies now face in the African pharmaceutical and health commodities market? Do regulatory standards still pose a major hurdle?

Zhou Kai : With the demand for pharmaceuticals and health commodities set to continue growing rapidly in Africa, the continent’s pharmaceutical market is similarly positioned to maintain a strong expansionary trend moving forward, creating many new opportunities for Chinese companies operating in this sector. Meanwhile, volumes of trade and investment between China and Africa have also continued their upward trend over the years, while products made in China have established a good track record given their overall cost-performance ratio. For instance, the report of 21 Country Profiles showed that all twenty-one countries were already importing pharmaceuticals and health commodities from China. Among them, South Africa, Egypt, and Nigeria were the top importers of Chinese pharmaceutical products, with each country having individually purchased imports valued at over USD 300 million in 2017 alone. The trade volume of pharmaceuticals and health commodities of China to Africa increased from 2.09 billion USD in 2012 to 2.43 billion USD in 2017. Given the current circumstances, Chinese companies have the potential to get more involved in international procurement while taking on an increasingly more active role in related supply chains. This in turn will ultimately provide China with an opportunity to develop a deeper cooperative partnership with Africa.

However, Chinese companies still face a large number of challenges. One of the most critical challenges is a lack of specialized knowledge regarding Africa. With over 50 countries in Africa, the respective pharmaceutical markets in these countries are still in a process of development, while the extent of informatization in these markets remains relatively low. Second of all, each country on the continent has different sets of laws and regulations, which is particularly true in terms of the varying regulatory requirements stipulated by each country’s national drug registration system. This therefore creates barriers in terms of the ability of Chinese companies to fully understand these markets, entailing significantly more time and effort on their part. Third and lastly, a combination of recurring risks arising from political instability and the spread of communicable diseases in some countries has given rise to exceedingly high impediments when Chinese companies consider whether or not to enter into the African market.

China Investment: What suggestions can UNAIDS provide to Chinese companies seeking to overcome these challenges?

Zhou Kai : Chinese companies should take advantage of the networks already in place through various international platforms, in this way developing a more thorough understanding of African countries and their policies, as well as collecting pertinent information related to local markets and their major players, including garnering an appreciation for the general rules of the game. At present, UNAIDS is working closely with the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) to encourage Chinese companies to join the African market and strengthen channels for increased international cooperation. In August 2018, UNAIDS encouraged key stakeholders to attend a conference on local access to medicines and the localization of production in Africa, which highlighted both the policy and technical dimensions on the ground. This platform provided a critical opportunity to develop mutual understanding and share pertinent information related to the African market for pharmaceutical and health commodities, giving Chinese partners operating in the industry a practical means to advance their insight into this continually expanding market. 

On the Chinese side, Chinese-based companies operating in the industry should continue to concentrate their attention on constantly improving the quality of their products, with the ability to produce and ensure a high-quality final product being of paramount importance for any pharmaceutical company seeking success in markets both at home and abroad. Chinese companies should also consider training a cadre of young professionals to begin leading efforts to expand their international cooperation and break out of the domestic market, while engaging with consulting companies that have already established in-depth partnerships with the major players in target countries abroad, soliciting their expertise to fill gaps as needed.