Access to medicines
Everyone should have effective access to the safe medicines they need. The EU has consistently sought ways to improve access to badly-needed medicines for developing countries.
Access to medicines in a nutshell
- Many factors may influence to what extent medicines are available and accessible to the populations of developing countries. Numerous important factors come to play to determine price of medicines: taxes and import tariffs, distribution mark-ups, lack of an efficient procurement system, etc.
- Scientific and technological innovation has significantly improved the treatment of human diseases. Intellectual property stimulates pharmaceutical companies to invest money to develop and produce new and better medicines.
- Bringing a medicine to market is a long and complex process that is very costly and takes many years to complete. Without the prospect of return on their investments pharmaceutical companies will not allocate large budgets to more research and development.
- Patent protection can lead to higher prices by delaying the supply of cheaper generic alternatives. Hence, the argument is often made that patents on medicines restrict access to treatment for citizens in low-income developing countries. However, developing countries are increasingly using patents to protect their innovative companies' efforts and help them compete more effectively on global markets.
- The EU seeks to strike the right balance between the need to promote and finance the research of new and better medicines and to ensure that medicines are accessible to those in need.
EU trade policy and access to medicines
Evaluation of Council Regulation (EC) 953/2003 to avoid trade diversion into the EU of certain key medicines
The EU has played a lead role in helping developing countries access medicines through its trade and development policies.
Access to key medicines for developing countries
Many of the poorest developing countries are in urgent need of access to affordable essential medicines for treatment of communicable diseases.
This is why the EU encourages pharmaceutical companies to sell key medicines at lower prices in developing countries.
Regulation EC No 953/2003 aims to prevent parrallel trade of discounted medicines intended for those markets.
The EU is the biggest provider of funds and technical assistance to support health policies in developing countries. Some examples include:
- The EU (with its Member States) is the biggest contributor to the Global Fund to Fight AIDS, Tuberculosis and Malaria (more than USD 11 billion paid to date) and to the GAVI Alliance (more than USD 1.4 billion by 2011) supporting immunisation for all.
- The EU is a major contributor to the EC/ACP/WHO Partnership on Pharmaceutical Policies with the aim to develop national health policies and improve access to essential medicines for the ACP countries.
- The EU is also a strong supporter of the programmes of global partners such as the WHO, UNICEF and UNFPA to provide developing countries with quality medicines and vaccines and support national supply and distribution systems.
- The EU is also supporting the development of medicines for the three main poverty-related diseases (HIV/AIDS, Tuberculosis and Malaria) through the Europe and Developing Countries Clinical Trial Partnership in sub-Saharan Africa and the EU 7th Research Framework Programme.
In addition, the EU has been one of the main supporters of the Doha Declaration on the TRIPS Agreement and Public Health so that developing countries which lack production capabilities can effectively access key medicines.
The EU has, in 2006, adopted legislation on compulsory licensing of patents for the production of medicines for export to countries facing public health problems (Regulation EC No 816/2006).
The EU systematically refers to the provisions of the Doha Declaration as an overarching principle in its bilateral trade agreements (see for example the agreements with Korea, Colombia and Peru, and Central America).
The EU also adopted legislation in 2003 to encourage pharmaceutical companies to sell their medicines at lower prices in developing countries and simplify such processes (Regulation EC No 953/2003).
The way forward on access to medicines
Falsified and counterfeit medicines
Falsified medicines are often of lower quality and sometimes infringe intellectual property (counterfeiting). They gravely endanger the health or even life of people across the globe. The populations of developing countries suffer disproportionately.
The EU takes the fight against falsified and counterfeit medicines very seriously. It is fundamental to prevent the sales of such dangerous medicines. Even in the EU last year more than 27 million pharmaceutical articles infringing intellectual property rights were detained at the EU’s borders.
To ensure that no one is exposed to such risks it is essential to effectively control national distribution systems and external borders.
The EU is negotiating bilateral trade agreements with a number of countries and these often include a chapter on intellectual property.
There is no one-size-fits-all approach for these trade negotiations and the EU is keen to ensure that it takes into account the specific legal, economic and social situation of its trading partners.
Nevertheless, in its trade agreements with developing countries, the EU always proposes to explicitly refer to the need to make any provisions dealing with intellectual property compatible with the Doha Declaration.
Goods in transit
Effective customs enforcement of intellectual property rights is essential but at the same time it must allow legitimate trade in medicines in transit through the EU.
The European Commission has made this clear in a new legislative proposal revising the 2003 EU rules on customs enforcement of intellectual property rights. The proposal would ensure that legitimate trade in medicines in transit through the EU is not impeded.
The Commission also published accompanying guidelines for EU customs officials in spring 2012.
More on Access to medicines
Access to medicines in other Commission departments
- Development and Cooperation:
- Enterprise and Industry
- Humanitarian Aid and Civil Protection:
- Research and Innovation:
- WIPO/WTO/WHO: Promoting Access to Medical Technologies and Innovation – Intersections between public health, intellectual property and trade (2013)
- World Health Organisation: International Medical Products Anti-Counterfeiting Taskforce (IMPACT)