How the Law Improves the Availability of Quality Safe Treatments

Lenias Hwenda

Geneva Switzerland. Lenias is passionate about improving access to quality affordable treatments.

The first priority for public health is to protect populations from harm. In their duty to protect, governments use the law to promote and protect public health. There are also instances where the law is used in ways harmful to health. A new report launched by the WHO and its partners outlines how countries use the law for better or worse. Protecting health using the law requires the commitment of lawmakers who are often confronted with competing economic and social interests both at international level and domestically amongst citizens.

In line with their fiscal responsibility, governments often use the law to shape the environments in which their people live and influence the choices people make about their lives. When laws help people to live longer and healthier lives, they enable economies to become more resilient. People require access to quality prevention, treatment and care in order to maintain good health and lead economically productive lives.

This is why the role that the law plays in improving access to treatments is important.  The law promotes and incentivises innovation of treatments needed to keep people healthy. In this case, it attempts to balance the rights of patients and those of innovators to ensure the common goal that treatment are available at affordable cost to those who need them. With affordability and access having become a mainstream concern, even in high-income countries, balancing the common and the competing interests of business is a constant source of tension between policy makers and businesses.

​Countries use the law to promote generic competition both at national and international level including through generic prescribing policies, guidelines for conducting bio-equivalence studies or through the pre-qualification of generic medicines. Generic medical products are considerably less expensive than originators, and competition among generic manufacturers reduces prices even further.  Generic products serve public health in multiple ways. Many governments in Europe including German and the UK have generic policies to promote the use of generics and places limits on mark-ups. In many African countries, there are no laws that limit the level of mark-ups. This has resulted in excessive cost of medicines as a result of the highly highly fragmented supply environment. Multiple distributors lead to multiple mark-ups along the value chain that result in excessive prices for patients who are in turn not able to afford paying for them.
 
Countries need appropriate laws and regulations and administrative procedures for registering medicines, quality control laboratories, and enforcement capacity. They are used to create national institutions that govern medicines quality and availability, such as regulatory or procurement agencies. The law must address factors that compromise quality, safety, and effectiveness such as poor manufacturing practices, improper packaging, transport, storage and product deterioration. This requires that suppliers of medicines apply for registration of medicines in order to gain access to the market. A medicine can only be imported and sold in a country where it is registered. Limited registration reduces the range and types of treatments that are available to national populations. Treatments without authorization but with a compelling need for use by patients can only be imported through special waivers that that serve as temporary marketing authorization. 

Such laws are necessary to keep patients safe by preventing their exposure to medicines that might be harmful because they do not meet the required quality standards. Harmful medicines can be can be both intentional and unintentional. Their entry into markets, and consumption by patients lead to failure of treatment, cause drug resistance or exacerbate illness. They cause injury and disability and in the worst cases even death. They waste scarce resources and damage public confidence in the health care systems with economic consequences for patients and countries alike.
 
Harmful medicines have multiple sources and are a result of growing criminal activities that compromise the integrity of global supply chain of medicines. They can be a result of illegitimate manufacture and distribution or false representation of the source. False representation of the manufacturer, county of manufacturing or origin, market authorization holder, a product's license or records, and documents relating to the distribution channels are all a problem. In some cases, harmful medicines violate trademarks.
 
The worst affected countries by harmful medicines are also the weakest in preventing their illicit trade. Counterfeiters have networks that are sophisticated and challenging for national efforts often facing inadequate capacity of national medicines regulatory authorities to tackle alone. The global medicines supply chain is only as strong as its weakest link. Cross-border law enforcement is needed and stemming their trade requires cooperation. 

​International legal instruments like the WHO’s International Health Regulations and Framework Convention on Tobacco Control have been used for public health challenges on which international cooperation is essential. TRIPS flexibilities promote international generic competition and reduce the cost of medicines to protect public health. Whilst international law protects the rights of patent holders, some suppliers have taken voluntarily decisions not to enforce their rights in order to allow other manufacturers to make generic versions of their products. They pledge to waive their patent rights for certain medicines in resource-limited settings.
 
International law has provided tools to allow poor countries without capacity to manufacture medicines to import them from third parties, with legal certainty that this would not infringe on the intellectual property rights of innovators. The protocol amending the TRIPS Agreement allow exporting countries to grant compulsory licenses to their generic manufacturers to produce and export to countries without capacity to manufacture needed medicines for themselves. Suppliers have used voluntary licensing to expand access to treatment primarily for HIV and AIDS, and recently for hepatitis C. There are also considerations to license outside of HIV/AIDS and hepatitis C in the future. The way laws are used in different circumstances and by countries provides useful insights into effective and ineffective approaches. The willingness of businesses to take decisions in the interest of public health are a cause of optimism that as long as the spirit of shared responsibility exists, there is tremendous scope for modifying the law in a way that it can serve the interests of all whilst protecting the most vulnerable.