Access to Medicine Foundation in their latest report on Generic and Biosimilar Medicine 2023 say that despite their ability to serve as lifelines to millions of patients, the generic and biosimilar products are still out of reach for many patients especially in low and middle income countries. Health Business editor Samwel Doe Ouma interviewed the organisation’s Research Programme Manager, Claudia Martinez, on the content of report and why it matters in the world today
HB: What is the difference between Generics and branded names?
CM: The main differences between generic medicines and branded medicines lies in both their pricing and who is responsible for manufacturing these medicines. Generic drugs are typically less expensive than their branded counterparts, this is because they have lost patent protections which allows multiple companies to enter the market and produce generic versions, driving down prices through competition. It is important to highlight as the business models that both manufacturers operate differ significantly, for instance R&D based pharmaceutical companies incur high levels of research and development expenses to develop innovative drugs, whilst generic manufacturers do not and only produce drugs once they come off patent.
Generic medicines are pharmaceutical products developed and manufactured to be identical to the originator medicine already authorised and offer the same therapeutic and clinical benefits containing the same active pharmaceutical ingredients (APIs), dose, strength, and route of administration. They comply with the same stringent rules and regulations regarding quality, safety and efficacy as the originator product, which has already been marketed.
Are generic medicines as effective and safe as brand-name medicines?
Yes, generic medicines are as effective and safe as brand name medicines. They are required by law to contain the same active ingredient in the same amount as the brand-name drug. As mentioned above, they meet the same safety, quality, strength, and efficacy than brand name drugs
Why are generic medicines often less expensive?
Generic medicines are less expensive due to the loss of patent protection. This allows companies to produce generic versions, thus driving down prices through competition. Generic companies also avoid incurring the high research and development (R&D) expenses that innovator companies do. While generic medicines are typically less expensive than originator medicines, this does not necessarily imply affordability, as many patients in low-and-middle income countries still face significant out of pocket expenses even for generics.
Why are generics so critical to expanding access to medicine?
For many years, the conversation around access to medicine has been focused on R&D based companies and their role in ensuring access to medicines yet, 90 percent of the medicines considered to be essential for the functioning of health systems – which the World Health Organization (WHO) lists in the Essential Medicines List (EML) – are off patent and available as cheaper generic options. However, many of these medicines are still out of the reach of people living in Lower to Middle Income Countries (LMICs). These can range from some basic antibiotics or contraceptives that people in high income countries are used to seeing in pharmacy shelves, to chemotherapy drugs that are essential for people to have a chance of beating the illness. This is where generic and biosimilar manufacturers come into play. In our report, we focused on the efforts of five companies, Cipla, Hikma, Sun Pharma, Teva and Viatris. These five companies have extensive portfolios that include many of the medicines listed on the WHO EML and have a wide reach into many of the LMICs that are facing the greatest access gaps.
Your foundation recently released a report spotlighting generics and biosimilar medicine industry: What did the report highlight?
The report has four key findings based on the five company profiles which are focused on areas where companies can progress.
Product registration: The five companies assessed in this report (Cipla, Hikma, Sun Pharma, Teva and Viatris) have demonstrated their regulatory expertise and prior success in registering products in 90 out of the 108 countries in scope, highlighting their proficiency in navigating regulatory environments and introducing products to markets in low- and middle-income countries. Nevertheless, an analysis of a subset of ten essential medicines per company reveals that there are still access gaps remaining for many essential medicines. For example, some of the assessed products have been registered in very few LMICs, despite the high need for them, and one company has not filed any of its ten assessed products in any low-income countries in scope.
Access strategies: Companies are using access strategies to expand access to their products and reach different segments of the populations, yet efforts fall short for the poorest patients. An analysis of 50 essential medicines (ten per company) found that 41 are covered by an access strategy in at least one of the LMICs in scope. Among these, the strategy most commonly used by companies to expand access to their products in the public sector is to participate in tenders. For the private sector, strategies are more limited, and affordability considerations are often insufficient – which disproportionately affects low-income and vulnerable populations. Across the 41 strategies, affordability is not adequately considered in pricing strategies for products; for only one product is there a pricing strategy that considers payers’ ability to pay in both the public and private sector.
Supply and manufacturing: Among the five companies, a handful of initiatives to bolster local manufacturing capacity in LMICs or facilitate technology transfer to local partners can be identified. Some companies’ efforts show a general, but limited, move towards investing in strengthening their own manufacturing capacity, particularly in Africa. Examples of companies engaging in initiatives with local partners to build manufacturing capacity or transfer technical skills remain scarce, with only two companies reporting such activities.
Adaptive R&D: The report highlights nine examples of adaptive R&D projects, where companies are tailoring products to the needs of people in LMICs – with the potential to enhance access. These include products specifically adapted for children; products adapted so that they do not require refrigeration; and formulations that simplify dosing regimens. All of the examples of late-stage adaptive R&D projects analysed in this report are supported by access plans, although these plans are limited in scope, and there is room for companies to strengthen their plans to ensure widespread and rapid access to adapted products in LMICs upon market launch.
In the context of Kenya, what are the current challenges and barriers in accessing affordable and reliable generic medicines, and how do the findings of this report address these issues?
One of the key challenges facing Kenyan patients is the lack of access to affordable medicines. Although the Kenyan government provide free or subsidised access to medications for a subset of diseases, including infectious and reproductive diseases, it is rare for health products beyond these to be subsidized. Coupled with the fact that it is estimated that only around 19 percent of the Kenyan population has some form of health insurance coverage, this often leaves Kenyan patients with no choice but to pay for medications out of pocket. This frequently leads to patients experiencing catastrophic health expenditures, treatment delays, or completely foregoing treatment.
The report found that despite this, there was a lack of comprehensive access strategies targeting vulnerable patients across the 108 LMICs in scope. Payers, referring to any entities or individuals responsible for covering the cost of medicines, encompass a wide range of parties such as public and private entities, organisations, and private sector patients paying out-of-pocket. It is imperative that generic manufacturers consider these private sector patients and their ability to pay when developing access strategies.
Despite initiatives to strengthen generics manufacturing it is not reaching the poorer patients who need them most, in your opinion what are other initiatives that are needed to safeguard product availability?
In addition to investing in local manufacturing efforts, it is important that companies have resilient supply chains so that there is an ongoing reliable supply of products for these countries. Companies can establish regional distribution hubs, maintain buffer stocks and support local sourcing to ensure timely and efficient delivery of medicines. Companies can also ensure that they are diversifying their suppliers, so they are not dependent on one single supplier. Additionally, companies communicate better with authorities to align demand and supply. Moreover, companies can share skills and knowledge with local manufacturers and develop local capacity with third parties to ultimately increase product availability. Lastly, to ensure that medicines are reaching the most vulnerable patients, companies can partner with local players and healthcare providers to understand the specific needs and challenges in accessing essential medicines and work together to distribute the medicines to those who need them most.
How can the insights and recommendations from this report be utilized by Kenyan policymakers, healthcare providers, and pharmaceutical companies to improve healthcare access and affordability in the country?
The report identifies how five major generic and biosimilar manufacturers are actively working to expand access to medicines. Among these five companies, four have a sales presence in Kenya, including Cipla, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries, and Viatris. This provides the Kenyan government and policy makers with valuable insights into potential partners for public-private collaborations. For instance, the report analyses various access strategies employed by these companies, governments can leverage this data on pricing strategies to negotiate fair and affordable pricing for essential medicines. This, in turn, can lead to cost savings for public healthcare programs and patients alike.
Kenyan healthcare providers, including physicians and clinicians, can leverage the findings from the report to enhance their understanding of generic and biosimilar medicines access, especially in the context of LMICs. In particular, enabling them to better their understanding of access strategies employed by generic manufacturers, as well as best practices in supply and quality, and forthcoming adaptive Research & Development projects.
Kenyan pharmaceutical companies can adopt best practices showcased in the report across the research areas of Expanding Access, Supply & Quality, and Research & Development. By doing so, they can contribute to expanding access to quality-assured essential medicines for the people who need it the most.
Can you elaborate on the importance of expanding access to generic and biosimilar medicines in Kenya, particularly in addressing health disparities and promoting public health in the country?
The unmet medical need in Kenya is significant, for example it is reported that many breast cancer never even begin to receive treatment because they cannot afford it, and a survey of a Kenyan clinics patients found that only 33 percent of breast cancer patients completed all 18 cycles of their trastuzumab treatment.
Generic medicines are often significantly less expensive than their brand-name counterparts, enabling individuals who may not be able to afford costly medications to access essential medical treatment. This is particularly important in countries like Kenya, where the majority of the population bears out of pocket expenses for healthcare.
Through expanding access to affordable generic and biosimilar medicines, more individuals across all income levels will be able to receive the treatment that they need. Meaning that gaining access to the appropriate medical treatment would no longer be a luxury limited to the wealthiest individuals in Kenya. This is particularly true because generic companies often maintain broader distribution networks and a stronger presence, allowing them to deliver essential medicines to remote rural areas.
Why is it that Generic medicines still remain out of reach for millions?
Generic medicines remain out of reach for millions for several reasons, including affordability challenges, even if a generic medicine is priced lower than the originator, it may still be unaffordable to many patients especially those who pay out of pocket. For example, at Moi Teaching and Referral Hospital which is one of two national referral hospitals in Kenya [source], the cost of trastuzumab is nine times the average household income in western Kenya [source]. Moreover, even when products are fully covered by health insurance, frequent stockouts and shortages arise leading to a lack of availability. When supply chain disruptions combine with poor regulatory and quality control systems, this can facilitate the entry of substandard and falsified products and create additional barriers for sustainable access. Additionally, there is often insufficient manufacturing of products in lower-income markets and a lack of suitability for local contexts such as formulations appropriate for the paediatric population or stable in warm environments which also pose significant barriers.
In most prescriptions Generics are less favoured how can this be improved?
There are multiple reasons for why most generics are less favoured. This includes lack of awareness about generic medications, especially the fact that they undergo the same stringent quality assurance process may lead patients to continue to use brand-name medicines, despite the availability of more cost-effective generic alternatives. Educational campaigns can help address this issue. Similarly, physician education can help improve prescribing of generics and newer biosimilars. From a policy perspective, policies to encourage the use of generic medicines, like generic substitution can also help. Ultimately, improving the public perception of generic medicines requires efforts from multiple players including policymakers, healthcare providers, the pharmaceutical industry, and the public.
Can writing generic name in prescription make it difficult for doctors and pharmacists to prescribe combination drugs or drugs with multiple ingredients?
Prescribing the international proprietary name (INN) instead of the brand name is a common practice, even a requirement in some countries. Prescribing by INN for all products, including combination drugs, would make procurement easier as the INN is recognised internationally as maybe some brands are not as common in other countries, therefore prescribing by the INN would generate less confusion than the brand name. Prescribing by the INN for combination drugs can be beneficial especially if the brand name is out of stock, then the pharmacist can prescribe another brand.
Are there plans for future reports or follow-up studies that will continue to track the progress and impact of access-to-medicine initiatives in LMICs?
We will be looking to expand in the future. In tandem, we do see our analytical framework as a valuable tool for guiding companies in their access-related strategies. This framework is integral to our engagement strategies with all companies, even those that have not undergone a complete assessment cycle.
Any other thing that you would like Health Business to know?
This is the first time that this industry has been assessed, and it is important to continue fostering accountability. This report highlights what major industry players, Cipla, Hikma, Sun Pharma, Teva and Viatris are doing to expand access to their essential medicines in LMICs, and key examples, but it also identifies opportunities for which companies can concentrate their efforts to drive change, tailored for each company. This report, alongside The Analytical Framework, will both serve as a roadmap for other manufacturers of generic and biosimilar medicines who seek to step up their approach to access to medicine, and as a tool for investors, policymakers, practitioners and patients to engage the generics industry on how to move forward.
