Cem Zorlular, CEO of Er-Kim Pharmaceuticals, shares his insights on how pharma manufacturers can better navigate the global commercialisation of treatments in an ever-changing landscape.
Key insights:
- Understanding updates pertaining to revised legislation and pharma manufacturing guidelines globally can assist manufacturers in meeting requirements for commercialising therapies.
- Close collaboration with well-established distribution partners on a launch strategy that includes managing early access, pharmacovigilance, and security solutions can minimise the risk to the supply chain and patients.
- Operating in international markets can be risky when it comes to healthcare and anti-bribery compliance, and finding a local partner with a top-down management commitment to compliance is critical.
While there is regulation and governance in place in most countries to protect companies and patients in the marketing and consumption of drugs, manufacturers need to keep their finger on the pulse for updates, and local partners can help. Understanding updates pertaining to revised legislation and pharmaceutical manufacturing guidelines globally can assist manufacturers in meeting requirements for commercialising therapies. How can companies mitigate the risk of unlawful promotion and distribution of treatments – among other things – to ensure the delivery of vital treatments to patients?
For example, the revised European Commission’s pharma legislation is expected to include sweeping changes to the regulation of pharmaceuticals, orphan drugs, and advanced therapies. This is just one instance of countries revising legislation to ensure treatments meet standards for a high level of public health protection and the quality, safety, and efficacy of authorised medicines while continuing to attract investment in the European pharmaceutical market.
Although there are customary and critical steps in the commercialisation process, there is no one-size-fits-all strategy for navigating the complexities of regulation, pricing, pharmacovigilance, and sales and marketing. But the odds for a successful launch are increased when selecting a partner with established capabilities in several key areas.
Financing a launch
Launching a drug in a new region is a capital-intensive process and significant resources are needed to ensure the best probability of success. In most developing markets, reaching cash flow positivity for newly launched drugs can take many years, leading most small to midsize pharmaceutical manufacturers to select a regional partner with experience and financial strength in those markets. A firmly established regional business partner with robust cash flow and a balanced income portfolio will be willing to assume the financial risk of launching - this model allows the manufacturer to transfer the risk to the regional partner, who will invest significant cash in launch preparation and financing product purchases.
Considering early access execution
For some conditions, such as rare diseases, pharmaceutical manufacturers may look for opportunities to accelerate patient access to treatment in international markets. There are numerous early access programs to support this process, and it is important to note that these programs do not follow the conventional wisdom of commercial markets: countries with more difficult market dynamics can offer very attractive early access opportunities to significantly improve accessibility to medicines. In addition, if actively supported by robust medical affairs and market access teams, the process can generate early cash flow.
Mitigating the potential of illegal use
Falsified, substandard, or unregistered medicines are a global problem, particularly in low- and middle-income countries, which can cause problems for pharmaceutical manufacturers looking to expand their treatment. In addition to putting the health of patients at risk, counterfeit products expose legitimate producers to substantial financial and reputational harm. Although a company may elect not to enter a country, it does not mean some version of the product will not end up in these markets if patient demand exists. Close collaboration with well-established distribution partners on a launch strategy that includes managing early access, pharmacovigilance, and security solutions can minimise the risk to the supply chain and patients.
Regulatory and compliance
Operating in international markets can be risky when it comes to healthcare and anti-bribery compliance, and finding a local partner with a top-down management commitment to compliance is critical. Without considerable experience and a strong framework in place, there is the potential for an unintentional act to set back a launch financially and delay patient access to treatment. As a first step, conducting due diligence on a prospective partner company will help ascertain if they adhere to industry best practices and standards, such as ISO 37001, which certifies independent review of anti-bribery policies and procedures.
Assessing the landscape for pricing and reimbursement
Pharmaceutical manufacturers looking to expand into international markets need to assess and analyse the pricing and reimbursement landscape to identify opportunities and plan for risks. Due to the ever-changing policies in this area of drug distribution, manufacturers are required to establish competitive pricing and educate the medical community about treatments to ensure buy-in from payors. Local partners who have done an analysis of the pricing landscape have a better understanding of the local nuances and concerns of the industry, as well as relationships with key stakeholders which avoids negative spirals on the list pricing and ensures the highest return for the value provided in reimbursement negotiations.
Medical affairs and technology infrastructure
A successful medical affairs strategy provides patients with the ability to easily access, understand, and use the product. Most international markets have different sets of needs when it comes to medical affairs, but many have underdeveloped technology infrastructure and lack the investment necessary to implement a robust medical affairs strategy, leading to suboptimal patient outcomes even after a drug launch. An established local partner with the infrastructure designed around local challenges is capable of building bespoke strategies to ensure as many patients as possible benefit from these newly available solutions.
Quality and supply chain
As we have seen over the last few years, the global pharma supply chain is vulnerable to disruptions, which can lead to drug shortages and result in an influx of counterfeit medicines. A global partner with expertise in navigating events and inventory can take a great deal of burden away from the manufacturer’s operations team and develop a supply chain optimisation strategy for a product launch that also meets the highest distribution guidance, such as the European Medicine Agency’s Good Distribution Practice (GDP) standards.
Local partners and representatives with familiarity in the laws and cultures of various countries can support pharmaceutical manufacturers of all sizes in their commercial success. As larger manufacturers may have a more established method for their commercialisation strategy for various countries, a regional partner that can navigate the process for the best possible outcome is essential.