Read the Conversation
EF: What is BioPhorum's strategic footprint in Colombia and globally?
JH: BioPhorum is a fantastic fourteen-year-old organization and business operating today across ten BioPhorums worldwide. Our members represent a broad range of organizations working together to solve intractable industry problems. The Colombian activity is a part of a much bigger global program with over 150 top global biopharmaceutical and medical device companies as participants. Each Phorum focuses on a different industry area to solve specific challenges, from supply chain issues, and regulatory, or implementation challenges to new technology opportunities and standardization of approaches to propel the bio-manufacturing biopharmaceutical industry and medical devices. Our members pay an annual subscription to be part of the organization, which allows us to work as a business. Most companies have subscriptions to multiple Phorums, each dealing with a different part of their value chain via manufacturing and pharmaceuticals. In one of those Phorums, the companies’ senior leaders identified the post-approval process in Latin America as a challenge. They pinpointed various geographies where it was a challenge regarding additional costs and slower opportunities to bring the latest medicines to patients in those countries. They asked us to work with them to see what could be done to support the Colombian regulatory authorities to improve the approach and bring it more in line with the rest of the world. We have more than a hundred workstreams globally, which shows the breadth of what we do across the pharmaceutical landscape. We work with our subject matter experts and internal regulatory experts –Isabelle is our expert leading the support story for Colombia.
IL: Colombia is the second Latin American country where we have worked directly with the regulatory agencies to adopt regulations and guidelines for post-approval changes. The Colombian regulatory agency and the Ministry of Health were very interested in learning about our experience in Brazil, the first Latin American country we had supported our members for PA changes. We first started in Brazil, we followed the order of Latam's commercial market size where our work with ANVISA was successful with the recent change in the post-approval .regulation for biologics Then we built a very good relationship with COFEPRIS (Mexico); we were involved in providing training on the latest regulatory science, innovation, and technical innovation, sharing BioPhorum's knowledge from the 100+ initiatives it facilitates on behalf of the biopharmaceutical industry. Unfortunately, after the gubernatorial elections, the political environment changed and this relationship with industry could not be sustained. . In Colombia, after the elections in June, we are again facing a similar situation with regard to political change. However there is no indication that the new administration will not continue its dialogue with industry, as many people are interested in improving things, which is highly motivating, and I hope we can continue our efforts with the new administration when it is in place.
EF: What was the key issue for going to Colombia, and what is the mission for the new initiative?
IL: The key issue in post-approval changes is two-fold:
- The complexity of the documents provided for post-approval changes. For example, the US or European post-approval change notifications can not readily be used, they need to be augmented with Colombia-specific requirements.
- The regulatory agency's time to review a post-approval change can take up to two years, impacting the new product when implemented.
The two issues are linked because the more information required, the longer it takes to review - a closed circle. Latam's regulatory agencies have fewer personnel than the FDA or European Agencies, and an already small team is even smaller for biopharmaceuticals. Last year, we started working with the regulatory agency, but we could not change regulations because there was a political decree on which regulations depend. We had to first talk to the Ministry of Health to change the political mandate, something we managed to do at the end of last year. The Decree was modified, and now we are waiting for the new regulations to come into existence.
There are multiple benefits to having local regulations aligned with other countries and international guidelines, such as those issued by the WHO. First, they are designed to put the most focus of regulatory review and approval on those changes that may have a potential impact on product quality and patient safety, allowing for minor changes to be either managed by the biomanufacturer or notify the agencies without a need for approval. Then, it allows for the local regulatory authority to utilize the review and conclusions on approval from other countries, to make their decision. If the regulations differ, then this is not possible. This can significantly accelerate the local review and approval process of the change, thereby aligning the approval of new products to the timelines of other markets (typically 6 months for a major change, as opposed to the current 2 years plus in Colombia). We always see this from the point of view of the patient, what if these eighteen months are critical to their survival, as biopharmaceutical products often are?
Finally, it allows the agency to collaborate with other agencies, demonstrating the same level of regulatory maturity, through ICH for example. Before approaching the agency, we spoke with ANDI and AFIDRO, who were instrumental in connecting us with the Agency and the Ministry of Health. It was a true collaboration between industry groups and, considered the bigger picture to benefit patient access to medicines.
TH: It has been a great example of how BioPhorum can bring different stakeholders together, something no individual company could do. We are not an industry body but a collaboration organization allowing this kind of discussion. We don't produce any drugs; we work and provide one voice for our members to highlight these challenges and opportunities for better patient outcomes and healthcare services in different geographies. We work as one voice for our members, and our message is more powerful, coming across as a group.
EF: Could you elaborate on the benefits of a more aligned and efficient regulatory policy for stakeholders across the health sector?
IL: Our first focus is the patient and their quick access to medicines, but we also reflect on the monetary value of the product; making it simple and streamlined allows companies to facilitate patient access. From the agency's point of view, they are able to focus on the important changes that will impact the quality and safety of the product through a demonstration of understanding of the product and the most recent advancements in regulatory science. A dossier demonstrates the quality of the product, the reason for the change, an assessment of the risks linked to the change, mitigation actions in a package, and the final impact of the change. It is beneficial for the patient, the agency, and the industry.
TH: From an industry perspective: simplification speed and cost. When regulations hinder access progress, there is a risk to patients' continuity of supply and access results. In the worst-case scenario, a bio manufacturer might have to keep a production line running for an extra year to provide one or two countries in Latin America simply because the regulatory pace is slower. These are the challenges the industry faces.
IL: Patient access is limited if a specific country requires a bigger inventory than allocated and is unavailable because it is not approved
EF: Cost is a big topic in Colombia; what is the role of regulatory strategy in reducing cost pressure in Latin America?
TH: In regulatory policy relating to cost, our view is tangential. We are not involved in pricing conversations for our pharma members and don't work with pharma companies on commercial aspects. If we have saved money for industry participants, it's because of the opportunity they have to negotiate with different payers to provide at a better price in different geographies. But, whatever the results are, they are beyond our scope.
IL: We are all about the science and streamlining as much as possible to keep the cost down, but we don't actively get involved with price negotiations with the government.
EF: In Colombia's poor regulatory framework, post-approval changes can take up to two years, hindering innovation and creativity. Could you elaborate on how your work promotes innovation?
IL: BioPhorum drives innovation; our members seek our help to collaborate on changes in innovation, the introduction of new ways of working, new technologies, new manufacturing platforms, etc. Innovation is our raison d´étre. However, the industry cannot move forward if the regulatory framework does not support innovation.
Innovation may happen before a product is launched or more often after launch. From a technical point of view, having a thorough understanding of the quality of the product such as when it has been commercially manufactured for several years, makes it easier to promote innovation. There is a barrier to innovation when there isn't a regulatory framework to change things after the original finding.
From a regulatory point of view, innovating with a new product is easier even though it presents more fundamental risks, as not only the product may be less well understood, but the topic of innovation may also be less known. y.
For innovation to advance, education must be carried out, as we began in Mexico and have been doing in Brazil, for example regarding continuous manufacturing for biopharmaceuticals. Also, some fundamental initiatives with more prominent agencies are required to educate and share challenges and risks, and how they can be mitigated.
TH: Innovation incorporates both producing new products and bringing those products to market. BioPhorum has always worked closely with members in relation to the production of manufactured products and how they are brought to market, particularly in bio-manufacturing. We have considerable experience in continuous production and other similar techniques. Two of our Phorums, BioPhorum Development Group, and BioPhorum Cell & Gene Therapy are focused on the first stages of bringing new products to market and how companies should work in that setting. Cell therapy is a very exciting growth area where we also play a big role. Companies are looking to collaborate to understand how to bring these new products to market and navigate what is still a very emerging regulatory landscape –particularly for cell therapy. The companies are looking for what they feel is the right way to adhere to the current regulation. They work in partnership with the regulators to shape the rules as it becomes clearer what products will be manufactured (their profiles and therapy areas.) We work across a landscape of innovation, supporting companies and alliances for manufacturing and innovation processes on speed, market access, and cost, helping bring new products to market.
EF: Having worked with ANDI, AFIDRO, and the Ministry of Health, could you reflect on the importance of public-private partnerships in healthcare and what they bring to the patient and industry stakeholders?
IL: Very simply, public organizations are responsible for the regulatory framework, and the private sector is responsible for the products, ensuring they comply with the regulatory framework, so working together makes perfect sense. The public sector ensures the safety of the patient and the quality of the product; the industry produces the product. Understanding and efficiency between both sides are critical for success. My experience working in Colombia involved aligning all stakeholders to ultimately benefit the Colombian patient; facilitating access to new products, both from the private and public sectors. BioPhorum is the science expert, focusing on the product's safety, efficacy and quality, and benefits both partnerships and collaborations.
TH: My experience working in various emerging and developed regions worldwide is that the collaboration between public bodies and private companies is an interaction. We do not form public-private entities; they are more common in the hospital construction space, where public-private partnerships play a big role. The more formal public-private partnerships formed by different types of business entities are what the Health Ministries think of as public-private partnerships. In our case, the business entity structure is less relevant but has a sense of collaboration between public bodies and private organizations in this particular context.
EF: What would you celebrate as an achievement for 2022 based on the one voice project for Colombia?
IL: The government publishing the decree to allow regulation changes has been a massive success. We are now waiting for the new regulation to be published, but we have no control over the timing. We would have liked to see the new regulation issued in June to finalize everything, but we depend on the agency's timing. We are delighted that we were able to present our members’ views as one voice to the Ministry of Health, which ultimately influenced the new Decree. The creation of new regulations leading to greater patient access will be another milestone, in which we are all very proud to have played a part.
TH: A key success this year has been achieving a collaborative, trusted relationship between the industry, the regulators, and the Ministry. The key output of that team effort has been the Decree, which has only been made possible through a trusted and collaborative relationship. This is at the core of BioPhorum’s strategy - and will allow for the next steps in regulatory change. This initiative has been a massive success, and Isabelle and the regulatory team should be very proud of working with the industry bodies on behalf of our members. We look forward to initiating change in other geographies that will benefit from the work already carried out in Colombia.
EF: Is there any final message you would like to share with our readers?
TH: From a BioPhorum perspective, this is one example of the power of collaboration. Building trusted relationships and communicating with a single industry voice, enables us to work with key industry partners and stakeholders to aid transformational change for patients, patient access, and the industry. BioPhorun is proud to be at the heart of such change.
IL: Adding to what Tim said, collaboration can be extremely effective, and we are here to ensure it works in the best way possible. We strive to set up further initiatives in different countries in Latin America so that the results can be broadened and the benefits seen by more patients.