LATAM Market Access Unlocked: Insights from Argentina, Brazil, Colombia, and Mexico

How do LATAM healthcare markets differ and what do these differences mean for Pharma and Medtech launch planning? What should global market access teams know to support affiliates in Argentina, Brazil, Colombia, and Mexico? How do evidence requirements, access routes, and payer expectations vary across the region?

For global market access teams planning for launch in Latin America (LATAM), understanding the diversity and complexity of this region is essential. Healthcare systems vary significantly between markets, regulatory and payer expectations differ, and health technology assessment (HTA) processes continue to evolve. These differences create both opportunities and challenges for Pharma and Medtech companies preparing evidence, developing global plans, and equipping local affiliates with the right materials to secure access.

In this episode, Louise Maddison (Senior Consultant – Global Pricing and Market Access, Petauri Evidence) interviewed four regional experts:

•  For Argentina: Eleonora Aiello (CEO at Ceibo Health Consulting)
•  For Brazil: Alessandra Calabró (Independent expert in market access and government affairs)
•  For Colombia: María Fernanda Escobar (Principal Advisor, InnovaSalud)
•  For Mexico: Fernando del Río (Partner at InnovaSalud, GP at XB Ventures)

Together, they unpack the access landscape in their countries, sharing experience‑based insight to help global teams refine evidence plans and align global materials to local payer expectations.

Together, they explore:

• Variation in healthcare systems, regulatory structures, and payer landscapes across LATAM
• HTA landscape in key markets and the influence of bodies such as CONITEC in Brazil, IETS in Colombia, CENETEC in Mexico, and ANEFiTS in Argentina
• Differences in evidence expectations, including clinical, economic, and real‑world data requirements
• How global dossiers, value messages, and evidence packages can better support affiliates engaging with local payers
• Opportunities and challenges for introducing Pharma and Medtech innovations into LATAM markets
• Future policy, regulatory, and reimbursement developments to monitor across the region

This episode was first broadcast as a live webinar on Thursday 19th March 2026. For more information about this webinar see: https://petauri.com/insights/latam-market-access-unlocked/

For support with market access strategy and global launch, please reach out to evidence@petauri.com.

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Transcript

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- [Announcer] Welcome to this Petauri Evidence webinar. At Petauri Evidence, we deliver market access and HEOR support throughout the product lifecycle to bring new treatments to patients across global markets. Follow us on LinkedIn for more great content from our team. We hope you enjoy the discussion.- Welcome everyone to our latest webinar. Please see our YouTube channel for past webinars and look out for more content from us in the future. The topic today is "LATAM Market Access Unlocked." Latin America is a huge region and access for health care technologies in Latin American markets involves diverse and complex national regulations, varying health care systems and differences in health care technology assessment maturity. To succeed, companies must tailor their strategies to individual countries, which are seeing growth driven by an ageing population, rising chronic diseases and increasing healthcare investment. I'm Louise Maddison, Senior Consultant at Petauri Evidence. We have a great mix of audience today across industry and healthcare systems. I'd like to particularly welcome our global affiliate partners who play a key role in the work that we do. For those that don't know us well, Petauri Evidence is a global specialist health economics outcomes and market access consultancy. With a track record in expert delivery, we provide specialist support to pharmaceutical and medtech clients as well as a collaborative partner to healthcare systems worldwide. Today, we focus on LATAM market access unlocked and I'm delighted welcome our guests today, Eleonora Aiello, Alessandra Calabro, Fernando Del Rio and Mafe Escobar, who are Latin American market access experts with extensive experience. So welcome everybody. Eleonora could you please take a moment to introduce yourself and then we'll go around the rest of the group. Oh, I think she's dropped. Mafe would you be able to introduce yourself?- For sure. Hello everyone, my name is Mafe Escobar. I'm an Independent Consultant and Principal Advisor at InnovaSalud. I have 20 years of experience in the pharmaceutical market supporting companies across Latin America and Colombia in commercial and market access strategy and I'm also very committed to bringing a humanised perspective to the healthcare systems, so always trying to bring the voice of the patients to the strategic conversation. Happy to be here.- Thank you. We'll get Eleonora now. Eleonora?- Hi sorry, I hit the wrong button. My name is Eleonora Aiello. I'm a pharmacist with more than 25 years of experience in the pharmaceutical industry. Since 2015, I help companies advance their technologies in the Latin region across all countries and other global markets as well. And I am very happy to be here and honoured to have been invited.- Thank you. And Alessandra is representing the Brazilian market.- Hello I am Alessandra Calabro, I am an independent market access expert with 30 years of experience in the Brazilian healthcare market. I have worked for top pharmaceutical and medical devices companies in the in the country, mostly in the areas of market access and also government affairs. And along my career, I had the opportunity to develop successful strategies, approving pricing and reimbursement for new technologies in the health care system. And I'm happy to be here with you today. Thank you very much for the invite.- Thank you. And we'll go to Fernando, he's bringing the perspective from Mexico.- Yes. Hello, everyone. I'm Fernando del Rio, market partner at InnovaSalud. I'm based in Mexico City and have worked like our colleagues for more than 20 years in the industry, doing consulting projects, including many market access projects in Mexico and in the major countries in Latin America, and happy to be here.- Thank you very much. So we'll go to the first question, and this is for everyone on the call. Could you each provide an overview of your market, including healthcare systems as well as regulatory and payer landscape. And I guess we want to start with the biggest market which is Brazil. So, Alessandra.- Yes, Brazil operates a dual healthcare system combining the strength of the universal coverage in public system SUS with a supplementary private insurance market covering 25% of the population with 51 million inhabitants. For pharmaceuticals, once the drug receives regulatory approval, manufacturers must submit a dossier to CMed, which is the Drug Market Regulation Chamber, which sets the limits for drug prices. In the dossier to request pricing approval, it's important to develop a strategic rationale with arguments based on scientific evidence, also reinforcing clinical and technical aspects of the product as well as operational elements that impact our own prices. For medical devices, there is no price control so far. We have an established health technology assessment system which is considered a regional reference in Latin America. It emerged with the creation of CTECH and local health technology assessment centre since the year 2000 and followed by CONITEC creation in 2011 by law. Health technology assessment is today a mandatory process to include new technologies in the healthcare system. CONITEC became a central mechanism for rationalising unified healthcare system also called SUS expenditures and improving access to effective technologies. It's important to evidence to CONITEC why the therapy must be available in and out and how it's different and more advanced than other therapies already available in the public system and currently it provides stakeholder participation including public consultations and hearings allowing civil society, industry and academia to contribute. However, some challenges still remain such as limited resources need for capacity building and balancing innovation with equity as the ongoing issues. In the private system, in-hospital drugs and also medical devices as well as oral cancer drugs need to submit a dossier to INS which is the agency which controls privacy insurance.- Thank you. Eleonora, could you provide the perspective from Argentina, please?- Sure, Louise. Well, Argentina has about 46 million people. The healthcare system is, we typically say that it's very fragmented, but I mean, I think that the best word to describe it is atomized, because it has more than 700 different types of payers for a limited population, because 6 million is not really that much of a population for such a big country. And 40% of that coverage is public, 45% corresponds to the social security, and 15% would be the private system. And look, companies typically commercialise through first having an approval from the regulatory agency called ANMAT, A-N-M-A-T, and then struggling to have coverage, I mean, in this atomized health care system, negotiating with payers, most of the times with different type of pathways. Although access to innovation, I mean, has always been somehow very good compared to other countries in the region. Although of course, constraints, budget constraints are the thing that undermines, undergoes everything in the system. A lot of innovation has come to the country in a timely manner. So, well, we have to deal with this type of atomization and it's key that companies know how to navigate the healthcare system.- Okay, Mafe, can you provide some perspective on Columbia?- Sure, we have a universal healthcare system that covers around 98% of the population. It's also a solidary system. So meaning we have two regimes, one for the employers, self-employed and pensioners that contribute to the subsidised part of the population that is roughly 60% of the population, but we are all covered. We also have mixed funding, so we have a part of public and private funds in the system, but again, 98% in paper is covered by the health care system. We also have some institutions that are called EPSs. And basically, they are the insurers and also the administratives of the health of all of this population. And we have in VIMA, that is the regulatory agency that approves the drugs. And once the drug is approved in paper, it should go to the HTA agency, the IETS, that was founded more or less in 2012. However, it hasn't been working perfectly. So not all of the new drugs in the market go through that pathway in terms of evaluating therapeutic value. And we also have a public fund called ADRES, that is the one that transfers the funds to the EPSs that are going to be the ones managing the money for all of the different services that the population requires.- Thank you, that's really clear. And Fernando for the Mexico perspective?- Yes, I think that the first thing that's important to know about Mexico is that it spends only 6% of its GDP on health care, and only around half of that amount is government spending. These are figures that are both figures are lower than, you know, the other countries in today's panel and then most middle income countries around the world. And these, you know, this creates many constraints along for for health care service provision and also for the access to new technologies. There are two distinct sectors in Mexico, the public and the private. Within the public system, there's two subsectors. One is the made up of the social security institutions, which are for formally employed population and their families, both in the private and the public sector. And then there is an assistance programme called Bienestar for that large population. Just as Mafe mentioned in Colombia, that is not formally, formally employed. And something that is also particular about Mexico, and as you can see, you know, each country is very different, is that in Mexico, in the public sector, the public institutions are both payers and providers. So they they have the funds, but they also own the pharmacies and are employers of the of the physicians. Now, despite these fragmentation of institutions, there are maybe, you know, around 10 relevant public health care institutions in the country, there are some key processes that are centralised, including the national formulary that applies to all of the public institutions. And all new technologies must gain access to these national formulary and known as compendio before they enter the individual institutions. Now, however, each of the institutions, some more than others, have their own requirements and their own list of drugs that they purchase and they provide to the population they cover. There is a body called Senate that has an HTA mandate, but in practise, they are focused more on technical guidelines than in evaluating technologies for inclusion into the formulary. So in practice, there's a body called Consejo Nacional de Salubridad that manages the national formulary and they take into account these HTA-like criteria to grant or deny access to new technologies. The private sector is mostly finance out of pocket. There's only around 10 percent of the population, you know, compared to 25% that Alessandra mentioned Brazil, only 10% of the population that has private insurance, mostly covering catastrophic diseases and not primary care. And most private insurance companies are some exceptions, but most of them don't have formularies. So, you know, access into the private sector, both for out of pocket and for, you know, reimbursed products through private insurance is, you know, is fairly easy compared to the public sector. So that's, you know, very quickly an overview of how the Mexican healthcare sector works and the implications for the access to new technologies.- Thank you. It's really clear about how diverse each of the markets are and how companies really need to think about the different situations for their launch. So coming on to that, so what are the opportunities for manufacturers wanting to launch in LATAM? If we go to Alessandra if you could speak through the perspective from Brazil that would be great. Sure, Louise. Firstly, Latin is a fast-growing region with ranging population, expanding middle class, rising chronic disease and digital health adoption. And talking about Brazil is the 80th largest market in the world in sales revenues, we traded 35.6 billion in 2023 according to IQVIA. Recent there was a regulatory improvements in electronic visa including regulatory reliance on assessments from FDA and EMA. This means that product approved in these agencies can undergo a streamlined review, reducing duplication of efforts and speeding up access. Usually companies entering LATAM started by the biggest markets which are Brazil and Mexico and for companies entering LATAM without a strong presence the most effective local partners are those with strong regulatory expertise and also establish a distribution that works and deep relations with the healthcare providers.- Thank you. Could you provide the perspective for Mexico, Fernando?- Yes, sure. In Mexico, at most, some of the opportunities are most new technologies become available in the private market very soon after global launch. And as is the case in Brazil, there have been some regulatory improvements and reliance guidelines that we have seen recently, you know, very quick approvals at the regulatory level. And since the access to the private sector is very fast, you know, companies can launch and start, you know, having KOLs and other physicians having experience with their products very, very fast. I think that would be the main opportunity. Also, I think in the public sector, most new technologies end up achieving inclusion in the national formulary, but it can take, you know, a year, two years or more after the launch in the private sector. The main challenge and the questions about opportunities, but the main challenge is having effective access. So as opposed to other countries where the product is approved then physicians can prescribe, you know, has been approved in the formularies or in the particular institution that the physicians can prescribe more or less freely, there are many many constraints given the budget restrictions in the system that limit the effective access to drugs even if they are present in the institutional formulas.- Thank you. And Mafe, from the Colombian perspective.- Yeah, I would say that Colombia represents a great opportunity since we have 98% coverage of the population in the health care system. And once the drug has access to the market and all patients have access through it even though they are in the different regimes or in the different EPSs. I would also say that Colombia considers health as a fundamental human right and that means that even though the drug is not in the national formulary called PBS, it can access through many other mechanisms. So until now, and I would say until now because probably we will talk about the challenges that we are now facing until now having access in the market in terms of regulatory pathway means that you have access to the population and the population can have access to that drug. So that's the best or the biggest opportunity in Colombia. We also have really or relatively good data systems. I would say they are improving and there's a lot of gaps, but at least in Colombia we have data. And also I think the market is quite regulated in terms of price, but at least companies know what are the rules in terms of pricing that they will get once they enter the market. So I think those are some of the opportunities I would say. There's a lot of challenges and probably we will talk about them, but good opportunities as well.- Thank you. And Eleonora, for the Argentinian perspective?- Sure, Liz. Well, like Colombia, in Argentina, health is also a fundamental human right. So lots of rights have been very well-leveraged by the manufacturers and lots of new technologies, but really new drugs really thrive in the Argentinian market, although perhaps less than in previous years because budget constraints are everywhere. Argentina has shown, has really surprised many in terms of access to technologies because as far as they are approved, physicians start mainly in the private and social security systems. People, I mean, physicians start prescribing. And through different pathways, these innovations finally end up being approved by the system. And most of the times, high-cost drugs or technologies are funded 100% with no co-payments. So that is really a differential in our market. As long as another thing that happened yesterday, that the patent system has been flexibilised or guidelines have been really removed for the innovation, for patenting, for innovation. So this is said that will triple the investment in clinical research, which has been last year of $700 million, but it could triple due to this very new regulatory change or patent change actually.- Okay, thank you. And I guess some of our listeners will be more familiar with the payer landscape in Europe and bodies that conduct health technology assessment like NICE and DBA as that additional hurdle after regulatory submission. Could you give me an overview of the type of evidence required by payer stakeholders in key LATAM markets? And I don't know who would like to go first here. Maybe Mafe?- For sure. So we have a regulatory agency called INVIMA that basically evaluates any drug similarly to any other regulatory agency. We have as reference FDA and EMEA for most of the drugs or at least innovative drugs. We also have an agency, as I said before, that is an HTA agency called IETS. However, it's not fully organised and it's not fully funded. So the capacity of IETS nowadays is very limited. And although in paper they should evaluate any new drug or any new technology that comes to the market in terms of their therapeutic value, they haven't been able to do this. They have been limited to evaluate certain key therapeutic areas and prioritise therapeutic areas and different therapies, but up until now, it's been very difficult. So once the drug is in the market, INVIMA grants regulatory approval. Once the drug is in the market, the different EPSs are required to have that drug in their scope. Let's say the drug needs to go to the PBS formulary and that formulary is constantly evaluated and updated. However, as I said before, if the drug is not in the PBS, there are many other mechanisms patients can have it. So the way EPSs normally prioritise different drugs in terms of line of treatment and things like that is, of course, through therapeutic value, but also through budget impact. So that's another big component when individual payers, or EPSs, sorry, are going to evaluate the drug. I would say most of the EPSs have those two criteria as the most important. However, we have recently seen an increase in requests for local data or real-world evidence as well, but that depends on the individual payer or EPS.- Okay, thank you. Alessandra for Brazil.- Brazil's CONITEC mandates health technology assessment including systematic review of comparative efficacy, effectiveness, safety, and also accuracy versus the source incorporated competitors. Plus pharmacoeconomic studies, including cost-effectiveness and budget impact With patient reported outcomes also included since December 2020. The main challenge I guess in pharmacy companies cannot prepare for Latin America as a single unified market because each country has its own regulatory frameworks. But regional harmonisation efforts are underway so it may facilitate the process in the near future. Brazil is often considered a benchmark for Latin America because the size of its pharmaceutical market and the sophistication of its health technology assessment process. So pricing and reimbursement decisions made by CONITEC can also influence negotiations in the neighbouring countries. So that's why pharmaceutical companies frequently prepare regional pricing strategies. And the process of evaluation and reimbursement typically takes at least two years. Once submitted the dossier, CONITEC ETA has 180 days to review it, it's tenable for another 90 days and with a positive recommendation and then CONITEC must include the technology in the formulary within 180 days. If negative, the dossier can be submitted again, and it takes nearly similar time.- Fernando from Mexico, would you be able to describe the evidence requirements?- Sure, yes. So as I mentioned before, the National Health Council is the one that manages the compendio, the national formulary, and they have guidelines published on what evidence is required. There is a component of clinical evidence, which is basically the same as what's included in the regulatory. A dossier may be in different format, but nothing new. In terms of economical submission, they accept several cost-effective studies. And the analysis must compare the technology with current started carrying the Mexican public system. That's important. And among the many options that, you know, some are options, some are, you know, not required, but the budget impact analysis is required, you know, as part of the submission with the financial impact for the key institutions in the public sector. So this is what the, you know, there are, as I said, the guides are published and are fairly clear. That is key for the national formulary. And then, as I said before, each institution, you know, has have their own committees, some more stringent than others. And for them, it's really the budget impact studies that are, you know, the key for inclusion or not in what they purchase and provide for the population.- Thank you. And last but not least, Eleonora for Argentina, because obviously, there's a lot of changes there with NFX that's coming online.- Sure. Well, Argentina, I would say, that it doesn't work as one size fits all approach. So it's key to have the correct expertise to, because, I mean, different payers request different things. And also, we have several Argentinas, so perhaps the data inputs that fit in a model that don't resonate with another payer. So I think that each, the key here is to submit the correct data that really makes sense to each payer so that they can grant access in this atomized healthcare system. Usually, typically budget impact models are adapted and studies are produced by manufacturers so that they show the value and often, I mean, lower uncertainty around many things that payers want to see before approving each prescription.- Okay, thank you. And we touched a little bit on real-world evidence, so I just wanted to understand a little bit more about LATAM payer preferences for real-world evidence and the opportunity for innovative contracting. Eleonora?- Sure, real-world evidence is valued and again, different pieces of approaches will make more sense to some payers than to others. The second thing, they want to see data that really makes sense, I mean, in terms of cost. And we all know that Latin American data is not always public or easy to collect. So also, well, in terms of this real-world data is most of the times needed to, because all payers are eager to have these innovative agreements or managed entry agreements that we all know that they are very, they aim to have, but sometimes it's, as in many other countries, difficult to administer, difficult to object device. Of course, there are so many that most of the times are confidential, but I think that the trend is there, and there will be more innovative agreements as new technologies come to the market.- Thank you. Fernando, did you have your perspective? Or Mafe, for Columbia with the diversity of data sources?- For sure, so definitely, real-world evidence is gaining traction and everyone talks about it and there's been a lot of conversations with the different payers and EPSs in order to get different innovative agreements related to real-world evidence. We do have some national data sources, I would say, they have been improving over time. They are not perfect and there's a lot of gaps around the data, so that's one opportunity, but also one big challenge. And is that I don't think the data sources are still reliable to do reliable evaluation of the data. However, also, I think as Argentina, most of the EPSs, although they are from the public system, they are private. So what happens is that most of the negotiations are confidential. So we don't know a lot of examples where innovative agreements have been done. However, we know they have been done. And I would say, it's going to be even increasing in terms of the trend to get this type of innovative agreements and to create real-world evidence.- Alessandra, what's the situation in Brazil with real-world evidence?- Well, in Brazil the use of real-world evidence is evolving quickly, especially for rare disease and also advanced therapies, where there are being researchers using their own database from the public system patients that can generate evidence of clinical and economic impact that in conditions different from clinical trials. So the country is applying real-world evidence in evaluation of medical device and vaccines and recently on these establish a guide of recommendations which may accelerate the use of real-world evidence. So we are in an accelerated learning curve with potential to align quickly to the international best practises, I guess.- Thank you. And Fernando, I understand the situation within Mexico is slightly different, a little bit more challenging.- Yes, it is. So I think as in contrast to other countries in Mexico we haven't made progress in the last, you know, 10, 15 years in terms of real-world evidence use. There has been some progress in using it. You know, once the technology has been approved and is in use to show the benefits and maybe support, you know, wider use of technology within the system, but not as part of, you know, innovative agreements. There have been a few pilots that have been launched, but haven't been having achieved enough traction to really make it more more available. Some of the challenges are legal, you know, contractual, you know, how the government can establish these contracts where the you know, the payment to the pharma company is not based on a unit consumption base. And also, I would say lack of trust sometimes between the industry and the government, particularly in the last in the previous administration. That was, you know, a very big hurdle. Now we have, I think, better relationship, a working relationship between the government and the industry. So companies are still trying to again, trying to introduce innovative agreements. but again, we're back where we were maybe 10 years ago so we'll see in the next few years, if things move more quickly.- Thank you. And I guess before we move off from this topic around the evidence requirements, there were a couple of questions that we had in advance around how long the process of evaluation and reimbursement typically takes. So I think Brazil, Alessandra, you mentioned around 18 months to years is that similar for the rest of the countries in in Latin America, how long does that process typically take?- I can speak to Argentina. I mean, it depends on the healthcare sector we are talking about. Most of the times, the social security and the private systems are, I mean, they're eager or they are more prone to innovation, to accepting innovation. So perhaps it could take from six months to one year or perhaps 18 months, but in the public system it may take much longer than this.- Thank you.- Yeah, for Colombia, I would say, it's a very different conversation four years ago than today. The Colombian healthcare system has been in a crisis in terms of financial crisis, but also administrative crisis and with this government. INVIMA used to be very effective at evaluating a drug and as I said, once the drug is in the market it has access to it, right, like and everyone can have access to it from one mechanism or the other one. However I would say that nowadays, INVIMA is also in an administrative crisis and they are delaying the time to get regulatory approval by quite a lot. So nowadays, most of the recent new technologies that have been seeking INVIMA's approval have been taking sometimes more than two years or even three years. So that's something that we are working towards amending, hopefully with the next government, but definitely historically, INVIMA had been quite good or comparing to the rest of the Latin America quite good at giving access. Then it depends how much time the drug gets access to the PBS that is the national formulary, but as I said, that in paper it doesn't matter because you either, be you are either in the PBS and get straight access to the formularies or you can have other pathways to have access to that drug. So basically, once the INVIMA has approved there's some type of access to that drug which is important.- And Fernando in Mexico?- Yes, in Mexico in the recent years, the access to the national formulary has improved and is probably, you know, there's a big variation now between between technologies. But I would say, you know, 18 months, two years is common. There are some prioritisation. So sometimes if the system is, you know, waiting for a new drug because it has a clear clinical advantage at maybe a cost that is not too much higher than the previous one, you know, it gets faster access. But I would say that would be typical. I think that the main challenge continues to be getting access to the individual institutions within the public system. And then once you get access to each individual institution, you know, how many patients that were, you know, for which the drug is indicated can actually get access. I think that is the key challenge. It's not, I mean, it's not easy, but it's not really getting international formulary, but getting effective access. So we still see drugs that maybe, you know, were granted access to the formulary, I don't know, maybe four years ago or five years ago, you know, they gain access to one or two institutions, but are not present in some of the others.- Yeah, thank you. And we've talked obviously around pharmaceuticals and drugs, but are there any differences we need to highlight around getting access for medtech and devices or digital health?- I think that that's the competitor product is the main challenge because sometimes that is not easy to identify which is the best competitor that are already included in the health care system. So it is the main challenge, I guess, and there are so many clinical trials as we have in the pharmaceuticals.- Thank you. Eleonora, did you want to come in?- Yeah, same thing. I mean, for instance, I haven't mentioned that we have a formal kind of HTA, which is called CONITEC, actually, that has already reviewed. It has no binding influence on most of the healthcare system. It's only binding for the public system. But within their evaluations, there are some evaluations for medical devices, but there are really a few compared to drugs, because actually, the drugs are what driving healthcare budgets, I mean, like four times what it used to be, like perhaps 10 or 20 years ago. So the country is much more, I mean, worried about new drugs rather than new devices, perhaps. But yeah, it's, as Alessandra said, it's difficult to find a competitor. I mean, so many, many new devices have a place in Argentina already.- Is it similar in Mexico and Colombia?- Yes. Yes, I would say that this financial crisis has touched everyone and I would say that the government is and the EPSs are trying to prioritise what to give to patients and what to really, how to make some type of barriers to not have access to certain new technologies. And that is even greater, I would say, for medical devices, yeah.- Fernando?- Yeah, very similar for Mexico and I see the same case in Argentina. Our HTA body that is not really working works a bit more with medical devices than with pharmaceuticals. So it's one of the pathways that companies can use. And in general, I would say that they are not as the access is, you know, formally the same, but it's slightly simpler for, you know, devices. And also some companies benefit from few regulation in Mexico, so I know some examples of companies that have been able to launch some, you know, the diagnosis tests or software-based products sooner in Mexico than, for example, in global markets, which is not typically the case for pharmaceuticals.- That's an interesting point, thank you. So if we move on, we've talked about some of the feature changes. So besides some of what we've mentioned today, what other changes are happening within LATAM that our audience needs to be aware of? I know there's some more changes happening in Brazil, Alessandra?- Well, in Brazil it's important to mention that the drug pharma chamber, CMed, has recently updated the pricing regulation which will be effective next month. So with that, drug prices categories increased adding the concept of therapeutical gain to encourage innovation. Another important change was also reviewing the international benchmarking list with the addition of some countries such as South Africa, Japan, Germany, UK and Switzerland. So it's important to understand that the right launch sequences to not impact the prices in Brazil. Another thing is that companies must show drug commercialisation in at least four reference countries to obtain the price approval and it may reduce price distortions and align Brazil closer to the global standards. And CMED also established a selling price of 80% of the reference biologic for the price of the biosimilars. These changes will be effective in the next month.- Okay. Mafe, did you want to bring in anything around Colombia?- Yeah, for sure. There's going to be definitely a lot of changes in the health care system. There's a lot of uncertainty because we have presidential elections in May, late in May. So we will have a new president this year and it will depend on what, or who's going to be the next president in order for us to know a little bit how the health care system is going to evolve. We definitely need a reform, however, the current government has tried to reform the healthcare system in a way that has made it even worse. So the formal reform was not approved by Congress, however the government has been implemented administrative reforms throughout these four years which have increased the financial and the administrative crisis in the healthcare system. Now, what we're waiting is to see if the next president is going to be in the same line as the current president and that will, of course, deepen the healthcare crisis. Well, that's my personal belief and some experts in health believe. And then if there is another type of different government, probably we we will have several other reforms, but definitely there is a need for a lot of different things. One is how the funds go to the EPSs or to whoever is going to act as the insurer for the population. Then there's a lot of uncertainty, as well as what is going to be the relationship between the health providers and the health insurance and administratives. And also around pricing and how new technologies are evaluated as well. So there's a lot of, I would say, to summarise, there's a lot of uncertainty, but definitely a need for change.- Yeah, Eleonora?- Well, in the case of Argentina, we have a new president since, I mean, yeah, he took the power two years ago, and as his motto is freedom, there are lots of things that have been freed. In this sense, also, another approach is being held for health in the country. One of the things that have been implement... I mean, not implemented, but yet ruled is the need of a real health technology assessment agency, which already has a name, but has not been implemented yet. And personally, I think that this is a huge opportunity if everybody sits at the table to see, to better structure that agency. We know that many stakeholders are influencing how this type of agency, this type of initiatives are created. So I think it could be there also, of course, associated challenges, but also an opportunity to have for the first time in many years, perhaps, or first time ever, a one health technology assessment agency that can really understand, can really guide many decisions that happen individually in this atomized healthcare system. And well, I think that perhaps our grandchildren will see a better healthcare system if it's driven by decisions, by good decisions in a constraint, in a budget constraint setting as any other Latin American country.- And are there anything to add from the Colombian perspective or is it business as usual?- For the Mexican perspective, it's business as usual. Some, you know, as I'll finish as I started, you know, with 6% of GDP in health care and only half of that being government spending. there's not a lot that can be done. And with a growing population, the economy is not growing, so the GDP is not expanding. So I would say that in general, we will continue to see the budget constraints that we've seen, probably even more acute, but at the same time with some process improvements to make things more agile, that at least is a tone of the current government that will still be in power for the next four years. And, you know, it looks like the party currently in power will be with us for a while. So I think that is, you know, the business as usual. There is an ambition of the government since many years ago of have a unified healthcare system where, or at least the same type of access for anyone in the public system, which today is very different, but realistically without a higher budget, there is no way to achieve that because the expenditure per capita is several times higher in some public systems than in others. So I think that's more ambition, hopefully not for my grandchildren, but before us in Argentina, but it's not something that will happen in the short-term.- Thank you. I wanted to ask what one thing from your perspective and experience do you wish global market access teams included in global dossiers and evidence packages that would make a difference for the Latin region? Fernando, would you like to go first?- So I think in general, you know, well-established companies that have been operating in the market for decades, you know, do it well, but some, you know, maybe smaller or newcomers to the market struggle a bit is, as I said, you know, the guidelines of what is required in the dossiers is very, you know, are well-written and clear, but there are nuances and emphasis and ways the reviewers like to see the data and things that they value more or less that, you know, are not explicit in the guidelines. And so I would say that knowledge is key to achieve access or at least reduce the time for access. And if not, you know, companies tend to try several times until they finally make it. And also we talked about how the need of, the value of having local data, particularly in the, you know, most in cost-effectiveness in the budget impact and the challenges to get that local data. And I think, you know, the more effort is put into making that, using as most local data as possible and make it robust, it's a good investment. And I would finally say not related to the package itself, the submission package itself, but, you know, this early engagement of stakeholders is key and makes a big difference, you know, you may have a strong value package and value proposition, but if the people reviewing the package and their advisors, you know, haven't heard of the new technology, don't have an experience perhaps in clinical trials before in some type of protocols, it makes access more difficult than if you have that early engagement with some of the decision makers or influencers in the decision.- Thank you. Mafe, did you want to add anything?- Yeah, I think it's similarly to fair, but then again, I would also say not for the regulatory dossier, but definitely to be able to have better access in Colombia, you definitely need to think about or at least give information in terms of budget impact. Also make sure that in Colombia, we have price regulations that have international and national referencing. So having understanding of how that works and to set your price and for your price strategy, that's very important. And definitely, if there is trials at least in Latin America with Latin population also helps quite a lot. And plans for local data or real-world evidence afterwards is also very helpful for access not for the regulatory dossier, but definitely access itself.- Thank you. Alessandra, did you have anything to add?- Similar to my colleagues, but from my experience, it's important to prepare in advance. So as Fernando and Mafe mentioned before, this early engagement with payers, medical society and also patient advocacy groups is a critical success factor for the submission, as it's very important to understand the major gaps, the current data availability about the disease to prepare for future submissions. I would say, at least two years ahead of the submission of the dossier it is important this pre-work. And also adding examples from external international agencies of health technology assessment, it's something that the Brazilian government pay attention to. And also, local trials as possible or at least real-world evidence is important to complement the material.- Thank you. Eleonora?- Well, I would add, I mean, on top of what everybody has said, a strong package of information is important. The early engagement is very important as well, but we don't have to forget that we are talking about Latin America, and Latin America relationships are very important as well. So, market access expertise is key, and good, strong relationships with payers, with main payers at least, is fundamental. We are driving by bonds, by relationship with people, so that is a big component of market access in Argentina.- Thank you. So we're coming to the end now, so I just want to say thank you so much for such an interesting discussion today. It's been really great to hear all your perspectives across the different markets within LATAM and I would like to thank the audience as well for listening to our conversation today. We will, of course, follow up with any of the questions that we haven't been able to cover and we're more than happy to help signpost anyone to the right place if you want to continue the conversation. But I'd just like to say thank you again to the great panellists that we've had today, so thank you very much.- [Announcer] Thank you for watching. If you'd like to find out more about how we can support your market access goals, get in touch today. 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