The harmonisation of different regulatory environments in the EU member states will help generic drugs enter the market, resulting in reduced prices for medicine and better patient access, Jacek Glinka told euractiv.com in an interview.
Jacek Glinka is the president of the Medicines for Europe, which represents the European generic, biosimilar and valued added pharmaceutical industries.
He spoke with euractiv.com’s Sarantis Michalopoulos and Hannah Black.
The discussion about the affordability and accessibility of medicines has taken centre stage in the EU and its member states. What is your approach?
I think the most important thing that many times politicians and the ministers of health don’t see properly is that the most effective way to create access to medicines is to let generic products enter the market and build their uptake. So as much as can be done to effectively manage the effective commercial launch of such products in the market, this is the best way to create access, because what happens, the original product is protected by patent. It’s very difficult to do something about the pricing of this product when it is patent-protected and it has like a natural market monopoly.
At the same time, it’s good to have a good price for this innovation because it encourages the industry to work on the innovation. But then the moment the product goes off patent, the government should do everything possible to make sure the product can be commercialised by the generic industry by as many players as possible in as many industries as possible.
This is what brings access and substantially improves the cost-benefit ratio. Because normally, when the generics are coming, not when the product is under patent, the pricing is going down — by market regulation, not (because) somebody negotiates the pricing. You encourage the competition.
If the generic players are coming, the prices are reduced dramatically and the access to the patients is created. Medicines for Europe is representing the generics industry, which is bringing 100 billion in savings through access to affordable quality medicine.
The public budget would have to spend €100 billion more in Europe if we would not offer the access to our products, according to IMS. So I’m saying that the more we create a positive environment to remove all the barriers from the effective launch of generic products one second after the off patent date, and the more incentives we are providing in the industry to build the market share of such products… the better access to medicines the government is providing.
But isn’t there a specific procedure that needs to be followed in order to offer the highest level of protection and safety for the patients?
Yeah, but the safety and protection are there. There was never a report (about) lack of parity between the branded and the generic products because by regulations they have to offer the same quality and they have to offer the same efficacy (as) the original product.
And why do we have these delays on the international level?
Because of the activities of the original companies — they are trying to protect these monopolies for as long as possible — and because of the inefficiency of the regulations. So, in many markets, there are still different mechanisms that are delaying the effective entry of generics.
Price-reimbursement approvals. You have (the patent) going off, you have the market authorisation, but then you need to wait 3, 6, 8, 12 months for the local agencies to give you the price-reimbursement approval decision, which is effectively delaying the launch. Why [can’t they] work ahead of time and approve these price-reimbursement approval decisions on the day one after patent expire?
In certain markets like Italy, we see we have patent linkage. So, there is a linkage between market entry and approval to commercialise the product and the patent situation, which is not the case in any other country in Europe because these countries have already recognised that these are two different discussions.
And there are many other instruments in many other countries which are effectively delaying the launch of generic products on average from three to even sometimes 18 months that are elapsing between the off patent date and the effective launch of generics.
And then, governments do not always support the industry properly and they are not creating a proper differentiation of the generic product by price to the patient or to the system, or incentives to the physicians or pharmacists or wholesalers, whoever is the key stakeholder to promote such products.
It should be in the interest of the government to make sure that, on day one, generics are capturing 100% of market share because this is creating access and this is creating the savings. So, for many reasons, the governments are not really doing a great job. It is not an efficient environment where generics are taking off.
How do you view the possibility of joint negotiations among a group of countries with similar medicine needs and the pharmaceuticals?
I think that really is an issue of the originator industry. We represent the generic medicines. For us, the question of whether they want to make this joint public procurement or not is that relevant. I think what is important to the system is at what price point they are effectively selling the product. And then if they think that there is a way to achieve a better outcome by joining the forces and making like government purchasing groups. This is possible if countries align their procurement rules.
I think what we are advocating for, which is true for the generic product and for the branded product the same way because it is the same product, is the harmonisation of regulatory environments, which is extremely critical to achieving any progress of this dimension. Even for generic products there are many situations where there is a shortage of the product in one country and there is an overstock in another country, but this product cannot be sold in the other country because the pack size is not the same, the language on the pack is not correct or other such regulations which are somehow prohibiting the movement of the products in the market. This is a really big problem for smaller countries especially.
It is the same tablet from the same producer but cannot be sold in other markets. We are advocating for the full harmonisation of these requirements — the pack sizes, the e-leaflets, the packaging are harmonised as much as possible [in the EU] so these national requirements are not killing the opportunities to reallocate the products between the markets and address the shortages issue.
And this is where you can achieve more by such negotiations, because if the product is not the same as the other countries from a regulatory standpoint, how can you make a joint procurement?
As an example, we’ve been asking for the last five years for a technical proposal for electronic leaflets. So you know when you get your medicine you get a little leaflet that tells you the side effects and how to use the medicine, etc.? So we’ve been asking for this for at least five years from a technical point of you.
We’ve said how you can do it technically and legally, and we have the support of others. And why would this be important? Because the package, regardless of where you get it, either the pharmacist prints (the leaflet) or you download it on your phone, you get the leaflet in your own language, right? And this has not moved one centimeter for five years. Of course, we are looking at lower-cost medicines.
But if you think countries want to cooperate with each other, you’d think we could solve this kind of thing. We respect that, in Greece, people want the leaflet in Greek. In Italy, they want it in Italian. In France, they want it in French. Totally understand that. But we could do this so much more quickly with an electronic leaflet than having to change each paper, put a new one in, cut down another rainforest, make leaflets out of it.
And harmonisation and standardisation of the requirements for the same products, so that they have the pack, the same number of tablets per pack, the same number of blisters per pack, the same requirement regarding how the blister and the final secondary packaging should look. All so that you can really use these kinds of techniques like joint procurement or reallocation in case of shortages, which is also from time to time creating issues for the healthcare industry in Europe.
What’s the current state of play of generics in Europe and how could they contribute in the long-term to sustainability in the healthcare market?
It’s good, but it could be so much better, because right now generic medicines are responsible for 56% of the total volume in Europe, but not value. But there are already countries in Europe, not to mention countries like the US, where this generic penetration efficiency is at the level of 80 or 90%.
So there is still a lot we want to achieve. Clearly, there is a lot of room for improvement here. This is why I was saying we have the tool to improve the performance of the healthcare system. Generics and biosimilars are the solutions. But we just (don’t) use it. There is still a lot that can be done to make sure that this efficiency is moved to 70, 80, 90, preferably 100%. There is no reason why we should protect the brands if there are generic products available.
And what’s the potential of biosimilar medicines?
It’s huge. In essence, biosimilars are the same, like generic products for the small molecules market. These are the products that are essentially bringing the same patient outcome, as the original product, because by essence no biologic can ever (even batch to batch) exactly the same. They can bring exactly the same outcome because the regulatory pathway is there to make sure that for the patients this principle is secured.
Are they affordable?
Generic is, by definition, always cheaper than the original, because there are small clinical studies required. The same biosimilar is always cheaper than the original biological product but, on average, the cost to manufacture and develop biosimilars is much higher than the small molecules. But the system works the same way, in the sense that the regulatory pathway is tailored to the scientific requirements of bioequivalence for generics or high similarity for biosimilar medicines. It’s just that the biosimilar pathway requires very large scale (and expensive) analytical studies and comparative clinical trials.
So, when I am saying that we have to create an efficient environment for generic products to enter the market on day one and create 100% market share opportunity for them, the same works for biosimilars. We have to create an efficient environment where, if biosimilars are coming, they are being approved to the market effectively, which means all the pricing, reimbursement decisions, and whatnot, and that there is enough incentives and education for patients, for pharmacists, for physicians, to create enough uptake for these products.
Back in the old days, generics were treated as something that is suspicious. Right now we all know that generics are good, there are no quality issues — the same strategy big pharma is trying to play right now for biosimilars, trying to protect the market and create suspicion, trying to create doubts between different stakeholders, just to delay the process of building the market share for the biosimilars. But we already have enough accumulated experience from the generics industry that we can simply apply for the biosimilars to make sure that these products are having efficient market conditions and to enter day one and to build market share as quickly as possible, because again, this is a solution for the huge, exploding budgets because of biologicals: to bring as quickly and as many biosimilar products as possible to the market and support them in a way that there is no doubt on the side of the pharmacists, patients, and physicians that these products are good.
What are your projections regarding biosimilars’ presence in the EU?
I think what you have to understand is on-patent biological drugs are the most expensive drugs on the drug list. So, in the top 10 of most expensive drugs — about 30 to 40% of spending is just the top 10 drugs — seven of them are biologics. And all of those seven are targeted by a biosimilar competitor. So even though there are fewer biosimilars, or there will be fewer biosimilars, there are over 1,000 generics. But there will probably be 25, 30 biosimilars within the next 10 years only, but the impact on the budget will be huge, because of the fact that these biological, on-patent drugs are such a huge cost to the system. So the estimate is around 30 to 40 billion euros in savings for Europe, for, like I said, about 25 drugs, whereas with generics it’s about 100 being out of 1,000. So you can see that the high cost of the on-patent drug, that this has a big impact.
So we want governments to like they are right now thinking about having an exchange of information and joint efforts to procure the branded product, the new original when it goes to the market. The same way, or even more, we want them to collaborate to make sure that they exchange the know-how and experience to make sure that they can launch effectively generics and biosimilars to the market, on day one with proper support so that they are building the market share as quickly as possible.
So what is the main obstacle you are facing?
Oh, there are many. First of all is the lack of proper understanding and education of the stakeholder. So, of course, there is a willingness from our side as the industry to share with the stakeholders that these products are safe and effective.
Who are the stakeholders?
Patients and physicians. Mostly the doctors and the patients. They are fed with the information from the original players that the biosimilars are not good, that the quality is not good, that the clinical studies are not sufficient… like they did with the generics in the old times.
This is all not true. All the official statements of the European Medicines Agency, and all authorities that the biosimilar products are good. But still, there is reluctance and a lack of trust at the level of patients and physicians for these products. So this is something where there is a lot of support required from the government because the industry doesn’t have that much power to create awareness, but the government and authorities, they have that power. They can institutionalise this knowledge. Sometimes forcefully, sometimes by education. So this is one area.
The second, again, the pricing reimbursement, patent-linkage decisions are there for the biosimilars even more than they are for the small molecules, so therefore the effective entrance to the market is substantially delayed or sometimes made impossible. There is lack of incentives on the market level to promote the uptake of biosimilars, it’s just—we are left alone. You have to figure this out.
Wherever there is a market like in Norway where the government started to proactively support the uptake of biosimilars, they could make 60%, 70%… even more market share in a relatively short period of time. Whenever that was not given, like in Canada, the same product would have like 1% market share development in a month’s time.
So this is the difference that the government can create for such products and should create if they really want to take advantage of (the) huge savings and increased patients access that can be created by the biosimilar products.
Could you name some examples on a national level?
In Germany, there are two examples of biosimilars that might be helpful. So, many biosimilars are products sold in a hospital. So when you have a biosimilar and a reference competing against each other, you usually have a tender system. When most countries, what they do is they have an annual tenure every year but if the patent expires then in March of this year, you have to wait until January of 2018 to have biosimilar competition, instead of reopening the tender, saying now we have a competitor, we’re going to put you, original product, in competition with the biosimilar and we see where the price goes. And then, of course, depending on the competition, how it goes.
So that’s one example. Another example is that, you know, when you introduce a what’s called a “biosimilar switch” , so when you switch the patient from using the reference product which you’ve used, let’s say, for the last 10 years, to the biosimilar, you need to inform the patients. And one of the things we have said is that hospitals or payers need to fund that important information work, because the doctors do not have enough time, they are too busy, etc. So in some countries, like the UK, payers and hospitals hired a nurse with the savings from the biosimilar to do all of this work, informing everybody, getting everyone’s opinion, and that has worked very successfully too, I think. So taking a little bit of the savings, reinvesting it so that everyone is happy, you reassure people, you explain, you tell them what a biosimilar is and the respective advantages.
There are many tools. In some countries, there is a forced switch, so they say, you have to use the biosimilar version like in Poland. In some countries there is an incentivized substitution, so they say you have to achieve certain minimum target of switch from the reference product. There are many, many things. I think the governments, they just need to sit down and review them and apply whatever works best in their country, but there is already like tons of different instruments that can help to build the proper access for the biosimilar products, like they do from time to time, not still fully effectively, for the generic products.