Patients' perception on generics

Generics and biosimilars: view of the patient

• The saving policies of National Health Systems

I wanted to start by the saving policies of National health systems because they are your main payor. I would like to stress the word payor, because patients are still the actual consumers of medicines and your final clients.

Crisis is the new trending topic of our governments to justify the trimming of expenditures in all aspects. As we know, at least in Spain, some of the regional governments take over two years to pay for the most expensive drugs that are given at the public hospitals. We have also seen during 2011 the entry into force of a Royal Decree that forces physicians to prescribe the active ingredient, instead of making prescriptions with mention of the brand.

It is quite impressive to observe as patients that the pharma industry is still divided in spite of the difficulties that the sector has to face. There is no doubt that the generics industry is the one experiencing the biggest growth in the short term but it would be short sighted to believe that the authorities will not try and press harder. We already have the example in Andalusia, Southern Spain.

The Andalusian Parliament has recently voted that the companies have to present their products in tender where the one with the lowest prices will get the market. In this way, the authorities respond to the questions raised by pharmacists and healthcare personnel who complained that the prescription by active ingredient provokes that patients receive the drug with a different name and presentation each time, which is a problem specially for the elderly who do not recognize anymore what medicines they are taking. Secondly, the authorities make further cuts in the budget because they will get at a discount what was already cheap.

We fear as patients that the race to get the market is clouding the views of the industry as a whole. We don’t see producers of generics and the big pharma brands sitting down to talk about the loss of income as a common problem and think about a common strategy to try and save part of the gains in the medicines market affected by reimbursement policies.

What we see is retaliation by individual companies. A very big company withdrew from the Greek market, another important one dismissed employees and reduced production in Spain so that they would not only reduce their own expenditures but cause financial loss to the Government because over two hundred workers stopped paying taxes and started receiving the payment for unemployment, also the production decrease means a decrease in taxes that feed the expending capacity of the country.

Many of us do not understand how our political leaders and those behind them believe that reducing the money circulating in the market will actually increase the production of wealth. But we keep praying that those brilliant minds that brought our economy to the present crisis will not suffocate the hen of the golden eggs (I mean the average citizen) to death.

I understand that the large picture would be a whole new and never ending subject. I just want to mention that the financial annihilation of the tax payer, who shapes the mass of the consumers, and is the one that supports the real economy, is not the best policy for the Governments or the private companies even if we are not relevant for the financial markets that rule the world.

Having made the political statement of the day, I continue with my presentation and return to saving policies of our governments.

Within the scheme of cost reduction of the public healthcare, there is the belief that patients are stupid. Therefore politicians are convinced that instead of increasing the efficiency of the public health services they will solve the problem forcing the citizens to shift to private health providers. This means that there is no reimbursement of medicines and there are several outputs of this policy:

-         Some patients will favor the medicines from the big pharma companies.

-         Most patients will reduce the length of the treatment or will avoid going to the doctor altogether in order to save money, which will have terrible consequences for their own health and will decrease the volume of overall medicine consumption.

Summarizing: the saving policies that seem to benefit the generics industry will harm the generics manufacturers as much as the big companies in the medium and long term.

• The patient as a customer not only as a consumer

Of course there will still be a market for medicines. But it is also time to think of the patient as customers not only as consumers. I suppose that all of you are familiar with the terms e-patient and patient empowerment. Some companies make advertisements about their products because they know that the patient has a choice when it comes to treat some of their problems such as the flu symptoms, articular or joint pain, erectile dysfunction, etc. The big companies also promote their products in medical Congresses and inviting the patients’ associations to their headquarters or manufacture plants.

There is no need to spend millions to promote the knowledge about your product especially when it comes to medicines that treat very specific diseases not as widespread as the flu. We, patients, have more and more access to internet and social networks. We join patients’ organizations, visit their forums or send e-mails to ask questions about medical treatments. Patients have more and more responsibility over the progress of their disease and make more decisions about what treatments they want to take.

The time when patients took their doctor advice and prescription without any question or input on their part is bound to pass. E-patients are growing in numbers and the social network is full of groups to give advice and support.

We have very strict ethical rules when it comes to giving advice or moderating a forum. NEVER GIVE A DIAGNOSE, NEVER PRESCRIBE. But it does not mean that we cannot give our opinion based on experience about safety and efficacy of drugs.

We also have a say when it comes to the survival of our National Health Systems. We understand that a good management of the expenditures contributes to the survival of benefits we obtain from the State when we deal with healthcare and reimbursement.

On the other hand, we also make decisions when we have to buy medicines that are not reimbursed. We take into account the cost, the side effects, the efficacy and most certainly we base our choice on how well we know and how good is the reputation of the manufacturer.

• Perception of the generics. How does the patient perceive the generics manufacturers?

We are no different than doctors and health personnel in general when we judge the origin of the drugs we will put into our bodies. The reputation of the authorities of the countries where the medicines are manufactured counts heavily when we evaluate the drug itself. The lack of adequate pharmacological control, the corruption of customs officials and such factors in countries that are known to export a great number of generics make the customer think twice before they buy a medicine that is not backed by big names of the pharmaceutical world.

http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html http://www.peoplespharmacy.com/2007/06/26/generic-drugs-f/

The above mentioned elements are the most relevant in the short term and the decision made when we are at a drugstore counter. But patients’ organizations have a larger view and we evaluate as much as the companies the return we get as patients when we make our choices.

The main objectives for patients are to get a cure or to have better quality of life. The way we see the generics manufacturers is that their investment in both objectives is reduced to the minimum or nonexistent. The main return we get as patients from the generics industry is that their lower prices are an incentive for the bigger companies to do research in the pursuit of new innovative products that do comply with our own medium and long term interests.

No doubt we see the advantage of lower prices as well, mainly when there is no reimbursement for the medicines we buy from our own family budget. However, it is not only research and new medicines what we need.

Research on the etiology of the diseases is strongly supported by the pharmaceutical industry. Their findings are key elements for the development of new molecules for new therapeutic targets. Scientific Congresses and support for the patients through projects and programmes implemented by patients’ organizations are also returns we get from the financial gains of pharmaceutical companies.

We seldom see the logo of generics manufacturers as sponsors in those activities that are as important for the patients as the drugs themselves.

In our association, we have never received a request from a generics manufacturer to conduct a study on quality of life, to publish a guide for patients or to donate some money we use to help finance a scientific research and shoulder our own running costs.

Whereas the big pharmaceutical companies charge heavily for their products but they also share part of their profit for our dissemination campaigns and many other activities which show real interest for the patient on their part.

Of course, some of you will be saying that there is no comparison between the gains of a big pharma company and one that produces generics. We see the rotation of your stock and we know what it means. We don’t expect you to invest in patients’ wellbeing as much as the big companies, but we would expect you to look more towards the patients. Maybe you should start thinking of social responsibility as an investment not as expenditure.

We, patients, grow increasingly worried because we are also aware that the growth of the generics in the medicines market is not only pushing the big pharma companies to do better. They are also reducing investments to keep their profits. The number of molecules that are candidate for development is reduced, the financial support for programmes and projects for patients is also trimmed down. However we don’t see compensation for that loss coming from the generics industry.

Furthermore, we see alliances between branded companies and generics manufacturers and we wonder, are branded companies slowly giving up on research to move to the greener pastures of the generics market?

• Backyard made generics a threat for the generics industry

There is also something that you might discover today. We patients look at the generics industry and we think that you don’t want to bother investing in research of a new drug because it is easier and cheaper to wait until the patent of an existing one is expired. We don’t see anything wrong with it because your products still go through a process of authorization and quality control. Besides it is not only your right to make that choice, it should also result in advantages for the patients because those who invest in new products must think harder to come with a better drug and to embark in anything that will give them an edge in the market based on quality, efficacy and proximity to the clients’ needs.

But it seems that there are some who think that they can do better than you in terms of cost savings and they don’t bother to work on a final product. They just put the molecule on the market and we see medicines at public hospitals that do not comply with the due processes of quality control and marketing authorization.

Patients receive capsules with just the name of the active ingredient on the label, there is a leaflet (if ever) that goes with the bottle but it does not say anything about the dosage each capsule contains or what other ingredients are used to manufacture it. The pharmacies of those hospitals go shopping for components and then apply the Ikea concept of lower prices if you do it yourself, believing that because they have their own pharmacists and they are part of the National Health Services they can just ignore the rules and regulations that apply to the generics manufacturers from production to the final consumer.

Those manufacturers of raw materials feel that they have no responsibility on the final product and have started to sell their stock not only to you but to a wider market.

And where is the limit? If a hospital can buy sildenafil and use it to treat pulmonary hypertension, what will prevent the pharmacist in my neighborhood to buy the molecule and prepare their own product for the treatment of erectile dysfunction?

The generics companies that sell their sildenafil products for erectile dysfunction in big quantities to the hospitals, and choose to close their eyes although they know it is being used for pulmonary hypertension, might find themselves seeing the proliferation of what I call backyard generics manufactured by the pharmacists in their own labs. You might witness the birth of a whole new small industry that will eat away your profits because what is good for sildenafil is good for many other molecules.

This quid pro quo scenario is not funny for you and most certainly is not safe for the patients. What happens today with sildenafil might happen tomorrow with any of your products.

If you think that the lack of capacity or will from our governments to put an end to what’s going on at our public hospitals is not your problem and you don’t support patients’ organizations efforts, you might find out that patients’ organizations won’t support your claims when it comes to clearing your name when the existence of fake and illegal drugs affects your reputation. Consumers put all generics manufacturers in the same package regardless whether you comply or not with the legislation. The general public does not make differences between legal generics and fake drugs, they just see “generics” as a threat for their health. You might want to make an effort to support the patients’ educational programmes.

The small pharmacies are losing income by the day with the saving policies of our governments I mentioned at the beginning of my presentation. They are looking for new business opportunities. It is only a matter of time before they shift from distributors to manufacturers if the pharmaceutical industry focuses on the actual crisis by sectors (big pharmaceuticals, generics manufacturers, neighborhood pharmacies).

I insist on my advice. The business paradise of the crisis for some generics manufacturers has a few snakes waiting to strike and some of them are already feasting. Either you consider that the pharmaceutical world is not made of watertight compartments and start worrying about each other in some aspects or you are bound to face serious problems whose real victims are the consumers.