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.
