Pharmaceutical Patent Policy

[#HBC | Acrostic]

Pharmaceutical Research and Development Departments are being continuously downsized and having their funding cut as they struggle to break even with producing new drugs that are able to pass the stringent multi-phase requirements employed by the FDA before approval. The high-risk type of business often results in failure and stems profit from high-impact results.

Numerous drugs are developed at a time and few are successful enough for pharmaceutical companies to cough up the money required to run FDA trials necessary to prove the drug is safe for patients. Data from DiMasi and Grabowski indicate that the R&D cost for developing an individual drug amounts to roughly $1.2 billion and around 10-15 years for the drug to develop.

In the past 50 years, only 261 organizations have managed to register at least one molecular entity, despite more than 4,300 companies currently involved in the process of drug innovation. Even after the drug is approved, the company that invested in the research & the trial testing has a limited time to exclusively market the drug before generic substitutes can replace it on the market and cut in on its profit.

After patent life expires, generic drug market companies have access to all the research files submitted to the FDA in order for them to engineer their own version of the drug. Generic drug market companies also do not have to run extensive patient trials, as the original drug has already completed such examinations. It takes on average around 1-2 months for the generic pills to hit the market after the patent expires. The main requirement for generic drug companies is to show "bioequivalence": showing that the generic drug has the same effects on patient as the old drug. This allows generic drug companies to cut research costs and allow them to market pills at a cheaper cost than their pricier counterparts.

Should the FDA should extend pharmaceutical patent life and take further action in securing the intellectual property of innovative research? Are there other questions that should be considered?

References
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1. Patents: Source
2. Industry: Source

 

[Bob Jane T-Mart]

Instead of extending patents, which would make prices of drugs higher for longer, there may be another option.

It's expensive for the government. It may not be 100% viable, but it's an option. Okay, if drugs cost lots of money to develop, maybe the government can compensate a certain percentage of the costs of research into new drugs. This would make it easier for companies to do R&D and mean smaller size firms can get a chance to participate in the research and development of new drugs. It'd mean that generic drug companies would still be able to sell drugs cheaply, while the firms that are into inventing drugs would be able to do more research and still make a profit.

Unfortunately, it's probably horrendously expensive and everyone's going to call it communist.

 

[Sucumbio]

We should consider the difference between drug innovation/implementation in the US and other countries. Canada for instance has considerably lower drug prices in general though not all generics are lower there than here. There are several factors involved, but one main factor is Canada's governmental regulation over prices - not a difference in manufacturing costs. The practices of the US Government/FDA basically end up driving the price up. Another factor in high prices are direct-to-consumer marketing, something only practiced in the US and New Zealand currently. This method of advertisement is expensive in itself, but causes consumers to choose pricier drugs oftentimes instead of generic counterparts.

Marketing. Regulation. 2 big "why's" when it comes to the high price of pharmaceuticals.

The solution to the US drug price conundrum would be to adopt a similar policy to Canada. The difficulty is that the FDA touts themselves as being the only real authority on what's safe for human consumption. They even advertise against web-based drug companies shipping from Canada. "You can do it, but you may be getting out-of date drugs, drugs that are too strong/weak, etc." If any real reform were to take place, it'd have to start with a total revamping of the FDA, its function, and its power.

 

[Sieguest]

Instead of extending patents, which would make prices of drugs higher for longer, there may be another option.

It's expensive for the government. It may not be 100% viable, but it's an option. Okay, if drugs cost lots of money to develop, maybe the government can compensate a certain percentage of the costs of research into new drugs. This would make it easier for companies to do R&D and mean smaller size firms can get a chance to participate in the research and development of new drugs. It'd mean that generic drug companies would still be able to sell drugs cheaply, while the firms that are into inventing drugs would be able to do more research and still make a profit.

Unfortunately, it's probably horrendously expensive and everyone's going to call it communist.

I wouldn't call it communist. While it would place the U.S. further away from the market side with its mixed economy, I would think of it more as a safety net to encourage companies to engage in this development. However, I don't believe the government has the funding to allocate to this though.

We should consider the difference between drug innovation/implementation in the US and other countries. Canada for instance has considerably lower drug prices in general though not all generics are lower there than here. There are several factors involved, but one main factor is Canada's governmental regulation over prices - not a difference in manufacturing costs. The practices of the US Government/FDA basically end up driving the price up. Another factor in high prices are direct-to-consumer marketing, something only practiced in the US and New Zealand currently. This method of advertisement is expensive in itself, but causes consumers to choose pricier drugs oftentimes instead of generic counterparts.

Marketing. Regulation. 2 big "why's" when it comes to the high price of pharmaceuticals.

The solution to the US drug price conundrum would be to adopt a similar policy to Canada. The difficulty is that the FDA touts themselves as being the only real authority on what's safe for human consumption. They even advertise against web-based drug companies shipping from Canada. "You can do it, but you may be getting out-of date drugs, drugs that are too strong/weak, etc." If any real reform were to take place, it'd have to start with a total revamping of the FDA, its function, and its power.

This may be true, however government regulation of prices would be even more of a step away from the market side of the U.S.'s mixed economy than Bob's would, it would also bring into question whether doing such things would extend outside of the pharmaceutical market.

I like both you guys of these ideas to a point. The only other problem I see is, that while this may cut down on prices the firms engaging in research may have to pay. There's still the issue with makers of generic pills taking the work that these other firms have done and making money off of them without near as much spending as the companies that engaged in the research have. These firms that go through the time to research and develop these drugs are still being undercut by "moocher" firms.

Because of this, I would also still go for extending patent life, so as to allow the these companies that have engaged in resource a chance to reap profits for their work.

 

[Sucumbio]

heh I'll admit I pretty much ignored that part of the problem, lol... I can't help but feel no sympathy when it comes to that aspect, because I for one always wait for a generic, mainly because paying "name price" is just absurd. for instance after just recently visiting the ER, and had prescribed 3 medicines, all of which had a generic version. having no medical insurance means that I still only had to pay 4 bucks per script at the local wal-mart. had they not been generic I could have been looking at hundreds of dollars, and considering the ER visit itself is going to be hundreds of dollars anyway, that wouldn't have been good (plus you can't get on a payment plan for the meds, like you can w/the visit).

Technically I've been prescribed and supposed to be taking a statin (lipitor), a triglyceride medicine (trilipix), fish oil (lovaza), and a BP med (diovan). now when I had insurance these things all still cost about 150 bucks a month! without? dude, it's sick. I'd rather just not take them and deal with my health issues the old fashioned way, through diet and exercise. (of course if I'd done that all along I wouldn't need these things now at only my mid 30's considering these things are normally meant for senior citizens).

Now add in I ALSO am prescribed Lexapro and Trazadone, both for clinical depression.

Those I do take, regularly, it'd been hell without them. I use my mother in law's script for the Traz cause she's got health coverage so it's only 3 bucks, and the lexapro I filled right before losing coverage and we'll have coverage again in November and I have enough to last until then.

'bout the only one of all those that can be got cheaply is fish oil, lovaza is fancy I even see commercials for it now, lol. but then again that's part of the problem. commercials are expensive to make, run, etc. the big pharma spend billions making the drugs, and billions more selling them, no wonder they cost an arm and a leg.

anyway, I wouldn't recommend extending patent life. instead I'd recommend new medicines be cheaper on the consumer in the first place, so that there's not necessarily such a push for the generic version. I'd also recommend that advertising costs be reduced by limiting access to public outlets. we don't need to see that on TV. the commercials. I hate them all, viagra especially, lol and they all end with "don't take this" basically because of the long *** list of side effects. "taking this may cause you to die horribly." great! yeah no Doctors should remain the go-to people for learning about new medicines.

Also Doctors should NOT get kickbacks from big pharma for "pushing" the latest meds. That's how I got prescribed prozac and it did a number on me. No clocks, calenders, notepads, free samples. None of that.

/rant :V

 

[gm jack]

The trouble here is balancing the cost to the consumer with the need for R&D. Keeping patents for longer is only going to mean that drugs that can save lives are being kept away from people who need them by price, or drain the budgets of countries with nationalised healthcare. From that perspective, the lower the patent length and the sooner generics can be produced, the better for consumers.

However, we do live in a world where profit rules, so the patents have to be long enough to cover the costs of developing the drugs and the costs of all the ones which failed to be suitable. As shown above, there are a lot of people trying to develop drugs, but very few are successful.

It really is a fine balance at the moment. However, as the big pharmaceutical companies seem to be turning over pretty big profits year on year, I couldn't see an argument for raising the length of patents, and a slight one for lowering the length of patents to force more successes to remain profitable. However, that could lead to a bad spell being more disastrous for a potentially useful developer if they have a few years without any new drugs that are marketable.

 

[Sucumbio]

Actually I can think of one pharmaceutical company that stuck that balance... AstraZeneca. Basically they thwarted generics by switching Prilosec to Nexium. This was a carefully planned moved that took them years to figure out, as they had been dreading the very issue we've outlined here. But it paid off for them. Nexium is one-half of the Prilosec molecule -- an isomer of it. It also has a special coating added to improve absorption in the small intestine. By making these tweaks they basically released the same drug and even spent tons of money and time "converting" their users. Me, I didn't switch. I was part of the original batch of patients to take Prilosec. I used to regurgitate "clumps" of nasty smelling matter from my stomach while belching, it was gross, lol I got one to come up in my doctor's office and he said "good grief how long has that been going on?" I explained it'd been happening for about 3 years or so, along with massive heart burn at night, as if my heart were about to stop, intense pain, welling from my chest, and exploding through my whole chest cavity. "Prilosec!" Now here I am in this thread touting "doctor's shouldn't push new meds" but in this case, it saved me, I've been on it literally since 95, and when they went OTC generic, I resisted and requested the prescription, and got Nexium, paid a buttload more for it, and hated it, because it wasn't exactly the same... probably psychological, but at any rate, the OTC works just fine.

TL:DR the balance of which you speak is rare but it happens, it is possible, and it's the kind of thing we should definitely hope for, because it keeps consumers happy, vendors happy, and R+D profitable.

 

[El Nino]

One thing to consider on this subject would be: how much innovation can we expect to come from the generic drug companies themselves? With the profits they make off the generic market, we can expect them to start up their own brand R&D divisions. So I wouldn't just assume that generic companies want to stay generic forever, or that they don't have the ambition to pursue their own innovations.

Also of note, the forced sharing of information caused by the limitations of patents is not unlike the sharing of information in the traditional scientific community. Academics are competitive to see who can publish first, but the point of publication is to make information available to everyone. With this sharing of information, other hands and other minds can take an idea and move it in a new direction. This is one of the things that make innovation possible. If someone had a monopoly on scientific information, it would probably work against innovation rather than for it.

Lastly, before any of the researchers working for these companies ever got their PhDs, they went to school like everyone else. And the information that they received while in school is information that was made available to them by academics, by other scientists who published their research openly. So none of these biotech companies would be where they are today without the contribution of others made in the spirit of free information exchange.

Conceptually, that makes it hard to argue in favor of limitless intellectual property rights in the field of scientific research and technology. How long patents should last, however, is kind of a guessing game. Too little and you lose the incentive for these companies to make these products, and the commerical sector often is more efficient than the public sector. But give them too much in terms of intellectual property rights and you will stifle both progress and innovation by promoting monopolies.

 

[gm jack]

Sucumbio, I don't think your doctor was so much pushing a med as knowing what was availible and picking the best for you, especially as the budget option was doing you no good at all. I would hope any doctor would have made that choice, if they were being paid to advertise certain meds or not.

 

[spookyskeptic]

"Evergreening" is the process to which Suco refers. The manufacturer only does something as simple as changing the buffer (Prilosec/Nexium) or finding a new application for it (Lexapro). The real solution is to do two things, increase the patent period and have the FDA less resistant to evergreening, but also cap the prices of drugs. It'd be simple to say that just give a percentage cap, but you could offer incentives for companies giving better prices on life saving medicines. Say a company has a great new cancer drug, but they also have a super-popular cosmetic drug. If they sell that cancer drug at or near cost, then the cap won't be enforced on the cosmetic drug.

 

[gm jack]

Who would decide the boundaries for this "favours" system though? What happen a company specialised in cancer drugs and wanted to sell one cheaply and one at a higher price for doing so?

 

[#HBC | Acrostic]

"Evergreening" is the process to which Suco refers. The manufacturer only does something as simple as changing the buffer (Prilosec/Nexium) or finding a new application for it (Lexapro).

Revising response.