The free trade agreement TTIP opens up pharmaceutical markets between the US and the EU more than ever before. But, does strengthening big pharma have potential repercussions on the medical marijuana industry?
What is TTIP?
There’s something happening under our noses. Right now, it’s difficult to tell whether the outcome will be good or bad. It’s safe to say one thing, though: it’ll definitely shake things up.
This “thing” is the Transatlantic Trade and Investment Partnership, or TTIP. TTIP is a monster of a trade agreement between the United States and the European Union that reduces regulations and trade barriers to a number of industries, including the pharmaceutical industry. Overall, the agreement will make it easier for pharmaceutical and medical technology companies in both regions to trade products and information. This has some serious positives and negatives.
Currently, large-scale drug companies have to jump through hoops in order to get their meds out on the market. Before a new drug is put out, a manufacturer must complete a series of regulatory tests and clinical trials. Once that drug passes, that company needs to re-perform any clinical trials in order to sell it in another country. TTIP seeks to standardize regulations between the US and the EU and eliminate the need to perform duplicate trials.
…Is that really so bad?
Making it easier to trade medical information and get potentially life-saving drugs to patients more quickly is a very good thing. But, one of the major criticisms of TTIP is that the agreement gives more power to large, transnational pharmaceutical companies. There are many reasons behind this, but one of them is intellectual property rights.
When a company puts a new drug out on the market, the standard patent time for a brand-name product is 20 years.According to a report by Commons Network, a European non-governmental organization, TTIP seeks to increase patent length and makes it easier to get a patent. This drives up the cost of medications and limits the availability of generic medicines. Commons Network explains:
The EU Commission’s own 2008 Inquiry into the pharmaceutical sector showed that the balance between providing incentives for innovation and guaranteeing affordability to health products has been lost. In fact, the EU Commission’s Inquiry revealed that companies structurally abuse intellectual property rights limiting generic competition, hurting innovation and costing European health systems billions. The TTIP proposals would aggravate this problematic state of affairs.
TTIP gives large drug developers more control over drug markets. Through TTIP, drug developers can make more money via extended patent times. According to the report, they’re also seeking to limit transparency in clinical trials.
The Commons Network report can only criticize to a point, however. The public currently does not have access to TTIP, and neither do many key government officials. Though pharmaceutical lobbyists have exclusive rights to view the full text of the trade documents, we do not. So, it’s really difficult to tell exactly what’s going on.
Should medical marijuana businesses care?
While no presidential candidate has outrightly agreed to legalize marijuana, it’s safe to say that there’s been some forward momentum when it comes to medical cannabis. Last year, there were hints that the U.S. Food and Drug Administration sent a letter to the DEA with suggestions on how to reschedule marijuana. The Compassionate Access, Research Expansion, and Respect States Act (CARERS) was also introduced last year. Though CARERS is currently stalled in Senate, it sought to downgrade cannabis from a Schedule 1 to a Schedule 2 substance and also remove CBD from being included as marijuana.
We may not be seeing any firm action yet, but these are all positive signs that reform may be just around the corner. However, this reform might look a lot different than we hope due to what’s happening with the pharmaceutical industry.
Reform + TTIP = more cannabis pharmaceuticals
TTIP is an agreement that helps big pharma get bigger. It makes it a lot easier for them to get their products approved for sale, and hang on to those products once they’re out. Coupled with movement on legalization, it could mean an influx of cannabis-based pharmaceuticals may arrive sooner than we thought.
Right now, UK-based GW Pharmaceuticals is the only publically traded pharmaceutical company that makes medications derived from the cannabis plant. We’re not talking synthetics, here. They use the real stuff. They’re currently selling cannabinoid medicines to 27 different countries, and the United States may soon be another one to add to the list.
This fact is a little puzzling because marijuana products are currently federally illegal in the U.S. According to the DEA, the marijuana plant has no medical value. But, somehow, the U.S. Government and FDA have let cannabis-based Sativex go through clinical trials as a treatment for cancer pain. The FDA is also expected to approve another GW Pharma medication, Epidiolex. Epidiolex is a CBD-based drug for pediatric epilepsy.
The trials on the drug were conducted in collaboration with Otsuka Pharmaceuticals, one of the largest pharmaceutical corporations in the world. It’s best known for its drug Abilify, which is used to treat schizophrenia and bipolar disorder. Abilify has earned well over $8 billion in sales since its original market debut.
Apparently marijuana laws don’t apply to mega pharmaceutical companies. But, regardless, the DEA’s red tape on the weed puts marijuana medicines in an awkward position. On one hand, it’s technically illegal for doctors to prescribe medicines derived from the marijuana plant via the DEA’s current scheduling laws. On the other hand, large multinational pharmaceutical corporations are quietly being allowed to test cannabis-based drugs.
Medical marijuana laws and the development of cannabis pharmaceuticals are in an odd sort of limbo. Whether it’s via rescheduling, re-wording, or legalization, something’s got to give somewhere or another. But, when true reform finally hits, it may follow alongside the biggest win for the pharma industry in recent decades: TTIP.
Patents, patents, patents
Regardless of marijuana’s present legal status, GW Pharmaceuticals currently holds over 40 patents on cannabinoids. These cannabinoids are compounds taken directly from the marijuana plant itself, they’re not recreated or molecularly reconstructed in a lab. Some of these patents include:
- The use of CBD and THCV to treat epileptic diseases
- The use of CBD and THCV to manage cholesterol levels
- The use of CBD and THC to treat pain
- The use of CBD, THC, THCV and CBDV to treat various forms of cancer
- The use of CBD, CBDA, CBG, CBGA, THCV, THCVA, CBC, and CBCA to treat psychotic disorders
What’s funny about these patents? Walk over to a local medical dispensary and you can already find strains, tinctures, and capsules that contain these cannabinoids. Another striking fact? GW Pharmaceuticals’ current headline-making drug Sativex sells for what equates to over $550USD per bottle (500 Euro). Sativex is a drug which has a 1:1 ratio of THC to CBD. You can find similar products in medical dispensaries for less than a quarter of that cost.
As mentioned earlier, barriers for drug sales by transnational corporations will significantly lax under TTIP. If we see both down-regulated marijuana and TTIP at the same time, it could mean some bad news for the mom and pop medical cannabis industry.
Murky waters for medical dispensaries
Because of all of their patents, GW Pharmaceuticals is well on its way to becoming the dominant developer of cannabinoid medicines. Since clinical trials and research can take years, it’s very difficult to say just when we’ll have more than one or two cannabis pharmaceuticals on the market. What we do know? Big pharma already has their eye on them.
With trade barriers eased through TTIP and canna-medications already well underway, it’s plausible that we’ll see some big shifts in the medical cannabis world. 23 states have legalized medical marijuana as compared to only 4 states that have legalized for recreational use. If we see an influx of cannabis pharmaceuticals, will medical cannabis shops still be viable sources of alternative medicine? Is there enough public momentum for medical marijuana access to combat the rise of cannabis-based pharmaceutical medicines?
Prescription drug companies are now close to putting out medications that growers like Colorado’s Stanley Brothers have willingly shared with the public. The Stanley Brothers were the masterminds behind Charlotte’s Web, a high CBD cannabis strain that famously helped Charlotte Figi overcome her Dravet’s Syndrome. GW Pharma’s Epidiolex is also a high-CBD cannabis product that targets the exact same condition, only that drug got the FDA’s attention.
The marijuana industry is the fastest growing industry in the United States. A report by ArcView Group estimates that medical cannabis has a compound growth rate of around 30%, with sales increasing to an estimated $6.7 billion this year. The marijuana industry employs an estimated 46 and 60,000 people, and many more depend on medical cannabis support networks and caregivers to manage their illnesses.
Yet, given the choice between the cannabis herb and a pharmaceutical cannabis drug, which is a doctor more likely to prescribe?
Is it worth it for better medicines?
While many in the marijuana industry cringe at the idea of pharmaceutical companies taking over cannabis medicines, there’s no doubt that these medications are still life-saving. Cannabis pharmaceuticals are already in development, and what little has been put on the market so far has been wildly successful.
Sativex, for example, helped New Zealand native Grace Yeats move her arms after being paralyzed by ganglia necrosis. “Even after her first spray,” her mother explains, “she said: ‘I feel happy. I feel good.’”
Drugs like Epidiolex are also standardized in dose, meaning that there is no estimating when it comes to exactly how much CBD an epileptic child will be getting. If TTIP enables companies like GW Pharmaceuticals and its partners to quickly put new cannabis-based drugs onto the market, then thousands of lives can be saved or improved by safe and effective cannabinoid medicines.
At the same time, the big pharma protectionism found in TTIP keeps medication costs high which limits access for many patients in need. There are also possible economic repercussions for medical marijuana growers, dispensaries, and caregivers. Will there be a need for growers that breed new medical strains if you can easily get a cannabis-based pill that’s designed for your condition from your doctor?
Just how exactly TTIP and the advancements of big pharma will impact the medical marijuana industry is unclear. There are several variables that need to align before we can get a true picture on just how cannabis medicines will be addressed in the upcoming years. More than anything, the response of our federal government to both TTIP and marijuana reform is critical. There’s no doubt that the decisions on how much muscle is given to large pharmaceutical companies will shape our future for many years to come.
TTIP enters its next round of negotiations February 22nd in Brussels.
How do you feel about the pending FDA approval of marijuana-based pharmaceuticals? Do you think the medical marijuana industry is at risk? Share your thoughts with us on social media or in the comments section below. We’d love to hear from you!