Three’s a crowd? Three-Parent Babies and the Future of Assisted Reproduction in Canada

Posted By Liam Harris

Earlier this year, a team of doctors successfully carried out a new fertility technique that resulted in the birth of a child containing the genetic information of three people: the mother, the father, and a female donor. The technique allowed the intended parents to have a healthy baby after all of their previous children had died of Leigh syndrome, a debilitating neurological disease.

However, the mitochondrial replacement technique (MRT) remains highly controversial, both medically, due to unknown side-effects, and ethically, because the donor’s genetic information will be passed on to future generations. In fact, American doctors performed this procedure in Mexico to bypass an American ban. MRT is illegal in Canada under the Assisted Human Reproduction Act (AHRA), but other jurisdictions such as the UK have legalized the technique.

What are the risks and benefits of MRT? And what can these developments tell us about our reproductive legal regime in Canada?

The Science

The vast majority of human genetic information is carried in the cell’s nucleus. However, there is also DNA contained in sub-cellular structures called mitochondria. Unlike nuclear DNA (nDNA), mitochondrial DNA (mtDNA) is inherited exclusively from the mother. While mtDNA accounts for a very small portion of the genome (about 1%), mutations in these genes can cause serious disease due to the mitochondria’s critical role in cellular energy generation and signalling.

Leigh syndrome is one of these diseases. Patients with Leigh syndrome experience a progressive loss of movement and neurological function. This decline often begins in early childhood, resulting from the inability of their neurons to metabolize energy effectively. These patients will rarely live more than a few years.

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This new procedure allows prospective parents to conceive a child from their own genetic materials without the risks carried by faulty mitochondrial DNA. || (Source: CBC News)

MRT aims to prevent Leigh syndrome in the children of mothers carrying mutant mtDNA genes. The mother’s egg is harvested and the nucleus, which contains the vast majority of genetic information she would pass to her child, is removed. The rest of the egg, including the disease-causing mitochondria, is discarded. The nucleus from the mother is then inserted into a donor’s egg. This hybrid egg, containing the mother’s nDNA and the donor’s mtDNA, is then fertilized by the father’s sperm, resulting in an embryo that is implanted in the mother through in-vitro fertilization (IVF). The result is a child whose nDNA comes from both parents, but with a mitochondrial genome inherited from a third party. This genetic material will, in turn, be passed on to future generations if that child is female and has biological children of her own.

The Risks

Opposition to MRT is based on two main arguments, one medical and one ethical. First, because the technique is new, its side effects are heretofore unknown. Some suggest that it could result in higher rates of cancer or early aging. While experts have no evidence showing the technique to be unsafe, uncertainty persists.

The result is a child whose nDNA comes from both parents, but with a mitochondrial genome inherited from a third party. This genetic material will, in turn, be passed on to future generations if that child is female and has biological children of her own.

Second, critics decry the alteration of the genome in a way that can affect future generations. Slippery slope arguments suggest that this is the first step down a road to “designer babies”, where parents modify the genome of their offspring to meet their every whim. In the case of MRT, it is important to remember that mtDNA accounts for only a tiny portion of the genome and that these genes control basic cellular functioning rather than the types of defining traits often pictured in the case of designer babies. This concern may therefore prove less relevant to this particular genetic change. However, caution is warranted whenever a heritable alteration occurs, because this permanently changes the composition of the gene pool, recognized as the common heritage of humanity.

The Law

The replacement of the egg’s mtDNA with that of the donor alters the genome in a way that is potentially inheritable, placing the technique within the ambit of prohibited practices in Canada. Section 5(1)(f) of the AHRA states that “[n]o person shall knowingly alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants”. Doctors carrying out the procedure in Canada could face harsh penalties: up to $500,000 and a ten-year prison term.

The outright criminalization of heritable genetic alterations seems less and less tenable as new techniques are developed that offer significant medical benefits and manageable risks. In addition to MRT, recent advances in human gene editing have fuelled hopes that inheritable genetic diseases could be eradicated forever, but these procedures would be prohibited under the AHRA for inducing inheritable genetic alterations.

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Doctors combine the mother’s nucleus, the donor’s egg, and the father’s sperm to produce a viable embryo for the mother to carry to term. || (Source: Science News)

Meanwhile, the promise of these techniques has begun to attract legislative and regulatory attention worldwide. Last year, the UK Parliament carved out a specific exemption from its prohibition to allow MRT. This legislation addresses a number of practical matters, including the right of the child to request medical information about the donor, and it clarifies that the child is not related to the donor despite the contribution of genetic information. Earlier this year, a report commissioned by the FDA recommended allowing clinical trials of MRT in the United States.

This technique and others like it certainly merit close regulatory attention due to the implications they have for our collective genetic heritage and the uncertainty regarding their side-effects. However, it is impossible to ignore the treatment potential of these techniques in the case of diseases like Leigh syndrome. These developments shine a negative light on the restrictive reproductive landscape in Canada. The embattled AHRA provides neither the flexibility nor the clarity needed to confront these new regulatory challenges. Patients, medical professionals, and the public deserve clear rules that properly manage the risks while securing the benefits associated with this promising new medical frontier.

Improving Organ Donation Rates in Canada: Barriers & Solutions to Federal Involvement

Posted By Jonathan Adessky

Canadians have increasingly been donating organs over the past ten years. Shouldn’t we be celebrating? According to the Canadian Blood Services’ early September report, Canada has seen a 23% increase in donations over the past decade. While this is definitely good news, we mustn’t be fully satisfied with our country’s progress on donation rates. According to the International Registry on Organ Donation and Transplantation, Canada lags behind its contemporaries by a large margin. This leads us to wonder: what are we doing wrong? How can Canada catch up to organ donation levels in other Western, industrialized nations?

Canadian Blood Services is a non-profit organization that manages and coordinates national blood and organ donation. We should take pride in the impressive results of their work. According to the organization’s 2015 report, “the national deceased donation rate has risen from 14.1 to 18.2 donors per million population (DPMP)” since 2006; most would agree this counts as an achievement. Nonetheless, the fact remains: Canada has some catching up to do.

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An increasing number of Canadians have registered as organ donors over the past ten years. Shouldn’t we be celebrating?|| (Source: Flickr // Share GK)

The question remains: how and to what extent can the Federal Government help further Canada’s progress? At least one Canadian parliamentarian, Ziad Aboultaif, believed that a federally mandated organ donor registry would help drive growth in the donation rate. In drafting this bill, he put his heart into his work; or, more accurately, his liver, a piece of which Alboutaif donated to his son. The proposed bill intended, in part, to establish a national promotion strategy for organ donation. The Minister of Health would be tasked with producing an annual report detailing the success level of the previous year’s strategic plan, with a set of recommendations for further improvement.

Despite broad support for the its stated goals, Aboultaif’s proposed private member’s bill was defeated in June. Parliament faced a major obstacle in that organ donation falls ultra vires federal jurisdiction. One doesn’t need to consult a learned lawyer to reach such a conclusion; a glance at the Constitution Act, 1867 would suffice. Provincial authority over matters relating to organ donation flows from jurisdiction to legislate on hospitals, as per section 92 of the Act.

Given these constitutional limitations, what role can the Federal Government play in furthering Canada’s progress promoting interest in organ donation? Records of the House debate indicate strong moral support for the Bill; for example, Kamal Khera, Parliamentary Secretary to the Minister of Health, admits that Aboultaif’s initiative is worthy of praise. She elaborates on how the Trudeau government is committed to further supporting the Canadian Blood Services, and how a formalization of the existing interprovincial sharing guideline is underway. Clearly, Ottawa is determined to help reform the system, but the ‘how’ remains murky.

Parliament faced a major obstacle in that organ donation falls ultra vires federal jurisdiction.

According to Canadian Blood Services, most of the provinces already have high registration rates. To add to that, CEO Dr. Graham Sher states that a federally-coordinated national registry alone may prove insufficient to realize the projected gains. If this holds true, the Federal Government need not worry about organizing a centralized registry; a truly daunting task. What alternatives can Ottawa turn to in its efforts to improve the organ donation system, besides the creation of a registry?

International best practice comparisons may prove useful in this endeavour; for example, one might wonder how Spain’s DPMP rests at more than double that of Canada, at a rate of 39.7. The key to Spain’s success may result from the manner in which its intensive care units operate. Kim Young, director of donation and transplantation for Canadian Blood Services, points to the staffing of Spanish ICU facilities with donation specialists as a the key to their success. Clearly, it would be wise and fair to make this approach a priority in tackling subpar growth in Canadian organ donation.

Ottawa has proven generous in directly funding third party organizations, and where money flows, influence follows. This relationship holds true especially as organizations depend more and more on these funds in their financial planning. Since 2008, the provinces and the Federal Government have collectively invested $64 million in the Canadian Blood Services. While the aforementioned constitutional limitations restrict Parliament from direct intervention, Ottawa is still in a good position to effect change from the sidelines.

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Jurisdictional boundaries do not necessarily fence off healthcare from federal involvement. || (Source: Flickr // mhambourger)

The weight placed on federal input is largely driven by its generosity and on the system’s dependence on external financial contributions. If the Canadian government wants to advance a strategic plan, its voice will surely be heard as it continues to provide funding. If the Trudeau government is as passionate about the issue as Khera makes it out to be, then it will consider reworking its strategy. Federal funding ought to entail guidelines that factor in best practices established by medical professionals in Spain.

Through deconstruction of the issue at hand, a subtle and important insight emerges: jurisdictional boundaries do not necessarily preclude federal involvement in healthcare. Yes, these matters fall under provincial jurisdiction. No, the Federal Government cannot directly manage national programs that clearly fall outside of its jurisdiction. Just because it cannot hop the constitutional fence, however, what barrier exists to prevent federally-supported third-party charities from taking action where the government cannot?

Saved By Delatestryl: The Importance of Accessible Hormone Replacement Therapy (Part 2)

Posted By Florence Paré

In last week’s segment, I explored the various extra-legal barriers to accessing hormone replacement therapy for trans individuals, for whom hormones are an essential part of their psychological and physical well-being. The discretion held by the provincial government over insurance coverage of prescription drugs also poses a significant risk to access to hormones, as there is a concern that the government will decide to delist hormones from provincial insurance coverage.

The potential delisting of hormones from insurance coverage is a recurrent fear in trans communities. At the political level, this seems unlikely, as trans rights have entered the progressive collective consciousness and cannot be openly opposed by governments who wish to appear progressive. Furthermore, insurance coverage for medication is largely done on a per-medicament basis, rather than based on the reason for the prescription, and drugs used in hormone replacement therapy are frequently used for other purposes, such as treating polycystic ovary syndrome or hypogonadism, both fairly common illnesses.

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Many trans Canadians choose hormone replacement therapy to help manage dysphoria. Given the disproportionate financial disadvantages trans Canadians face, delisting hormones would further threaten their safety and well-being. || (Source: Susan Bein // wizmosis)

Delisting hormone treatments could arguably be contrary to the Canadian Charter of Rights and Freedoms and to the Québec Charter of Human Rights and Freedoms, CQLR c. C-12. The Canadian Charter prohibits discrimination on the basis of sex at section 15. Human rights tribunals across Canada have long held that the term “sex” in human rights acts includes transgender persons, and would otherwise almost certainly be protected as an analogous ground of discrimination (Andrews v. Law Society of British Columbia, [1989] 1 SCR 143).

In Québec (whereas in the past trans persons have been protected from discrimination under the basis of “civil status”, “disability”, or “sex”) gender identity and expression are explicitly included in the Charter‘s section 10 as of June 10th, 2016.

The potential delisting of hormones from insurance coverage is a recurrent fear in trans communities.

The delisting could also be challenged through judicial review of administrative action. A serious argument can be made under either Charter, most notably pursuant to the Canadian Charter which includes a proportionality criterion (Loyola High School v. Quebec (Attorney General), 2015 SCC 12, [2015] 1 SCR 613 at paras. 38, 40): a slight cost reduction compared with the totality of Public Drug Insurance expenditures is hardly proportional to the lives and well-being of trans people, given that trans people account for less than 0.6% of the total population, and not all trans people wish to take hormones. The Supreme Court of Canada’s decision in Eldridge v. British Columbia (Attorney General), [1997] 3 S.C.R. 624 also supports this argument.

Hogan v. Ontario (Health and Long-Term Care), 2006 HRTO 32, 58 CHRR 317 shows how uncertain guarantees under the Canadian Charter and Québec Charter can be with regards to trans healthcare. While the delisting of genital reassignment surgery in Ontario was found to be prima facie discriminatory, and would likely also have been found discriminatory under the Canadian Charter, it was saved by the bona fide justification analysis.

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Trans rights groups have long battled for the human rights protections now entrenched in Canadian law. Governments have a duty to stand by these protections, including access to healthcare. || (Source: Wikimedia Commons)

We are here confronted not with clearly invalid potential regulations, but potential regulations which only may be invalid despite being imminently immoral. As for Hogan itself, I do not believe that it correctly applied the law. Despite the strong legal arguments that can be levied against delisting, Hogan shows a very real risk that any regulations delisting trans healthcare will be upheld as valid by the Courts, a risk that should not exist given the unnecessary anxiety it causes and the moral landscape of hormone replacement therapy in relation to trans well-being.

Ensuring access to hormone replacement therapy is a difficult and multifaceted task, and if improperly handled provides a fertile soil for the exacerbation of trans people’s vulnerabilities. On the legal plane, trans issues surrounding hormone therapy show the limitations of human rights law both in supervising the decisions of governments and private actors who may too easily bestow help on the least vulnerable of the vulnerable, instead of the most vulnerable of the vulnerable, and in addressing broader systemic issues arising from the interrelations between various public and private bodies. In the end, we can only hope that the government takes seriously the words of the Supreme Court of Canada in Eldridge: once the state provides a benefit, it is obliged to do so in a non-discriminatory manner.

Saved By Delatestryl: The Importance of Accessible Hormone Replacement Therapy (Part 1)

Posted By Florence Paré

Every time I looked in a mirror, I saw someone else. I was what I was not. But unlike Lindsay Lohan in Freaky Friday, I had no one else to be. It was not until I had taken estrogen and anti-androgens for a few months that my face started changing and I started recognising myself in the mirror. To this day, it varies: on worse days, I feel the dread of self-misrecognition. On better days, I am relieved to see myself as I am. Well-being is unavoidably hampered if you cannot ever feel at home anywhere. Through our bodies, our consciousness is embodied. People typically feel at home in their body, but for many of us it does not feel like home.

Far from being a caprice, hormone replacement therapy, for those of us who wish to receive it, is often a lifesaver. Amongst trans people who have considered medical transition, those on hormone replacement therapy were about half as likely to have seriously considered suicide in the last year. In total, around 35% of all trans people have seriously considered suicide in the last year. Of those who desired to medically transition but had not begun hormone replacement therapy, 53% have seriously considered suicide in the last year.

To this day, it varies: on worse days, I feel the dread of self-misrecognition. On better days, I am relieved to see myself as I am.

Apart from alleviating dysphoria by creating changes in our body which we desire as ends in themselves, those changes also participate in our well-being because of their relationship with what we call “passing as cisgender”.

A person is cisgender if they are of the same gender as they were assigned at their birth; in other words, a person who is not transgender. Someone is said to pass as cisgender if they are read as cisgender. For example, if someone were to believe that I am a cisgender woman rather than a trans woman, I would be said to pass as a cisgender woman. Passing is not a yes or no feature: people may pass in some contexts and not in others, and may pass or not in the same contexts at different times or to different people. Not every trans person wishes to pass, nor can everyone pass; non-binary people cannot pass as cisgender as there are no cisgender non-binary people, and some people’s anatomy puts passing out of reach.

By changing a person’s appearance, hormones help trans people to pass as cisgender. This can alleviate some of the difficulties trans people face: it curtails misgendering, can reduce social anxiety, and decreases the number of opportunities for transphobic violence, discrimination, and harassment. Insurance coverage for hormone replacement therapy across Canada varies by province. My considerations will focus on the situation in the province of Québec, as it is the jurisdiction I am most familiar with. However, many of my comments will also apply to other provinces.

Passing is not a yes or no feature: people may pass in some contexts and not in others, and may pass or not in the same contexts at different times or to different people.

In Québec, hormone replacement therapy is covered under the basic plan established by An Act Respecting Drug Insurance, C.Q.L.R. c. A-29.01. The person is covered either through a private insurer or, if ineligible for private coverage, through the RAMQ’s Prescription Drug Insurance. Under the Act, the person’s coverage through a private insurer must be at least equivalent to the basic plan coverage. Thus, in Québec, hormone replacement therapy is, in theory, covered by insurance. In my case, I am lucky to have a private plan which covers the totality of my hormone replacement therapy costs.

Even when hormone replacement therapy is covered by insurance, other factors work to limit its access by trans people. First, it can often be difficult to obtain a prescription. Only a handful of doctors prescribe hormones on an informed consent basis, meaning without a letter from a psychologist. The waitlist to see those doctors (there seem to be around four in all of Montreal, based on anecdotal evidence) is often between six months to a year, and to this is added the weeks to months it takes between the first consultation and the writing of the prescription.

In the case of doctors who follow the World Professional Association for Transgender Health (WPATH) standards (who can also be fairly difficult to find), the individual must find a therapist ready to write a letter of referral. Those therapists are too few (though not as few as doctors prescribing hormones on an informed consent basis), have long waitlists, and often charge a substantial sum of money for consultations. Those costs can be prohibitive given the prevalence of poverty within the trans community. Trans individuals are more than four times as likely as the general population to have a household income of under $10,000 per year; 15% of trans people live under that household income, and 27% of trans people report a household income below $20,000 per year, a situation that is even worse amongst trans people of colour and trans people living with disabilities.

Depo-Photo-1024x500In addition to global hormone shortages, the prohibitive costs involved in seeking hormone replacement therapy threaten to deny access to trans Canadians who choose this treatment. || (Source: Teen Health Source)

Under An Act Respecting Drug Insurance, a coinsurance payment of 34% of the cost of the drug can be asked of trans people filling their prescription, up to a yearly total of $1,029 (sections 11, 13, and 27). Although in exceptional situations the coinsurance payment can be waived, coinsurance payments are the norm, and can be prohibitive to trans people in precarious economic situations. On the other hand, private plans which are frequently unavailable to less privileged trans people regularly cover the complete costs of hormones.

Many trans people fear that hormones themselves will be unavailable in the future. In the last few years, some forms of injectable oestrogen and testosterone have been in shortage. People I know have an extra vial of hormones reserved for them at their pharmacy, “just in case”, and many people report being unable to obtain injectable hormones. Different forms of hormones have different primary and side effects, and are not interchangeable, and switching to a different form is not possible or desirable for many due to potential adverse health effects. This constantly looming threat remains at the background of many of our minds, and contributes to a state of perpetual anxiety seldom absent from trans subjectivities.

Despite the presence of public prescription drug insurance in Québec, a number of barriers confront trans people who seek to obtain life-saving hormone replacement therapy. In this article, I have considered extra-legal barriers. In the companion article to this piece, I will consider the threat of delisting hormone replacement therapy from drug insurance under human rights law.

Medical Marijuana’s Liberalization and the Legislative Purgatory of Recreational Use

Posted By Colleen Morawetz

As Canadians await the federal government’s plan to legalize and regulate cannabis, expected next spring, this summer has seen unprecedented growth in the dispensary market. In cities such as Vancouver and Toronto, a booming industry of “compassion clubs” has sprung up over the past few months, with some commentators describing a “pot-shop bubble” to rival soaring housing prices.

Dispensaries have the veneer of operating in a legal grey zone, with purported medical professionals “prescribing” medical marijuana for eager customers, but this medical aura can only be for marketing purposes; Health Canada makes it clear that these storefront businesses are strictly illegal. At the same time, beyond the booming market for recreational cannabis, the legitimate medical marijuana system in Canada has experienced dramatic shifts in the past year.

Circumscribed exceptions to the Controlled Drugs and Substances Act have allowed physicians to prescribe marijuana for medical purposes since 1999. In 2013, the Government of Canada implemented the Marihuana for Medical Purposes Regulations (MMPR), creating conditions for licensed producers to compete for medical marijuana consumers in a commercial market.

The most recent judicial challenge to this scheme occurred in a February 2016 Federal Court of Appeal decision, which found that limiting medical marijuana production to Canada’s licensed producers (currently 35) unjustifiably limited patients’ constitutional rights to life, liberty and security of the person by subjecting them to market-driven pricing structures.

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Many Canadians are thrilled for the Liberal leadership to follow through on a long-awaited legalization plan for recreational marijuana use and distribution. || (Source: Flickr // Cannabis Culture)

Since Allard struck down as invalid the entire MMPR, the federal government responded by implementing the Access to Cannabis for Medical Purposes Regulations (ACMPR), which came into force on August 24. The part of the new regulations most worthy of attention is the provision on self-production: individuals with a medical document from a health practitioner may now choose to produce a limited amount for their own purposes, designate another individual to produce it for them, or stick to the mail-order system offered by licensed producers.Meanwhile, in July, the Globe and Mail published the results of a large-scale investigation as to the safety of dispensary-obtained marijuana, finding that one-third of cannabis samples from nine storefronts in Toronto would not pass a Health Canada test for safe levels of mould, harmful bacteria, pesticides and other contaminants. This investigation was novel due to its illegality; at the time of the investigation, federally licensed laboratories were banned from testing marijuana samples, and the newspaper did not disclose the identity of lab used.This ban on testing caused particular concern for patients with compromised immune systems or parents who desired extra confirmation as to the safety of the cannabis oil extract they were giving to their children to treat the symptoms of conditions such as epilepsy and brain tumors. Health Canada had safety standards in place for federally regulated medical marijuana producers; however, patients and caregivers wanting to administer a prescribed dosage through cannabis oil must produce it themselves from dried leaves – with no way of testing the finished product under the ban.

Two weeks after the publication of the investigation, according to the Globe, Health Canada sent an urgent memo to federally accredited labs, asking whether they would be willing to start testing for the public under new federal regulations. As of September, 17 such labs had offered to provide independent testing of marijuana for medical purposes.

Even in the face of these significant changes in medical marijuana laws, the nagging question remains as to why we should care. Surely, the logic goes, the promised legalization of marijuana for recreational use will render all of these laws and regulations useless within the next year?

5377506106_060a578a86_zThe current state of federal legislation in Canada means that medical marijuana has not undergone sufficient quality testing before reaching the patient, putting immunocompromised users at risk. || (Source: Flickr // Dank Depot)

However, the details of the legalization plan remain murky as of yet. Although 30 000 Canadians weighed in during an online consultation this summer, it remains to be seen how much (if at all) the responses will inform the recommendations of the marijuana task force, which is on track to issue a report to the federal government in November. It is also unclear whether the task force will incorporate the set of recommendations issued by the Canadian Medical Association in September.One of the CMA’s critical suggestions is for home cultivation of marijuana, other than for medical purposes, to remain prohibited. This recommendation essentially calls for a two-tier medical/recreational cannabis system, with access to the drug for recreational purposes remaining somewhat constrained. The ACMPR, therefore, has the potential to affect the production patterns of cannabis in Canada well into the future.

Of greater concern, perhaps, is the lower profile decision of Health Canada to allow for laboratory testing of cannabis only if it was obtained for medical use. The Globe’s investigation discovered contaminants in much of the cannabis sold in Toronto’s illegal dispensary market, and it is fair to assume that the situation in other cities is no different.

Among its objectives, Health Canada “strives to … prevent and reduce risks to individual health and the overall environment,” indicating that harm reduction is a core tenet of the department’s mandate. However, its measures must also be allowable by law, and, one would assume, toe the party line in terms of current moral-legal narratives.

While allowing for testing of cannabis not proven to be obtained for medical purposes is technically compatible with cannabis itself being illegal, it certainly seems to question the moral legitimacy of the criminal prohibition. But how strong is this claim to moral legitimacy, when the Government of Canada has announced imminent legalization?

If Health Canada is to properly “strive” for its objective, perhaps certain interim measures should be taken by the federal government to allow for regulation in this legislative purgatory, where harsh local sanctions such as raids seem more and more incongruous with the legalization policy proposal.

Cannabis-Counter-Harborside-DispensaryEnsuring the quality of the product with the safety of users in mind, marijuana dispensaries will stand alongside pharmacies and liquor stores as licensed distributors of controlled substances. || (Source: Flickr // Dank Depot)

Though the boundary between medical marijuana and cannabis obtained for recreational purposes may prove enduring in the new policy framework, the present moral uncertainty could benefit from allowing for licensed testing of all cannabis. As Vancouver city councilor Kerry Jang notes, speaking from a city that has started its own licensing of dispensaries absent of federal guidance, the federal government should no longer “hid[e] behind a legal shield” and avoid giving proper guidance for regulation and control.

After all, what is the point holding out on harm reduction measures when the political tide has already turned?