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POWERFUL PENAL REFORM TALKS HELD

A mock murder trial marked the highlight of a recent conference regarding proposed revolutionary changes to Oaxaca’s code of criminal procedure. About 4,000 lawyers, academics, bureaucrats and politicians including the governor and mayor packed two salons at Misi?n de Los ?ngeles to first hear impassioned ple

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

as for the passage of the draft legislation and then watch as a three judge panel evaluated evidence and submissions tendered by teams of barristers for the prosecution and defense.

Oaxaca is one of a handful of Mexico’s 32 states pioneering a project intended to break down a Napoleonic inquisitorial system and replace it with the more Britis

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

h adversarial system as practiced in Canada and the USA. Chief Prosecutor Patricia Villanueva’s discourse was one of a number of which was peppered with phrases such as due process, procedural fairness, judicial restraint and impartiality, and advancement of the principles of democracy, human rights and presumption of innocence.

Attendees wi

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tnessed first hand how the trial of “El Tigre” would unfold. He allegedly shot his neighbour, a couple of weeks after threatening to do so upon learning that his wife had been insulted by the deceased. The only eyewitness that early morning was a gentleman who’d been drinking and smoking marijuana all night, as a result of which his senses

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

of observation had been dulled. But the forensic evidence pointed to the accused, a former drug dealer now in rehab, as the only possible suspect, fingerprint on the pistol and gunshot residue on his right hand. He admitted to being in a struggle to quell tempers, but no more. The realism was striking, right down to The Tiger’s answer on c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ross-examination as to why he didn’t phone police when he heard a ruckus on the street, rather than run outside: “I couldn’t. My phone service had been cut off because I hadn’t paid the previous month’s bill.” The retort struck a familiar chord with Mexicans as the audience roared.

Throughout the day a strong undercurrent could be sensed.

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

Could Oaxaca actually create a more efficient and expedient criminal dispute resolution model which would arrest the sweeping and arbitrary powers of the Minsterio P?blico (office of the Attorney General)? Is it realistic to even attempt to create procedures which would result in an entire criminal proceeding, from arrest to sentencing, conc

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

uding in 4 months as the moderator submitted would be the case, instead of the current snail’s pace practice which can keep the innocent behind bars for years pending trial? It all seemed a little overly optimistic for a stunned crowd. In response to my questioning, a local lawyer commented “it’s like something out of a movie,” while a judge

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

simply answered “radically different.”

COMMENTARY: IS OAXACA RIPE FOR REFORM?

It took a while to sink in. Why the reticence to the dramatic changes proposed for the Mexican penal system, when civil rights groups have for years been craving major transformation towards “truth, justice and the American way?” When asked for the most importa

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

nt change that reform would bring to the current system, a lawyer attending the recent conference on Reform to the Superior Court of Justice’s Penal Code answered: the Ministerio P?blico (M.P.) would be stripped of its arbitrary and punitive powers which at present lack appropriate judicial sanction and supervision.

Currently, because of th

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

e command it wields, the M.P. strikes fear in the hearts of those Oaxacans not entirely on the side of righteousness. The mere allegation of wrongdoing can lead to a swift period of incarceration without a judicial finding of even a probability of guilt…not for only alleged breaches of society’s more serious standards which north of the borde

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

r would result in incarceration without bail pending trial (i.e. a murder charge), but rather for the purported committing of lesser faux pas more in the nature of civil wrongs such as theft, fraud and breach of trust. If it looks like on balance you probably did it, off you go, directly to jail: do not pass go, do not collect $200.

This lib

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

eral leaning writer is not convinced that penal reform should occur prior to the advent of more basic alterations to the Mexican social order. Thrice in the past year the power of the M.P. has served me well. Under similar circumstances to those which have befallen me here, in Toronto I would still be waiting for justice, and in fact its a

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

rrival might never have produced a just result. But in Oaxaca , noted for its incongruities:

1) The fellow who was living in and looking after our home pending our permanent residence in Oaxaca left us with outstanding utility bills and damaged contents, and he outright defrauded us of cash. The threat of contacting the M.P. caused his fami

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

y members to agree to pay his debt, and they did. Otherwise, he was facing jail for breach of trust, theft, etc. North of the Rio Grande he might have been charged by the police, but would have entered into a plea bargain for a suspended sentence and probation. The civil proceeding to recover our losses would have taken years, and in the en

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

d our net recovery would have been half.

2) Our cleaning lady stole cash from us. If we went to the M.P. she was looking at immediate incarceration for perhaps 2 – 3 years…even though we had no documentary proof of the theft. After getting on her knees and showing my wife photos of her young children while begging and crying and initially d

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

enying the theft, she signed a payment agreement and in exchange for her honoring it we agreed to take no further steps. The result in El Norte? Same as the first case.

3) The secretary at the Honda dealership gave me an official receipt upon tendering her with my final cash installment for my motorcycle. When I returned for my factura,

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

the official document enabling me to license the bike, the general manager exclaimed: “What last payment?!” Six of us including the scoundrel and her lawyer signed a lengthy legal document following which I received my factura. If she fails to pay Honda, you guessed it.

Will the foregoing fast and economic justice in civil and quasi-crimi

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

nal matters be lost if we adopt a British common law model at this juncture in the transformation of Mexican society? Are there not such circumstances where the presumption of innocence and taking care not to pre-judge ought to take a back seat to swift sweet justice? Should there not be qualification to the adage it’s better to let 10,000 c

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

riminals go than wrongly convict a single innocent? Will the impoverished in Oaxaca have even less access to fairness under the proposed regime if implemented now? Are there perhaps other more critical social concerns that should be addressed as a precursor to or at minimum alongside overhauling the legal system such as poverty and education

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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