Category Archives: Legal

An Overview on Oman’s Pharmacy Law no. 35/2015

 

Objective of the Law

To regulate the practice of the pharmacy profession and pharmaceutical establishments.

 

Main Points of Pharmacy Law

 

Interpretations of some terminology mentioned in the Law

 

• Pharmaceutical profession:

According to the Law it means preparing, installing, manufacturing, packing, storing, importing, exporting, selling or distributing medicine.

• Pharmaceutical institutions:

It includes the following >>> Pharmacies, drug stores, drug factories, scientific offices and consulting Pharmaceuticals offices, drug analysis laboratories and any other institutions to be determined by a decision from the minister in a later stage.

 

• Scientific office:

A licensed place that provides technical or marketing information about medicines by all scientific means.

• Pharmaceutical Consultation Office:

A licensed place that provides consultations, research or studies related to the practice of Pharmacy profession.

License and Insurance is Required

 

According to article 2 of Pharmacy Law it is not allowed for anyone to practice pharmaceutical profession or work as a pharmacist’s assistant unless he/she has a license from the Ministry of Health, and he must be insured for the benefit of third parties against his/her liability (Professional Liability Insurance).

The period of the license is two years and it could be renewed for a similar period as per the same requirements for obtaining a license.

 

 

 

Prohibition of Practicing any other Profession

 

Pursuant to article 7 of Pharmacy Law, it is not permitted to combine the practice of Pharmacy profession with the medical profession or any other profession contradicting with the Pharmacy Profession.

However, Pharmacists may provide the necessary first aid in case of emergency.

 

Agreements with Doctors

 

According to article 8 of Pharmacy Law, pharmacists and doctors are not allowed to agree on the method of writing medical prescriptions, and it is also prohibited to have any financial distribution between pharmacists and doctors.

 

Pharmacy’s Owner

Article 11 of Pharmacy Law states, except for the pharmaceutical factories, the owner of the pharmaceutical establishment or one of his partners must be an Omani pharmacist.

If the Pharmacy owner dies, the ownership of the license passes to the heirs, provided that they adjust their status within a maximum period of (5) five years from the date of death.

 

Obligations of pharmaceutical warehouses, factories, and medical supplies providers

Pursuant to article 12 of Pharmacy Law, the aforementioned establishments are prohibited from the following:

A – Refraining from selling medicines or medical supplies to licensed pharmaceutical institutions or forcing the pharmacies to purchase any certain quantities, or charging a price higher than its licensed price.

b- carrying out any activity aimed at monopolizing the trading of medicines or medical supplies on its own or with others.

 

 

Managing the Pharmaceutical Entity

According to article 13, a pharmaceutical institution should have a licensed pharmacist who is responsible for the management of it. Pharmacists are not allowed to be in charge of managing more than one pharmaceutical institution.

 

Owner and Manager Obligation

Article 24 of Pharmacy Law provides that, the owner of the pharmaceutical establishment or its responsible manager shall immediately notify the Directorate when inventorying the pharmacy’s content, or stealing accident happened or damage to the medicines whatever the cause.

 

Penalties

Articles 37 and 39 of Pharmacy Law stipulate that, anyone who violates the provisions of this law or its regulations, then imprisonment shall be applied  for a period of not less than (1) month, and not exceeding (1) year, and a fine of not less than (100) One hundred Riyals Omani, and not exceeding (1,000) one thousand Rial Omani, or either of these two penalties.

Further, the technical committee stipulated in Article (27) of this law have the authority to consider the violations committed by pharmacists or pharmacists’ assistants or the owners of pharmaceutical establishments for the provisions of this law and its regulations.

Where, the violator has to be notified in order to personally attend before the committee and confront him with the violations and hear his statements regarding it and investigate his defense.

If a violation is proven, the committee has the right to apply one of the following penalties:

 

• An administrative fine of not less than (100) one hundred Riyals Omani, and not more than (1000) thousand Omani riyals.
• Suspension from practicing the profession or the closure of a pharmaceutical establishment in which the violation occurred for a period not exceeding one year.
• Cancellation of the violator’s license and a removal of his name from the register, or revocation of the institution’s license

 

written by :

Mohammed Abbas

The doctrine of men’s rea ensures that those who cause the actus reus are legally responsible for doing so. There are different forms of men’s rea, from intention and knowledge to recklessness. Focussing upon ‘recklessness’, it can be submitted that over time the courts have alternated between the ‘subjective’ and ‘objective’ test Caldwell . However, the subjective approach continues to be that favoured by the courts as illustrated in the case of that now overrules the case.

 

The question concerns the area of recklessness which includes two main elements and they are if the defendant takes an unjustifiable risk of specific consequence and if the defendant is known to that risk. The House of Lords now overruled Caldwell, however it remains significant theoretically even after its demise. It can be argued that while R v G ensured that the ones who did not meet the demands of Caldwell were excluded from liability.

 

There is a growing body of literature that recognises the importance of R v Cunningham (Cunningham) where the House of Lords established the subjective recklessness, as having actual foresight of the consequence, and taking the risk of that consequence unreasonably and it continued to apply to such offences. However, the House of Lords in Caldwell, that is controlled by Lord Diplock, created a new objective standard for recklessness, the reason for this is it allowed too many defendants to escape liability as they claim they did not foresee the risk extending not only to actual foresight, but situations where defendant fails to appreciate an obvious risk that the outcome will occur.

 

Furthermore, the court took an objective approach which follows the case of Metropolitan Commissioner v Caldwell (Caldwell) under s.1 of the Criminal Damages Act 1971 where the court states that two tests must be satisfied and they are S. that an obvious and serious risk of damage and S no thought of the risk possibilities and carried on with the act whilst knowing of the risk. The house of lords reassessed subjective recklessness of men’s rea when they overruled Caldwell. Moreover, Lord Steyn mentioned that the arguments against Caldwell were irresistible. He argued the problems in terms of that it was a difficult for jurors to understand, and sometimes offended their sense of fairness and the thought process of the risks in terms of their age were not justified. This injustice was especially obvious in the case of Elliot v C, where a girl with learning difficulties was found guilty of arson even though she was unable of anticipating the risk.

This case was treated on the basis of objective standard however if they look the subjective aspect, where it can be argued that is based entirely on the defendant’s state of mind allowing too many defendants to escape liability by making a claim of not foreseeing the risk therefore the defendant would not have been found guilty and reform will be needed.

 

Caldwell was criticised by many academics because it was able to cause bias as it made people guilty of not being able to foresee the risk. Furthermore, the courts moved away from the objective principle which was the current position due to the criticism. The subjective approach was confirmed in Cunningham. In R v G, the House of Lords concluded that the subjective approach in Cunningham should be restored. The shift is towards adopting a subjective approach. In general, it is necessary to look at the matter from the defendant’s perspective and how it appeared for instance, if the accused did not perceive a risk, he will not be culpable. In the case of Booth v Crown prosecution service, the courts applied the objective test to recklessness because they thought that the damage could be foreseen. However, complications continue in R v G, where Lord Diplock in Caldwell was addressing the accountability of a defendant who, rather than being unable to identify the risks, can be liable for failing to offer any thoughts. The final state of mind is not more nor less subjective than the first state if one is attaching labels, as suggested by Lord Diplock. Reform bodies have been recommended both after and before Caldwell that the Cunningham definition should be continued, it was argued that it is easier to apply and for the jury to comprehend and not mistake recklessness and negligence to have the same meaning in court.

In conclusion, ultimately, while R v G is comprehensible in its strengths to deal with the vibrant prejudice of cases like Elliot v C, previously following Caldwell, for those respondents who merely fail to provide proper thought to evident risks. It is suggested that both objective and subjective recklessness exists the requirement that the defendant’s behaviour must not be understandable. Lord Diplock argued, that this type of mental state can potentially be equally as subjective to actual foresight of consequence.

 

 

Lawyer: Maram Al Lawati

Partial defences to murder were originally introduced to avoid the death penalty. Today they remain in use to avoid a mandatory life sentence and indeed the obvious stigma attached to a murder conviction. Focusing in particular on diminished responsibility, and what is defined as ‘a substantial impairment of mental ability’.

 

The question advances that the meaning of substantial and recent interpretation is now too narrow following the Supreme court decision in R v golds (Golds). In criminal law, diminished responsibility (DR) is a potential defence by excuse where defendants argue that although they broke the law, they should not be held fully liable because their mental functions were impaired. The defence of diminished responsibility was reformulated. Consequently, a special defence can apply only to murder under s.2(1) of the Homicide Act 1957 which was amended by the s.52 Coroners and Justice Act 2009 .Three requirements have to be met, where a person who kills is not to be convicted of murder and if defendant was suffering from an abnormality of mental functioning.

 

The first requirement is that defendant must have suffered from an abnormality of mental functioning. In R v Byrne. it was held that the defendant’s state of mind was significantly different from that of an ordinary human being that a reasonable man would term in abnormality. This would lower the conviction to voluntary manslaughter, and he would avoid the mandatory life sentence. The second requirement is that abnormality must come from a recognised medical condition

. This can be anything that the World Health Organisations list of illnesses including depression, pre-menstrual syndrome and PTSD . In R v. Dowds the Court of Appeal mentioned that just because a disease is listed it does not necessarily mean it will be a recognised for the purpose of DR. It would have to be proved by medical evidence, possibly from expert witnesses. However, the jury will aim to examine whether the abnormality is the reason behind the defendant’s conduct. In the case of R v. Anthony Martin, the legal principle of defence of DR can be applied where D has a paranoid personality disorder and depression.

 

The third part requires substantial impairment of the defendant’s ability to form rational judgements, understand the nature of his conduct or exercise self-control.

R v Lloyd  states that substantial impairment means more than minimal but less than the total impairment, if established on balance of probabilities the verdict must be manslaughter.

The sentence will almost certainly be much more lenient than the mandatory life-sentence for murder. The latest authority was in the case Golds where it decided that the definition of substantial was incorrect. The right approach is when the jury members to ask of a definition, they should be instructed that substantial means significant therefore it is more than trivial.

 

Significant contributory factor to the killing is the new addition to the defence of diminished responsibility, under s.2(1) (b) a clarification was made that the cause or significant cause in D killing the victim, if it made no difference where he/she would kill anyway the defence will not be available. In R v. Osborne, The Court of Appeal rejected the appeal, it would have been accepted if ADHD was the support of DR defence however, it did not substantially impair his mental responsibility, but the use of drugs and anger explained his conduct. In R v. Hobson, the court accepted that ‘battered woman’s syndrome’ was a mental disease and could cause abnormality of the mind. Furthermore, the new definition is likely to be interpreted more narrowly because it creates unfairness between the cases which leads to inconsistency as the jury are emotionally attached and have no legal background which suggests that they view the case in an objective manner rather than an expert point of view. It can lead to unfortunate punishments due to unfair judgements from the jury. It gives the jury a restriction as there is no guarantee they could interpret substantially impaired too harsh or too generous. However, when the jury’s definition of substantial is not in line with the legal definition, the judge will remind the jury of the statutory definition to ensure the case is fair.

 

In conclusion, having the defence of diminished responsibility is convicted of manslaughter and is often imprisoned. The modern rationalisation leads to the unfair judgments by the jury leading to the judge being unable to be flexible when sentencing, as the jury may be too harsh with their definition of substantial impairment. However, if the defence of DR is abolished, a mentally disabled defendant might not be able to plea the defence because of its narrowness and therefore he will be convicted of murder.

 

Lawyer: Maram Al Lawati

In every result crime causation in fact and law must be established. Difficulties can arise when the latter test is contested by a Novus actus interveniens. The defendant’s (D) conduct must be a ‘substantial’ cause, but the use of the word is misleading and seems to mean only that D’s contribution must be more than negligible or be so minute that it will be ignored under the ‘de minimise principle’

 

Result crimes requires defendants to satisfy both legal and factual causation to be held accountable for the crime.  Causation in fact uses the ‘but for’ test which is expressed as if the defendant did not act upon it the result would not have occurred. However, legal causation questions whether the respondent was a substantial and operating cause to the victim’s harm.

Problems occur with legal causation because it is said that it has to be a substantial cause.

Additionally, Novus actus interveniens can break of the chain of causation. An unrestricted intentional and knowledgeable act of third party renders the novel act not a substantial cause of the outcome. Hence the defendant’s (D) contribution needs to be more than de minimis because it was not their responsibility that the action occurred.

 

In R.v Cheshire (Cheshire), the court advanced that the act of the accused must not be the only cause of the demise. It is adequate if his action considerably contributed to the victim’s death. Therefore, requirements were not needed to show that the respondents act was the substantial cause of death. Medical negligence will not break the chain of causation by itself and the carelessness of the staff was not so abnormal to break the chain of causation.

A criticism of the case of Cheshire is that at the time of the victim’s death, the actions of the D no longer were compelling sufficiently to cause death. The court mentioned that the negligent treatment was the instant cause of death.

The instant cause of death, was not the D’s act, but he was guilty since he had made a significant contribution to the death, whereas making a

significant contribution which is equivalent to being held accountable.

The Court of Appeal held in Kimsey. which involved racing cars along the public road, killing the driver of one of the cars in the race, while the term ‘substantial’ could be used, it may lead the jury to consider that the cause really had to be substantial where the omission or act leaves no rational uncertainty to the defendant’s intention to oblige the crime, he will be charged with attempting which is misleading as it only means more than slight link also it has not been given an ordinary meaning in the cases

. The defendants driving caused the death had to be ‘a cause’, not necessarily the principal cause of the death. There had to be more than ‘a slight or trifling link’ between the driving and the deat.

Therefore, the defendant’s conduct had to be more than de minimis, where the trial judge correctly defined it as ‘slight or trifling’.

where the victim was stabbed by the defendant, but the wound largely healed. Consequently, the victim was injected with a drug that he was allergic to and passed away. The defendant was not liable of killing, as the cure was so peculiar and negligent that the injury was just the scene of the death, not the cause itself.

In those two cases mentioned above, the courts did not have to consider the effects of medical treatment which fell short of the standard of care that was excepted from competent and experienced practitioners.Although, the negligence in the treatment was the instant cause of the death. Whereby, the jury should not have favoured it as eliminating the accountability of the defendant and the contribution of his acts that were insignificant.

In conclusion, the explanation of substantial is left to the combined wisdom of the jury to agree upon. Furthermore, imprecise legal concepts will be interpreted by common sense of the citizen’s and not through the constricted lens of training and tradition of lawyers in general or in practice. The broad-brush approach includes the law, common sense and policies that takes everything included into consideration to further achieve justice in criminal law. Therefore, the outcome of this approach is positively required and desirable in the law.

Lawyer: Maram Al Lawati

Business Incubators

Regulations for creating business incubators (No.45/2022) were released by the public authority  for small & medium  enterprises development in February 2022. Minister of Trade, Industry, and Investment Promotion Qais bin Muhammad bin Musa Al-Yousef

To begin, applicants must be either an institution or a firm. A suitable location for a business incubator must be found. Except for virtual business incubators and accelerators, the business incubator should be congruent with its aims and suited for the purpose and activities for which it was founded. The application for a license must be filed on the supplied form to the Authority’s responsible department. The data and documentation indicated in the above-mentioned form must be sent with the application. The following facts and documents, in particular: A copy of the current commercial registration as well as an action plan are required.

Moreover, the license period is one year, it can be renewable for a similar period. The types of business incubators that have been licensed by the Authority are specified as the follow:

• Business incubators and accelerators
• Co-working space incubators
• Virtual business incubators and accelerators.

Business incubators main missions are

• Provide the appropriate environment for the beneficiary while carrying out their work
• Providing technical support for the start-up phase of small and medium enterprises
• Supporting innovation and development for the beneficiary
• Encouraging and supporting investment in the business incubator sector and small, medium-sized enterprises
• Providing appropriate technical support to transform investment, commercial and economic ideas, in the form of successful small and medium enterprises.
• Providing administrative, advisory, legal, accounting and marketing services. Periodic follow-up and assistance in preparing feasibility studies, work plans and services

On the other hand, Business incubators must adhere to the following licensing provisions: Not to use the business incubator headquarters or any part of it for purposes other than those designated for it. Submit an annual report to the Authority on its performance, achievements, and activities it has practiced. Based on the prior written consent of the authority, provided that this data is updated In the Authority’s database (30) thirty days from the date of the legal disposal. A change in its legal form, or any other legal action, only thereafter.

The authority, based on the provisions of this system, may take the following administrative penalties: Warning the business incubator to remove the causes of the violation. An administrative fine of (250) two hundred and fifty Omani riyals. Suspension of the license for a period not exceeding (30) thirty days, which can be extended for a similar period.

The license is canceled in the following cases: Failure to engage in business incubator activity for a period of (6) months from the date of obtaining the license without providing an excuse acceptable to the Authority. Repeating the same violation of the provisions of this system within a year. Evidence of obtaining a license for deception, fraud, forgery, or submission.

 

 

 

written by :

Maram Al Farsi
Wijdan

Personal data protection law

 

Introduction:

After perusal of the basic law of the state, the electronic transactions law issued by Royal Decree no. 69/2008, and Royal Decree no. 64/2020 establishing the electronic defense center and issuing its system, and after submission to the council of Oman, this law was issued to discuss the protection of personal data.

Definitions:

What is personal data?

It’s the data that makes a natural person identifiable, directly, or indirectly by one or more identifiers such as:

• Name
• Civil ID number
• Electronic identifier data
• Spatial data

Or by reference to one or more factors related to:

• Genetic identity
• Physical identity
• Mental identity
• psychological identity
• Social identity
• Cultural identity
• Economic identity

What is genetic data?

It’s the personal data that are genetically inherited or acquired characteristics that result from the analysis of a biological sample.

What is vital data?

It’s the Personal data that results from specific technical processing related to physical, psychological or behavioral characteristics such as facial image or genetic fingerprint data.

What is health data?  

It’s the personal data relating to physical, mental, and psychological health.

Processing: an operation or a set of operations performed on personal data that includes its collection, recording, analysis, organization, storage, modification, retrieval, review, coordination, merging, blocking, erasing, cancellation or disclosing it by sending, distributing, transmitting transferring, or made available by other means.

Who is the owner of the personal data?

A natural person who can be identified through his personal data.

The controller: is the person who determines the goals and means of processing personal data and performs this processing himself or entrusts it to others.

The processor: is the person who processes personal data on behalf of the controller.

The provisions of this law do not apply to the processing of personal data in the following cases:

1. Protecting national security or the public interest.
2. Execution by units of the state’s administrative apparatus or other public legal persons of the powers prescribed for them by law.
3. Execution of a legal obligation placed on the controller under any law, judgment or decisions of the court.
4. Protecting the economic and financial interests of the state.
5. Protecting of vital interest of the personal data owner.
6. Detection or prevention of any criminal offence based on an official written request from the investigation authorities.
7. Execution of a contract to which the owner of personal data is a party.
8. If the treatment is in a personal or family context.
9. The purposes of historical, statistical, scientific literary or economic research by the authorities authorized to carry out these works, provided that no indication or reference related to the owner of personal data is used in the research and statistical publication it publishes to ensure that the personal data in not attributed to an identified or identifiable natural person.
10. If the data is available to the public and in a manner that does not violate the provisions of this law.

What precautions the ministry can take to protect the personal data owners’ rights? 

1. Warn the controller or the processor of the violation of the provisions of this law.
2. The order to correct and erase personal data that has been processed in violations of the provisions of this law.
3. Temporarily or permanently stop processing personal data.
4. Stop transferring personal data to another country or international organization.
5. Any other measures that the ministry deems necessary to protect personal data, in the manner specified by the regulation.

the ministry’s employees who are designated by a decision issued by the competent authority in agreement with the ministry shall have the capacity of a judicial officer in implementing the provisions of this law and the regulations and decisions issued in implementation thereof.

What are the rights of the owner of the personal data?

• The data shall be processed within the framework of transparency, honesty, and respect for human dignity, and above all the explicit consent of the data owner in writing.
• Can revoke the consent to data processing, without prejudice to the processing that took place before the cancellation.
• Request to amend, update, and block the data.
• Obtain a copy of the processed data.
• Transfer data to another microcontroller.
• Request to erase the personal data, except in the case of national preservation and documentation.
• Be notified of any violation or breach of the data and the actions are taken in this regard.
• The data subject may file a complaint with the Ministry in case the processing does not agree with the law.

What are the obligations of the controller and processor?

• The controller determines what must be adhered to when processing, as follows:
• Determine potential risks.
• Data transfer procedures and controls.
• Technical and procedural measures and any other related controls.
• Before starting processing, the controller will provide the following information:
• The data of the controller and processor.
• Purpose of processing and sources of data collection.
• Description and procedure of treatment.
• Data owner rights.
• The processor and controller shall abide by the Ministry’s controls and procedures.
• The processor and controller are obligated to appoint an external auditor to ensure that the processing process meets the requirements of the regulation, with a copy of the report sent to the Ministry.
• The processor and controller keep the processing process documents according to the specified legal period.
• When a data breach occurs, the controller is obligated to inform the Ministry and the owner of personal data.
• The controller is obligated to designate the data protection official in accordance with the regulations’ controls.
• The controller is obligated to ensure the confidentiality of the data and not to publish it without the consent of the owner.
• The controller is obligated to obtain the written consent of the owner of personal data before sending any material for commercial purposes to the owner.
• The controller may transfer personal data outside the borders of the Sultanate of Oman without prejudice to the controls and laws. On the other hand, the controller is prohibited from transferring it if it was handled in violation of the prescribed provisions, or in a situation that would harm its owner.

What are the penalties?

• The penalties vary between (500 – 500,000 OR) depending on the type of violation. In addition to, confiscation of the tools used to commit the crime in some cases.

 

 

 

written by :

angel zadjali
Hoda Al Farsi