Are there any restrictions on interactions between patients or patient organisations and industry (e.g., consultation, sponsorship)? If so, please describe those briefly.
With regard to consumers, any distribution of samples of medicinal products or vouchers for the free purchase of medicinal products is prohibited.
The collaboration between pharmaceutical companies and patient organisations is regulated under the Pharmig Code of Conduct. Accordingly, the patient organisations' right to self-determination is regarded as a fundamental principle, so that they must be independent of pharmaceutical companies. In addition, cooperation must take place on an ethical basis and must be transparent. The exclusive support of a patient organisation by a single pharmaceutical company is therefore inadmissible. Furthermore, a written agreement is required describing the purpose of the support. Finally, the patient organisations must give their consent for the donations to be published on the homepage of the supporting company.
Services provided by the patient organisation to the pharmaceutical company may be provided exclusively for training, research or health support purposes or may only be provided within the framework of a scientific or technical activity.
Belgian law does not contain provisions on relations with patient organisations. A patient organisation having a healthcare professional among its members should in any event be treated as a healthcare organisation to which article 10 AMP applies. Pharmaceutical companies should make sure that their public interaction with patient organisations within a certain therapeutic area does not qualify as an advertisement to the general public regarding their related drug products.
Chapter 6 of pharma.be’s Code of Deontology contains rules on relations with patient organisations. Pharmaceutical companies may (i) provide financial support to a patient organisation, (ii) call on patient organisations for the performance of certain services for the support of healthcare or research, or (iii) sponsor events organised by patient organisations if such support is covered by a written agreement.
There are basically no restrictions. The cooperation must be transparent and legally substantiated.
Pursuant the GHL, HLR and CGCPI it’s forbidden any kind of promotion of prescribed medicines geared towards the Patients Organisations (“PO”), any kind of materials intended to increase the sales or use of medicines should require an advertisement permit.
The industry in any case should provide medical or diagnose information for patients or PO (e.g. call centre).
The Consumer Healthcare Code applies to consumers and therefore can apply to patients. Under the Consumer Healthcare Code, a company shall not:
a) Be associated in any way with any prize competition, or other activity, which is intended to encourage the unnecessary use of a consumer healthcare medicine;
b) Promote or be in any way associated with any other schemes which are intended to encourage the sale of a consumer healthcare medicine if it is likely to introduce any hazard to the consumer or to lower the tone of the Industry;
c) Offer to refund money to dissatisfied users;
d) Offer or supply any samples of medicinal products to the general public.
Further the Pharmaceutical Industry Code allows companies to provide informational or educational material to healthcare professionals for the benefit of patients if the materials are: (i) inexpensive; (ii) directly relevant to the practice of medicine or pharmacy; and (iii) directly beneficial to patient care. Industry may provide healthcare professionals with items which are to be passed on to patients, which may bear the name of a medicine and/or information about medicines only if such detail is relevant to the appropriate use of the medicine by patients who have been prescribed that medicine. Items of medical utility aimed directly at the education of healthcare professionals and patient care may be provided if they are inexpensive and do not offset the routine business practice costs of the recipient.
Companies may not provide free samples of products directly to patients. If the provision of samples to patients relates to prescription only medicines this could be considered indirect advertising of a prescription only medicine.
Regarding the patients, although there is no specific legal provision prohibiting interactions between the industry and the same, the prohibitions and constrains mentioned in previous paragraph 9 concerning the advertising of over the counter medicines and of prescribed medicines are to be considered as restriction for such interactions. In addition, there is a legal prohibition to grant or promise to grant, directly or indirectly, to patients benefits: prizes, gifts, bonus or pecuniary or in-kind benefits by the industry.
In what concerns the interactions with patient organizations, sponsorship and consultation is permitted. Apifarma´s Code of Conduct governing the relations between Pharmaceutical Industry and Patient Organisations, contains several rules on such interactions, namely the following:
(a) The industry is required to conclude a written agreement with any patient organization when granting, directly or indirectly, any sponsorship or any pecuniary or in-kind benefit;
(b) Patient organizations may conclude services agreements with the industry concerning the support and investigation on health matters;
(c) The industry may contact the patient associations to participate in meetings though designated speakers, experts and/or consultants;
(d) The industry may support the hospitality costs of the representatives of patient organizations, which are limited to traveling, meals, lodging and register costs.
Under Sec. 7 HWG granting benefits ("Zuwendungen") is prohibited. This does not only concern monetary benefits, also benefits in form of goods and services.
In addition, granting/accepting benefits can also result in criminal liability under Sec. 299a, 299b of the German Criminal Code ("Strafgesetzbuch – StGB"), which penalizes bribery of healthcare professionals, i.e. the provision of benefits for gaining unfair advantage over competitors.
Yes. The PPPMD Guidelines recognize that prescription pharmaceutical product companies may give support to patient organizations, provided that the autonomy of such groups is upheld and support is not intended to influence them to favour any particular product. Patient organizations must also make a public disclosure of their funding sources.
Under the PHAP Code, when working with patient organizations, companies must ensure that the involvement of the company and the nature of the involvement are clear from the outset. No company may require that it be the sole funder of the patient organization or any of its programs. Companies that provide financial support or in-kind contribution must have in place, written documentation setting out the nature of support including the purpose of the activity and its funding. Companies may provide financial support for patient organization meetings provided that the primary purpose of the meeting is professional, educational, and scientific in nature, or otherwise supports the mission of the patient organization.
Yes, LER provides a framework for the interaction between patient organisations and pharmaceutical companies, divided into rules for: (i) consultations; and (ii) economic (and other) support. Below is a non-exhaustive list of restrictions and requirements in relation to such collaborations.
All collaboration shall take place in a responsible and meaningful manner, and in such a manner that the parties' independence from one another is not jeopardised or questioned from legal and/or ethical standpoints. This means inter alia that the chosen collaborative projects may not comprise an overwhelming share of the patient organisation's activity and/or economy. All collaborations must be regulated in written contracts and must clearly state, e.g., the scope and purpose of the project and each party's rights and obligations. Such contracts must always be readily available for a third party and a shortened version of the documents must be available in the database on collaborations administered by LIF (Sw. LIFs Samarbetsdatabaser) for the duration of the project and for at least a month after the project has been concluded.
For economical (and other) support, further rules apply, e.g.:
- support may only be provided for specific projects and may not be used to finance the ordinary work of the patient organisation, or any other work which would give rise to a situation of dependency for the organisation;
- if the collaboration relates to the financing of events, meetings or gatherings, the invitation should be sent to the organisation's operations manager, who then decides if and who should be in attendance; and
- no independent social activities may be provided by the pharmaceutical company.
For consultations, further rules apply, e.g.:
- the number of consultants should not be higher than what is necessary for the project;
- there must be a legitimate need for the assignment;
- the consultation may not be part of an incentive to choose a specific medicinal product; and
- monetary compensation must be reasonable in comparison to the work being provided.
There is no specific rule regarding this issue in the law. However, if such interaction is considered as advertising, it will not be permitted unless it is included in the restrictive permitted types of advertising to the general public (Art. 15 OAM). For instance, in case of a website offering patients to download general information tools on various symptoms in order to facilitate the diagnosis by the doctor, the tools cannot contain any reference to prescription medicines and must comply with the advertising rules for over-the-counter medicines (Swissmedic Journal 08/2006 p. 806).
The Pharma Cooperation Code provides some rules regarding the cooperation between pharmaceutical companies and patient organisations at its Article 3. For instance:
- pharmaceutical companies may neither require patient organisations to promote certain specific prescription medicines nor may they consider corresponding requests made by patient organisations;
- the aims, scope and agreement on any support and partnerships must be evidenced in writing and transparent;
- where pharmaceutical companies grant financial or other support on a significant scale to a patient organisation, they must agree such support in writing with the patient organisation before it begins and include relevant details;
- pharmaceutical companies must not try to influence the content of documents of patient organisations to which they are granting financial or other support in their own commercial interest;
- if the pharmaceutical company wishes to use logos or legally protected documents of patient organisations for publications, it must obtain the written permission of the organisation concerned;
- in case of benefits in favour of patients’ organisations, the pharmaceutical companies shall disclose the pecuniary benefits granted, on an individual basis and annually for a full calendar year (accessible to the public for at least three years);
- contracts between pharmaceutical companies and patient organisations, in virtue of which the latter provide consultancy tasks or services of any kind for the pharmaceutical company, are permitted only if such consultancy tasks or services are provided to support healthcare or research and at certain conditions;
- pharmaceutical companies may ask representatives of patient organisations to act as experts for consultancy or services, for instance to attend meetings of consultancy bodies or to provide speaker services;
- events and hospitality are to be held on premises, which are appropriate and conducive to the main purpose of the event.
There are no specific legal restrictions on interactions between patients or patient organizations and industry.
The Blue Guide states, in Chapter 5 (Advertising to the Public), that "sponsorship linked to a brand of medicine would be acceptable in principle for products classified as over-the-counter". It goes on to clarify that where any manufacturers or pharmaceutical companies sponsor a medicine, the advertisement "should not include any promotion of prescription-only medicines".
Clause 27 of the ABPI Code governs relationships with patient organisations. Clause 27.1 states that "[p]harmaceutical companies can interact with patient organisations or any user organisation such as disability organisations, carer or relative organisations and consumer organisations to support their work, including assistance in the provision of appropriate information to the public, patients and carers. Companies must respect the independence of patient organisations." This clause contains many rules for the interaction between patient organisations and the industry. However, in the interest of brevity, only two of the more prominent sub-clauses are included below:
"27.3: Companies working with patient organisations must have in place a written agreement setting out exactly what has been agreed, including funding, in relation to every significant activity or ongoing relationship.
27.8: Contracts between companies and patient organisations under which they provide any type of services to companies are only allowed if such services are provided for the purpose of supporting healthcare or research."
In general, Clause 27 is designed to ensure maximum transparency of any industry involvement with patient organisations, thereby trying to limit the influence that it may have upon any such organisations.
The PAGB Consumer Code states that corporate sponsorship may include the umbrella name of the brand so long as no claims are made alongside the name. The PAGB Consumer Code goes on to state that sponsorship of television programmes, events and certain educational materials is also possible although it would need to abide by the Code's other rules.
The Venezuelan law does not have a provision regulating interactions between patients or patient organisations and pharma industry. However, if meetings and funding of patients support groups are not with promotional or advertising content and without making express mention of a certain medicine, and it is in benefit of the population, there would not be reason for which it cannot be conducted.
Pharmaceutical Research and Manufacturers of America (“PhRMA”) is a trade group that represents pharmaceutical companies in the United States. On November 20, 2014, PhRMA released guidelines entitled PhRMA Principles on Interactions with Patient Organizations (https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/phrma_principles_paper_20120919_final.pdf). These guidelines provide a brief overview of the suggested nature of the relationship that pharmaceutical companies should have with patients and patient organizations. Specifically, PhRMA states that “[n]o company should require that it be the sole funder of the patient organization or any of its programs,” “[c]ompanies that provide financial support or in-kind contributions to patient organizations should have in place written documentation setting out the nature of support, including the purpose of any activity and its funding,” and that “[c]ompanies may provide financial support for patient organization meetings or other activities provided that the primary purpose of the activity is professional, educational, or scientific in nature, or otherwise supports the mission of the patient organization.”
Pharmaceutical companies should also be aware of the federal anti-kickback laws. The federal anti-kickback statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. The Office of the Inspector General (“OIG”) has issued several advisory opinions discussing whether or not the anti-kickback statute applies to pharmaceutical companies providing support to patient organizations. For example, in OIG Advisory Opinion No. 19-02, issued on January 24, 2019, a pharmaceutical company sought an advisory opinion regarding its proposal to “loan, on a temporary basis, a limited-functionality smartphone to financially needy patients who do not have the technology necessary to receive adherence data from a sensor embedded in prescribed antipsychotic medication.” The OIG stated that although the proposed arrangement could “potentially generate prohibited remuneration under the anti-kickback statute,” that it would not impose sanctions in connection with the proposed arrangement. Further, in OIG Advisory Opinion No. 07-04, issued on March 30, 2007, a pharmaceutical company sought an advisory opinion regarding its “patient assistance programs” which would “provide free outpatient prescription drugs to financially-needy Medicare Part D enrollees entirely outside of the Part D benefit.” The OIG concluded that the proposed arrangement could “potentially generate prohibited remuneration under the anti-kickback statute, if the required intent to induce or reward referrals of Federal health care program business were present,” but that it “would not impose administrative sanctions.” Companies looking to interact with patients and patient organizations should keep abreast of any relevant OIG advisory opinions, and may choose to seek their own advisory opinion before engaging in certain interactions.
The TG Advertising Code places restrictions on the use of endorsements by patients or patient organisations in advertising. Subject to limited exceptions, advertising cannot expressly or implicitly contain an endorsement from a patient organisation unless it specifies the organisation, the nature of the endorsement and any valuable consideration given for the endorsement. Similarly patient testimonials can only be used under limited circumstances. A person providing a testimonial must be a verified patient, who has used the medicine for its intended purpose, prior to the advertising and must depict results which are typical for normal use of the product. The advertisement must also disclose if the patient has received payment for the testimonial, if an actor is taking the place of the patient and if the patient is an immediate family member of someone involved in the supply of the product.
The industry codes of conduct provide general guidelines for interaction with and sponsorship of patient groups. Interactions must be consistent with enhancing the quality use of medicines, transparent and able to withstand public scrutiny. Support for patient groups must be appropriately declared and companies must not request to be the sole sponsor of a patient group. A sponsor must not seek to influence the content of patient organisation material and must not make use of the organisation's logo without obtaining express permission. Further guidelines for relationships with consumer organisations are provided by Medicines Australia.
Medicines Australia also requires members to report annually the names of any sponsored organisations and the nature and value of the support.
 - Therapeutic Goods Advertising Code (No. 2) 2018, s 16(3).
 - Ibid, s 17.
 - Ibid.
 - Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 6.1; Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 14.
 - Consumer Healthcare Products Industry, Australia Self-Medication Industry Code of Practice, November 2016, s 6.5; Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 14.1.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 14.2-14.3.
 - Medicines Australia, Working Together – A Guide to relationships between Health Consumer Organisations and Pharmaceutical Companies, 2008, Medicines Australia Working Together Guide,https://medicinesaustralia.com.au/community/working-together-guide.
 - Medicines Australia, Medicines Australia Code of Conduct, 18th ed. June 2015, s 41.1.