Medicinal products

In order to receive [points or discounts per position], the supplier must provide information regarding where (country or countries) the formulation of offered medicinal products from active pharmaceutical ingredients (APIs) takes place.

If the award criterion is met for one of more medicinal products, the supplier must, for the duration of the contract and without undue delay, inform the contracting authority of any changes regarding where (country or countries) the formulation of APIs into medicinal products for which the supplier has provided information takes place.

In order to receive [points or discounts per position], the supplier must provide information regarding where (country or countries) active pharmaceutical ingredients (APIs) are made for medicinal products that are offered.

If this award criterion is fulfilled, the supplier must, without delay during the contract period, notify of any changes with regard to where (country or countries) APIs are manufactured for the medicinal products for which the supplier has provided information.

In order to receive [points or discounts per position], the supplier must provide information regarding where (name and address(es) of production facility) the offered medicinal product(s) are formulated. If the offered medicinal product is manufactured in more than one location, all production facilities must be listed.

If this award criterion is fulfilled, the supplier must, without delay during the contract period, notify of any changes with regard to where (name(s) and address(es) of production facility) pharmaceutical formulation takes place for the medicinal products for which the supplier has provided information.

In order to receive [points or discounts per position], the supplier must provide information regarding where (name(s) and accompanying address(es) of production facility) active pharmaceutical ingredients (APIs) are manufactured for the medicinal products that are offered.

If this award criterion is met, the supplier must, without delay during the contract period, notify of any changes with regards to where (name(s) and address(es) of production facility) APIs are manufactured for the medicinal products for which the supplier has provided information.

In order to receive [points or discounts per position], the supplier must submit information in its tender for [state relevant positions/medicinal product that shows that environmental information has been obtained and is publicly available. Publicly available environmental information refers to information that is available on a free website without requiring membership, payment etc.

The environmental information must at least include details regarding persistence, bioaccumulation, toxicity and environmental risk. It must be compiled in accordance with the European Medicines Agency's (EMA's) latest guidelines¹ the most recently published FASS guidelines regarding environmental information for medicinal products,² or another equivalent publicly available model for environmental information.

If the award criterion is met for one or more of the medicinal products included in the tender, the winning supplier must keep environmental information for the medicinal products in question available according to this requirement for the entire duration of the agreement.

The award criterion does not apply to medicinal products that are covered by the European Medicines Agency's (EMA') guidelines.^{1, 2} Neither does the requirement apply to medicinal products that are exempted from environmental information requirements according to the same guidelines.

The winning supplier must, no later than the start of the agreement, make environmental information available for the medicinal products that are included in the agreement and that are covered by the European Medicines Agency's (EMA's) guidelines^{1, 2} for environmental risk assessments. 

At the request of the contracting authority, or in accordance with an implementation plan for the agreement or similar, the supplier must be able to refer to where environmental information for contracted medicinal products is available to the public. Publicly available environmental information refers to information that is available on a free website without any requirement for membership, payment etc.

The environmental information must at least include details regarding persistence, bioaccumulation, toxicity and environmental risk. It must be compiled in accordance with the EMA's latest guidelines,^{1, 2} the most recently published FASS guidelines regarding environmental information for medicinal products,² or another equivalent publicly available model for environmental information.

The special contract term does not cover medicinal products that are exempted from environmental information requirements according to the EMA's guidelines.^{1, 2} The winning supplier must ensure that environmental information is kept available for the entire term of the contract for these medicinal products. 

If the supplier deems that access to the information requested according to the special contract term is missing, the supplier must make reasonable efforts to compile or obtain access to the information. The supplier must be able to explain the efforts that have been made in this regard.

During the entire contract period, the supplier must implement procedures to reduce the risk of active pharmaceutical ingredients (APIs) being released into the environment during the manufacture of medicinal products that are included in the agreement. These procedures must be implemented when APIs are produced as well as when APIs are used in pharmaceutical formulation.  

At the start of the contract, the supplier must have: 

1. adopted a publicly available environmental policy approved by top level management that includes a commitment to reduce the risks of APIs being released into the environment during the manufacture of medicinal products included in the agreement;

2. appointed an individual at the management level who is responsible for ensuring compliance with the policy;

3. adopted procedures for forwarding the environmental policy in writing to any subcontractors it has a contractual relationship with, and for conveying the environmental policy to any subcontractors beyond the first step in the supply chain; 

4. adopted procedures for regularly identifying and prioritising the risks of APIs being released into the environment during the manufacture of medicinal products included in the agreement, including mapping the supply chain; 

5. adopted procedures for regularly monitoring compliance with the environmental policy; and

6. adopted procedures for taking measures without undue delay when deviations from the environmental policy are identified. 

The procedures must be documented and applied over the entire duration of the contract period in the supplier’s own operations as well as those of any subcontractors that contribute to fulfilling the contract.

The measures must be proportionate to the supplier’s operations and its ability to influence the supply chain. If the supplier considers that it lacks such influence, it must take appropriate measures in order to increase its influence. The supplier must be able to explain what measures have been taken with regards to its influence in the supply chain. 

 

Follow-up 

[The contracting authority] is entitled to check that the supplier fulfils its obligations under the special contract term. The follow-up may be carried out in different stages: self-assessment and audit. 

Upon the request of [the contracting authority] the supplier shall, [within eight (8) weeks/other time period specified by the contracting authority] of receiving the request, confirm compliance with the special contract term in writing. The confirmation can be submitted using the Self-assessment questionnaire—Environmental risk management annex. The supplier must provide the information requested in the form. 

The supplier must enable [the contracting authority] to perform audits—carried out by itself or through a representative—of the supplier and/or any subcontractors to ensure that the supplier fulfils its commitment. The supplier must provide the information and documentation needed for confirming that the commitment is followed. 

In case of non-compliance 

If the supplier does not participate in the follow-up or if there are deficiencies in the documentation that must be provided, corrections must be made within a reasonable time determined by [the contracting authority]. 

In case of non-compliance with the commitment, the supplier must rectify the situation in accordance with an action plan set by the supplier and approved by [the contracting authority]. The action plan must be prepared within the time frame decided by [the contracting authority], must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the specified time frame. 

1. The supplier's obligation 

Throughout the entire contract period, the supplier shall apply the contract terms under item 1-4. The contract shall be fulfilled in accordance with the following terms regarding workers’ rights:

• The eight core conventions of ILO regarding forced labour, child labour, discrimination, freedom of association, and the right to collective bargaining (no. 29, 87, 98, 100, 105, 111, 138, and 182).

The terms regarding workers’ rights are called “the Terms” hereafter.

In the event of the core conventions of the ILO are in conflict with national law, the supplier shall take reasonable measures to ensure compliancy with the international regulations.

The obligations concerns workers when they perform work within the frame of the contract.

The supplier shall, according to item 2, ensure that the Terms are fulfilled by hired subcontractors that directly contribute to the performance of the contract, regardless of the number of intermediaries. In addition, the supplier shall ensure that these subcontractors participate in the follow-up,
according to item 3.

The obligations concerns work carried out under such conditions where Swedish labour law is not applicable.

2. Policies and routines

To fulfil the obligations under item 1, the supplier shall take measures to prevent and manage any deviations from the Terms according to item 2.1-2.6 below. The measures shall be documented and applied throughout the entire contract period in their own operation and the operation of any subcontractors who directly contribute to the performance of the contract, regardless of the number of intermediaries.

At the start of the contract the supplier shall have:

2.1 adopted a commonly accessible policy, adopted by the highest management including a commitment to respect the Terms,

2.2. adopted routines to convey their commitment to respect the Terms in their own operation and in the supply chain,

2.3 appointed a manager at the highest management level, responsible for compliance with the Terms,

2.4 adopted routines to regularly carry out risk analyses, i.e. to identify and prioritise current and potential risks of deviation from the Terms, as well as mapping the supply chain with special regard to high risk operations,

2.5 adopted routines for regular follow-up of the Terms compliance, and

2.6 adopted routines to immediate action to prevent and limit deviations from the Terms, and to make amendments to identified deviations.

The measures shall be taken in accordance with the UN Guiding Principles on Business and Human Rights, or the equivalent.

3. Follow-up

[The contracting authority] has the right to follow-up that the supplier fulfils its obligations. The follow-up may be carried out in different steps; self-assessment and audit.

3.1 Self-assessment
Upon request from [the contracting authority] the supplier shall, [within six (6) weeks/other time period, specified by the contracting authority] from the receipt of the request, report compliance with the Terms in writing. The account can be submitted by form, according to appendix 1: self-assessment questionnaire. The supplier is expected to provide the information requested in the appendix.

3.2 Audit
The supplier shall enable [the contracting authority] to perform audits, on their own or through a representative, with the supplier and/or its subcontractors to ensure that the supplier fulfils the obligations according to item 1 and complies with the Terms. The supplier shall provide the information and documentation necessary in connection with the audit

4. Management of deficiencies

If the supplier does not participate in follow-up or if there are deficiencies in the documentation to be provided under item 3, a correction shall be made within the time determined by [the contracting authority].

In case of deficiencies in compliance to the Terms, the supplier shall amend this according to a schedule and action plan, developed by the supplier, and to be approved by [the contracting authority]. The schedule and action plan are to be developed within the time period decided by [the contracting authority] and must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the established schedule.

[The contracting authority] has the right to terminate the contract with immediate effect if the supplier do not make amendments within the established period or do not remedy deficiencies within the established
schedule.

[The contracting authority] has the right to terminate the contract with immediate effect in the case of severe deviations from the Terms.

1. The supplier’s obligation

Throughout the entire contract period, the supplier shall apply the contract terms under item 1-4. The contract shall be fulfilled in accordance with the following terms regarding human rights, workers’ rights, environmental protection, and anti-corruption (sustainable supply chains):

• the UN Universal Declaration on Human Rights,
• the UN Convention on the Rights of the Child, Article 32,
• the eight core conventions of the ILO regarding forced or compulsory labour, child labour, discrimination, as well as freedom of association and the right to collective bargaining, (no 29, 87, 98, 100, 105, 111, 138, and 182),
• the labour law in force in the country were the work is performed, including regulations for salary, working hours, leisure time, and work environment,
• the environmental law in force in the country were the work is performed, and
• the UN Convention against Corruption.

The terms regarding sustainable supply chains are called “the Terms”  hereafter.

When international regulations prescribe a stronger protection for the individual than the national legislation, the supplier shall take reasonable measures to ensure compliancy with the international regulations.

The obligations concerns all operations connected to the performance of the contract.

The supplier shall, according to item 2, ensure that the Terms are fulfilled by hired subcontractors in all parts of the supply chain. In addition, the supplier shall ensure that these subcontractors participate in the follow-up, according to item 3.

2. Policies and routines

To fulfil the obligations under item 1, the supplier shall take measures to prevent and manage any deviations from the Terms according to item 2.1-2.6 below. The measures shall be documented and applied concurrently throughout the entire contract period in their own operation as well as in the operation of any subcontractors in all parts of the supply chain.

At the start of the contract the supplier shall have:

2.1 adopted a commonly accessible policy, adopted by the highest management including a commitment to respect the Terms,

2.2. adopted routines to convey their commitment to respect the Terms in their own operation and in the supply chain,

2.3 appointed a manager at the highest management level, responsible for compliance with the Terms,

2.4 adopted routines to regularly carry out risk analyses, i.e. to identify and prioritise current and potential risks of deviation from the Terms, as well as mapping the supply chain with special regard to high risk operations,

2.5 adopted routines for regular follow-up of the Terms compliance, and

2.6 adopted routines to immediate action to prevent and limit deviations from the Terms, and to make amendments to identified deviations.

The measures shall be taken in accordance with the UN Guiding Principles on Business and Human Rights, or the equivalent.

3. Follow-up

[The contracting authority] has the right to follow-up that the supplier fulfils its obligations. The follow-up may be carried out in different steps; self-assessment and audit.

3.1 Self-assessment
Upon request from [the contracting authority] the supplier shall, [within six (6) weeks/other time period, specified by the contracting authority] from the receipt of the request, report compliance with the Terms in writing. The account can be submitted by form, according to appendix 1: self-assessment questionnaire. The supplier is expected to provide the information requested in the appendix.

3.2 Audit
The supplier shall enable [the contracting authority] to perform audits, on their own or through a representative, with the supplier and/or its subcontractors to ensure that the supplier fulfils the obligations according to item 1 and complies with the Terms. The supplier shall provide the information and documentation necessary in connection with the audit.

4. Management of deficiencies

If the supplier does not participate in follow-up or if there are deficiencies in the documentation to be provided under item 3, a correction shall be made within the time determined by [the contracting authority].

In case of deficiencies in compliance to the Terms, the supplier shall amend this according to a schedule and action plan, developed by the supplier, and to be approved by [the contracting authority]. The schedule and action plan are to be developed within the time period decided by [the contracting authority] and must be proportionate to the nature of the deficiencies and clearly describe how these are to be remedied within the established schedule.

[The contracting authority] has the right to terminate the contract with immediate effect if the supplier do not make amendments within the established period or do not remedy deficiencies within the established
schedule.

[The contracting authority] has the right to terminate the contract with  immediate effect in the case of severe deviations from the Terms.